Recruiting adults aged 18-70 with a diagnosis of plaque psoriasis (PsO) for an investigational study. Eligible participants must have diagnosis of PsO for at least 6 months, with 10% or more of their body surface area (BSA) covered in psoriatic plaques (roughly equivalent to the size of 10 palm prints). Participants must also have a body weight >50kg (110lbs), a body mass index (BMI) of 18-40kg/m2, and not have any history or risk of tuberculosis. Participants must be willing to discontinue topical and systemic therapies (with the exception of topical emollients and low potency topical steroids).
Participants will receive an investigational oral tablet (study drug) or placebo. Study treatment and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last about 16 weeks and involve about 9 visits to the study centre.
Hamilton - LEADER Research
Toronto - North York Research Inc.
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Last Update Posted: December 10, 2023
NCT05730725
Bristol-Myers Squibb
Brief Summary:
The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.
Condition or Disease:
Psoriasis
Intervention/Treatment:
Drug: BMS-986322Phase:
Phase 2
Ages Eligible for Study:
18 Years and 70 Years (Adult)
Sexes Eligible for Study:
All
Inclusion Criteria:
Diagnosis of plaque psoriasis (PsO) for ≥ 6 months
Body mass index 18 to 40 kg/m^2 and total body weight > 50 kg (110 lbs)
Deemed by Investigator to be eligible for phototherapy or systemic therapy
Psoriatic plaques must cover ≥ 10% of body surface area at baseline
Psoriasis Area and Severity Index (PASI) score ≥ 12 and static Physician Global Assessment (sPGA) ≥ 3 at baseline
Exclusion Criteria:
Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic)
Diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with PsO for which a participant requires current systemic immunosuppressant medical treatment
Any significant acute or chronic medical illness
Other protocol-defined inclusion/exclusion criteria apply
Terms and Conditions – ClinicalTrials.gov
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