Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis

Launched by ALUMIS INC · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ESK-001 to see how safe it is when taken for a long time by people with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The trial aims to find out if taking ESK-001 regularly can help reduce the severity of psoriasis symptoms. Eligible participants are adults aged 18 and older who have previously taken part in related studies of ESK-001 and found it to be safe for them. Women who can become pregnant and men who are sexually active with such women must agree to use effective birth control during the study.

Participants will take ESK-001 twice a day for 24 weeks, and then some will be randomly chosen to continue with either ESK-001 or a placebo (a treatment that does not contain the active drug) for an additional period. Throughout the study, participants will have regular check-ups, provide blood and urine samples, and must keep taking the medication as prescribed. If at any time their psoriasis worsens, they can return to taking ESK-001. This study is currently recruiting participants, and it’s important for anyone considering joining to understand the commitment involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females, age ≥18 years
• • 2. Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017)
• • 3. ESK-001 safety and tolerability were acceptable in the parent study
• • 4. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception for the entirety of the study
• Exclusion Criteria:
• • 1. Pregnant, lactating, or planning to get pregnant during the study period
• • 2. Any acute or chronic illness/condition or evidence of an unstable clinical condition that in the Investigator's judgment will substantially increase the risk to the patient if they continue to receive ESK-001 treatment in this extension study
• • 3. Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol