A Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Patients With Plaque Psoriasis
Overview
- Phase
- Phase 2
- Intervention
- ESK-001
- Conditions
- Plaque Psoriasis
- Sponsor
- Alumis Inc
- Enrollment
- 165
- Locations
- 38
- Primary Endpoint
- To assess the safety and tolerability of long-term ESK-001 treatment
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.
Detailed Description
This study will consist of patients who have completed their participation in a previous plaque psoriasis study of ESK-001. Each patient will be assigned to receive ESK-001 at one of two open-label dose levels. Patients have the option to remain on study until ESK-001 is commercially available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must have completed a prior ESK-001 study
- •Men and Women must use highly effective methods of contraception for the entirety of the study
Exclusion Criteria
- •Pregnancy
- •Received a prohibited concomitant medication
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
Outcomes
Primary Outcomes
To assess the safety and tolerability of long-term ESK-001 treatment
Time Frame: Approximately 3 years
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Secondary Outcomes
- To assess the long-term efficacy of ESK-001(Approximately 3 years)
- To assess the change in quality of life (QoL) with long-term ESK-001 administration(Approximately 3 years)
- To assess the pharmacokinetics (PK) of ESK-001 (ctrough)(2 years)