Clinical trial • Phase II • Immunology
deucravacitinib for Plaque psoriasis
Phase II trial of deucravacitinib for Plaque psoriasis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Plaque psoriasis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 31-10-2025
- First CTIS Authorization Date
- 19-02-2026
Trial design
Randomised, open-label, two-treatment crossover comparison between: - deucravacitinib tablets 6 mg (manufactured by sun pharmaceutical industries limited, india) and - sotyktu (deucravacitinib) tablets 6 mg (distributed by bristol-myers squibb company). single-dose, two-period, two-sequence crossover under fed condition.-controlled, crossover Phase II trial across 1 site in Romania.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Two-treatment crossover comparison between: - Deucravacitinib tablets 6 mg (Manufactured by Sun Pharmaceutical Industries Limited, India) and - SOTYKTU (deucravacitinib) tablets 6 mg (Distributed by Bristol-Myers Squibb Company). Single-dose, two-period, two-sequence crossover under fed condition.
- Crossover
- Yes
- Target Sample Size
- 40
Eligibility
Recruits 40 Vulnerable population selected: healthy volunteers indicated (clinicalTrialGroups: "Healthy volunteers"); both sexes eligible. No details on consent or assent handling provided in the available record..
- Vulnerable Population
- Vulnerable population selected: healthy volunteers indicated (clinicalTrialGroups: "Healthy volunteers"); both sexes eligible. No details on consent or assent handling provided in the available record.
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 3
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 40
Romania
- Earliest CTIS Part Ii Submission Date
- 23-09-2025
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 149
- Number Of Sites
- 1
- Number Of Participants
- 40
Sites
- Site Name
- Terapia S.A.
- Department Name
- Clinical Pharmacology and Pharmacokinetics
- Contact Person Name
- Elena Timofte
- Contact Person Email
- Elena.Timofte@sunpharma.com
- Number Of Participants
- 40
Sponsor
Primary sponsor
- Full Name
- Sun Pharmaceutical Industries Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- India
Investigational products
- Investigational Product Name
- Deucravacitinib tablets 6 mg (test) and SOTYKTU (deucravacitinib) tablets 6 mg (reference)
- Active Substance
- deucravacitinib
- Modality
- Small molecule
- Routes Of Administration
- oral (tablets)
- Route
- oral
- Starting Dose
- 6 mg
- Dose Levels
- 6 mg
- Frequency
- single-dose (two-period crossover)
- Maximum Dose
- 6 mg
Related trials
Other published trials that may interest you.