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

JRCT ID: jRCT2051240267

Registered date:12/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Moderate to Severe Plaque Psoriasis
• Date of first enrollment: 12/02/2025
• Target sample size: 60
• Countries of recruitment: Australia,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Czech Republic,Japan,Germany,Japan,Poland,Japan,Portugal,Japan,South Korea,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): 40 mg ESK-001 administered orally twice daily.

Outcome(s)

Primary Outcome

1. Proportion of participants achieving >=75% reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) PASI-75 at Week 16
2. Proportion of participants achieving static Physician's Global Assessment (sPGA) score of '0' ('cleared'; sPGA-0) or '1' ('minimal'; sPGA-1) at Week 16

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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 TNF alpha 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

Related Information

• Primary Sponsor: Momotani Yu
• Secondary ID(s): NCT06586112