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A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05600036
Recruitment Status : Completed
First Posted : October 31, 2022
Last Update Posted : September 1, 2023
Sponsor:
Information provided by (Responsible Party):
Alumis Inc

Study Description
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Brief Summary:
This is a multi-center, randomized, double-blind, placebo-controlled study in patients with moderate to severe plaque psoriasis.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: ESK-001 Drug: Placebo Phase 2

Detailed Description:
This study will consist of a 4 week screening period, 12 week treatment period, and a 4 week follow up period for a total of 20 weeks. Each participant will be randomized to receive ESK-001 or placebo daily for 12 weeks. An open label extension study will be available for those patients who complete the study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
Actual Study Start Date : September 27, 2022
Actual Primary Completion Date : June 29, 2023
Actual Study Completion Date : July 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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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
Experimental: ESK-001 Dose Level 3
ESK-001 administered as an oral tablet
 Drug: ESK-001
Oral tablet
Experimental: ESK-001 Dose Level 4
ESK-001 administered as an oral tablet
 Drug: ESK-001
Oral tablet
Experimental: ESK-001 Dose Level 5
ESK-001 administered as an oral tablet
 Drug: ESK-001
Oral tablet
Placebo Comparator: Placebo
Placebo administered as an oral tablet
 Drug: Placebo
Oral tablet


Outcome Measures
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Primary Outcome Measures :
  1. To compare the Psoriasis Area and Severity Index (PASI-75) between doses of ESK-001 and placebo [ Time Frame: 12 weeks ]
    Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score


Secondary Outcome Measures :
  1. To assess the safety and tolerability of ESK-001 dose in moderate to severe psoriasis patients [ Time Frame: 12 weeks ]
    Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  2. To assess the response rate in static Physician's Global Assessment (sPGA) score [ Time Frame: 12 weeks ]
    Proportion of patients achieving an sPGA score of "0" ("cleared") or "1" ("minimal")

  3. To characterize the pharmacokinetics (PK) of ESK-001 (Cmax) [ Time Frame: 8 weeks ]
    Plasma concentrations and PK parameters including steady-state maximum observed concentration (Cmax) for ESK-001 at Week 8

  4. To characterize the pharmacokinetics (PK) of ESK-001 (Ctrough) [ Time Frame: 8 weeks ]
    Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001 at Week 8


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Total body weight >40 kg (88 lb)
  • Men and woman age 18-75
  • Men and Women must use highly effective methods of contraception for the entirety of the study

Exclusion Criteria:

  • History of malignancy within the last 5 years
  • Positive for HIV, Hepatitis B or C
  • History of tuberculosis
  • Diagnosis of non-plaque psoriasis
  • Patients with QTcF >450 msec (males) or >470 msec (females) at screening
  • Live vaccines
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05600036


Locations
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Sponsors and Collaborators
Alumis Inc
More Information
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Responsible Party: Alumis Inc
ClinicalTrials.gov Identifier: NCT05600036    
Other Study ID Numbers: ESK-001-006
First Posted: October 31, 2022    Key Record Dates
Last Update Posted: September 1, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases