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AzTrials

Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)Phase 3SINUS-24NCT02912468

A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps

A Phase 3 study testing Dupilumab SAR231893 (REGN668) and Mometasone furoate 50 micrograms in people with Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP), run by Sanofi at 76 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyposis (NP). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dupilumab SAR231893 (REGN668) and Mometasone furoate 50 micrograms
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
76 sitesin 13 countries
Study dates
5 Dec 2016to 5 Jul 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or had a medical contraindication / intolerance to SCS; and/or had prior surgery for NP at the screening visit, had:
  • An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).
  • Ongoing symptoms (for at least 8 weeks prior to Visit [V] 1) of nasal congestion/blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at the time of randomization (V2), and another symptom such as loss of smell, rhinorrhea (anterior/posterior).
  • Signed written informed consent.

Who cannot join

  • Participants <18 years of age.
  • Participants who were previously treated in dupilumab studies.
  • Participants who had taken:
  • Biologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) within 2 months before V1 or 5 half-lives, whichever was longer.
  • Any experimental monoclonal antibody (mAB) within 5 half-lives or within 6 months before V1 if the half-life was unknown.
  • Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days prior to V1.
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  • Participants who received leukotriene antagonists/modifiers at V1 unless they were on a continuous treatment for at least 30 days prior to V1.
  • Initiated allergen immunotherapy within 3 months prior to V1 or planned to begin therapy or changed its dose during the run-in period or the randomized treatment period.
  • Participants who undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to V1.
  • Participants who had a sinonasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS.
  • Participants with conditions/concomitant diseases making them nonevaluable at V1 or for the primary efficacy endpoint such as:
  • Antrochoanal polyps;
  • Nasal septal deviation that would occlude at least one nostril;
  • Acute sinusitis, nasal infection or upper respiratory infection;
  • Ongoing rhinitis medicamentosa;
  • Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis;
  • Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis.
  • Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil, etc).
  • Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal).
  • Participants who received concomitant treatment prohibited in the study.
  • Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
  • History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
  • Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit.
  • Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit.
  • Known or suspected history of immunosuppression.
  • Pregnant or breastfeeding women, or women planned to become pregnant or breastfeed during the study.
  • Women unwilling to use adequate birth control, if of reproductive potential and sexually active.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

76 sites in 13 countries.

