Plaque PsoriasisPhase 2NCT05600036

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

A Phase 2 study testing ESK-001 in people with Plaque Psoriasis, run by Alumis Inc at 53 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Plaque Psoriasis
What is being tested?: ESK-001
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 228 participants
Where: 53 sitesin 3 countries
Study dates: 27 Sep 2022to 25 Jul 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

53 sites in 3 countries.

Country

City, postcode or hospital

53 sites in 3 countries

United States38 sites

Investigator Site #1009
Bay City, Michigan, 48706
Investigator Site #1029
Birmingham, Alabama, 35205
Investigator Site #1039
Brandon, Florida, 33511
Investigator Site #1013
Brandon, Florida, 33756
Investigator Site # 1010
Clarkston, Michigan, 48346
Investigator Site #1021
Encinitas, California, 92024
Investigator Site #1030
Fort Lauderdale, Florida, 33308
Investigator Site # 1008
Fremont, California, 94538
Investigator Site #1025
Hialeah, Florida, 33012
Investigator Site # 1015
Houston, Texas, 77056
Investigator Site #1011
Indianapolis, Indiana, 46250
Investigator Site #1014
Las Vegas, Nevada, 89148
Investigator Site #1024
Los Angeles, California, 90033
Investigator Site # 1018
Los Angeles, California, 90045
Investigator Site #1034
Louisville, Kentucky, 40241
Investigator Site #1035
Macon, Georgia, 31217
Investigator Site #1028
Miami, Florida, 33175
Investigator Site #1031
New Brighton, Minnesota, 55112
Investigator Site #1033
Oklahoma City, Oklahoma, 73170
Investigator Site #1036
Overland Park, Kansas, 66210
Investigator Site #1017
Owensboro, Kentucky, 42303
Investigator Site #1022
Philadelphia, Pennsylvania, 19103
Investigator Site # 1001
Phoenix, Arizona, 85032
Investigator Site # 1019
Portland, Oregon, 97223
Investigator Site #1037
Portsmouth, New Hampshire, 03801
Investigator Site #1012
Rapid City, South Dakota, 57702
Investigator Site #1026
Rockville, Maryland, 20850
Investigator Site #1023
Rogers, Arkansas, 72758
Investigator Site # 1005
Rolling Meadows, Illinois, 60008
Investigator Site #1006
San Antonio, Texas, 78213
Investigator Site #1016
San Diego, California, 92123
Investigator Site #1043
Sandy Springs, Georgia, 30328
Investigator Site # 1007
Santa Monica, California, 90404
Investigator Site # 1002
Sherman Oaks, California, 91403
Investigator Site #1027
South Bend, Indiana, 46617
Investigator Site #1041
South Jordan, Utah, 84095
Investigator Site #1042
Tampa, Florida, 33613
Investigator Site #1038
Warren, Michigan, 48088

Other trials in United States

Canada10 sites

Investigator Site #2001
Edmonton, Alberta, T6G 1C3
Investigator Site #2006
London, Ontario, N6H 5L5
Investigator Site #2004
Mississauga, Ontario, L4Y 4C5
Investigator Site #2007
North Bay, Ontario, P1B 3Z7
Investigator Site #2005
Oakville, Ontario, L6J 7W5
Investigator Site #2010
Québec, Quebec, G1V 4X7
Investigator Sie #2008
Surrey, British Columbia, V3V 0C6
Investigator Site #2009
Toronto, Ontario, M3H 5Y8
Investigator Site #2002
Waterloo, Ontario, N2J 1C4
Investigator Site #2003
Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Czechia5 sites

Investigator Site #5507
Nový Jičín, 741 01
Investigator Site #5514
Pardubice, 530 02
Investigator Site #5506
Prague, 100 00
Investigator Site #5505
Prague, 100 34
Investigator Site #5515
Svitavy, Pardubice, 568 02

Other trials in Czechia

About this study

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

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.

