Deucravacitinib for Sjögren's Syndrome
(POETYK SjS-1 Trial)
Recruiting in Palo Alto (17 mi)
+348 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Bristol-Myers Squibb
Must not be taking: Tyrosine kinase 2 inhibitors
Disqualifiers: Rheumatoid arthritis, SLE, systemic sclerosis, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Eligibility 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.
+2 more
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.
+2 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Deucravacitinib, Dose 2Experimental Treatment1 Intervention
Group II: Deucravacitinib, Dose 1Experimental Treatment1 Intervention
Group III: Placebo, followed by Deucravacitinib Dose 1 or Dose 2Placebo Group2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Augusta UniversityAugusta, GA
Local Institution - 0222La Palma, CA
Local Institution - 0218San Francisco, CA
Institute for Rheumatic & Autoimmune Diseases, Overlook Medical CenterSummit, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
Bristol-Myers SquibbLead Sponsor
References
SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]SOTYKTUTM (deucravacitinib) is a newly approved oral agent for managing moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is a highly selective allosteric tyrosine kinase 2 inhibitor targeting dysregulated cytokine responses in psoriasis patients. Its efficacy was demonstrated in two randomized, placebo- and active comparator-controlled phase 3 trials, where a significantly higher proportion of patients, up to 58.4% (194/332), achieved lessening of symptoms at week 16. The recommended dosing regimen of deucravacitinib is 6 mg once daily. More frequent adverse reactions occurring in the deucravacitinib-treated patients include upper respiratory infection (19.2% [161/840]), increase in blood creatine phosphokinase (2.7% [23/840]), herpes simplex infection (2.0% [17/840]), mouth ulcers (1.9% [16/840]), folliculitis (1.7% [14/840]), and acne (1.4% [12/840]). Continuance of treatment for up to week 52 did not increase the exposure-adjusted rates of adverse reactions. The selectivity and specificity of deucravacitinib treatment may improve its long-term safety profile, compared to other Janus kinase inhibitors.
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]To evaluate the safety and efficacy of remibrutinib in patients with moderate-to-severe Sjögren's syndrome (SjS) in a phase 2 randomised, double-blind trial (NCT04035668; LOUiSSE (LOU064 in Sjögren's Syndrome) study).
First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. [2023]This randomized, double-blind, single- and multiple-ascending dose study assessed the pharmacokinetics (PKs), pharmacodynamics, and safety of deucravacitinib (Sotyktu™), a selective and potent small-molecule inhibitor of tyrosine kinase 2, in 100 (75 active, 25 placebo) healthy volunteers (NCT02534636). Deucravacitinib was rapidly absorbed, with a half-life of 8-15 h, and 1.4-1.9-fold accumulation after multiple dosing. Deucravacitinib inhibited interleukin (IL)-12/IL-18-induced interferon (IFN)γ production ex vivo in a dose- and concentration-dependent manner. Following in vivo challenge with IFNα-2a, deucravacitinib demonstrated dose-dependent inhibition of lymphocyte count decreases and expression of 53 IFN-regulated genes. There were no serious adverse events (AEs); the overall frequency of AEs was similar in the deucravacitinib (64%) and placebo (68%) groups. In this first-in-human study, deucravacitinib inhibited IL-12/IL-23 and type I IFN pathways in healthy volunteers, with favorable PK and safety profiles. Deucravacitinib is a promising therapeutic option for immune-mediated diseases, including Crohn's disease, psoriasis, psoriatic arthritis, and systemic lupus erythematosus.
Deucravacitinib: First Approval. [2022]Deucravacitinib (SOTYKTU™) is a first-in-class, highly selective, oral tyrosine kinase 2 (TYK2) inhibitor. It acts via an allosteric mechanism, binding to the catalytically inactive pseudokinase regulatory domain of TYK2 and stabilizing an inhibitory interaction between the regulatory and catalytic domains. Deucravacitinib is being developed by Bristol Myers Squibb for the treatment of multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. It received its first approval (in the USA on 9 September 2022) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. On 26 September 2022, it was subsequently approved in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis. The Marketing Authorisation Application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis has been validated in the EU, and clinical development of the drug for the treatment of multiple immune-mediated diseases is underway in numerous countries worldwide. This article summarizes the milestones in the development of deucravacitinib leading to this first approval for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjögren's syndrome. [2021]This phase 2 proof-of-concept study (NCT02610543) assessed efficacy, safety and effects on salivary gland inflammation of seletalisib, a potent and selective PI3Kδ inhibitor, in patients with moderate-to-severe primary Sjögren's syndrome (PSS).