76 sites in 13 countries

United States18 sites

  • Investigational Site Number 8400007

    Boston, Massachusetts, 02115

  • Investigational Site Number 8400016

    Centennial, Colorado, 80112

  • Investigational Site Number 8400018

    Charleston, South Carolina, 29425

  • Investigational Site Number 8400001

    Dallas, Texas, 75231

  • Investigational Site Number 8400009

    Long Beach, California, 90720

  • Investigational Site Number 8400020

    Medford, Oregon, 97504

  • Investigational Site Number 8400010

    Milwaukee, Wisconsin, 53226

  • Investigational Site Number 8400003

    Nashville, Tennessee, 37232-8695

  • Investigational Site Number 8400015

    Norfolk, Virginia, 23507

  • Investigational Site Number 8400004

    Orange, California, 92868

  • Investigational Site Number 8400005

    Rochester, Minnesota, 55905

  • Investigational Site Number 8400014

    San Diego, California, 92123

  • Investigational Site Number 8400021

    St Louis, Missouri, 63141

  • Investigational Site Number 8400002

    Stockton, California, 95207

  • Investigational Site Number 8400013

    Tampa, Florida, 33613

  • Investigational Site Number 8400019

    Tulsa, Oklahoma, 74136

  • Investigational Site Number 8400022

    West Des Moines, Iowa, 50265

  • Investigational Site Number 8400008

    Winston-Salem, North Carolina, 27103

Other trials in United States

France7 sites

  • Investigational Site Number 2500005

    La Roche-sur-Yon, 85925

  • Investigational Site Number 2500007

    Lille, 59000

  • Investigational Site Number 2500003

    Lyon, 69317

  • Investigational Site Number 2500001

    Montpellier, 34000

  • Investigational Site Number 2500006

    Nantes, 44035

  • Investigational Site Number 2500002

    Toulouse, 31059

  • Investigational Site Number 2500004

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Hungary7 sites

  • Investigational Site Number 3480006

    Budapest, 1062

  • Investigational Site Number 3480007

    Budapest, 1083

  • Investigational Site Number 3480004

    Budapest, 1115

  • Investigational Site Number 3480003

    Budapest, 1125

  • Investigational Site Number 3480005

    Debrecen, 4032

  • Investigational Site Number 3480002

    Pécs, 7621

  • Investigational Site Number 3480001

    Szeged, 6725

Other trials in Hungary

Italy7 sites

  • Investigational Site Number 3800007

    Bologna, 40139

  • Investigational Site Number 3800002

    Catania, 95123

  • Investigational Site Number 3800004

    Milan, 20132

  • Investigational Site Number 3800006

    Milan, 20142

  • Investigational Site Number 3800001

    Pisa, 56124

  • Investigational Site Number 3800005

    Rozzano, 20089

  • Investigational Site Number 3800003

    Varese, 21100

Other trials in Italy

Romania6 sites

  • Investigational Site Number 6420007

    Brasov, 500283

  • Investigational Site Number 6420013

    Brasov, 500283

  • Investigational Site Number 6420003

    Bucharest, 011172

  • Investigational Site Number 6420009

    Cluj-Napoca, 400015

  • Investigational Site Number 6420008

    Craiova, 200642

  • Investigational Site Number 6420010

    Târgu Mureş, 540098

Other trials in Romania

Russia6 sites

  • Investigational Site Number 6430004

    Moscow, 119435

  • Investigational Site Number 6430003

    Moscow, 129090

  • Investigational Site Number 6430002

    Saint Petersburg, 190013

  • Investigational Site Number 6430001

    Saint Petersburg, 195030

  • Investigational Site Number 6430007

    Saint Petersburg, 197022

  • Investigational Site Number 6430006

    Yaroslavl, 150003

Other trials in Russia

Ukraine6 sites

  • Investigational Site Number 8040002

    Ivano-Frankivsk, 76000

  • Investigational Site Number 8040004

    Kharkiv, 61166

  • Investigational Site Number 8040005

    Kyiv, 01133

  • Investigational Site Number 8040006

    Kyiv, 03680

  • Investigational Site Number 8040001

    Poltava, 36011

  • Investigational Site Number 8040008

    Ternopil, 46000

Other trials in Ukraine

United Kingdom6 sites

  • Investigational Site Number 8260001

    Bradford, BD9 6RJ

  • Investigational Site Number 8260002

    Dundee, DD1 9SY

  • Investigational Site Number 8260007

    Great Yarmouth, NR31 6LA

  • Investigational Site Number 8260006

    London, SE1 7EH

  • Investigational Site Number 8260004

    Stockport, SK2 7JE

  • Investigational Site Number 8260005

    Wigan, WN1 2NN

Other trials in United Kingdom

Bulgaria3 sites

  • Investigational Site Number 1000003

    Plovdiv, 4002

  • Investigational Site Number 1000002

    Sofia, 1527

  • Investigational Site Number 1000001

    Sofia, 1606

Other trials in Bulgaria

Czechia3 sites

  • Investigational Site Number 2030001

    Hradec Králové, 50005

  • Investigational Site Number 2030002

    Pardubice, 53203

  • Investigational Site Number 2030004

    Prague, 12808

Other trials in Czechia

Germany3 sites

  • Investigational Site Number 2760001

    Berlin, 13353

  • Investigational Site Number 2760003

    München, 81377

  • Investigational Site Number 2760002

    Münster, 48149

Other trials in Germany

Poland3 sites

  • Investigational Site Number 6160002

    Katowice, 40-611

  • Investigational Site Number 6160001

    Lodz, 90-153

  • Investigational Site Number 6160003

    Warsaw, 04-141

Other trials in Poland

Netherlands1 site

  • Investigational Site Number 5280001

    Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

Official title: A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

Primary Objective:

To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in computed tomography (CT) scan opacification of the sinuses was a coprimary objective.

