Phase 3 Clinical Study of JTE-061 Cream - 52-week Long-term Study in Patients with Plaque Psoriasis -

JRCT ID: jRCT2031210254

Registered date:18/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Plaque psoriasis
• Date of first enrollment: 22/09/2021
• Target sample size: 300
• Study type: Interventional
• Intervention(s): Once daily topical application of thin layer of JTE-061 cream 1% to all affected areas (except the hairy scalp)

Outcome(s)

Primary Outcome

Adverse events and adverse drug reactions
Change from Baseline and clinically significant abnormalities in laboratory test results
Change from Baseline and clinically significant abnormalities in vital signs

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