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

Phase 2

Active, not recruiting

• Conditions: Plaque Psoriasis
• Interventions: Drug: ESK-001

• Registration Number: NCT05739435
• Lead Sponsor: Alumis Inc

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.

Study Timeline

• Study Start: 2023-01-17
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESK-001 Dose Level 2	ESK-001	ESK-001 administered as an oral tablet
ESK-001 Dose Level 1	ESK-001	ESK-001 administered as an oral tablet

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of long-term ESK-001 treatment	Approximately 3 years	Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Secondary Outcome Measures

Name	Time	Method
To assess the long-term efficacy of ESK-001	Approximately 3 years	Change from baseline in Psoriasis Area and Severity Index (PASI) over time
To assess the change in quality of life (QoL) with long-term ESK-001 administration	Approximately 3 years	Change from baseline in Dermatology Life Quality Index (DLQI) over time
To assess the pharmacokinetics (PK) of ESK-001 (ctrough)	2 years	Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001

Trial Locations

Locations (38)

Investigator Site # 1029; 🇺🇸 Birmingham, Alabama, United States

Investigator Site #1001; 🇺🇸 Phoenix, Arizona, United States

Investigator Site # 1023; 🇺🇸 Rogers, Arkansas, United States

Investigator Site #1021; 🇺🇸 Encinitas, California, United States

Investigator Site #1018; 🇺🇸 Los Angeles, California, United States

Investigator Site #1007; 🇺🇸 Santa Monica, California, United States

Investigator Site #1002; 🇺🇸 Sherman Oaks, California, United States

Investigator site # 1030; 🇺🇸 Fort Lauderdale, Florida, United States

Investigator Site #1025; 🇺🇸 Hialeah, Florida, United States

Investigator site # 1028; 🇺🇸 Miami, Florida, United States

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