Read more

Secondary Objectives:

  • To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).
  • To evaluate the efficacy of dupilumab in improving sense of smell.
  • To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japan).
  • To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery.
  • To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22).
  • To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated respiratory disease [ERD]).
  • To evaluate residual effect in follow up.
  • To evaluate the safety of dupilumab in participants with bilateral NP.
  • To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment-emergent anti-drug antibodies.
Read the detailed description

The total study duration per participant was expected to be up to 52 weeks that consisted of a 4-weeks run-in period, 24-weeks treatment period, and a 24-weeks post treatment period.

Being tested
Dupilumab SAR231893 (REGN668), Placebo, Mometasone furoate 50 micrograms
Keywords
Nasal polyposis, Chronic rhinosinusitis, Intranasal corticosteroids, Dupilumab, Human monoclonal antibody
Medical subject headings
Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dupilumab SAR231893 (REGN668)Drug

    Pharmaceutical form: Solution

    Route of administration: Subcutaneous

  • PlaceboDrug

    Pharmaceutical form: Solution

    Route of administration: Subcutaneous

  • Mometasone furoate 50 microgramsDrug

    Also called NASONEX®

    Pharmaceutical form: Suspension (Nasal spray)

    Route of administration: Intranasal

Study groups in NCT02912468
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo (for dupilumab), 1 subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal mometasone furoate nasal spray (MFNS) at stable dose.
Receives: Drug: Placebo; Drug: Mometasone furoate 50 micrograms
Dupilumab 300 mgExperimentalDupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose.
Receives: Drug: Dupilumab SAR231893 (REGN668); Drug: Mometasone furoate 50 micrograms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score

    NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model described in Statistical Analysis Overview.

    Measured: Baseline, Week 24

  2. Change From Baseline at Week 24 in Nasal Polyp Score

    NPS: sum of right, left nostril scores, evaluated by nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller-sized polyps. Total NPS: sum of right and left nostril scores; ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.

    Measured: Baseline, Week 24

Secondary outcomes (35)

  1. Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund-Mackay (LMK) Score

    The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. NOTE: For Japan regulatory submission only, this endpoint is not included as a secondary outcome measure and is instead one of the co-primary outcome measures.

    Measured: Baseline, Week 24

  2. Change From Baseline at Week 24 in Total Symptom Score (TSS)

    The TSS was the sum of participant-assessed nasal symptom scores for nasal congestion/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranged from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.

    Measured: Baseline, Week 24

  3. Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score

    The UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.

    Measured: Baseline, Week 24

  4. Change From Baseline at Week 24 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily

    The severity of decreased/loss of sense of smell was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.

    Measured: Baseline, Week 24

  5. Change From Baseline at Week 24 in 22-item Sino-nasal Outcome Test (SNOT-22) Scores

    The SNOT-22 is a validated questionnaire that was used to assess the impact of chronic rhinosinusitis phenotype with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.

    Measured: Baseline, Week 24

  6. Rescue Treatment Use: Estimate of Percentage of Participants With >=1 Event by Week 24 Obtained Using Kaplan-Meier Method

    Rescue treatment was defined as usage of systemic corticosteroids (SCS) or NP surgery (actual or planned) during the treatment period. Rescue treatment included:

    • SCS: Betamethasone, dexamethasone, dexamethasone sodium phosphate, Hydrocortisone sodium succinate, methylprednisolone, prednisolone, prednisolone metasulfobenzoate sodium, prednisone, and triamcinolone.
    • Sino-nasal surgery for nasal polyps when there was worsening of signs and/or symptoms during the study.

    Estimate of percentage of participants with event by Week 24 was obtained using Kaplan-Meier method.

