Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active Psoriatic Arthritis (PsA) who are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or had Previously Received TNFa Inhibitor Treatment

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2021
INTERVENTION: 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 descriptive name: BMS986165 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Otezla 10 mg film‐coated tablets Product Name: Apremilast Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: apremilast CAS Number: 608141‐41‐9 Other descriptive name: APREMILAST Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Otezla 20 mg film‐coated tablets Product Name: Apremilast Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: apremilast CAS Number: 608141‐41‐9 Other descriptive name: APREMILAST Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Otezla 30 mg film‐coated tablets Product Name: Apremilast Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: apremilast CAS Number: 608141‐41‐9 Other descriptive name: APREMILAST Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Active Psoriatic Arthritis ; MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: To compare the efficacy of deucravacitinib to placebo in the treatment of participants with active PsA Primary end point(s): Proportion of participants meeting ACR 20 response 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 Timepoint(s) of evaluation of this end point: At Week 16 SECONDARY OUTCOME: 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 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, ad
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First added on: Feb 15, 2022