Phase 3 Clinical Study of JTE-061 Cream - 52-week Long-term Study in Patients with Plaque Psoriasis
- Conditions
- Plaque psoriasis
- Registration Number
- JPRN-jRCT2031210254
- Lead Sponsor
- emoto Takanori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
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 Adverse events and adverse drug reactions<br>Change from Baseline and clinically significant abnormalities in laboratory test results<br>Change from Baseline and clinically significant abnormalities in vital signs
- Secondary Outcome Measures
Name Time Method