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BMS-986322 in moderate-to-severe psoriasis
NCT05730725Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2023
- Primary completion
- Aug 2024
- Countries
- 5
- Sponsor
- Bristol Myers Squibb
- Modality
- Small Molecules
- Drugs
- lomedeucitinib
- Conditions
- psoriasis
01
Overview
Phase 2, randomised, double-blind trial of lomedeucitinib in psoriasis (4 arms), sponsored by Bristol Myers Squibb. Primary endpoints: Percentage of Participants Achieving 75% Reduction in Psoriasis Area and Severity Index at 12 weeks, Number of Participants With Safety Related Events at 85 days and 5 more. Started Apr 2023; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
BMS-986322 Dose 1
Experimental arm receiving BMS-986322 at dose level 1
BMS-986322 Dose 2
Experimental arm receiving BMS-986322 at dose level 2
BMS-986322 Dose 3
Experimental arm receiving BMS-986322 at dose level 3
Placebo
Placebo comparator arm
03
Who it enrols
Adults with plaque psoriasis for ≥6 months, BSA ≥10%, PASI ≥12, sPGA ≥3, BMI 18-40 kg/m^2, body weight >50 kg, eligible for phototherapy or systemic therapy. Excludes non-plaque psoriasis variants and other immune-mediated conditions requiring systemic immunosuppression.
04
Endpoints
Primary
Percentage of Participants Achieving 75% Reduction in Psoriasis Area and Severity Index
Number of Participants With Safety Related Events
Number of Participants With Treatment-Emergent Adverse Events by Worst Intensity
Number of Participants With Adverse Events Indicating Clinical Laboratory Abnormality
Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations
Secondary
Percentage of Participants Achieving Static Physician Global Assessment Score of 0 or 1
Percentage of Participants Achieving 50% Reduction in Psoriasis Area and Severity Index
Percentage of Participants Achieving 90% Reduction in Psoriasis Area and Severity Index
Percentage of Participants Achieving 100% Reduction in Psoriasis Area and Severity Index
Mean Change From Baseline of Psoriasis Area and Severity Index
Trough Concentration Measurements Overtime
Maximum Plasma Concentration at Day 15
Time to Maximum Plasma Concentration at Day 15
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