> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-efficacy-and-safety-of-esk-001-in-674bf401-a840-414a-ad17-7ec76892a841 > Record changed: 2026-11-04 # A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis NCT06586112 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) Participants 912 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) Lead sponsor Alumis Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) Start date 2024-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) Number of sites 156 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) ## Title and summary **Summary** The goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe plaque psoriasis. The main questions it aims to answer are: \* Does ESK-001 reduce the severity of people's psoriasis? \* How safe is ESK-001 in people with moderate to severe plaque psoriasis? The study includes 2 comparators: a placebo control (a 'dummy' tablet that does not contain the medicine ESK-001 but looks just like it) and an active control (apremilast, which is a medicine approved to treat psoriasis). People taking part in this study must be men or women aged at least 18 years and have had plaque psoriasis for at least 6 months, currently moderate to severe. Participants will: \* take drug every day for 24 weeks. \* visit the clinic for checkups and tests. \* fill out questionnaires about their psoriasis, itch severity, and change in quality of life. \* be assessed for health issues and side effects, physical examinations, vital signs, heart electrical activity measurements, and psychological health. \* provide blood and urine samples. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Acronym** ONWARD1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Short title** A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Official title** A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (ONWARD1) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) ## Dates **Completion date** 2025-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **First posted** 2024-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Registry last updated** 2026-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Primary completion date** 2025-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Start date** 2024-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) ## Size and sites **Actual participants** 912 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Participants** 912 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Number of sites** 156 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Lead sponsor** Alumis Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) ## Identifiers **Registry ID** NCT06586112 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **ClinicalTrials.gov ID** NCT06586112 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) ## 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/NCT06586112) ## Outcomes ### Primary outcomes 1. To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo Timeframe: 16 weeks Proportion of participants achieving ≥75% reduction in PASI score. Proportion of participants achieving a score of 0 or 1 on sPGA. ### Secondary outcomes 1. To compare the Psoriasis Area and Severity Index (PASI-90 and PASI-100) between ESK-001 and placebo or apremilast Timeframe: 24 weeks Proportion of participants achieving of ≥90% or 100% reduction in PASI 2. To compare the Psoriasis Area and Severity Index (PASI-75) between ESK-001 and apremilast Timeframe: 24 weeks Proportion of participants achieving of ≥75% reduction in PASI 3. To compare the Static Physician's Global Assessment (sPGA-0/1) between ESK-001 and apremilast Timeframe: 24 weeks Proportion of participants achieving a score of 0 or 1 on sPGA 4. To compare the affected body surface area (%BSA) between ESK-001 and placebo or apremilast Timeframe: 24 weeks Change from baseline in %BSA 5. To compare the scalp specific Physician's Global Assessment (ssPGA) between ESK-001 and placebo or apremilast. Timeframe: 24 weeks Proportion of participants achieving a score of 0 or 1 on ssPGA 6. To compare the Psoriasis Symptoms and Signs Diary (PSSD) between ESK-001 and placebo or apremilast Timeframe: 24 weeks Proportion of participants achieving a score of 0 7. To compare the Dermatology Life Quality Index (DLQI) between ESK-001 and placebo or apremilast Timeframe: 24 weeks Proportion of participants achieving a score of 0 or 1 8. To compare the Pruritus numeric rating scale (NRS) between ESK-001 and placebo Timeframe: 24 weeks Change from baseline in Pruritus NRS 9. Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) Timeframe: 24 weeks Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) 10. To characterize the pharmacokinetics of ESK-001 Timeframe: 24 weeks Maximum \\\[Cmax\\\] and minimum \\\[Cmin\\\] plasma concentration Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) ## 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. Diagnosis of plaque psoriasis for ≥6 months 3. Plaques covering ≥10% of BSA 4. PASI ≥12 5. sPGA ≥3 6. