Clinical trial • Phase III • Dermatology
ENVUDEUCITINIB for Moderate to severe plaque psoriasis
Phase III trial of ENVUDEUCITINIB for Moderate to severe plaque psoriasis.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Moderate to severe plaque psoriasis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 20-12-2024
- First CTIS Authorization Date
- 29-04-2025
Trial design
Randomised, open-label, blinded placebo comparator: matching placebo film-coated tablet (esk-001 placebo) used in the blinded treatment withdrawal period; active comparator arm is esk-001 40 mg twice per day (bid) orally (open-label); first 200 pasi-75 responders randomized 1:1 to blinded esk-001 or blinded placebo from week 24 to week 48.-controlled Phase III trial in Austria, Belgium, Romania and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Blinded placebo comparator: matching placebo film-coated tablet (ESK-001 placebo) used in the Blinded Treatment Withdrawal Period; active comparator arm is ESK-001 40 mg twice per day (BID) orally (open-label); first 200 PASI-75 responders randomized 1:1 to blinded ESK-001 or blinded placebo from Week 24 to Week 48.
- Target Sample Size
- 857
- Trial Duration For Participant
- 672
Eligibility
Recruits 857 No vulnerable populations selected. Study enrols adults only (age ≥18 years). Informed consent is provided by the participant (ICFs available); no assent procedures for minors are indicated..
- Pregnancy Exclusion
- 1. Pregnant, lactating, or planning to get pregnant during the study
- Vulnerable Population
- No vulnerable populations selected. Study enrols adults only (age ≥18 years). Informed consent is provided by the participant (ICFs available); no assent procedures for minors are indicated.
Inclusion criteria
- {"criterion_text":"- 1. Males or females, age ≥18 years"}
- {"criterion_text":"- 2. Completed either of the two previous (parent) studies of ESK-001 in moderate to severe plaque psoriasis"}
- {"criterion_text":"- 3. ESK-001 safety and tolerability were acceptable in the parent study"}
- {"criterion_text":"- 4. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to a highly effective method of contraception for the entirety of the study"}
Exclusion criteria
- {"criterion_text":"- 1. Pregnant, lactating, or planning to get pregnant during the study"}
- {"criterion_text":"- 2. Any acute or chronic illness/condition or evidence of an unstable clinical condition that, in the opinion of the Investigator, will substantially increase the risk to the patient if they continue to receive ESK-001 treatment in this extension study"}
- {"criterion_text":"- 3. Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence and severity of treatment-emergent adverse events and serious adverse events","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Long-term efficacy endpoints: * Achievement of ≥75%, ≥90%, and ≥100% reductions in PASI after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Achievement of sPGA-0, sPGA-0/1 and ssPGA after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Mean change from baseline in PASI %BSA","definition_or_measurement_approach":"Measured using PASI percent reduction thresholds (≥75%, ≥90%, ≥100%), sPGA and ssPGA assessments, and %BSA; assessments at Weeks 24, 48, 72, 96."}
- {"endpoint_text":"- Clinical response endpoints: * Following ESK-001 withdrawal, loss of response in: PASI-75 sPGA-0/1 PASI-90 PASI-100 and median time to loss of response in PASI-75 and sPGA0/1. * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1","definition_or_measurement_approach":"Measured by PASI thresholds and sPGA assessments; time-to-event for loss of response (median time) and maintenance evaluated at Weeks 24 and 48 of LTE."}
- {"endpoint_text":"- Clinical response endpoints (continued): * Lack of response at Week 24 in parent study followed by an achievement of response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1","definition_or_measurement_approach":"Assessed by PASI and sPGA criteria at Weeks 24 and 48 in LTE."}
- {"endpoint_text":"- Quality of life endpoints: * Achievement of the following after 24, 48, 72, 96 weeks of overall ESK-001 treatment: DLQI-0/1 Change from baseline in DLQI, PSSD, NRS (Pruritus, Joint Pain, and Joint Disease Activity), SF-36 * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: DLQI-0/1 4 point improvement in DLQI PSSD-0","definition_or_measurement_approach":"Measured using DLQI, PSSD, NRS (Pruritus, Joint Pain, Joint Disease Activity) and SF-36 at scheduled timepoints (Weeks 24, 48, 72, 96); maintenance evaluated at Weeks 24 and 48 in LTE."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 857
- Recruitment Window Months
- 40
- Consent Approach
- Informed consent obtained from adult participants (age ≥18). Country-specific subject information sheets and informed consent forms are provided; multiple language versions and country-specific ICFs are available (examples in the dossier: English, French, Dutch, Spanish, Portuguese, German, Hungarian, Polish, Czech, Estonian, Russian, Bulgarian, Romanian, Latvian). There are dedicated ICFs/materials for pregnant patients and pregnant partners and optional research consents; site-facing and patient-facing web portal materials documented. No assent for minors (min age 18).
