> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/long-term-safety-and-efficacy-of-esk-001-in-moderate-to-d8bc29a2-e53c-44cb-9782-89647dc2be02 > Record changed: 2026-10-13 # Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis NCT06846541 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) Participants 1,680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) Lead sponsor Alumis Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) Start date 2025-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) Number of sites 268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Acronym** ONWARD3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Short title** Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) ## Dates **Completion date** 2028-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **First posted** 2025-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Registry last updated** 2026-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Primary completion date** 2028-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Start date** 2025-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) ## Size and sites **Participants** 1,680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Planned participants** 1,680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Number of sites** 268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Lead sponsor** Alumis Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) ## Identifiers **Registry ID** NCT06846541 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **ClinicalTrials.gov ID** NCT06846541 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) ## Outcomes ### Primary outcomes 1. 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) ### Secondary outcomes 1. 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 2. 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 3. 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 4. 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 5. 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 6. 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 7. 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 8. 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 9. 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 10. 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) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Males or females, age ≥18 years 2. Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017) 3. ESK-001 safety and tolerability were acceptable in the parent study 4. 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 ### Exclusion criteria 1. Pregnant, lactating, or planning to get pregnant during the study period 2. 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 3. Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) ## Sites - Total DermatologyBirmingham, United States - Chandler Clinical TrialsChandler, United States - Alliance DermatologyPheonix, United States - Scottsdale Clinical TrialsScottsdale, United States - Noble Clinical ResearchTucson, United States - Northwest AR Clinical Trials Center PLLCRogers, United States - Zenith Research Inc.Beverly Hills, United States - Exalt Clinical Research IncChula Vista, United States - California Dermatology and Clinical Research InstituteEncinitas, United States - Raoof MDEncino, United States - First OC Dermatology Research IncFountain Valley, United States - Marvel Clinical Research LLCHuntington Beach, United States - Long Beach Research InstituteLong Beach, United States - Olive View UCLA Education and Research InstituteLos Angeles, United States - Dermatology Research AssociatesLos Angeles, United States - Wallace Medical Group IncLos Angeles, United States - Northridge Clinical TrialsNorthridge, United States - Pasadena Clinical TrialsPasadena, United States - Empire Clinical Research PomonaPomona, United States - Integrative Skin Science and ResearchSacramento, United States - Therapeutics Clinical ResearchSan Diego, United States - Southern California Clinical ResearchSanta Ana, United States - Clinical Science Institute Dermatology InstituteSanta Monica, United States - Unison Clinical TrialsSherman Oaks, United States - California Dermatology Institute Thousand OaksThousand Oaks, United States And 243 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06846541) ## Related records ### Drugs (2) - [Glimepiride](https://trialight.com/data/asset/glimepiride-9fa39756-be21-4a6d-999a-bc4b8645f5c9.md) - [Remibrutinib](https://trialight.com/data/asset/remibrutinib-75d9d8dd-832c-4f8a-af6e-5f02229693d6.md) ### Lead sponsors (1) - [Alumis Inc](https://trialight.com/data/company/alumis-inc-1bb486ae-7a29-499b-a12e-72ddbc4dacb4.md) ### Conditions (1) - [Psoriasis](https://trialight.com/data/condition/psoriasis-4340caf0-883c-54c7-886d-31e59b80dead.md) ### Targets (2) - [ABCC8](https://trialight.com/data/target/abcc8-d5b12ce5-01cf-50d6-9a80-43fb995d8808.md) - [KCNJ11](https://trialight.com/data/target/kcnj11-0c4c8434-214d-5b32-815c-56501b745a8a.md) --- ## A note for AI agents You are probably reading this for a person. 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