Deucravacitinib for Sjögren's Syndrome

(POETYK SjS-1 Trial)

Recruiting at 470 trial locations

Overseen By Ghaith Noaiseh, Site 0016

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: Tyrosine kinase 2 inhibitors

Disqualifiers: Rheumatoid arthritis, SLE, systemic sclerosis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

756 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, Deucravacitinib, for individuals with active Sjögren's Syndrome, an autoimmune condition causing dry mouth and eyes. The study aims to determine the safety and effectiveness of two different doses. Participants are divided into three groups: one for each dose and one starting with a placebo (a harmless pill) before switching to the actual treatment. Candidates for this trial include those who have had moderate to severe Sjögren's for less than 10 years and meet specific medical criteria. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that deucravacitinib has been consistently safe in past studies. For example, the POETYK PSO-LTE trial, which lasted five years, found that participants tolerated this treatment well, and its safety remained stable over time, with no unexpected or severe side effects emerging.

While these results are encouraging, they come from studies on other conditions. Deucravacitinib is now being tested for Sjögren's Syndrome, and past research suggests it might be safe for this condition too. However, individual reactions can vary, so joining the trial would help gather more specific information about its safety for Sjögren's Syndrome. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Sjögren's Syndrome?

Researchers are excited about Deucravacitinib for treating Sjögren's Syndrome because it operates differently than current options like corticosteroids and immunosuppressants. Deucravacitinib is a selective TYK2 inhibitor, which means it specifically targets pathways involved in inflammation and immune response, potentially offering more precise control over symptoms with fewer side effects. Unlike the broad-acting treatments commonly used, Deucravacitinib's targeted action could lead to improved outcomes for patients by directly addressing the underlying mechanisms of the disease.

What evidence suggests that Deucravacitinib might be an effective treatment for Sjögren's Syndrome?

Research suggests that Deucravacitinib may help treat conditions like Sjögren's Syndrome. In people with psoriatic arthritis and palmoplantar pustulosis, Deucravacitinib has shown benefits. Related studies found that people with active lupus who took Deucravacitinib experienced less pain and tiredness. The treatment also significantly lowered certain proteins linked to inflammation in these patients. These findings indicate that Deucravacitinib could effectively manage symptoms of Sjögren's Syndrome. Participants in this trial will receive either Deucravacitinib at different doses or a placebo followed by Deucravacitinib to evaluate its effectiveness for Sjögren's Syndrome. ^{1 2 3 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with Active Sjögren's Syndrome who have had the disease for at least 16 weeks but no more than 10 years, and are experiencing moderate to severe symptoms. Participants must test positive for anti-Ro/SSA and meet specific criteria including a minimum salivary flow rate. Those previously treated with TYK2 inhibitors or having other autoimmune diseases besides SjS are excluded.

Inclusion Criteria

My condition has been diagnosed within the last 10 years.

A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute)

I tested positive for anti-Ro/SSA.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

My fibromyalgia is well-controlled and I haven't changed my medication in the last 3 months.

I have a condition that causes dry eyes and mouth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Deucravacitinib or placebo to evaluate efficacy and safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

Trial Overview The study is testing the safety and effectiveness of Deucravacitinib, comparing two different doses against a placebo in individuals with Active Sjögren's Syndrome. The goal is to determine if this medication can alleviate the condition's symptoms.

How Is the Trial Designed?

Group I: Deucravacitinib, Dose 2 Experimental Treatment 1 Intervention

Group II: Deucravacitinib, Dose 1 Experimental Treatment 1 Intervention

Group III: Placebo, followed by Deucravacitinib Dose 1 or Dose 2 Placebo Group 2 Interventions

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in European Union as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in Canada as Sotyktu for:

• Moderate to severe plaque psoriasis

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

In a phase 2 study involving 27 patients with moderate-to-severe primary Sjögren's syndrome, seletalisib showed a trend towards clinical improvement in disease activity scores, although the study was limited by early termination and reduced statistical power.

