A Study to Evaluate the Efficacy and Safety of ESK-001 in... | NCT05600036 | Trialant
NCT05600036
Sponsor
Alumis Inc
Status
Completed
Last Update Posted
Jun 18, 2025Actual
Enrollment
228Actual
Phase
Phase 2
Conditions
Plaque Psoriasis
Interventions
ESK-001
Placebo
Countries
United States
Canada
Czechia
Protocol Section
Identification Module
NCT ID
NCT05600036
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ESK-001-006
Secondary IDs
Not provided
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
Acronym
Not provided
Organization
Alumis IncINDUSTRY
Status Module
Record Verification Date
Jun 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 27, 2022Actual
Primary Completion Date
Jun 29, 2023Actual
Completion Date
Jul 25, 2023Actual
First Submitted Date
Oct 12, 2022
First Submission Date that Met QC Criteria
Oct 27, 2022
First Posted Date
Oct 31, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Jun 26, 2024
Results First Submitted that Met QC Criteria
Jun 26, 2024
Results First Posted Date
Jul 23, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 3, 2025
Last Update Posted Date
Jun 18, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alumis IncINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Plaque Psoriasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
228Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ESK-001 Dose Level 1
Experimental
ESK-001 administered as an oral tablet
Drug: ESK-001
ESK-001 Dose Level 2
Experimental
ESK-001 administered as an oral tablet
Drug: ESK-001
ESK-001 Dose Level 3
Experimental
ESK-001 administered as an oral tablet
Drug: ESK-001
ESK-001 Dose Level 4
Experimental
ESK-001 administered as an oral tablet
Drug: ESK-001
ESK-001 Dose Level 5
Experimental
ESK-001 administered as an oral tablet
Drug: ESK-001
Placebo
Placebo Comparator
Placebo administered as an oral tablet
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ESK-001
Drug
Oral tablet
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
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
12 weeks
Secondary Outcomes
Measure
Description
Time Frame
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). See Adverse Events section.
12 weeks
To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score
Other Outcomes
Not provided
Eligibility Module
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
Blauvelt A, Arenberger P, Sauder MB, Couvillion M, Rubio RG, Vlahakis NE, Ucpinar S, Ma G, Hitraya E, Tilley MK, Papp KA; STRIDE Investigators. Highly selective, allosteric inhibition of TYK2 with oral ESK-001 in patients with moderate-to-severe plaque psoriasis: Results from STRIDE, a 12-week, randomized, double-blinded, placebo-controlled, dose-ranging phase 2 study. J Am Acad Dermatol. 2026 Jan;94(1):57-65. doi: 10.1016/j.jaad.2025.07.013. Epub 2025 Jul 12.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ESK-001 10mg QD
ESK-001 10mg tablet once a day
FG001
ESK-001 20mg QD
ESK-001 20mg tablet once a day
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 9, 2022
Jun 26, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Placebo
Drug
Oral tablet
Placebo
Proportion of patients achieving an sPGA score of "0" ("cleared") or "1" ("minimal")
12 weeks
To Characterize the Pharmacokinetics (PK) of ESK-001
Plasma concentrations and PK parameters of ESK-001.
