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CompletedNCT05600036Updated Jun 18, 2025Results posted

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

A Phase 2 interventional study of ESK-001 and Placebo in Plaque Psoriasis, sponsored by Alumis Inc. Completed at 53 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Alumis Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
228
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Plaque Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 228 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Alumis Inc is the lead sponsor of 12 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
228 participants (actual)

Study arms

  • Experimental
    ESK-001 Dose Level 1

    ESK-001 administered as an oral tablet

    Drug: ESK-001

  • Experimental
    ESK-001 Dose Level 2

    ESK-001 administered as an oral tablet

    Drug: ESK-001

  • Experimental
    ESK-001 Dose Level 3

    ESK-001 administered as an oral tablet

    Drug: ESK-001

  • Experimental
    ESK-001 Dose Level 4

    ESK-001 administered as an oral tablet

    Drug: ESK-001

  • Experimental
    ESK-001 Dose Level 5

    ESK-001 administered as an oral tablet

    Drug: ESK-001

  • Placebo comparator
    Placebo

    Placebo administered as an oral tablet

    Drug: Placebo

Interventions

  • DrugESK-001

    Oral tablet

  • DrugPlacebo

    Oral tablet

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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")

    Time frame: 12 weeks

  3. To Characterize the Pharmacokinetics (PK) of ESK-001

    Plasma concentrations and PK parameters of ESK-001.

    Time frame: 14 weeks

07

Results

Posted Jul 23, 2024

Participant flow

Participant flow — Overall Study
MilestoneESK-001 10mg QDESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlacebo
Started363639403938
Completed363033373533
Not completed066345
Withdrew: Adverse event021010
Withdrew: Lost to follow-up021100
Withdrew: Protocol violation002000
Withdrew: Withdrawal by subject012035
Withdrew: Discontinued prior to dosing due to the blood sample logistics000100
Withdrew: Subject can't continue with week 16 visit010000
Withdrew: The patient was terminated from the study due to sponsor requirements000100

Outcome measures

PrimaryTo 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

Time frame:
12 weeks
Reported as:
Number · Percentage
To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo
PercentageESK-001 10mg QDESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlacebo
To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo19.4 (8.2 to 36.0)33.3 (18.6 to 51.0)56.4 (39.6 to 72.2)56.4 (36.6 to 72.2)64.1 (47.2 to 78.8)0 (0.0 to 9.3)
Statistical analysis
  • ESK-001 10mg QD vs Placebo · Cochran-Mantel-Haenszel · p = 0.0025
  • ESK-001 20mg QD vs Placebo · Cochran-Mantel-Haenszel · p = 0.0001
  • ESK-001 40mg QD vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001
  • ESK-001 20mg BID vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001
  • ESK-001 40mg BID vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001
SecondaryTo 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.

Time frame:
12 weeks
Reported as:
Count of participants · Participants
To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients
ParticipantsESK-001 Dose Level 1ESK-001 Dose Level 2ESK-001 Dose Level 3ESK-001 Dose Level 4ESK-001 Dose Level 5Placebo
To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients191419182515
SecondaryTo 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")

Time frame:
12 weeks
Reported as:
Count of participants · Participants
To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score
ParticipantsESK-001 10mg QDESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlacebo
To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score6142119233
SecondaryTo Characterize the Pharmacokinetics (PK) of ESK-001

Plasma concentrations and PK parameters of ESK-001.