    Measured: Baseline up to Week 24

  7. Change From Baseline at Week 24 in Visual Analogue Scale (VAS) for Rhinosinusitis

    The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters (cm) VAS the answer to the question, "How troublesome are your symptoms of your rhinosinusitis?" The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 24

  8. Change From Baseline at Week 24 in Nasal Peak Inspiratory Flow (NPIF)

    NPIF evaluation represented a physiologic measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute. Higher NPIF values are indicative of better nasal air flow. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 24

  9. Change From Baseline at Week 24 in Rhinorrhea Daily Symptom Score

    Rhinorrhea was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), where higher scores indicated more severe symptoms. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 24

  10. Change From Baseline at Week 24 in Forced Expiratory Volume in 1 Second (FEV1) for Participants With Asthma

    FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 24

  11. Change From Baseline at Week 24 in Asthma Control Questionnaire-6 (ACQ-6) Scores for Participants With Asthma

    ACQ-6 had 6 questions which assessed the most common asthma symptoms (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, puffs/inhalations use). Participants were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale ranged from 0 = no impairment to 6 = maximum impairment. The ACQ-6 score was the mean of the scores of all 6 questions and therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), with higher scores indicated lower asthma control. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, prior surgery, and regions as covariates.

    Measured: Baseline, Week 24

  12. Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Nasal Congestion Symptom Severity Score (Assessments Performed 4-24 Weeks After End of Treatment)

    NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 (Post-baseline assessments performed 4-24 weeks after end of treatment)

  13. Change From Baseline at Weeks 36 and 48 in Nasal Polyp Score (Assessments Performed 12 and 24 Weeks After End of Treatment)

    NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model.

    Measured: Baseline, Week 36, Week 48 (post-baseline assessments performed 12 and 24 weeks after end of treatment)

  14. Change From Baseline at Week 48 in Opacification of Sinuses Measured by Lund-Mackay Score (Assessment Performed 24 Weeks After End of Treatment)

    The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 48 (Post-baseline assessment performed 24 weeks after end of treatment)

  15. Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Total Symptom Score (Assessments Performed 4-24 Weeks After End of Treatment)

    The TSS was the sum of participant-assessed nasal symptom scores for NC/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranged from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated more severe symptoms. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 (Post-baseline assessments performed 4-24 weeks after end of treatment)

  16. Change From Baseline at Week 48 in University of Pennsylvania Smell Identification Test (Assessment Performed 24 Weeks After End of Treatment)

    The UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 48 (Post-baseline assessment performed 24 weeks after end of treatment)

  17. Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily (Assessments Performed 4-24 Weeks After End of Treatment)

    The severity of decreased/loss of sense of smell was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), higher score indicated more severe symptoms. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 (Post-baseline assessments performed 4-24 weeks after end of treatment)

  18. Change From Baseline at Weeks 36 and 48 in 22-item Sino-nasal Outcome Test Scores (Assessments Performed 12 and 24 Weeks After End of Treatment)

    The SNOT-22 is a validated questionnaire that was used to assess the impact of CRSwNP on HRQoL. It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 36 and Week 48 (Post-baseline assessments performed 12 and 24 weeks after end of treatment)

  19. Rescue Treatment Use: Estimate of Percentage of Participants With >=1 Event by Week 48 Obtained Using Kaplan-Meier Method

    Rescue treatment was defined as usage of SCS or NP surgery (actual or planned) during the study. Rescue treatment included:

    • SCS: Betamethasone, dexamethasone, dexamethasone sodium phosphate, Hydrocortisone sodium succinate, methylprednisolone, prednisolone, prednisolone metasulfobenzoate sodium, prednisone, and triamcinolone.
    • Sino-nasal surgery for nasal polyps when there was worsening of signs and/or symptoms during the study.

    Estimate of percentage of participants with event by Week 48 was obtained using Kaplan-Meier method.

