Active Psoriatic Arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: deucravacitinib
Product Code: [BMS-986165]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: deucratinib
CAS Number: 1609392-27-9
Current Sponsor code: BMS-986165
Other descri
Sponsors
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ¿¿Participant has been diagnosed to have PsA (by any criteria) of at least 3 months duration at Screening. ¿¿Participant meets the CASPAR criteria at Screening. ¿¿Participant has active plaque psoriatic skin lesion(s) or documented medical history of plaque PsO at Screening. ¿¿Participant has active arthritis as shown by = 3 swollen joints and = 3 tender joints (66/68 joint counts) at Screening and Day 1. ¿¿Participant has hsCRP = 3 mg/L at Screening. ¿¿Participant has had documented inadequate response, loss of response or intolerance to at least 1 of the following: •¿A csDMARD at maximally tolerated dose, and/or apremilast, after a minimum of 12 weeks duration of therapy given for the treatment of PsA •¿An NSAID after a minimum of 4 weeks duration of therapy given for the treatment of PsA, or participant has intolerance to those treatments in the opinion of the investigator •¿A TNF-inhibitor after a minimum of 12 weeks of etanercept,adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar), or a minimum of 14 weeks (i.e., at least 4 doses) of infliximab (or biosimilar) given for the treatment of PsA and/or PsO. A shorter duration may be considered if documentation of inadequate response can be obtained and provided to the Medical Monitor for review Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 979 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 187
Exclusion criteria
Exclusion criteria: ¿¿Participant has non-plaque PsO (ie, guttate, pustular, erythrodermic or drug-induced PsO) at Screening or Day 1. ¿¿Participant has any other autoimmune condition such as, systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis. ¿¿Participant has prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease). ¿¿Participant has active (ie, currently symptomatic) fibromyalgia whose symptoms or therapy will significantly impact the assessment of PsA disease manifestations and activity in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of deucravacitinib to placebo in the treatment of participants with active PsA;Secondary Objective: To compare the efficacy of deucravacitinib to placebo at Week 16: - as assessed by DAS28-CRP - as assessed by HAQ-DI - as assessed by PASI 75 response - as assessed by SF-36 PCS score - in enthesitis resolution - in MDA response - in FACIT-Fatigue - in dactylitis resolution;Primary end point(s): Proportion of participants meeting ACR 20 response;Timepoint(s) of evaluation of this end point: At Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Change from baseline in DAS28-CRP score 1- Change from baseline in HAQ-DI score 1- Proportion of participants meeting PASI 75 response 1- Change from baseline in the SF-36 PCS 1- Proportion of participants meeting enthesitis resolution 1- Proportion of participants meeting achievement of MDA 1- Change from baseline in FACIT-Fatigue 1- Proportion of participants meeting dactylitis resolution 2- Additional Secondary Endpoints: Proportion of participants meeting ACR 20, ACR 50, and ACR 70 response Change from baseline in HAQ-DI score Proportion of participants who achieve a clinically meaningful improvement in HAQ-DI score Proportion of participants with achievement of PASI 75/90/100 response Change from baseline in the SF-36 PCS score Proportion of participants meeting enthesitis resolution Proportion of participants meeting achievement of MDA Change from baseline in SF-36 Score MCS Change from baseline in FACIT-Fatigue Proportion of participants meeting dactylitis resolution Change from baseline in PsAID 12 Change from baseline in DAPSA score Proportion of participants meeting achievement of PGA-F of 0/1 Change from baseline in DAS28-CRP score Change from baseline in PASDAS Change from baseline in mCPDAI score Proportion of participants achieving PsARC response Proportion of participants meeting achievement of improvement from baseline in BASDAI score Change from baseline in domain scales scores, PCS, and MCS of SF-36 Change from baseline in the subcomponents of the WPAI questionnaire Change from baseline in the 5-level EQ-5D utility scores and its subcomponents Change from baseline in PROMIS sleep disturbance (short form);Timepoint(s) of evaluation of this end point: 1- At Week 16 2- At Each Time Point up to Week 16 | — |
Countries
Argentina, Belgium, Brazil, Chile, China, Colombia, Czechia, Czech Republic, Finland, France, Germany, Hungary, Ireland, Italy, Mexico, Poland, Romania, Russian Federation, Spain, Taiwan, United Kingdom
Contacts
Public ContactHead of the GSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed