PruritusPhase 3NCT05263206
Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
A Phase 3 study testing Dupilumab and Fexofenadine (loratadine if not available) in people with Pruritus, run by Sanofi at 94 sites in 13 countries.
Trial summary
The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO. This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pruritus
- What is being tested?
- Dupilumab and Fexofenadine (loratadine if not available)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 94 sitesin 13 countries
- Study dates
- 15 Feb 2022to 25 Aug 2027
- Phase
- Phase 3
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent.
- Participants with chronic pruritus for at least 6 months before the screening visit.
- Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs).
- Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk.
- History of insufficient control of the chronic pruritus with prior treatment.
- Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency).
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- Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient Global Impression of Severity (PGIS) of pruritus scored "severe" at screening.
- Participants must have an average worst itch score of ≥7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS.
- Participants scored "severe" in the PGIS of pruritus on Day 1.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study.
- Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent.
- Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit.
- HIV infection.
- Severe renal failure (dialysis).
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- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit.
- Known or suspected immunodeficiency.
- Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
- History of hypersensitivity or intolerance to non-sedative antihistamines.
- Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
94 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free number for US & Canada) contact
94 sites in 13 countries
United States19 sites, 18 recruiting
- Completed
Kern Allergy and Medical Research- Site Number : 8400016
Bakersfield, California, 93301
- Recruiting
Johns Hopkins Hospital- Site Number : 8400020
Baltimore, Maryland, 21287
- Recruiting
Palm Harbor Dermatology- Site Number : 8400024
Belleair, Florida, 32756
- Recruiting
The Asthma and Allergy Center- Site Number : 8400014
Bellevue, Nebraska, 68123
- Recruiting
Optima Research - Boardman- Site Number : 8400039
Boardman, Ohio, 44512
- Recruiting
Treasure Valley Medical Research- Site Number : 8400049
Boise, Idaho, 83706
- Recruiting
Columbia Dermatology & Aesthetics- Site Number : 8400047
Columbia, South Carolina, 29212
- Recruiting
AXIS Clinicals - Fargo- Site Number : 8400037
Fargo, North Dakota, 58103
- Recruiting
Dawes Fretzin Clinical Research- Site Number : 8400007
Indianapolis, Indiana, 46250
- Recruiting
Modena Allergy + Asthma- Site Number : 8400038
La Jolla, California, 92037
- Recruiting
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031
Louisville, Kentucky, 40241
- Recruiting
Skin Care Physicians of Georgia - Macon- Site Number : 8400030
Macon, Georgia, 31217
- Recruiting
University of Miami Hospital- Site Number : 8400011
Miami, Florida, 33136
- Recruiting
Tulane University School of Medicine- Site Number : 8400045
New Orleans, Louisiana, 70112
- Recruiting
Mount Sinai - Union Square- Site Number : 8400034
New York, New York, 10003
- Recruiting
National Allergy and Asthma Research- Site Number : 8400032
North Charleston, South Carolina, 29420
- Recruiting
Aeroallergy Research Laboratory- Site Number : 8400036
Savannah, Georgia, 31406
- Recruiting
Complete Dermatology - Site Number : 8400046
Sugar Land, Texas, 77479
- Recruiting
FoxHall Dermatology- Site Number : 8400042
Washington D.C., District of Columbia, 20016
China9 sites, 9 recruiting
- Recruiting
Investigational Site Number : 1560003
Beijing, 100191
- Recruiting
Investigational Site Number : 1560004
Chengdu, 610041
- Recruiting
Investigational Site Number : 1560009
Chongqing, 400016
- Recruiting
Investigational Site Number : 1560006
Guangzhou, 510018
- Recruiting
Investigational Site Number : 1560005
Guangzhou, 510080
- Recruiting
Investigational Site Number : 1560002
Hangzhou, 310006
- Recruiting
Investigational Site Number : 1560001
Shanghai, 200040
- Recruiting
Investigational Site Number : 1560011
Suzhou, 215006
- Recruiting
