Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Part 1) and Extension Study (Part 2) in Patients with Plaque Psoriasis -

JRCT ID: jRCT2031210253

Registered date:18/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Plaque psoriasis
• Date of first enrollment: 01/10/2021
• Target sample size: 150
• Study type: Interventional

Intervention(s)

<Part 1>
Once daily topical application of thin layer of JTE-061 cream 1% or vehicle cream to all affected areas (except the hairy scalp)
<Part 2>
Once daily topical application of thin layer of JTE-061 cream 1% to all affected areas (except the hairy scalp)

Outcome(s)

• Primary Outcome: Proportion of subjects who achieve a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from Baseline at Week 12

Key inclusion & exclusion criteria

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

Include criteria

1. Japanese patients aged >= 18 years at informed consent who can visit the study site as an outpatient
2. Patients with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months at informed consent
3. Patients whose PGA score, PASI score, and %BSA affected meet the criteria specified in the study protocol

Exclude criteria

1. Patients with psoriasis other than plaque variant
2. Patients with a history of or current significant dermatologic or inflammatory condition that, in the investigator's opinion, would make it difficult to interpret data or assessments during the study
3. Patients with a history of or current acute active bacterial, fungal, or viral (e.g., herpes simplex, herpes zoster, and varicella) skin infection within 1 week prior to Week 0
4. Patients who have used any prohibited therapy specified in the study protocol within the indicated period before Week 0
5. Patients with serious concomitant disease(s)
6. Patients with a history of or current cancer within 5 years prior to screening visit

Related Information

• Primary Sponsor: Nemoto Takanori
• Secondary Sponsor: Torii Pharmaceutical Co.,LTD