14 weeks
Phoenix
Arizona
85032
United States
Investigator Site #1023
Rogers
Arkansas
72758
United States
Investigator Site #1021
Encinitas
California
92024
United States
Investigator Site # 1008
Fremont
California
94538
United States
Investigator Site #1024
Los Angeles
California
90033
United States
Investigator Site # 1018
Los Angeles
California
90045
United States
Investigator Site #1016
San Diego
California
92123
United States
Investigator Site # 1007
Santa Monica
California
90404
United States
Investigator Site # 1002
Sherman Oaks
California
91403
United States
Investigator Site #1039
Brandon
Florida
33511
United States
Investigator Site #1013
Brandon
Florida
33756
United States
Investigator Site #1030
Fort Lauderdale
Florida
33308
United States
Investigator Site #1025
Hialeah
Florida
33012
United States
Investigator Site #1028
Miami
Florida
33175
United States
Investigator Site #1042
Tampa
Florida
33613
United States
Investigator Site #1035
Macon
Georgia
31217
United States
Investigator Site #1043
Sandy Springs
Georgia
30328
United States
Investigator Site # 1005
Rolling Meadows
Illinois
60008
United States
Investigator Site #1011
Indianapolis
Indiana
46250
United States
Investigator Site #1027
South Bend
Indiana
46617
United States
Investigator Site #1036
Overland Park
Kansas
66210
United States
Investigator Site #1034
Louisville
Kentucky
40241
United States
Investigator Site #1017
Owensboro
Kentucky
42303
United States
Investigator Site #1026
Rockville
Maryland
20850
United States
Investigator Site #1009
Bay City
Michigan
48706
United States
Investigator Site # 1010
Clarkston
Michigan
48346
United States
Investigator Site #1038
Warren
Michigan
48088
United States
Investigator Site #1031
New Brighton
Minnesota
55112
United States
Investigator Site #1014
Las Vegas
Nevada
89148
United States
Investigator Site #1037
Portsmouth
New Hampshire
03801
United States
Investigator Site #1033
Oklahoma City
Oklahoma
73170
United States
Investigator Site # 1019
Portland
Oregon
97223
United States
Investigator Site #1022
Philadelphia
Pennsylvania
19103
United States
Investigator Site #1012
Rapid City
South Dakota
57702
United States
Investigator Site # 1015
Houston
Texas
77056
United States
Investigator Site #1006
San Antonio
Texas
78213
United States
Investigator Site #1041
South Jordan
Utah
84095
United States
Investigator Site #2001
Edmonton
Alberta
T6G 1C3
Canada
Investigator Sie #2008
Surrey
British Columbia
V3V 0C6
Canada
Investigator Site #2003
Winnipeg
Manitoba
R3M 3Z4
Canada
Investigator Site #2006
London
Ontario
N6H 5L5
Canada
Investigator Site #2004
Mississauga
Ontario
L4Y 4C5
Canada
Investigator Site #2007
North Bay
Ontario
P1B 3Z7
Canada
Investigator Site #2005
Oakville
Ontario
L6J 7W5
Canada
Investigator Site #2009
Toronto
Ontario
M3H 5Y8
Canada
Investigator Site #2002
Waterloo
Ontario
N2J 1C4
Canada
Investigator Site #2010
Québec
Quebec
G1V 4X7
Canada
Investigator Site #5515
Svitavy
Pardubice
568 02
Czechia
Investigator Site #5507
Nový Jičín
741 01
Czechia
Investigator Site #5514
Pardubice
530 02
Czechia
Investigator Site #5506
Prague
100 00
Czechia
Investigator Site #5505
Prague
100 34
Czechia
FG002
ESK-001 40mg QD
ESK-001 40mg tablet once a day
FG003
ESK-001 20mg BID
ESK-001 20mg tablet twice a day
FG004
ESK-001 40mg BID
ESK-001 40mg tablet twice a day
FG005
Placebo
Placebo tablet
FG00036 subjects
FG00136 subjects
FG00239 subjects
FG00340 subjects
FG00439 subjects
FG00538 subjects
COMPLETED
FG00036 subjects
FG00130 subjects
FG00233 subjects
FG00337 subjects
FG00435 subjects
FG00533 subjects
NOT COMPLETED
FG0000 subjects
FG0016 subjects
FG0026 subjects
FG0033 subjects
FG0044 subjects
FG0055 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Discontinued Prior to Dosing Due to the Blood Sample Logistics
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Subject Can't Continue With Week 16 Visit
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
The Patient was Terminated From The Study Due to Sponsor Requirements
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ESK-001 10mg QD
ESK-001 10mg tablet once a day
BG001
ESK-001 20mg QD
ESK-001 20mg tablet once a day
BG002
ESK-001 40mg QD
ESK-001 40mg tablet once a day
BG003
ESK-001 20mg BID
ESK-001 20mg tablet twice a day
BG004
ESK-001 40mg BID
ESK-001 40mg tablet twice a day
BG005
Placebo
Placebo tablet
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00036
BG00136
BG00239
BG00340
BG00439
BG00538
BG006228
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00048.8± 12.7
BG00143.9± 11.99
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG00112
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0007
BG00114
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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
All Randomized and Treated Participants
Posted
Number
95% Confidence Interval
Percentage
12 weeks
ID
Title
Description
OG000
ESK-001 10mg QD
ESK-001 10mg tablet once a day
OG001
ESK-001 20mg QD
ESK-001 20mg tablet once a day
OG002
ESK-001 40mg QD
ESK-001 40mg tablet once a day
OG003
ESK-001 20mg BID
ESK-001 20mg tablet twice a day
OG004
ESK-001 40mg BID
ESK-001 40mg tablet twice a day
OG005
Placebo
Placebo tablet
Units
Counts
Participants
OG00036
OG00136
OG00239
OG003
Title
Denominators
Categories
Title
Measurements
OG00019.4(8.2 to 36.0)
OG00133.3(18.6 to 51.0)
OG00256.4(39.6 to 72.2)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Cochran-Mantel-Haenszel
0.0025
Superiority
OG001
OG005
Cochran-Mantel-Haenszel
0.0001
Secondary
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). See Adverse Events section.
