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

Sponsor

Alumis Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05600036

Collaborator

(none)

210

Enrollment

Locations

Arms

12.1

Anticipated Duration (Months)

6.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated Enrollment :

210 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 :

Sep 27, 2022

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

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
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

Primary Outcome Measures

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

Secondary Outcome Measures

To assess the safety and tolerability of ESK-001 dose in moderate to severe psoriasis patients [12 weeks]
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
To assess the response rate in static Physician's Global Assessment (sPGA) score [12 weeks]
Proportion of patients achieving an sPGA score of "0" ("cleared") or "1" ("minimal")
To characterize the pharmacokinetics (PK) of ESK-001 (Cmax) [8 weeks]
Plasma concentrations and PK parameters including steady-state maximum observed concentration (Cmax) for ESK-001 at Week 8
To characterize the pharmacokinetics (PK) of ESK-001 (Ctrough) [8 weeks]
Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001 at Week 8

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Investigator Site # 1001	Phoenix	Arizona	United States	85032
2	Investigator Site #1023	Rogers	Arkansas	United States	72758
3	Investigator Site #1021	Encinitas	California	United States	92024
4	Investigator Site # 1008	Fremont	California	United States	94538
5	Investigator Site # 1018	Los Angeles	California	United States	90045
6	Investigator Site #1016	San Diego	California	United States	92123
7	Investigator Site # 1007	Santa Monica	California	United States	90404
8	Investigator Site # 1002	Sherman Oaks	California	United States	91403
9	Investigator Site #1013	Brandon	Florida	United States	33756
10	Investigator Site #1030	Fort Lauderdale	Florida	United States	33308
11	Investigator Site #1025	Hialeah	Florida	United States	33012
12	Investigator Site #1028	Miami	Florida	United States	33175
13	Investigator Site #1035	Macon	Georgia	United States	31217
14	Investigator Site # 1005	Rolling Meadows	Illinois	United States	60008
15	Investigator Site #1011	Indianapolis	Indiana	United States	46250
16	Investigator Site #1027	South Bend	Indiana	United States	46617
17	Investigator Site #1036	Overland Park	Kansas	United States	66210
18	Investigator Site #1017	Owensboro	Kentucky	United States	42303
19	Investigator Site #1009	Bay City	Michigan	United States	48706
20	Investigator Site # 1010	Clarkston	Michigan	United States	48346
21	Investigator Site #1038	Warren	Michigan	United States	48088
22	Investigator Site #1031	New Brighton	Minnesota	United States	55112
23	Investigator Site #1033	Oklahoma City	Oklahoma	United States	73170
24	Investigator Site # 1019	Portland	Oregon	United States	97223
25	Investigator Site #1022	Philadelphia	Pennsylvania	United States	19103
26	Investigator Site #1012	Rapid City	South Dakota	United States	57702
27	Investigator Site # 1015	Houston	Texas	United States	77056
28	Investigator Site #1006	San Antonio	Texas	United States	78213
29	Investigator Site #1041	South Jordan	Utah	United States	84095
30	Investigator Site #2004	Mississauga	Ontario	Canada	L4Y 4C5
31	Investigator Site #2007	North Bay	Ontario	Canada	P1B 3Z7
32	Investigator Site #2002	Waterloo	Ontario	Canada	N2J 1C4
33	Investigator Site #2010	Quebec City	Quebec	Canada	G1V 4X7

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:

NCT05600036

Other Study ID Numbers:

ESK-001-006

First Posted:

Oct 31, 2022

Last Update Posted:

Dec 27, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Psoriasis

Study Results

No Results Posted as of Dec 27, 2022