Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne
• Treatments: Antibodies, Monoclonal

Criteria

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 principal coordinating investigator.

• Topical immunosuppressive therapy less than 1 month before enrollment

• Concurrent phototherapy

• Known infection with helminths (helminthosis)

• Any condition or laboratory abnormality that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study. E.g. uncontrolled psychiatric illness or history of clinical relevant drug abuse.

• Known hypersensitivity to any components of the IMP

• Treatment with a live (attenuated) vaccine within 3 months prior to enrollment

• History of malignancy (except patients with completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin)

• Known diagnosis of active tuberculosis or non-tuberculous mycobacterial infection or latent untreated tuberculosis unless it is well documented by a specialist that the patient has been adequately treated

• Known diagnosis of HIV, HBV or HCV infection

• Regular use (more than 2 visits per week) of a tanning booth/parlor

• Known diagnosis of asthma