Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis

Alumis

Status and phase: Active, not recruiting; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: ESK-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05739435

ESK-001-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

ESK-001 Dose Level 1

Experimental group

Description:

ESK-001 administered as an oral tablet

Treatment:

Drug: ESK-001

ESK-001 Dose Level 2

Experimental group

Description:

ESK-001 administered as an oral tablet

Treatment:

Drug: ESK-001