Investigational Site Number : 1560008
Wuhan, 430022
Argentina8 sites, 6 recruiting
- Recruiting
Investigational Site Number : 0320005
Buenos Aires, 1012
- Completed
Investigational Site Number : 0320001
Buenos Aires, 1023
- Recruiting
Investigational Site Number : 0320006
Buenos Aires, 1055
- Recruiting
Investigational Site Number : 0320007
Buenos Aires, 1061
- Recruiting
Investigational Site Number : 0320002
Buenos Aires, 1121
- Recruiting
Investigational Site Number : 0320003
Buenos Aires, 1414
- Completed
Investigational Site Number : 0320004
Rosario, Santa Fe Province, 2000
- Recruiting
Investigational Site Number : 0320008
Rosario, Santa Fe Province, 2000
Japan8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 3920004
Habikino, Osaka, 583-8588
- Recruiting
Investigational Site Number : 3920005
Izumo, Shimane, 693-8501
- Recruiting
Investigational Site Number : 3920009
Matsudo, Chiba, 271-0092
- Recruiting
Investigational Site Number : 3920002
Sakai, Osaka, 593-8324
- Recruiting
Investigational Site Number : 3920006
Sapporo, Hokkaido, 060-0063
- Recruiting
Investigational Site Number : 3920001
Tachikawa, Tokyo, 190-0023
- Recruiting
Investigational Site Number : 3920007
Urayasu, Chiba, 279-0011
- Recruiting
Investigational Site Number : 3920008
Yokohama, Kanagawa, 220-6208
Canada7 sites, 4 recruiting
- Recruiting
Investigational Site Number : 1240001
Calgary, Alberta, T2G 1B1
- Completed
Investigational Site Number : 1240008
Edmonton, Alberta, T6G 1C3
- Recruiting
Investigational Site Number : 1240002
London, Ontario, L6A 2C2
- Completed
Investigational Site Number : 1240003
Markham, Ontario, L3P 1X2
- Completed
Investigational Site Number : 1240005
Montreal, Quebec, H4A 3T2
- Recruiting
Investigational Site Number : 1240006
Toronto, Ontario, M4C 1L1
- Recruiting
Investigational Site Number : 1240004
Verdun, Quebec, H4G 2L8
Hungary7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 3480001
Budapest, 1036
- Recruiting
Investigational Site Number : 3480009
Budapest, 1066
- Recruiting
Investigational Site Number : 3480005
Debrecen, 4031
- Recruiting
Investigational Site Number : 3480010
Gyula, 5700
- Recruiting
Investigational Site Number : 3480003
Szeged, 6720
- Recruiting
Investigational Site Number : 3480011
Székesfehérvár, 8000
- Recruiting
Investigational Site Number : 3480002
Zalaegerszeg, 8900
Italy7 sites, 7 recruiting
- Recruiting
Azienda Ospedaliero Universitaria delle Marche-Site Number : 3800004
Ancona, 60126
Carolina Finale, 0039 0715965451, carolina.finale@ospedaliriuniti.marche.it
Oriana Simonetti
- Recruiting
Azienda Ospedaliero-Universitaria di Ferrara-Site Number : 3800007
Cona, Ferrara, 44124
Alessandro Borghi, 0039 0532236398, alessandro.borghi@unife.it
Alessandro Borghi
- Recruiting
AUSL Toscana Centro - Presidio Ospedaliero "Piero Palagi-"Site Number : 3800005
Florence, Firenze, 50125
Vincenzina Rubino, 0039 0556939664, vincenzina.rubino@unifi.it
Emiliano Antiga
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Site Number : 3800003
Milan, Milano, 20122
Silvia Mariel Ferrucci, silvia.ferrucci@policlinico.mi.it
Silvia Mariel Ferrucci
- Recruiting
Investigational Site Number : 3800006
Naples, Napoli, 80131
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001
Rome, Roma, 00168
Niccolò Gori, niccolo.gori@policlinicogemelli.it
Ketty Peris
- Recruiting
Investigational Site Number : 3800002
Rozzano, Milano, 20089
South Korea7 sites, 2 recruiting
- Completed
Investigational Site Number : 4100004
Ansan-si, Gyeonggi-do, 15355
- Completed
Investigational Site Number : 4100003
Busan, Busan, 49241
- Completed
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi, 03080
- Completed
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 03722
- Recruiting
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, 05030
- Completed
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, 07441
- Recruiting
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi, 07804
Germany5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 2760005
Bad Bentheim, 48455
- Recruiting
Investigational Site Number : 2760002
Berlin, 12203
- Recruiting
Investigational Site Number : 2760004
Frankfurt, 60590
- Recruiting
Investigational Site Number : 2760003
Mainz, 55131
- Recruiting
Investigational Site Number : 2760001
Münster, 48149
Poland5 sites, 4 recruiting
- Recruiting
Investigational Site Number : 6160001
Krakow, Lesser Poland Voivodeship, 30-033
- Recruiting
Investigational Site Number : 6160008