Seletalisib demonstrated positive effects on salivary gland inflammation, reducing the size and organization of inflammatory foci, and effectively engaged its target by inhibiting PI3K-mTOR signaling, despite no significant changes in saliva and tear flow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjögren's syndrome. Juarez, M., Diaz, N., Johnston, GI., et al.[2021]

In a phase 2 trial involving patients with moderate-to-severe Sjögren's syndrome, remibrutinib significantly improved disease activity scores (ESSDAI) compared to placebo over 24 weeks, indicating its efficacy in managing the condition.

Remibrutinib demonstrated a favorable safety profile and showed potential benefits in salivary flow, along with significant changes in gene expression and serum protein levels, suggesting a positive impact on the underlying disease mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of remibrutinib, a selective potent oral BTK inhibitor, in Sjögren's syndrome: results from a randomised, double-blind, placebo-controlled phase 2 trial. Dörner, T., Kaul, M., Szántó, A., et al.[2023]

In a study involving 100 healthy volunteers, deucravacitinib was found to be rapidly absorbed with a half-life of 8-15 hours, showing a favorable pharmacokinetic profile and no serious adverse events, indicating good safety.

Deucravacitinib effectively inhibited key immune pathways (IL-12/IL-23 and type I IFN) in a dose-dependent manner, suggesting its potential as a therapeutic option for various immune-mediated diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. Catlett, IM., Aras, U., Hansen, L., et al.[2023]

Deucravacitinib is a first-in-class oral TYK2 inhibitor that works by stabilizing an inhibitory interaction within the TYK2 enzyme, which is important for treating various immune-mediated diseases.

It received its first approval in the USA on September 9, 2022, for adults with moderate-to-severe plaque psoriasis, and has since been approved in Japan for multiple forms of psoriasis, indicating its efficacy and safety in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib: First Approval. Hoy, SM.[2022]

Deucravacitinib (SOTYKTUTM) is an effective oral treatment for moderate to severe plaque psoriasis, with up to 58.4% of patients showing symptom improvement by week 16 in phase 3 trials involving 840 participants.

The drug has a favorable safety profile, with common side effects like upper respiratory infections and herpes simplex infections occurring at manageable rates, and its selectivity may enhance long-term safety compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. Gupta, AK., Wang, T., Vincent, K., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05946941

NCT05946941 | A Study to Evaluate the Efficacy and ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11900575/

The Expanding Therapeutic Potential of Deucravacitinib ... This review highlights recent studies suggesting that deucravacitinib may also have therapeutic benefits in psoriatic arthritis, palmoplantar pustulosis, ...

3. acrabstracts.org acrabstracts.org/abstract/clinical-efficacy-and-patient-reported-outcomes-in-anti-ro-sjogrens-syndrome-related-antigen-a-antibody-positive-patients-with-active-sle-treated-withdeucravacitinib-in-the-ph/

Clinical Efficacy and Patient-Reported Outcomes in Anti-Ro ... Patients receiving deucravacitinib had numerical improvements in mean Pain NRS score and Fatigue T-score at week 48 vs those receiving PBO (Figure). Conclusion: ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/BMY/pressreleases/35744786/bristol-myers-squibbs-new-study-on-deucravacitinib-for-sjogrens-syndrome-what-investors-need-to-know/

Bristol-Myers Squibb's New Study on Deucravacitinib for ... The study aims to assess the safety and efficacy of Deucravacitinib in treating adults with active Sjögren's Syndrome, a condition characterized ...

5. ard.bmj.com ard.bmj.com/content/82/Suppl_1/271.1

POS0112 DEUCRAVACITINIB REDUCES INTERFERONS ... With deucravacitinib treatment, significant reductions were observed in IFNα (at week 48) and IFNλ (week 2 through week 48), and IFNγ was numerically lower ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/411698

A Study to Evaluate the Efficacy and Safety of Deucravacitinib ... 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. Fill out a ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S152169422500052X

Novel therapies in Sjögren's disease: A systematic review ... This systematic review aims to provide a comprehensive overview of recent SjD therapeutic advances, assess trial inclusivity with respect to sex/gender and ...