HumRes64961
|
SNCTP000005884
|
BASEC2023-01648
|
NCT05946941
Study to assess the efficacy and safety of Deucravacitinib in adults with active Sjögren's syndrome
Summary description of the study
By conducting this study, the researchers hope to learn more about whether Deucravacitinib can help in the treatment of Sjögren's syndrome (SjS) compared to placebo and how safe its use is in participants with active SjS. Deucravacitinib is an investigational drug, meaning its safety and efficacy have not yet been established and it is not yet approved for the treatment of SjS in Switzerland.
(BASEC)
Intervention under investigation
In the 52-week, double-blind treatment period, eligible participants will be randomized in a 2:1 ratio to one of 3 treatment groups to receive Deucravacitinib (one of two doses) or corresponding placebo. After the 52-week double-blind period, participants will be eligible to participate in an additional optional 104-week LTE period, during which all participants will receive active treatment with Deucravacitinib.
(BASEC)
Disease under investigation
Sjögren's syndrome
(BASEC)
Criteria for participation in trial
Eligible participants are adults (≥ 18 years old or of legal age in the country of residence) who meet the criteria of the American College of Rheumatology/European League Against Rheumatism from 2016 for the classification of SjS, suffering from moderate to severe SjS (ESSDAI score ≥ 5) and positive for anti-SSA/Ro antibodies. Additional selection criteria include a short disease duration (≤ 10 years) and a SWSF value ≥ 0.05 ml/minute. (BASEC)
Exclusion criteria
Autoimmune disease other than SjS (e.g., rheumatoid arthritis, SLE, systemic sclerosis), active fibromyalgia, disease(s) associated with the Sicca syndrome, severe complications of SjS (vasculitis, lymphoma, active involvement of the central nervous system or peripheral nervous system, severe involvement of the kidneys/lungs/muscles). Participants with prior exposure to Deucravacitinib or a TYK2 inhibitor, prior exposure to a biological therapy within a washout phase, or who have received treatment for an active or chronic infection are also excluded. (BASEC)
Eligible participants are adults (≥ 18 years old or of legal age in the country of residence) who meet the criteria of the American College of Rheumatology/European League Against Rheumatism from 2016 for the classification of SjS, suffering from moderate to severe SjS (ESSDAI score ≥ 5) and positive for anti-SSA/Ro antibodies. Additional selection criteria include a short disease duration (≤ 10 years) and a SWSF value ≥ 0.05 ml/minute. (BASEC)
Exclusion criteria
Autoimmune disease other than SjS (e.g., rheumatoid arthritis, SLE, systemic sclerosis), active fibromyalgia, disease(s) associated with the Sicca syndrome, severe complications of SjS (vasculitis, lymphoma, active involvement of the central nervous system or peripheral nervous system, severe involvement of the kidneys/lungs/muscles). Participants with prior exposure to Deucravacitinib or a TYK2 inhibitor, prior exposure to a biological therapy within a washout phase, or who have received treatment for an active or chronic infection are also excluded. (BASEC)
Trial sites
Bern, St. Gallen
(BASEC)
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Romania, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States (ICTRP)
Sponsor
Bristol-Myers Squibb Switzerland
(BASEC)
Contact
Contact Person Switzerland
Bristol-Myers Squibb Services Unlimited Company
+32 2352 7611
mg-gsm-ct@clutterbms.comPlaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
25.04.2024
(BASEC)
ICTRP Trial ID
NCT05946941 (ICTRP)
Official title (approved by ethics committee)
Eine randomisierte, doppelblinde, placebokontrollierte Phase-III-Studie zur Beurteilung der Wirksamkeit und Sicherheit von Deucravacitinib bei Erwachsenen mit aktivem Sjögren-Syndrom (POETYK SjS-1) (BASEC)
Academic title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjgren's Syndrome (POETYK SjS-1) (ICTRP)
Public title
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjgren's Syndrome (ICTRP)
Disease under investigation
Sjgren's Syndrome (ICTRP)
Intervention under investigation
Drug: DeucravacitinibOther: Placebo (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion 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-Sjgren'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. (ICTRP)
not available
Primary and secondary end points
Change from baseline in European League Against Rheumatism Sj�gren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 (ICTRP)
Change from baseline in European League Against Rheumatism Sj�gren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52;Number of participants with decrease in ESSPRI = 1 or 15% from baseline at Week 52;Number of participants with decrease in ESSDAI = 3 points from baseline at Week 52;Number of participants with ESSDAI < 5 at Week 52;Change from baseline in ESSDAI at Week 24;Change from baseline in stimulated whole salivary flow (SWSF) at Week 52;Change from baseline in physician global assessment (PhGA) at Week 52;Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52;Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52;Change from baseline in oral dryness NRS at Week 52;Change from baseline in joint/ muscle pain NRS at Week 52;Number of participants with an increase of Schirmer's test = 5 mm if abnormal baseline or no change of Schirmer's test to abnormal if baseline is normal;Number of participants with adverse events (AEs);Number of participants with serious AEs (SAEs);Number of participants with AEs leading to discontinuation of treatment and study discontinuation;Number of participants with AEs of special interest (AESIs);Number of participants with clinical laboratory abnormalities;Number of participants with electrocardiogram (ECG) abnormalities;Number of participants with vital sign abnormalities (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Bristol-Myers Squibb;BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, Clinical.Trials@bms.com, 855-907-3286, Bristol-Myers Squibb, (ICTRP)
Secondary trial IDs
2023-503327-26, U111-1289-6072, IM011-1069 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05946941 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available