Warsaw, Masovian Voivodeship, 01-142
- Recruiting
Investigational Site Number : 6160005
Warsaw, Masovian Voivodeship, 02-172
- Recruiting
Investigational Site Number : 6160007
Wroclaw, Lower Silesian Voivodeship, 50-566
- Active, not recruiting
Investigational Site Number : 6160003
Wroclaw, Lower Silesian Voivodeship, 51-318
Spain5 sites, 4 recruiting
- Recruiting
Investigational Site Number : 7240005
Alicante, 03010
- Completed
Investigational Site Number : 7240003
Barcelona, Catalunya [Cataluña], 08003
- Recruiting
Investigational Site Number : 7240006
Barcelona, Catalunya [Cataluña], 08041
- Recruiting
Investigational Site Number : 7240004
Córdoba, 14004
- Recruiting
Investigational Site Number : 7240001
Pontevedra, Pontevedra [Pontevedra], 36002
Taiwan4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 1580003
Kaohsiung City, 833
- Recruiting
Investigational Site Number : 1580004
New Taipei City, 235
- Recruiting
Investigational Site Number : 1580001
Taipei, 100
- Recruiting
Investigational Site Number : 1580002
Taoyuan City, 333
France3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 2500001
Brest, 29200
- Recruiting
Investigational Site Number : 2500003
Nice, 06202
- Recruiting
Investigational Site Number : 2500004
Reims, 51100
About this study
Official title: Master Protocol of Two Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Studies to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Chronic Pruritus of Unknown Origin (CPUO)
The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO.
This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO. Study B design was to be adapted based on the results of Study A.
For both Study A and B, after an up-to-4-week screening period, participants with severe pruritus (worst-itch numerical rating scale [WI-NRS ≥7) will enter a 4-week run-in period and will be treated with a non-sedative antihistamine and an emollient (moisturizer). Participants with severe pruritus (WI-NRS ≥7) at baseline will be randomized (1:1) to be treated for 24 weeks with either dupilumab or matching placebo in addition to their non-sedative antihistamine and emollient regimen. The treatment period for both study A and B will be followed by a 12-week follow-up period.
Read the detailed description
Study duration per participant will be up to 44 weeks for both Study A and Study B.
- Conditions
- Pruritus
- Being tested
- Dupilumab, Placebo, Fexofenadine (loratadine if not available)
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Injection solution subcutaneous
PlaceboDrug
Injection solution SC
Fexofenadine (loratadine if not available)Drug
Tablet or capsule Oral
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer Receives: Drug: Dupilumab; Drug: Fexofenadine (loratadine if not available) |
| Placebo | Placebo comparator | Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer Receives: Drug: Placebo; Drug: Fexofenadine (loratadine if not available) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24
WI-NRS is a patient reported outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 24
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 12
Secondary outcomes (41)
Study A; Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 12
Study A: Proportion of participants who scored "none" or "mild" in Patient Global Impression of Severity (PGIS) of pruritus at Week 24
The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe".
Measured: Week 24
Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline over time until Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 24
Study A: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 24
Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 24
Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 24
Study A: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12
The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe".
Measured: Week 12
Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 12
Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 12
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 12
Study A: Absolute change from baseline in weekly average of daily sleep disturbance numerical rating scale (NRS) at Week 24
The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.
Measured: Baseline to Week 24
Study A: Percent change from baseline in weekly average of daily sleep disturbance NRS at Week 24
The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.
