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

• Sponsor: Alumis Inc (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05739435
• Collaborator: (none)
• Enrollment: 210
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 47.4
• Patients Per Site: 105
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis	Drug: ESK-001	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Patients With Plaque Psoriasis
• Actual Study Start Date: Jan 17, 2023
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ESK-001 Dose Level 1 ESK-001 administered as an oral tablet	Drug: ESK-001; Oral tablet
Experimental: ESK-001 Dose Level 2 ESK-001 administered as an oral tablet	Drug: ESK-001; Oral tablet

Outcome Measures

Primary Outcome Measures

1. 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

1. To assess the long-term efficacy of ESK-001 [Approximately 3 years]

   Change from baseline in Psoriasis Area and Severity Index (PASI) over time

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigator Site #1001	Phoenix	Arizona	United States	85032
2	Investigator Site #1005	Rolling Meadows	Illinois	United States	60008

Sponsors and Collaborators

• Alumis Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alumis Inc
• ClinicalTrials.gov Identifier: NCT05739435
• Other Study ID Numbers: ESK-001-007
• First Posted: Feb 22, 2023
• Last Update Posted: Feb 22, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Feb 22, 2023