A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)
Evaluate Deucravacitinib for Active Sjögren's Syndrome
Plain English Summary
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome is a Phase 3 clinical trial sponsored by Bristol-Myers Squibb studying Sjögren's Syndrome. Tests two doses of Deucravacitinib to see if they help with Sjögren's Syndrome symptoms. For adults with moderate to severe Sjögren's Syndrome, who have had symptoms for at least 16 weeks. Participation involves taking study medication for up to 52 weeks and regular check-ups. Alternative treatments include other medications or no treatment, depending on the severity of symptoms. The trial aims to enroll 774 participants.
Official Summary
The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with Sjögren's Syndrome who meet the criteria can join. Those with other autoimmune diseases or active fibromyalgia cannot join. Must be at least 18 years old and have had Sjögren's for at least 16 weeks. Must have a certain level of saliva production and specific blood tests. This trial is studying Sjögren's Syndrome, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures show how well the treatment works in reducing symptoms and improving quality of life. The specific primary outcome measures are: Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 (Baseline, Week 52). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial is important as it aims to fill a treatment gap for those with moderate to severe Sjögren's Syndrome. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Sjögren's Syndrome, where improved treatment options are needed.
Investor Insight
The large market size and competitive landscape suggest a high approval probability for this treatment. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 774 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you meet the criteria for this study. Participation involves taking study medication and attending regular check-ups. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 774 participants
Interventions
- DRUG: Deucravacitinib — Specified dose on specified days
- OTHER: Placebo — Specified dose on specified days
Primary Outcomes
- Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 (Baseline, Week 52)
Secondary Outcomes
- Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52 (Baseline, Week 52)
- Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52 (Baseline, Week 52)
- Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52 (Baseline, Week 52)
- Number of participants with ESSDAI < 5 at Week 52 (Baseline, Week 52)
- Change from baseline in ESSDAI at Week 24 (Baseline, Week 24)
Full Eligibility Criteria
Inclusion Criteria * Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS at screening (score ≥ 4), and who have disease duration (from time of initial clinical SjS diagnosis) of at least 16 weeks prior to screening. * Have moderate to severe SjS ESSDAI ≥ 5. * Short duration of disease (≤ 10 years) before screening. * A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute). * Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening. Exclusion Criteria * Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus \[SLE\], systemic sclerosis). * Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered. * Medical condition associated with sicca syndrome. * Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds. * Other protocol-defined Inclusion/Exclusion criteria apply.
Trial Locations
- Local Institution - 0228, Fullerton, California, United States
- Local Institution - 0222, La Palma, California, United States
- Local Institution - 0218, San Francisco, California, United States
- Local Institution - 0203, Santa Monica, California, United States
- Local Institution - 0067, Denver, Colorado, United States
- Local Institution - 0049, Clearwater, Florida, United States
- Local Institution - 0226, Cooper City, Florida, United States
- Local Institution - 0223, Sarasota, Florida, United States
- Local Institution - 0140, Augusta, Georgia, United States
- Local Institution - 0229, Lawrenceville, Georgia, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT05946941?
NCT05946941 is a Phase 3 INTERVENTIONAL study titled "A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome." It is currently active, not recruiting and is sponsored by Bristol-Myers Squibb. The trial targets enrollment of 774 participants.
What conditions does NCT05946941 study?
This trial investigates treatments for Sjögren's Syndrome. The primary condition under study is Sjögren's Syndrome.
What treatments are being tested in NCT05946941?
The interventions being studied include: Deucravacitinib (DRUG), Placebo (OTHER). Specified dose on specified days
What does Phase 3 mean for NCT05946941?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT05946941?
This trial is currently "Active, Not Recruiting." It started on 2023-09-11. The estimated completion date is 2028-11-16.
Who is sponsoring NCT05946941?
NCT05946941 is sponsored by Bristol-Myers Squibb. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05946941?
The trial aims to enroll 774 participants. The trial status is active, not recruiting.
How is NCT05946941 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT05946941?
The primary outcome measures are: Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 (Baseline, Week 52). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05946941 being conducted?
This trial is being conducted at 20 sites, including Fullerton, California; La Palma, California; San Francisco, California; Santa Monica, California and 16 more sites (United States).
Where can I find official information about NCT05946941?
The official record for NCT05946941 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05946941. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05946941 testing in simple terms?
Tests two doses of Deucravacitinib to see if they help with Sjögren's Syndrome symptoms. For adults with moderate to severe Sjögren's Syndrome, who have had symptoms for at least 16 weeks.
Why is this trial significant?
This trial is important as it aims to fill a treatment gap for those with moderate to severe Sjögren's Syndrome. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT05946941?
Possible side effects include nausea, headache, and fatigue. Monitor any new symptoms and report them to your doctor. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05946941?
Ask your doctor if you meet the criteria for this study. Participation involves taking study medication and attending regular check-ups. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05946941 signal from an investment perspective?
The large market size and competitive landscape suggest a high approval probability for this treatment. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves taking study medication for up to 52 weeks and regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.