    Measured: Baseline up to Week 48

  20. Change From Baseline at Weeks 36 and 48 in Visual Analog Scale for Rhinosinusitis (Assessments Performed 12 and 24 Weeks After End of Treatment)

    The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 cm VAS the answer to the question, "How troublesome are your symptoms of your rhinosinusitis?" The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 36 and Week 48 (Post-baseline assessments performed 12 and 24 weeks after end of treatment)

  21. Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Rhinorrhea Daily Symptom Score (Assessments Performed 4-24 Weeks After End of Treatment)

    Rhinorrhea was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), where higher scores indicated more severe symptoms. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 (Post-baseline assessments performed 4-24 weeks after end of treatment)

  22. Change From Baseline at Week 48 in Forced Expiratory Volume in 1 Second for Participants With Asthma (Assessment Performed 24 Weeks After End of Treatment)

    FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 48 (Post-baseline assessment performed 24 weeks after end of treatment)

  23. Change From Baseline at Week 48 in Asthma Control Questionnaire-6 Scores for Participants With Asthma (Assessment Performed 24 Weeks After End of Treatment)

    ACQ-6 had 6 questions which assessed the most common asthma symptoms (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, puffs/inhalations use). Participants were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale ranged from 0 = no impairment to 6 = maximum impairment. The ACQ-6 score was the mean of the scores of all 6 questions and therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), with higher scores indicated lower asthma control. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, prior surgery, and regions as covariates.

    Measured: Baseline, Week 48 (Post-baseline assessment performed 24 weeks after end of treatment)

  24. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation

    An Adverse Event (AE) was defined as any untoward medical occurrence that did not necessarily have to have a causal relationship with the study treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during TEAE period which was defined as the period from the time of first dose of study drug until 98 days following the last administration of study drug. Serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.

    Measured: Baseline up to 98 days following the last administration of study drug (up to 36 weeks)

  25. Functional Dupilumab Concentration in Serum

    Measured: Baseline, Week 4, 8, 16, 24, 36, End of study (Week 48)

  26. Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies (ADA) Response

    ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as a positive response in the ADA assay post first dose, when baseline results are negative or missing. 2) Treatment boosted was defined as: An ADA positive response in the assay post first dose that is greater-than or equal to 4-fold over baseline titer levels, when baseline results are positive.

    Measured: Baseline to End of study (Week 48)

  27. Mean Total Systemic Corticosteroids Rescue Dose Prescribed During Treatment Period

    SCS included: Betamethasone, dexamethasone, dexamethasone sodium phosphate, hydrocortisone sodium succinate, methylprednisolone, prednisolone, prednisolone metasulfobenzoate sodium, prednisone, and triamcinolone. For every participant, total dose was calculated as (prescribed total daily dose*duration of SCS use). Then, mean of the total dose of 25 participants (placebo group) and 9 participants (Dupilumab group) was derived.

    Measured: Baseline to Week 24

  28. Total Systemic Corticosteroids Rescue Intake Duration: Average Duration Per Participant

    Rescue treatment was defined as usage of SCS or NP surgery (actual or planned) during the treatment period. SCS rescue intake duration was defined as the duration (in days) from start of SCS rescue medication till the end of SCS rescue treatment.

    Measured: Baseline to Week 24

  29. Change From Baseline at Week 24 in European Quality of Life 5 Dimension (EQ-5D) Visual Analog Scale Score

    The EQ-5D was a standardized HRQoL questionnaire consisting of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ-VAS recorded the participant's self-rated health on a vertical VAS that allowed them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).

    Measured: Baseline, Week 24

  30. Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score: Subgroup of Participants With Asthma

    NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 24

  31. Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery

    NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates.

    Measured: Baseline, Week 24

  32. Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Asthma

    NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model.

    Measured: Baseline, Week 24

  33. Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery

    NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model.

    Measured: Baseline, Week 24

  34. Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma

    The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates.

    Measured: Baseline, Week 24

  35. Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery

    The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates.