Measured: Baseline to Week 24
Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 24
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Measured: Baseline to Week 24
Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 24
ItchyQoL is a pruritus-specific QoL instrument that measures specifically disease burden in pruritus patients.
Measured: Baseline to Week 24
Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 24
The HADS is a validated questionnaire for screening anxiety and depression in non-psychiatric populations. The total score ranges from 0 to 42. 0 to 7= normal; 8 to 10= borderline abnormal; 11 to 21= abnormal.
Measured: Baseline to Week 24
Study A: Absolute change from baseline in weekly average of daily sleep disturbance NRS at Week 12
The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.
Measured: Baseline to Week 12
Study A: Percent change from baseline in weekly average of daily sleep disturbance NRS at Week 12
The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.
Measured: Baseline to Week 12
Study A: Change from baseline in DLQI score at Week 12
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Measured: Baseline to Week 12
Study A: Change from baseline in the ItchyQoL score at Week 12
ItchyQoL is a pruritus-specific QoL instrument that measures specifically disease burden in pruritus patients. It is a 22-item instrument that measures the degree to which pruritus affects quality-of-life for the past week. The overall score is the average of the 22 items ranging from 1 to 5. A higher score corresponds to a more adverse impact on QoL.
Measured: Baseline to Week 12
Study A: Change from baseline in HADS total score at Week 12
The HADS is a validated questionnaire for screening anxiety and depression in non-psychiatric populations. The total score ranges from 0 to 42. 0 to 7= normal; 8 to 10= borderline abnormal; 11 to 21= abnormal.
Measured: Baseline to Week 12
Study A: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through end of study (EOS)
Percentage of participants experiencing TEAEs or SAEs from baseline through EOS
Measured: Baseline to Week 36
Study A: Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab
Incidence of treatment-emergent ADA against dupilumab
Measured: Baseline to Week 36
Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 24
The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe".
Measured: Week 24
Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12
The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe".
Measured: Week 12
Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 12
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 12
Study B: Percent change from baseline in weekly average of daily WI-NRS at Week 12
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 12
Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 24
Study B: Percentage change from baseline in weekly average of daily WI-NRS at Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 24
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline, sustained from Week 19 through Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 19 through Week 24
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from baseline to Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 24
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 24
Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Week 24
Study B: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 24
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from baseline to Week 12
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Baseline to Week 12
Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 12
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Measured: Week 12
Study B: Absolute change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24
The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.
Measured: Baseline to Week 12 and Week 24
Study B: Percent change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24
The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.
Measured: Baseline to Week 12 and Week 24
Study B: Change from baseline in DLQI score at Week 12 and Week 24
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Measured: Baseline to Week 12 and Week 24
Study B: Change from baseline in the ItchyQoL score at Week 12 and Week 24
ItchyQoL is a pruritus-specific QoL instrument that measures specifically disease burden in pruritus patients. It is a 22-item instrument that measures the degree to which pruritus affects quality-of-life for the past week. The overall score is the average of the 22 items ranging from 1 to 5. A higher score corresponds to a more adverse impact on QoL.
Measured: Baseline to Week 12 and Week 24
Study B: Change from baseline in HADS total score at Week 12 and Week 24
The HADS is a validated questionnaire for screening anxiety and depression in non-psychiatric populations. The total score ranges from 0 to 42. 0 to 7= normal; 8 to 10= borderline abnormal; 11 to 21= abnormal.
Measured: Baseline to Week 12 and Week 24
Study B: Percentage of participants experiencing TEAEs or SAEs from baseline through EOS
Percentage of participants experiencing TEAEs or SAEs from baseline through EOS
Measured: Baseline to Week 36
Study B: Incidence of treatment-emergent ADA against dupilumab
Incidence of treatment-emergent ADA against dupilumab
Measured: Baseline to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Feb 2022
- Primary completion2 Jun 2027 (estimated)
- Study completion25 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263206
- Sponsor's protocol ID
- EFC16973
- Other IDs
- U1111-1253-9888, 2023-508879-36-00, 2023-508879-36, 2021-004315-76, 2023
- Status last verified
- Oct 2026
- First submitted
- 22 Feb 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org