Bioequivalence study of JTE-052

JRCT ID: jRCT2031230713

Registered date:15/03/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: atopic dermatitis
• Date of first enrollment: 22/04/2024
• Target sample size: 234
• Study type: Interventional
• Intervention(s): Twice daily topical application of JTE-052 new drug product or JTE-052 ointment 0.5%

Outcome(s)

• Primary Outcome: Percent change in mEASI score from Week 0 at the final evaluation (the end of treatment [EOT])

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients diagnosed with moderate or severe atopic dermatitis
2. Modified Eczema Area and Severity Index (mEASI) = >10

Exclude criteria

1. Patients with active infection at the study drug application site
2. Use of topical corticosteroids (strongest or very strong) within 28 days before an initiation of study drug (Week 0)
3. Use of topical corticosteroids (strong, medium or weak) within 7 days before an initiation of study drug (Week 0)

Related Information

• Primary Sponsor: Mitsui Hironori
• Source(s) of Monetary Support: Torii Pharmaceutical Co.,Ltd