Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Part 1) and Extension Study (Part 2) in Patients with Plaque Psoriasis
- Conditions
- Plaque psoriasis
- Registration Number
- JPRN-jRCT2031210253
- Lead Sponsor
- emoto Takanori
- Brief Summary
When JTE-061 cream 1% was administered once daily for 12 weeks to patients with plaque psoriasis, improvements in the PGA, PASI, %BSA affected, pruritus NRS, and Skindex-16 were noted as compared to the vehicle cream. When JTE-061 cream 1% was administered once daily for up to 24 weeks to patients with plaque psoriasis, the plasma concentration was low, and treatment with JTE-061 was generally safe. The efficacy of JTE-061 cream 1% in the treatment of plaque psoriasis was maintained for up to 24 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 158
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method