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2016 (estimated)
  2. Study start5 Dec 2016
  3. Primary completion5 Jul 2018
  4. Study completion5 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02912468
Sponsor's protocol ID
EFC14146
Other IDs
2015-003101-42, U1111-1178-5390, 2015
Acronym
SINUS-24
Status last verified
Jul 2019
First submitted
21 Sep 2016
Last updated
25 Jul 2019
Data monitoring committee
Yes
Individual data sharing
No: Not yet available

Publications

  • Lane AP, Mullol J, Hopkins C, Fokkens WJ, Lee SE, Msihid J, Nash S, Sacks H, Borsos K, Kamat S, Rowe PJ, Deniz Y, Jacob-Nara JA. Dupilumab improves sense of smell and clinical outcomes in patients with severe chronic rhinosinusitis with nasal polyps with anosmia. Curr Med Res Opin. 2025 Jan;41(1):53-59. doi: 10.1080/03007995.2024.2434083. Epub 2024 Dec 14.

    PubMed 39618256

  • Bachert C, Khan AH, Hopkins C, Han JK, Fokkens WJ, Mannent LP, Msihid J, Borsos K, Kamat S, Nash S, Sacks H, Rowe PJ, Deniz Y, Jacob-Nara JA. Mild and symptom-free months in patients with chronic rhinosinusitis with nasal polyps treated with dupilumab. Ann Allergy Asthma Immunol. 2025 Jan;134(1):61-69.e12. doi: 10.1016/j.anai.2024.09.015. Epub 2024 Sep 28.

    PubMed 39343385

  • Hopkins C, Mullol J, Khan AH, Lee SE, Wagenmann M, Hellings P, Fokkens W, Msihid J, Nair R, Kamat S, Nash S, Radwan A, Jacob-Nara JA, Deniz Y, Rowe PJ. Impact of Dupilumab on Sinonasal Symptoms and Outcomes in Severe Chronic Rhinosinusitis With Nasal Polyps. Otolaryngol Head Neck Surg. 2024 Apr;170(4):1173-1182. doi: 10.1002/ohn.627. Epub 2023 Dec 29.

    PubMed 38156522

  • Bachert C, Khan AH, Lee SE, Hopkins C, Peters AT, Fokkens W, Praestgaard A, Radwan A, Nash S, Jacob-Nara JA, Deniz Y, Rowe PJ. Prevalence of type 2 inflammatory signatures and efficacy of dupilumab in patients with chronic rhinosinusitis with nasal polyps from two phase 3 clinical trials: SINUS-24 and SINUS-52. Int Forum Allergy Rhinol. 2024 Mar;14(3):668-678. doi: 10.1002/alr.23249. Epub 2023 Aug 22.

    PubMed 37548085

  • Maspero JF, Bachert C, Martinez FJ, Hanania NA, Ortiz B, Patel N, Mannent LP, Praestgaard A, Pandit-Abid N, Siddiqui S, Hardin M. Clinical Efficacy among Patients with Chronic Rhinosinusitis with Nasal Polyps and Clinical Features of Obstructive Lung Disease: Post Hoc Analysis of the Phase III SINUS-24 and SINUS-52 Studies. J Asthma Allergy. 2023 Mar 31;16:333-342. doi: 10.2147/JAA.S357393. eCollection 2023.

    PubMed 37026112

  • Peters AT, Soler ZM, Kern RC, Heffler E, Maspero JF, Crampette L, Fujieda S, Lane AP, Zhang H, Nash S, Khan AH, Siddiqui S, Jacob-Nara JA, Rowe P, Deniz Y. Improvement in patient-reported "taste" and association with smell in dupilumab-treated patients with severe chronic rhinosinusitis with nasal polyps from the SINUS-24 and SINUS-52 trials. Clin Exp Allergy. 2022 Sep;52(9):1105-1109. doi: 10.1111/cea.14194. Epub 2022 Jul 12. No abstract available.

    PubMed 35775319

  • Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

    PubMed 35636689

  • Bachert C, Peters AT, Heffler E, Han JK, Olze H, Pfaar O, Chuang CC, Rout R, Attre R, Goga L, Jacob-Nara JA, Rowe PJ, Deniz Y, Chen Z, Kamat S, Siddiqui S. Responder analysis to demonstrate the effect of targeting type 2 inflammatory mechanisms with dupilumab across objective and patient-reported endpoints for patients with severe chronic rhinosinusitis with nasal polyps in the SINUS-24 and SINUS-52 studies. Clin Exp Allergy. 2022 Feb;52(2):244-249. doi: 10.1111/cea.14051. No abstract available.

