A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
Overview
- Phase
- Phase 2
- Intervention
- ESK-001
- Conditions
- Plaque Psoriasis
- Sponsor
- Alumis Inc
- Enrollment
- 228
- Locations
- 53
- Primary Endpoint
- To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled study in patients with moderate to severe plaque psoriasis.
Detailed Description
This study will consist of a 4 week screening period, 12 week treatment period, and a 4 week follow up period for a total of 20 weeks. Each participant will be randomized to receive ESK-001 or placebo daily for 12 weeks. An open label extension study will be available for those patients who complete the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Total body weight \>40 kg (88 lb)
- •Men and woman age 18-75
- •Men and Women must use highly effective methods of contraception for the entirety of the study
Exclusion Criteria
- •History of malignancy within the last 5 years
- •Positive for HIV, Hepatitis B or C
- •History of tuberculosis
- •Diagnosis of non-plaque psoriasis
- •Patients with QTcF \>450 msec (males) or \>470 msec (females) at screening
- •Live vaccines
Arms & Interventions
ESK-001 Dose Level 1
ESK-001 administered as an oral tablet
Intervention: ESK-001
ESK-001 Dose Level 2
ESK-001 administered as an oral tablet
Intervention: ESK-001
ESK-001 Dose Level 3
ESK-001 administered as an oral tablet
Intervention: ESK-001
ESK-001 Dose Level 4
ESK-001 administered as an oral tablet
Intervention: ESK-001
ESK-001 Dose Level 5
ESK-001 administered as an oral tablet
Intervention: ESK-001
Placebo
Placebo administered as an oral tablet
Intervention: Placebo
Outcomes
Primary Outcomes
To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo
Time Frame: 12 weeks
Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score
Secondary Outcomes
- To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients(12 weeks)
- To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score(12 weeks)
- To Characterize the Pharmacokinetics (PK) of ESK-001(14 weeks)