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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05600036
Enrollment
228
Registered
2022-10-31
Start date
2022-09-27
Completion date
2023-07-25
Last updated
2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

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.

Interventions

DRUGESK-001

Oral tablet

DRUGPlacebo

Oral tablet

Sponsors

Alumis Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo12 weeksProportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score

Secondary

MeasureTime frameDescription
To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients12 weeksIncidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). See Adverse Events section.
To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score12 weeksProportion of patients achieving an sPGA score of 0 (cleared) or 1 (minimal)
To Characterize the Pharmacokinetics (PK) of ESK-00114 weeksPlasma concentrations and PK parameters of ESK-001.

Countries

Canada, Czechia, United States

Participant flow

Participants by arm

ArmCount
ESK-001 10mg QD
ESK-001 10mg tablet once a day
36
ESK-001 20mg QD
ESK-001 20mg tablet once a day
36
ESK-001 40mg QD
ESK-001 40mg tablet once a day
39
ESK-001 20mg BID
ESK-001 20mg tablet twice a day
40
ESK-001 40mg BID
ESK-001 40mg tablet twice a day
39
Placebo
Placebo tablet
38
Total228

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyAdverse Event021010
Overall StudyDiscontinued Prior to Dosing Due to the Blood Sample Logistics000100
Overall StudyLost to Follow-up021100
Overall StudyProtocol Violation002000
Overall StudySubject Can't Continue With Week 16 Visit010000
Overall StudyThe Patient was Terminated From The Study Due to Sponsor Requirements000100
Overall StudyWithdrawal by Subject012035

Baseline characteristics

CharacteristicESK-001 20mg QDESK-001 40mg QDESK-001 20mg BIDESK-001 40mg BIDPlaceboESK-001 10mg QDTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants2 Participants5 Participants6 Participants3 Participants3 Participants22 Participants
Age, Categorical
Between 18 and 65 years
33 Participants37 Participants35 Participants33 Participants35 Participants33 Participants206 Participants
Age, Continuous43.9 years
STANDARD_DEVIATION 11.99
49.5 years
STANDARD_DEVIATION 10.45
47.7 years
STANDARD_DEVIATION 12.52
47.9 years
STANDARD_DEVIATION 14.17
49.1 years
STANDARD_DEVIATION 11.67
48.8 years
STANDARD_DEVIATION 12.7
47.8 years
STANDARD_DEVIATION 12.3
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants13 Participants7 Participants11 Participants13 Participants7 Participants65 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants26 Participants33 Participants28 Participants24 Participants29 Participants161 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants2 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Asian
2 Participants2 Participants2 Participants2 Participants4 Participants1 Participants13 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants1 Participants1 Participants1 Participants3 Participants4 Participants10 Participants
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
0 Participants0 Participants2 Participants0 Participants0 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Other
2 Participants2 Participants1 Participants1 Participants4 Participants0 Participants10 Participants
Race/Ethnicity, Customized
Unknown or Not Reported
0 Participants0 Participants0 Participants2 Participants0 Participants0 Participants2 Participants
Race/Ethnicity, Customized
White
31 Participants33 Participants34 Participants33 Participants27 Participants30 Participants188 Participants
Sex: Female, Male
Female
12 Participants13 Participants17 Participants13 Participants7 Participants12 Participants74 Participants
Sex: Female, Male
Male
24 Participants26 Participants23 Participants26 Participants31 Participants24 Participants154 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 360 / 360 / 390 / 390 / 390 / 38
other
Total, other adverse events
8 / 364 / 3611 / 3918 / 3918 / 399 / 38
serious
Total, serious adverse events
1 / 360 / 361 / 393 / 390 / 390 / 38

Outcome results

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

Time frame: 12 weeks

Population: All Randomized and Treated Participants

ArmMeasureValue (NUMBER)
ESK-001 10mg QDTo Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo19.4 Percentage
ESK-001 20mg QDTo Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo33.3 Percentage
ESK-001 40mg QDTo Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo56.4 Percentage
ESK-001 20mg BIDTo Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo56.4 Percentage
ESK-001 40mg BIDTo Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo64.1 Percentage
PlaceboTo Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo0 Percentage
p-value: 0.0025Cochran-Mantel-Haenszel
p-value: 0.0001Cochran-Mantel-Haenszel
p-value: <0.0001Cochran-Mantel-Haenszel
p-value: <0.0001Cochran-Mantel-Haenszel
p-value: <0.0001Cochran-Mantel-Haenszel
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)

Time frame: 12 weeks

Population: mITT population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ESK-001 10mg QDTo Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score6 Participants
ESK-001 20mg QDTo Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score14 Participants
ESK-001 40mg QDTo Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score21 Participants
ESK-001 20mg BIDTo Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score19 Participants
ESK-001 40mg BIDTo Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score23 Participants
PlaceboTo Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score3 Participants
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.

Time frame: 12 weeks

Population: Safety Analysis Set

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ESK-001 10mg QDTo Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients19 Participants
ESK-001 20mg QDTo Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients14 Participants
ESK-001 40mg QDTo Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients19 Participants
ESK-001 20mg BIDTo Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients18 Participants
ESK-001 40mg BIDTo Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients25 Participants
PlaceboTo Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients15 Participants
Secondary

To Characterize the Pharmacokinetics (PK) of ESK-001

Plasma concentrations and PK parameters of ESK-001.

Time frame: 14 weeks

Population: PK Analysis Set

ArmMeasureValue (MEAN)Dispersion
ESK-001 10mg QDTo Characterize the Pharmacokinetics (PK) of ESK-00111.9 ng/mlStandard Deviation 12.4
ESK-001 20mg QDTo Characterize the Pharmacokinetics (PK) of ESK-00133.0 ng/mlStandard Deviation 49.9
ESK-001 40mg QDTo Characterize the Pharmacokinetics (PK) of ESK-00150.7 ng/mlStandard Deviation 44.8
ESK-001 20mg BIDTo Characterize the Pharmacokinetics (PK) of ESK-00163.9 ng/mlStandard Deviation 44.8
ESK-001 40mg BIDTo Characterize the Pharmacokinetics (PK) of ESK-001174.0 ng/mlStandard Deviation 125
PlaceboTo Characterize the Pharmacokinetics (PK) of ESK-0012.9 ng/mlStandard Deviation 10.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026