Deucravacitinib for Sjögren's Syndrome

(POETYK SjS-1 Trial)

Recruiting at 357 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

Trial Summary

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.

What makes the drug Deucravacitinib unique for treating Sjögren's Syndrome?

Deucravacitinib is unique because it is a first-in-class, highly selective oral inhibitor of tyrosine kinase 2 (TYK2), which works by stabilizing an inhibitory interaction within the enzyme, potentially offering a novel approach for treating immune-mediated diseases like Sjögren's Syndrome. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Deucravacitinib: First Approval. [2022]

5. England 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. [2021]