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: deucravacitinib
CAS Number: 1609392-27-9
Current Sponsor code: BMS-986165
Other desc
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 = 1 PsA-related hand and/or foot joint erosion on X-ray during Screening period that is confirmed by central reading. - 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 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 1092 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 208
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. - Participant has received an approved or investigational biologic therapy for the treatment of PsA or PsO.
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 - as assessed by structural damage ;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 1- Change from baseline in PsA-modified SvdH score Additional Secondary Endpoints 2- Proportion of participants meeting ACR 20, ACR 50, and ACR 70 response 2- Change from baseline in HAQ-DI score 2- Proportion of participants who achieve a clinically meaningful improvement in HAQ-DI score 2- Proportion of participants with achievement of PASI 75/90/100 response 2- Change from baseline in the SF-36 PCS score 2- Proportion of participants meeting enthesitis resolution 2- Proportion of participants meeting achievement of MDA 2- Change from baseline in SF-36 Score MCS 2- Change from baseline in FACIT-Fatigue 2- Proportion of participants meeting dactylitis resolution 2- Change from baseline in PsAID 12 2- Change from baseline in DAPSA score 2- Proportion of participants meeting achievement of PGA-F of 0/1 2- Change from baseline in DAS28-CRP score 2- Change from baseline in PASDAS 2- Change from baseline in mCPDAI score 2- Proportion of participants achieving PsARC response 2- Proportion of participants meeting achievement of improvement from baseline in BASDAI score 1- Proportion of participants meeting achievement of total PsA-modified SvdH score of = 0, = 0.5, and = SDC 1- Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of = 0, = 0.5, and = SDC 1- Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of = 0, = 0.5, and = SDC 1- Change in PsA-modified SvdH erosion score from baseline 1- Change in PsA-modified SvdH JSN score 2- Change fro | — |
Countries
Argentina, Brazil, Bulgaria, Chile, China, Colombia, Czechia, Czech Republic, Finland, France, Germany, Hungary, Ireland, Italy, Mexico, Poland, Romania, Russian Federation, Spain, Taiwan, United Kingdom
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed