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

NCT04200755 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-10-26

No results posted yet for this study

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.

Conditions

  • Localized Scleroderma

Interventions

DRUG

Dupilumab 300Mg Solution for Injection

First dose: 600 mg (2 syringes); subsequent doses: 300 mg (1 syringe)

OTHER

Placebo

First dose: 2 syringes, no active substance; subsequent doses: 1 syringe, no active substance

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Sabine Eming, Prof. Dr. · University of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-19
Primary Completion
2023-11-30
Completion
2023-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200755 on ClinicalTrials.gov