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

Phase 1

• Conditions: Active Psoriatic Arthritis; MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-005097-10-HU
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-08
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1300

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified