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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031210253
Enrollment
150
Registered
2021-08-18
Start date
2021-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque psoriasis

Interventions

Sponsors

Nemoto Takanori
Lead Sponsor
Torii Pharmaceutical Co.,LTD
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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

Contacts

Public Contactclinical trials information

Shionogi & Co.,Ltd.

clinicaltrials-info@shionogi.co.jp+81-3-6635-3505

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026