Conditions: Plaque Psoriasis
Being tested: ESK-001, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ESK-001Drug
Oral tablet
PlaceboDrug
Oral tablet

Study groups in NCT05600036
Study group	Role	What they receive
ESK-001 Dose Level 1	Experimental	ESK-001 administered as an oral tablet Receives: Drug: ESK-001
ESK-001 Dose Level 2	Experimental	ESK-001 administered as an oral tablet Receives: Drug: ESK-001
ESK-001 Dose Level 3	Experimental	ESK-001 administered as an oral tablet Receives: Drug: ESK-001
ESK-001 Dose Level 4	Experimental	ESK-001 administered as an oral tablet Receives: Drug: ESK-001
ESK-001 Dose Level 5	Experimental	ESK-001 administered as an oral tablet Receives: Drug: ESK-001
Placebo	Placebo comparator	Placebo administered as an oral tablet Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 weeks

Secondary outcomes (3)

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.
Measured: 12 weeks
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")
Measured: 12 weeks
To Characterize the Pharmacokinetics (PK) of ESK-001
Plasma concentrations and PK parameters of ESK-001.
Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 202225 Jul 2023

First posted31 Oct 2022
Study start27 Sep 2022
Primary completion29 Jun 2023
Study completion25 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05600036
Sponsor's protocol ID: ESK-001-006
Status last verified: Jun 2025
First submitted: 12 Oct 2022
Last updated: 18 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40659116

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05600036
Acronym / sponsor ID: ESK-001-006
Conditions: Plaque Psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: Alumis IncIndustry (pharma, biotech, devices)
Study start: 27 Sep 2022 (actual)
Primary completion: 29 Jun 2023 (actual)
Study completion: 25 Jul 2023 (actual)
First posted: 31 Oct 2022 (actual)
Results: Posted 23 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
ESK-001 Dose Level 1	Experimental	Drug: ESK-001ESK-001 administered as an oral tablet
ESK-001 Dose Level 2	Experimental	Drug: ESK-001ESK-001 administered as an oral tablet
ESK-001 Dose Level 3	Experimental	Drug: ESK-001ESK-001 administered as an oral tablet
ESK-001 Dose Level 4	Experimental	Drug: ESK-001ESK-001 administered as an oral tablet
ESK-001 Dose Level 5	Experimental	Drug: ESK-001ESK-001 administered as an oral tablet
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered as an oral tablet

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ESK-001Oral tablet	Drug	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
PlaceboOral tablet	Drug	Placebo

Primary outcome

To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo
Time frame: 12 weeks
Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score

3 secondary outcomes

To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients
Time frame: 12 weeks
To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score
Time frame: 12 weeks
To Characterize the Pharmacokinetics (PK) of ESK-001
Time frame: 14 weeks

Results and safety

Results posted to the registry on 23 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ESK-001 10mg QD	36	36
ESK-001 20mg QD	36	30
ESK-001 40mg QD	39	33
ESK-001 20mg BID	40	37
ESK-001 40mg BID	39	35
Placebo	38	33

Primary outcome: To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo

Time frame: 12 weeks. Number (95% Confidence Interval). Unit: Percentage

Measure	ESK-001 10mg QD n = 36	ESK-001 20mg QD n = 36	ESK-001 40mg QD n = 39	ESK-001 20mg BID n = 39	ESK-001 40mg BID n = 39	Placebo n = 38
Value	19.4 (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)

ESK-001 10mg QD vs Placebo: p = 0.0025, Cochran-Mantel-Haenszel
ESK-001 20mg QD vs Placebo: p = 0.0001, Cochran-Mantel-Haenszel
ESK-001 40mg QD vs Placebo: p <0.0001, Cochran-Mantel-Haenszel

Population analysed: All Randomized and Treated Participants

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event data was collected from Screening through end of study (Week 16).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ESK-001 10mg QD	1 of 36 (2.8%)	8 of 36 (22.2%)	0 of 36
ESK-001 20mg QD	0 of 36 (0%)	4 of 36 (11.1%)	0 of 36
ESK-001 40mg QD	1 of 39 (2.6%)	11 of 39 (28.2%)	0 of 39
ESK-001 20mg BID	3 of 39 (7.7%)	18 of 39 (46.2%)	0 of 39
ESK-001 40mg BID	0 of 39 (0%)	18 of 39 (46.2%)	0 of 39
Placebo	0 of 38 (0%)	9 of 38 (23.7%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40659116Blauvelt 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.
Individual participant dataSharing planned: No

Related trials for Plaque Psoriasis

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

53 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ESK-001 in people with Plaque Psoriasis, run by Alumis Inc at 53 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Canada, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05600036, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.