    PubMed 35092110

  • Lee SE, Hopkins C, Mullol J, Msihid J, Guillemin I, Amin N, Mannent LP, Li Y, Siddiqui S, Chuang CC, Kamat S, Khan AH. Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies. Allergy. 2022 Jul;77(7):2211-2221. doi: 10.1111/all.15222. Epub 2022 Feb 1.

    PubMed 35034364

  • Bachert C, Corren J, Lee SE, Zhang H, Harel S, Cunoosamy D, Khan AH, Jacob-Nara JA, Siddiqui S, Nash S, Rowe PJ, Deniz Y. Dupilumab efficacy and biomarkers in chronic rhinosinusitis with nasal polyps: Association between dupilumab treatment effect on nasal polyp score and biomarkers of type 2 inflammation in patients with chronic rhinosinusitis with nasal polyps in the phase 3 SINUS-24 and SINUS-52 trials. Int Forum Allergy Rhinol. 2022 Sep;12(9):1191-1195. doi: 10.1002/alr.22964. Epub 2022 Jan 31. No abstract available.

    PubMed 34970860

  • Hellings PW, Peters AT, Chaker AM, Heffler E, Zhang H, Praestgaard A, Nash S, Khan AH, Siddiqui S, Jacob-Nara JA, Rowe PJ, Deniz Y. Rapid and sustained effects of dupilumab in severe chronic rhinosinusitis with nasal polyps. Int Forum Allergy Rhinol. 2022 Jul;12(7):958-962. doi: 10.1002/alr.22944. Epub 2022 Jan 23. No abstract available.

    PubMed 34911163

  • Han JK, Bachert C, Lee SE, Hopkins C, Heffler E, Hellings PW, Peters AT, Kamat S, Whalley D, Qin S, Nelson L, Siddiqui S, Khan AH, Li Y, Mannent LP, Guillemin I, Chuang CC. Estimating Clinically Meaningful Change of Efficacy Outcomes in Inadequately Controlled Chronic Rhinosinusitis with Nasal Polyposis. Laryngoscope. 2022 Feb;132(2):265-271. doi: 10.1002/lary.29888. Epub 2021 Dec 1.

    PubMed 34850966

  • Chuang CC, Guillemin I, Bachert C, Lee SE, Hellings PW, Fokkens WJ, Duverger N, Fan C, Daizadeh N, Amin N, Mannent LP, Khan AH, Kamat S. Dupilumab in CRSwNP: Responder Analysis Using Clinically Meaningful Efficacy Outcome Thresholds. Laryngoscope. 2022 Feb;132(2):259-264. doi: 10.1002/lary.29911. Epub 2021 Nov 24.

    PubMed 34817082

  • Mullol J, Laidlaw TM, Bachert C, Mannent LP, Canonica GW, Han JK, Maspero JF, Picado C, Daizadeh N, Ortiz B, Li Y, Ruddy M, Laws E, Amin N. Efficacy and safety of dupilumab in patients with uncontrolled severe chronic rhinosinusitis with nasal polyps and a clinical diagnosis of NSAID-ERD: Results from two randomized placebo-controlled phase 3 trials. Allergy. 2022 Apr;77(4):1231-1244. doi: 10.1111/all.15067. Epub 2021 Oct 1.

    PubMed 34459002

  • Khan AH, Reaney M, Guillemin I, Nelson L, Qin S, Kamat S, Mannent L, Amin N, Whalley D, Hopkins C. Development of Sinonasal Outcome Test (SNOT-22) Domains in Chronic Rhinosinusitis With Nasal Polyps. Laryngoscope. 2022 May;132(5):933-941. doi: 10.1002/lary.29766. Epub 2021 Aug 26.

    PubMed 34437720

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab SAR231893 (REGN668) and Mometasone furoate 50 micrograms in people with Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP), run by Sanofi at 76 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, France, Hungary, Italy, Romania and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (time frame: Baseline, Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02912468, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.

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