Sjogren's SyndromePhase 2NCT03100942

Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome

A Phase 2 study testing Lanraplenib, Filgotinib and Tirabrutinib in people with Sjogren's Syndrome, run by Gilead Sciences at 53 sites in 4 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

The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Sjogren's Syndrome
What is being tested?: Lanraplenib, Filgotinib and Tirabrutinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 152 participants
Where: 53 sitesin 4 countries
Study dates: 1 May 2017to 2 Oct 2019
Phase: Phase 2
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with primary or secondary SjS according to the 2002 American European Consensus Group (AECG) classification
Active SjS as defined by an European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI) ≥ 5
Seropositivity for antibodies to SjS-associated antigens A and/or B (anti-SSA or anti-SSB)

Who cannot join

Concurrent treatment with any biologic disease modifying antirheumatic drug (bDMARD) (prior bDMARD treatment allowed with appropriate washout as per study protocol)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

53 sites in 4 countries.

Country

City, postcode or hospital

53 sites in 4 countries

United States34 sites

Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Diagnostic Group Integrated Healthcare System, Pllc
Beaumont, Texas, 77701
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, 18015
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204
ClinSearch
Chattanooga, Tennessee, 37421
The Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, 23320
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Medvin Clinical Research
Covina, California, 91723
Omega Research Consultants LLC
DeBary, Florida, 32713
Denver Arthritis Clinic
Denver, Colorado, 80230
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, 42701
Center for Rheumatology Immunology and Arthritis
Fort Lauderdale, Florida, 33309
Accurate Clinical Research Inc.
Houston, Texas, 77034
June DO, PC
Lansing, Michigan, 48910
North Georgia Rheumatology Group, PC
Lawrenceville, Georgia, 30046
Wasatch Peak Family Practice
Layton, Utah, 84041
Cape Fear Arthritis Care, PLLC
Leland, North Carolina, 28451
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516
Ramesh C. Gupta, MD
Memphis, Tennessee, 38119
AARR Arizona Arthritis & Rheumatology Research
Mesa, Arizona, 85202
Southwest Rheumatology Research
Mesquite, Texas, 75150
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34668
AARR Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85032
Trinity Universal Research Associates
Plano, Texas, 75024
IRIS Research and Development, LLC
Plantation, Florida, 33324
PMG Research of Salisbury
Salisbury, North Carolina, 28144
Arthritis Northwest
Spokane, Washington, 99204
Springfield Clinic
Springfield, Illinois, 62703
Clayton Medical Associates
St Louis, Missouri, 63117
North Mississippi Medical Clinics, Inc. - Clinical Research
Tupelo, Mississippi, 38801
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786
Arthritis & Osteoporosis Clinic
Waco, Texas, 76710
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, 19610

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Spain8 sites

Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital General Universitario De Elche
Elche, 03203
Hospital Universitario de Fuenlabrada
Fuenlabrada, 28942
Hospital Regional Universitario de Malaga
Málaga, 29009
Hospital De Merida
Mérida, 6800
Corporacio Sanitaria Parc Taulí de Sabadell
Sabadell, 08208
Hospital Clinico Universitario de Salamanca
San Vicente, 37007
Hospital Quironsalud Infanta Luisa
Seville, 41010

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Poland6 sites

Centrum Kliniczno-Badawcze
Elblag, 82-300
Intermedius
Kościan, 64-000
Centrum Badan Klinicznych S.C
Poznan, 60-733
Ai Centrum Medyczne
Poznan, 61-113
Centrum Medyczne Amed Warszawa Targowek
Warsaw, 03-921
Centrum Medyczne Oporow
Wroclaw, 52-416

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United Kingdom5 sites

Doncaster Royal Infirmary
Doncaster, DN2 5LT
Western General Hospital
Edinburgh, EX4 2XU
Princess Alexandra Hospital
Harlow, CM20 1QX
Great Western Hospital
Swindon, SN3 6BB
Warrington Hospital
Warrington, WA5 1QG

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About this study

Official title: A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects With Active Sjogren's Syndrome

The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS).

Conditions: Sjogren's Syndrome
Being tested: Lanraplenib, Filgotinib, Tirabrutinib, Lanraplenib placebo, Filgotinib placebo
Medical subject headings: Sjogren's Syndrome

What participants receive

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

LanraplenibDrug
Also called GS-9876
1 x 30 mg tablet administered orally once daily
FilgotinibDrug
Also called GS-6034
1 x 200 mg tablet administered orally once daily
TirabrutinibDrug
Also called GS-4059
1 x 40 mg tablet administered orally once daily
Lanraplenib placeboDrug
1 x tablet administered orally once daily
Filgotinib placeboDrug
1 x tablet administered orally once daily
Tirabrutinib placeboDrug
1 x tablet administered orally once daily

Study groups in NCT03100942
Study group	Role	What they receive
Lanraplenib	Experimental	Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks. Receives: Drug: Lanraplenib; Drug: Filgotinib placebo; Drug: Tirabrutinib placebo
Filgotinib	Experimental	Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks. Receives: Drug: Filgotinib; Drug: Lanraplenib placebo; Drug: Tirabrutinib placebo
Tirabrutinib	Experimental	Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks. Receives: Drug: Tirabrutinib; Drug: Lanraplenib placebo; Drug: Filgotinib placebo
Placebo, then active treatment	Placebo comparator	Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48: * filgotinib + lanraplenib placebo + tirabrutinib placebo * lanraplenib + filgotinib placebo + tirabrutinib placebo * tirabrutinib + filgotinib placebo + lanraplenib placebo Receives: Drug: Lanraplenib; Drug: Filgotinib; Drug: Tirabrutinib; Drug: Lanraplenib placebo; Drug: Filgotinib placebo; Drug: Tirabrutinib placebo

What is being measured

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

Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline
Response was defined as: Improvement ≥ 20% in ≥ 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as > 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either ≥ 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP ≥ 1.5 x upper limit of normal [ULN] on Day 1) or no increase in hsCRP to ≥ 1.5 x ULN (if hsCRP < 1.5 x ULN on Day 1).
Measured: Week 12

Secondary outcomes (4)

Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12
The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Measured: Baseline; Week 12
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12
The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Measured: Baseline; Week 12
Change From Baseline in ESSDAI at Week 24
The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Measured: Baseline; Week 24
Change From Baseline in ESSPRI at Week 24
The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
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 May 20172 Oct 2019

First posted4 Apr 2017
Study start1 May 2017
Primary completion10 Jan 2019
Study completion2 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03100942
Sponsor's protocol ID: GS-US-445-4189
Other IDs: 2016-003558-34, 2016
Status last verified: Oct 2020
First submitted: 31 Mar 2017
Last updated: 23 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Price E, Bombardieri M, Kivitz A, Matzkies F, Gurtovaya O, Pechonkina A, Jiang W, Downie B, Mathur A, Mozaffarian A, Mozaffarian N, Gottenberg JE. Safety and efficacy of filgotinib, lanraplenib and tirabrutinib in Sjogren's syndrome: a randomized, phase 2, double-blind, placebo-controlled study. Rheumatology (Oxford). 2022 Nov 28;61(12):4797-4808. doi: 10.1093/rheumatology/keac167.
PubMed 35377447

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects With Active Sjogren's Syndrome
ClinicalTrials.gov ID: NCT03100942
Acronym / sponsor ID: GS-US-445-4189
Conditions: Sjogren's Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Collaborators: Lakefront Biotherapeutics NV, Ono Pharmaceutical Co., Ltd.
Study start: 1 May 2017 (actual)
Primary completion: 10 Jan 2019 (actual)
Study completion: 2 Oct 2019 (actual)
First posted: 4 Apr 2017 (actual)
Results: Posted 22 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Lanraplenib	Experimental	Drug: Lanraplenib, Drug: Filgotinib placebo, Drug: Tirabrutinib placeboLanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks.
Filgotinib	Experimental	Drug: Filgotinib, Drug: Lanraplenib placebo, Drug: Tirabrutinib placeboFilgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks.
Tirabrutinib	Experimental	Drug: Tirabrutinib, Drug: Lanraplenib placebo, Drug: Filgotinib placeboTirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks.
Placebo, then active treatment	Placebo comparator	Drug: Lanraplenib, Drug: Filgotinib, Drug: Tirabrutinib, Drug: Lanraplenib placebo, Drug: Filgotinib placebo, Drug: Tirabrutinib placeboFilgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48: * filgotinib + lanraplenib placebo + tirabrutinib placebo * lanraplenib + filgotinib placebo + tirabrutinib placebo * tirabrutinib + filgotinib placebo + lanraplenib placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosed with primary or secondary SjS according to the 2002 American European Consensus Group (AECG) classification
Active SjS as defined by an European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI) ≥ 5
Seropositivity for antibodies to SjS-associated antigens A and/or B (anti-SSA or anti-SSB)

Key exclusion criteria (2 listed)

