Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma
- Sponsor
- University of Cologne
- Study ID
- NCT04200755
- Phase
- PHASE2
- Status
- Completed
Conditions
- Localized Scleroderma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dupilumab 300Mg Solution for Injection — DRUGFirst dose: 600 mg (2 syringes); subsequent doses: 300 mg (1 syringe)
- Placebo — OTHERFirst dose: 2 syringes, no active substance; subsequent doses: 1 syringe, no active substance
Study Details
The DupiMorph study evaluates the efficacy of Dupilumab in localized scleroderma patients. Dupilumab is approved in the US and EU for the treatment of moderate/severe atopic dermatitis and since 2018 in the US for severe asthma therapy.
Key Dates
- Start date
- May 19, 2020
- Status verified
- Oct 2024
- Primary completion
- Nov 30, 2023
- Completion
- Nov 30, 2023
Study Design
- Enrollment
- 45 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dupilumab30 patients; Dupilumab s.c. injection; 2 ready-to-use syringes (600 mg) initial (V1), 1 ready-to-use syringe (300 mg) every 14 days (V2- V13) Dupilumab s.c. injection in healthy skin, 24 weeks
- Placebo Comparator: Placebo15 patients; placebo s.c. injection; 2 ready-to-use syringes initial (V1), 1 ready-to-use syringe every 14 days (V2-V13) placebo s.c. injection in healthy skin, 24 weeks
Primary Outcome Measure
LoSCAT target lesion [ Time Frame: Baseline to End of Treatment Visit, 24 weeks ]