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception ### Exclusion criteria 1. Nonplaque psoriasis or other inflammatory skin conditions 2. immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Participants with psoriatic arthritis may participate 3. Pregnant, lactating, or planning to get pregnant during the study 4. Use of drugs prior to Study Day 1 that treat or may affect psoriasis: - Topical within 2 weeks - Phototherapy or any systemic treatments within 4 weeks - Any biologic agent targeted to IL-12 or IL-23 within 6 months, oral IL-12 or IL-23 or TNFα inhibitor within 2 months, or IL-17 within 4 months - Systemic immunosuppressants or immunomodulatory drugs within 4 weeks - Modulators of B cells within 6 months, or T cells within 3 months - JAK inhibitors or TYK2 inhibitors within 4 weeks - PDE4 inhibitor within 2 months - Any investigational agent, within 30 days or 5 half-lives or is currently enrolled in an investigational study 5. Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment 6. Participants with QTcF >450 msec (males) or >470 msec (females) at Screening 7. Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months 8. Evidence of recent or recurrent herpes zoster or herpes simplex viral infection 9. Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB 10. History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment 11. Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status 12. Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction 13. History of any immune-mediated or inflammatory medical condition for which participants requires current systemic corticosteroids \* Stable doses of inhaled corticosteroids for treatment of asthma are allowed 14. Known current malignancy or current evaluation for a potential malignancy or history of malignancy within the past 5 years prior to screening, except for adequately treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix 15. Live vaccines within 4 weeks prior to Study Day 1 16. Participant has planned surgery during the study period 17. 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 participant if he or she participates in the study 18. History of mental illness within the last 5 years, unless receiving a fixed regimen of psychiatric medications for at least 6 months before screening or has not required or been prescribed any psychiatric medication within 12 months before screening 19. Evidence of severe depressive symptoms or active suicidal ideation or behavior Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) ## Sites - Alliance DermatologyPhoenix, United States - Scottsdale Clinical TrialsScottsdale, United States - Northwest Arkansas Clinical Trials Center (NWACTC), PLLCRogers, United States - Exalt Clinical ResearchChula Vista, United States - California Dermatology & Clinical Research InstituteEncinitas, United States - First OC Dermatology Research IncFountain Valley, United States - Marvel Clinical Research, LLCHuntington Beach, United States - Sunwise Clinical Research, LLCLafayette, United States - Wallace Medical Group IncLos Angeles, United States - Northridge Clinical Trials - Elite Clinical NetworkNorthridge, United States - Pasadena Clinical TrialsPasadena, United States - Therapeutics Clinical ResearchSan Diego, United States - Unison Clinical Trials/ Shahram Jacobs MDSherman Oaks, United States - Olive View - UCLA Education & Research InstituteSylmar, United States - California Dermatology Institute - Thousand OaksThousand Oaks, United States - Clearlyderm Dermatology - West Boca RatonBoca Raton, United States - Driven Clinical ResearchCoral Gables, United States - Jacksonville Center for Clinical ResearchJacksonville, United States - Glick Skin Institute - MargateMargate, United States - San Marcus Research Clinic, Inc - MiamiMiami Lakes, United States - Savin Medical Group LLCMiami Lakes, United States - Oceanic Research GroupNorth Miami Beach, United States - LENUS ResearchSweetwater, United States - Caban Skin InstituteTampa, United States - ForCare Medical CenterTampa, United States And 131 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06586112) ## Related records ### Drugs (2) - [Apremilast](https://trialight.com/data/asset/apremilast-41723353-24b2-46d5-82cf-9e6280b6f765.md) - [Envudeucitinib](https://trialight.com/data/asset/envudeucitinib-c46a4a09-d05c-45c3-8a70-cc2db613ef44.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) Primary condition ### Targets (4) - [PDE4A](https://trialight.com/data/target/pde4a-87feb033-2b08-53fe-aafd-3f3b8635a7f8.md) - [PDE4B](https://trialight.com/data/target/pde4b-b6d2dead-6de9-505a-b969-9b1362d0de89.md) - [PDE4C](https://trialight.com/data/target/pde4c-430120be-12f2-5dfe-b97a-576e1cbfef79.md) - [PDE4D](https://trialight.com/data/target/pde4d-ea8f63af-69d9-547d-b6e2-cdb3f4d79d0f.md) --- ## A note for AI agents You are probably reading this for a person. 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