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

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ESK-001
Placebo
Sponsored by
Alumis Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Investigator Site #1029
  • Investigator Site # 1001
  • Investigator Site #1023
  • Investigator Site #1021
  • Investigator Site # 1008
  • Investigator Site #1024
  • Investigator Site # 1018
  • Investigator Site #1016
  • Investigator Site # 1007
  • Investigator Site # 1002
  • Investigator Site #1039
  • Investigator Site #1013
  • Investigator Site #1030
  • Investigator Site #1025
  • Investigator Site #1028
  • Investigator Site #1042
  • Investigator Site #1035
  • Investigator Site #1043
  • Investigator Site # 1005
  • Investigator Site #1011
  • Investigator Site #1027
  • Investigator Site #1036
  • Investigator Site #1034
  • Investigator Site #1017
  • Investigator Site #1026
  • Investigator Site #1009
  • Investigator Site # 1010
  • Investigator Site #1038
  • Investigator Site #1031
  • Investigator Site #1014
  • Investigator Site #1037
  • Investigator Site #1033
  • Investigator Site # 1019
  • Investigator Site #1022
  • Investigator Site #1012
  • Investigator Site # 1015
  • Investigator Site #1006
  • Investigator Site #1041
  • Investigator Site #2001
  • Investigator Sie #2008
  • Investigator Site #2003
  • Investigator Site #2006
  • Investigator Site #2004
  • Investigator Site #2007
  • Investigator Site #2005
  • Investigator Site #2009
  • Investigator Site #2002
  • Investigator Site #2010
  • Investigator Site #5515
  • Investigator Site #5507
  • Investigator Site #5514
  • Investigator Site #5506
  • Investigator Site #5505

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ESK-001 Dose Level 1

ESK-001 Dose Level 2

ESK-001 Dose Level 3

ESK-001 Dose Level 4

ESK-001 Dose Level 5

Placebo

Arm Description

ESK-001 administered as an oral tablet

ESK-001 administered as an oral tablet

ESK-001 administered as an oral tablet

ESK-001 administered as an oral tablet

ESK-001 administered as an oral tablet

Placebo administered as an oral tablet

Outcomes

Primary Outcome Measures

To compare the Psoriasis Area and Severity Index (PASI-75) between doses of ESK-001 and placebo
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
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
Proportion of patients achieving an sPGA score of "0" ("cleared") or "1" ("minimal")
To characterize the pharmacokinetics (PK) of ESK-001 (Cmax)
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)
Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001 at Week 8

Full Information

First Posted
October 12, 2022
Last Updated
August 31, 2023
Sponsor
Alumis Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05600036
Brief Title
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
June 29, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alumis Inc

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESK-001 Dose Level 1
Arm Type
Experimental
Arm Description
ESK-001 administered as an oral tablet
Arm Title
ESK-001 Dose Level 2
Arm Type
Experimental
Arm Description
ESK-001 administered as an oral tablet
Arm Title
ESK-001 Dose Level 3
Arm Type
Experimental
Arm Description
ESK-001 administered as an oral tablet
Arm Title
ESK-001 Dose Level 4
Arm Type
Experimental
Arm Description
ESK-001 administered as an oral tablet
Arm Title
ESK-001 Dose Level 5
Arm Type
Experimental
Arm Description
ESK-001 administered as an oral tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered as an oral tablet
Intervention Type
Drug
Intervention Name(s)
ESK-001
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
To compare the Psoriasis Area and Severity Index (PASI-75) between doses of ESK-001 and placebo
Description
Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability of ESK-001 dose in moderate to severe psoriasis patients
Description
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame
12 weeks
Title
To assess the response rate in static Physician's Global Assessment (sPGA) score
Description
Proportion of patients achieving an sPGA score of "0" ("cleared") or "1" ("minimal")
Time Frame
12 weeks
Title
To characterize the pharmacokinetics (PK) of ESK-001 (Cmax)
Description
Plasma concentrations and PK parameters including steady-state maximum observed concentration (Cmax) for ESK-001 at Week 8
Time Frame
8 weeks
Title
To characterize the pharmacokinetics (PK) of ESK-001 (Ctrough)
Description
Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001 at Week 8
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Investigator Site #1029
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Investigator Site # 1001
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Investigator Site #1023
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Investigator Site #1021
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Investigator Site # 1008
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Investigator Site #1024
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Investigator Site # 1018
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Investigator Site #1016
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Investigator Site # 1007
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Investigator Site # 1002
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Investigator Site #1039
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Investigator Site #1013
City
Brandon
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Investigator Site #1030
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Investigator Site #1025
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Investigator Site #1028
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Investigator Site #1042
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Investigator Site #1035
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Investigator Site #1043
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Investigator Site # 1005
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Investigator Site #1011
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Investigator Site #1027
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Investigator Site #1036
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Investigator Site #1034
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Investigator Site #1017
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Investigator Site #1026
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Investigator Site #1009
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Investigator Site # 1010
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Investigator Site #1038
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Investigator Site #1031
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Investigator Site #1014
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Investigator Site #1037
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Investigator Site #1033
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73170
Country
United States
Facility Name
Investigator Site # 1019
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Investigator Site #1022
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Investigator Site #1012
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Investigator Site # 1015
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Investigator Site #1006
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Investigator Site #1041
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Investigator Site #2001
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
Investigator Sie #2008
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Investigator Site #2003
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Investigator Site #2006
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Investigator Site #2004
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Facility Name
Investigator Site #2007
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Investigator Site #2005
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Investigator Site #2009
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Facility Name
Investigator Site #2002
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Investigator Site #2010
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Investigator Site #5515
City
Svitavy
State/Province
Pardubice
ZIP/Postal Code
568 02
Country
Czechia
Facility Name
Investigator Site #5507
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Investigator Site #5514
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Investigator Site #5506
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Investigator Site #5505
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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