Geography
- Total Number Of Participants
- 931
Austria
- Earliest CTIS Part Ii Submission Date
- 14-04-2025
- Latest Decision Or Authorization Date
- 06-05-2025
- Processing Time Days
- 22
- Number Of Participants
- 28
Belgium
- Earliest CTIS Part Ii Submission Date
- 10-04-2025
- Latest Decision Or Authorization Date
- 29-04-2025
- Processing Time Days
- 19
- Number Of Participants
- 30
Romania
- Earliest CTIS Part Ii Submission Date
- 30-01-2025
- Latest Decision Or Authorization Date
- 06-05-2025
- Processing Time Days
- 96
- Number Of Participants
- 50
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 16-04-2025
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 293
- Number Of Participants
- 16
Hungary
- Earliest CTIS Part Ii Submission Date
- 17-04-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 291
- Number Of Participants
- 38
Estonia
- Earliest CTIS Part Ii Submission Date
- 17-04-2025
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 293
- Number Of Participants
- 45
Spain
- Earliest CTIS Part Ii Submission Date
- 11-04-2025
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 299
- Number Of Participants
- 7
Portugal
- Earliest CTIS Part Ii Submission Date
- 08-04-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 300
- Number Of Participants
- 13
Germany
- Earliest CTIS Part Ii Submission Date
- 08-04-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 300
- Number Of Participants
- 114
France
- Earliest CTIS Part Ii Submission Date
- 10-04-2025
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 295
- Number Of Participants
- 19
Poland
- Earliest CTIS Part Ii Submission Date
- 16-04-2025
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 293
- Number Of Participants
- 397
Czechia
- Earliest CTIS Part Ii Submission Date
- 11-04-2025
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 319
- Number Of Participants
- 137
Latvia
- Earliest CTIS Part Ii Submission Date
- 17-04-2025
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 334
- Number Of Participants
- 37
Sponsor
Primary sponsor
- Full Name
- Alumis Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- WCG Clinical Inc.
- Responsibilities
- PASI, BSA, sPGA rater training
- Name
- Longboat Clinical Limited
- Responsibilities
- Site-facing and patient-facing web portal for the study
- Name
- Medidata Solutions Inc.
- Name
- Fortrea Inc.
- Name
- Veranex Inc.
Third parties
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"PASI, BSA, sPGA rater training","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Site-facing and patient-facing web portal for the study","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Scarritt Group Inc.","duties_or_roles":"Patient travel and reimbursement for Spain and Hungary","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Veranex Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Pharmaspecific","duties_or_roles":"Patient travel and reimbursement for France","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"Business development / digital support (site-facing duties)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Emsere B.V.","duties_or_roles":"Provide rental equipment and supplies; technical support; customs/import assistance","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"24/7 medical coverage call center","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG review","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"24/7 medical coverage call center","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"Laboratory services","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- ESK-001
- Active Substance
- ENVUDEUCITINIB
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Investigational medicinal product (MIA: DE_BB_01_MIA_2024_0015 & IMP11566/00001)
- Starting Dose
- 40 mg twice per day (BID)
- Dose Levels
- 40 mg BID
- Frequency
- Twice per day (BID)
- Maximum Dose
- 80 mg per day
- Investigational Product Name
- ESK-001 placebo / Film-coated tablet
- Modality
- Other
- Routes Of Administration
- Oral use
- Route
- Oral
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