Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
- Summary
- The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are: * How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis? * Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis? Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study. Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis. Patients must consent and agree to: * ensure drug daily compliance until end of study or discontinuation. * visit the clinic for checkups and assessments. * provide blood and urine samples.
- Acronym
- ONWARD3
- Short title
- Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
- Official title
- An Extension Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2028-11-01
- First posted
- 2025-02-26
- Registry last updated
- 2026-04-13
- Primary completion date
- 2028-11-01
- Start date
- 2025-01-08
- Participants
- 1,680
- Participant count basis
- Estimated
- Planned participants
- 1,680
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Alumis Inc
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06846541
- ClinicalTrials.gov ID
- NCT06846541
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
To assess the long-term safety and tolerability of ESK-001 throughout the duration of the study
Timeframe: Approximately 4 years
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-75)
Timeframe: 24, 48, 72, and 96 weeks
Proportion of patients achieving ≥75% reduction in PASI
To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-90)
Timeframe: 24, 48, 72, and 96 weeks
Proportion of patients achieving ≥90% reduction in PASI
To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-100)
Timeframe: 24, 48, 72, and 96 weeks
Proportion of patients achieving 100% reduction in PASI
To assess the long-term efficacy of ESK-001 using the Static Physician's Global Assessment (sPGA 0/1)
Timeframe: 24, 48, 72, and 96 weeks
Proportion of patients achieving a score of 0 or 1 on sPGA
To assess the long-term efficacy of ESK-001 based on change in Psoriasis Area and Severity Index (PASI)
Timeframe: 24, 48, 72, and 96 weeks
Change in Psoriasis Area and Severity Index (PASI) from baseline assessments
To assess the long-term efficacy of ESK-001 based on change in Affected Body Surface Area (%BSA)
Timeframe: 24, 48, 72, and 96 weeks
Change in affected body surface area (%BSA) from baseline assessments
To characterize the loss of PASI-75 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)
Timeframe: Week 48
Median time to loss of PASI-75 response
To characterize the loss of PASI-90 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)
Timeframe: Week 48
Median time to loss of PASI-90 response
To characterize the loss of sPGA-0/1 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)
Timeframe: Week 48
Median time to loss of sPGA-0/1 response
To assess the change in quality of life (QoL) using Dermatology Life Quality Index after long-term ESK-001 administration
Timeframe: Week 24, Week 48, and Week 72
Proportion of patients achieving a DLQI-0/1 score of 0 (no effect) or 1 (minimal effect)
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Males or females, age ≥18 years
- Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017)
- ESK-001 safety and tolerability were acceptable in the parent study
- Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception for the entirety of the study
- Pregnant, lactating, or planning to get pregnant during the study period
- Any acute or chronic illness/condition or evidence of an unstable clinical condition that in the Investigator's judgment will substantially increase the risk to the patient if they continue to receive ESK-001 treatment in this extension study
- Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol
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And 243 more, listed on the interactive page.