Plaque PsoriasisPhase 2NCT05739435
Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis
A Phase 2 study testing envudeucitinib in people with Plaque Psoriasis, run by Alumis Inc at 38 sites in 2 countries.
Trial summary
This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- envudeucitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 38 sitesin 2 countries
- Study dates
- 17 Jan 2023to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have completed a prior ESK-001 study
- Men and Women must use highly effective methods of contraception for the entirety of the study
Who cannot join
- Pregnancy
- Received a prohibited concomitant medication
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United States28 sites
Investigator Site # 1029
Birmingham, Alabama, 35205
Investigator Site #1010
Clarkston, Michigan, 48346
Investigator Site # 1011
Columbus, Indiana, 47201
Investigator Site #1021
Encinitas, California, 92024
Investigator site # 1030
Fort Lauderdale, Florida, 33308
Investigator Site #1025
Hialeah, Florida, 33012
Investigator Site #1015
Houston, Texas, 77056
Investigator Site #1018
Los Angeles, California, 90045
Investigator Site #1035
Macon, Georgia, 31217
Investigator site # 1028
Miami, Florida, 33175
Investigator Site #1031
New Brighton, Minnesota, 55112
Investigator Site #1033
Norman, Oklahoma, 73071
Investigator SIte#1036
Overland Park, Kansas, 66210
Investigator Site #1017
Owensboro, Kentucky, 42301
Investigator Site #1022
Philadelphia, Pennsylvania, 19103
Investigator Site #1001
Phoenix, Arizona, 85032
Investigator Site #1019
Portland, Oregon, 97223
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 #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 # 1013
Tampa, Florida, 33614
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, PiB 3Z7
Investigator Site #2005
Oakville, Ontario, L6J 7W5
Investigator Site # 2010
Québec, Quebec, G1V 4X7
Investigator Site # 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
About this study
Official title: A Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Patients With Plaque Psoriasis
This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.
Read the detailed description
This study will consist of patients who have completed their participation in a previous plaque psoriasis study of ESK-001. Each patient will be assigned to receive ESK-001 at one of two open-label dose levels. Patients have the option to remain on study until ESK-001 is commercially available.
- Conditions
- Plaque Psoriasis
- Being tested
- envudeucitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
envudeucitinibDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| envudeucitinib Dose Level 1 | Experimental | envudeucitinib administered as an oral tablet Receives: Drug: envudeucitinib |
| envudeucitinib Dose Level 2 | Experimental | envudeucitinib administered as an oral tablet Receives: Drug: envudeucitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of long-term ESK-001 treatment
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: Approximately 3 years
Secondary outcomes (3)
To assess the long-term efficacy of ESK-001
Change from baseline in Psoriasis Area and Severity Index (PASI) over time
Measured: Approximately 3 years
To assess the change in quality of life (QoL) with long-term ESK-001 administration
Change from baseline in Dermatology Life Quality Index (DLQI) over time
Measured: Approximately 3 years
To assess the pharmacokinetics (PK) of ESK-001 (ctrough)
Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start17 Jan 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alumis Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739435
- Sponsor's protocol ID
- ESK-001-007
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2023
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Papp KA, Jacobs S, Sofen H, Bukhalo M, Muscianisi E, Ma G, Lau G, Bettinger M, Rubio RG, Hitraya E, Blauvelt A; Open-Label Extension study team. Safety and efficacy of envudeucitinib, a highly selective, oral allosteric TYK2 inhibitor, in patients with moderate-to-severe plaque psoriasis: Results from the 52-week open-label extension period of the phase 2 STRIDE study. J Am Acad Dermatol. 2026 Jan;94(1):187-195. doi: 10.1016/j.jaad.2025.10.005. Epub 2025 Oct 6.
PubMed 41061968
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Patients With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05739435
- Acronym / sponsor ID
- ESK-001-007
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Alumis IncIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
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, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.
Detailed description
This study will consist of patients who have completed their participation in a previous plaque psoriasis study of ESK-001. Each patient will be assigned to receive ESK-001 at one of two open-label dose levels. Patients have the option to remain on study until ESK-001 is commercially available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| envudeucitinib Dose Level 1 | Experimental | Drug: envudeucitinibenvudeucitinib administered as an oral tablet |
| envudeucitinib Dose Level 2 | Experimental | Drug: envudeucitinibenvudeucitinib administered as an oral tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have completed a prior ESK-001 study
- Men and Women must use highly effective methods of contraception for the entirety of the study
Key exclusion criteria (2 listed)
- Pregnancy
- Received a prohibited concomitant medication
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 |
|---|---|---|
| envudeucitinibOral tablet | Drug | envudeucitinib Dose Level 1, envudeucitinib Dose Level 2 |
Primary outcome
To assess the safety and tolerability of long-term ESK-001 treatment
Time frame: Approximately 3 years
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
3 secondary outcomes
To assess the long-term efficacy of ESK-001
Time frame: Approximately 3 years
To assess the change in quality of life (QoL) with long-term ESK-001 administration
Time frame: Approximately 3 years
To assess the pharmacokinetics (PK) of ESK-001 (ctrough)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Derived from this study: PubMed 41061968Papp KA, Jacobs S, Sofen H, Bukhalo M, Muscianisi E, Ma G, Lau G, Bettinger M, Rubio RG, Hitraya E, Blauvelt A; Open-Label Extension study team. Safety and efficacy of envudeucitinib, a highly selective, oral allosteric TYK2 inhibitor, in patients with moderate-to-severe plaque psoriasis: Results from the 52-week open-label extension period of the phase 2 STRIDE study. J Am Acad Dermatol. 2026 Jan;94(1):187-195. doi: 10.1016/j.jaad.2025.10.005. Epub 2025 Oct 6.
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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.
38 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing envudeucitinib in people with Plaque Psoriasis, run by Alumis Inc at 38 sites in 2 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Canada. 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. 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?
This study is still under way. Results are not available in the source record yet.
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 assess the safety and tolerability of long-term ESK-001 treatment (time frame: Approximately 3 years). 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 NCT05739435, 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 28 Jul 2026.