Clinical trial • Phase III • Immunology
Deuruxolitinib for Alopecia areata
Phase III trial of Deuruxolitinib for Alopecia areata. Randomised, placebo, dose/schedule not specified-controlled. 30 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Alopecia areata
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 30-06-2025
- First CTIS Authorization Date
- 27-10-2025
Trial design
Randomised, placebo, dose/schedule not specified-controlled Phase III trial across 1 site in Romania.
- Randomised
- Yes
- Comparator
- Placebo, dose/schedule not specified
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 30
Eligibility
Recruits 30 isVulnerablePopulationSelected: true; population: Healthy volunteers; no consent or assent handling details provided in the record..
- Vulnerable Population
- isVulnerablePopulationSelected: true; population: Healthy volunteers; no consent or assent handling details provided in the record.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 12
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 30
Romania
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 27-10-2025
- Processing Time Days
- 24
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Terapia S.A.
- Department Name
- CPP Department
- Contact Person Name
- Elena Timofte
- Contact Person Email
- Elena.Timofte@sunpharma.com
- Number Of Participants
- 30
Sponsor
Primary sponsor
- Full Name
- Sun Pharmaceutical Industries Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Deuruxolitinib
- Active Substance
- Deuruxolitinib
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