Time frame:
14 weeks
Reported as:
Mean · ng/ml
To Characterize the Pharmacokinetics (PK) of ESK-001
ng/mlESK-001 10mg QDESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlacebo
To Characterize the Pharmacokinetics (PK) of ESK-00111.9 ± 12.433.0 ± 49.950.7 ± 44.863.9 ± 44.8174.0 ± 125.02.9 ± 10.5

Adverse events

Collected over Adverse Event data was collected from Screening through end of study (Week 16).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ESK-001 10mg QD0/36 (0%)1/36 (2.8%)8/36 (22.2%)
ESK-001 20mg QD0/36 (0%)0/36 (0%)4/36 (11.1%)
ESK-001 40mg QD0/39 (0%)1/39 (2.6%)11/39 (28.2%)
ESK-001 20mg BID0/39 (0%)3/39 (7.7%)18/39 (46.2%)
ESK-001 40mg BID0/39 (0%)0/39 (0%)18/39 (46.2%)
Placebo0/38 (0%)0/38 (0%)9/38 (23.7%)
Most frequent serious events
Most frequent serious events
EventESK-001 10mg QDESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlacebo
Lower limb fractureInjury, poisoning and procedural complications1/360/360/390/390/390/38
Tibia fractureInjury, poisoning and procedural complications0/360/360/391/390/390/38
Coronary artery occlusionCardiac disorders0/360/360/391/390/390/38
ColitisGastrointestinal disorders0/360/360/391/390/390/38
EnteritisGastrointestinal disorders0/360/360/391/390/390/38
Dermatitis contactSkin and subcutaneous tissue disorders0/360/361/390/390/390/38
Most frequent other events
Showing 10 of 13
Most frequent other events
EventESK-001 10mg QDESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlacebo
HeadacheNervous system disorders0/362/364/393/393/392/38
NasopharyngitisInfections and infestations2/360/361/391/393/393/38
COVID-19Infections and infestations0/360/360/391/391/393/38
Upper respiratory tract infectionInfections and infestations2/362/362/391/393/390/38
Diabetes mellitusMetabolism and nutrition disorders2/360/360/391/390/390/38
DizzinessNervous system disorders0/360/361/392/390/390/38
DiarrheaGastrointestinal disorders1/360/361/392/390/390/38
DyspepsiaGastrointestinal disorders0/360/360/392/390/390/38
NauseaGastrointestinal disorders0/360/360/392/390/391/38
AcneSkin and subcutaneous tissue disorders0/360/362/390/392/390/38

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)ESK-001 10mg QDESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlaceboTotal
<=18 years0000000
Between 18 and 65 years333337353335206
>=65 years33256322
Age, Continuous
Age, Continuous(years)ESK-001 10mg QDESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlaceboTotal
Mean48.8 ± 12.743.9 ± 11.9949.5 ± 10.4547.7 ± 12.5247.9 ± 14.1749.1 ± 11.6747.8 ± 12.3
Sex: Female, Male
Sex: Female, Male(Participants)ESK-001 10mg QDESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlaceboTotal
Female1212131713774
Male242426232631154
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ESK-001 10mg QDESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlaceboTotal
Hispanic or Latino714137111365
Not Hispanic or Latino292126332824161
Unknown or Not Reported0100012
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ESK-001 10mg QDESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlaceboTotal
American Indian or Alaska Native0110002
Asian12222413
Native Hawaiian or Pacific Islander1002003
Black or African American40111310
White303133343327188
Other02211410
Unknown or Not Reported0000202
08

Study locations

53 sites
  • Investigator Site #1029
    Birmingham, Alabama 35205, United States
  • Investigator Site # 1001
    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
    Quebec City, Quebec G1V 4X7, Canada
  • Investigator Site #5515
    Svitavy, Pardubice 568 02, Czechia
  • Investigator Site #5507
    Novy Jicin, 741 01, Czechia
  • Investigator Site #5514
    Pardubice, 530 02, Czechia
  • Investigator Site #5506
    Praha 10, 100 00, Czechia
  • Investigator Site #5505
    Praha 10, 100 34, Czechia
09

References and documents

Study documents

  • Study protocol · Aug 9, 2022
  • Statistical analysis plan · Jul 20, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05600036
Lead sponsor
Alumis Inc
Responsible party
Sponsor
First posted
Oct 31, 2022
Start date
Sep 27, 2022
Primary completion
Jun 29, 2023
Completion
Jul 25, 2023
Results posted
Jul 23, 2024
Last update
Jun 18, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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