Safety Analysis Set
Posted
Count of Participants
Participants
12 weeks
ID
Title
Description
OG000
ESK-001 Dose Level 1
ESK-001 administered as an oral tablet
ESK-001: Oral tablet
OG001
ESK-001 Dose Level 2
ESK-001 administered as an oral tablet
ESK-001: Oral tablet
OG002
ESK-001 Dose Level 3
ESK-001 administered as an oral tablet
ESK-001: Oral tablet
OG003
ESK-001 Dose Level 4
ESK-001 administered as an oral tablet
ESK-001: Oral tablet
OG004
ESK-001 Dose Level 5
Secondary
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")
mITT population
Posted
Count of Participants
Participants
12 weeks
ID
Title
Description
OG000
ESK-001 10mg QD
ESK-001 10mg tablet once a day
OG001
ESK-001 20mg QD
ESK-001 20mg tablet once a day
OG002
ESK-001 40mg QD
ESK-001 40mg tablet once a day
OG003
ESK-001 20mg BID
ESK-001 20mg tablet twice a day
OG004
ESK-001 40mg BID
ESK-001 40mg tablet twice a day
OG005
Secondary
To Characterize the Pharmacokinetics (PK) of ESK-001
Plasma concentrations and PK parameters of ESK-001.
PK Analysis Set
Posted
Mean
Standard Deviation
ng/ml
14 weeks
ID
Title
Description
OG000
ESK-001 10mg QD
ESK-001 10mg tablet once a day
OG001
ESK-001 20mg QD
ESK-001 20mg tablet once a day
OG002
ESK-001 40mg QD
ESK-001 40mg tablet once a day
OG003
ESK-001 20mg BID
ESK-001 20mg tablet twice a day
OG004
ESK-001 40mg BID
ESK-001 40mg tablet twice a day
OG005
Placebo
Time Frame
Adverse Event data was collected from Screening through end of study (Week 16).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ESK-001 10mg QD
ESK-001 10mg tablet once a day
0
36
1
36
8
36
EG001
ESK-001 20mg QD
ESK-001 20mg tablet once a day
0
36
0
36
4
36
EG002
ESK-001 40mg QD
ESK-001 40mg tablet once a day
0
39
1
39
11
39
EG003
ESK-001 20mg BID
ESK-001 20mg tablet twice a day
0
39
3
39
18
39
EG004
ESK-001 40mg BID
ESK-001 40mg tablet twice a day
0
39
0
39
18
39
EG005
Placebo
Placebo tablet
0
38
0
38
9
38
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG0030 affected39 at risk
EG004
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0021 affected39 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 affected36 at risk
EG0012 affected36 at risk
EG0022 affected39 at risk
EG0031 affected39 at risk
EG0043 affected39 at risk
EG0050 affected38 at risk
Nasopharyngitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected36 at risk
EG0021 affected39 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0012 affected36 at risk
EG0024 affected39 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0021 affected39 at risk
EG003
Diarrhea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected36 at risk
EG0021 affected39 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0022 affected39 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected36 at risk
EG0020 affected39 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Investigator may publish after the earlier of: publication of the final multicenter publication or 24 months after completion of the Study.
Investigator will provide to Sponsor a copy of any publication at least 60 days prior to submission. Sponsor may delete any confidential or proprietary information of Sponsor from the publication. Investigator will delay any publication an additional 90 days if requested to enable Sponsor to secure patent protection.