Concurrent treatment with any biologic disease modifying antirheumatic drug (bDMARD) (prior bDMARD treatment allowed with appropriate washout as per study protocol)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LanraplenibAlso: GS-98761 x 30 mg tablet administered orally once daily	Drug	Lanraplenib, Placebo, then active treatment
FilgotinibAlso: GS-60341 x 200 mg tablet administered orally once daily	Drug	Filgotinib, Placebo, then active treatment
TirabrutinibAlso: GS-40591 x 40 mg tablet administered orally once daily	Drug	Placebo, then active treatment, Tirabrutinib
Lanraplenib placebo1 x tablet administered orally once daily	Drug	Filgotinib, Placebo, then active treatment, Tirabrutinib
Filgotinib placebo1 x tablet administered orally once daily	Drug	Lanraplenib, Placebo, then active treatment, Tirabrutinib
Tirabrutinib placebo1 x tablet administered orally once daily	Drug	Filgotinib, Lanraplenib, Placebo, then active treatment

Primary outcome

Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline
Time frame: Week 12
Response was defined as: Improvement ≥ 20% in ≥ 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as > 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either ≥ 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP ≥ 1.5 x upper limit of normal [ULN] on Day 1) or no increase in hsCRP to ≥ 1.5 x ULN (if hsCRP < 1.5 x ULN on Day 1).

4 secondary outcomes

Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12
Time frame: Baseline; Week 12
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12
Time frame: Baseline; Week 12
Change From Baseline in ESSDAI at Week 24
Time frame: Baseline; Week 24
Change From Baseline in ESSPRI at Week 24
Time frame: Baseline; Week 24

Results and safety

Results posted to the registry on 22 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lanraplenib	38	26
Filgotinib	38	29
Tirabrutinib	39	33
Placebo	37	32
Placebo to Lanraplenib	0	0
Placebo to Filgotinib	0	0
Placebo to Tirabrutinib	0	0

Primary outcome: Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline

Time frame: Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Lanraplenib n = 35	Filgotinib n = 37	Tirabrutinib n = 37	Placebo n = 34
Value	42.9 (25.0 to 60.7)	43.2 (25.9 to 60.6)	35.1 (18.4 to 51.9)	26.5 (10.2 to 42.8)

Lanraplenib vs Placebo: Difference in Response Rates: 15.6 (95% CI -6.3 to 37.6), p = 0.1597, Cochran-Mantel-Haenszel
Filgotinib vs Placebo: Difference in Response Rates: 16.6 (95% CI -5.1 to 38.3), p = 0.1694, Cochran-Mantel-Haenszel
Tirabrutinib vs Placebo: Difference in Response Rates: 8.1 (95% CI -13.2 to 29.4), p = 0.3309, Cochran-Mantel-Haenszel

Population analysed: The Full Analysis Set included all randomized participants who received at least one dose of study drug. Included participants with available data.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lanraplenib	3 of 37 (8.1%)	30 of 37 (81.1%)	0 of 37
Filgotinib	5 of 38 (13.2%)	31 of 38 (81.6%)	0 of 38
Tirabrutinib	1 of 39 (2.6%)	32 of 39 (82.1%)	0 of 39
Placebo to Lanraplenib	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Placebo to Filgotinib	1 of 12 (8.3%)	10 of 12 (83.3%)	0 of 12
Placebo to Tirabrutinib	0 of 10 (0%)	7 of 10 (70%)	0 of 10
Placebo on Placebo Controlled Period	2 of 36 (5.6%)	23 of 36 (63.9%)	0 of 36

Limitations and caveats (from the sponsor): An unplanned review of unblinded clinical trial data was performed in this study that was not prospectively specified in the protocol. There was no impact on the overall integrity or conclusions of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35377447Price E, Bombardieri M, Kivitz A, Matzkies F, Gurtovaya O, Pechonkina A, Jiang W, Downie B, Mathur A, Mozaffarian A, Mozaffarian N, Gottenberg JE. Safety and efficacy of filgotinib, lanraplenib and tirabrutinib in Sjogren's syndrome: a randomized, phase 2, double-blind, placebo-controlled study. Rheumatology (Oxford). 2022 Nov 28;61(12):4797-4808. doi: 10.1093/rheumatology/keac167.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

53 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lanraplenib, Filgotinib and Tirabrutinib in people with Sjogren's Syndrome, run by Gilead Sciences at 53 sites in 4 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 3 inclusion and 2 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 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Spain, Poland, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 22 Jan 2020). 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?

Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline (time frame: Week 12). 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 NCT03100942, which also lists 1 linked publication.

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 23 Oct 2020.