Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma (NCT04200755) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma
Germany45 participantsStarted 2020-05-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is a male or female ≥18 years of age on the day the study informed consent is signed
* Out-patient status
* Caucasian
* Morphea (plaque type) or Generalized localized scleroderma (affecting at least three anatomic sites)
* At least one lesions with lilac ring (active phase of the disease);
* Activity of LS within the last 12 month (as defined by progression of size or new developing plaque)
* For women of childbearing potential: negative pregnancy test at Visit 1
* For women of childbearing potential: Use of effective method of contraception from 4 weeks prior to enrolment, throughout study treatment until 12 weeks after the last IMP dose.
* Written informed consent signed
Exclusion Criteria:
* Systemic immunosuppressive therapy or UV therapy less than 3 months before enrollment.
* Participation in another trial of IMPs or devices parallel to, or less than 6 months before or previous participation in this trial
* Pregnancy or breastfeeding mother
* Diagnosis of other significant chronic inflammatory or autoimmune disorders. Patients with the following autoimmune disorders are excluded from the study: Multiple sclerosis, primary biliary cirrhosis, type I diabetes mellitus. Patients with the following autoimmune disorders are regarded as eligible: Lichen sclerosus, vitiligo, alopecia arthritis, thyroid diseases (e.g. Hashimoto disease). Patients with any autoimmune disorder not listed above should only be included after consultation with the pri…
What they're measuring
1
LoSCAT target lesion
Timeframe: Baseline to End of Treatment Visit, 24 weeks