Trial intelligence / Profile preview

Dupilumab in Localized Scleroderma

NCT04200755Phase 2

Key facts

Status: Completed
Start: May 2020
Primary completion: Nov 2023
Countries: 1
Sponsor: University of Cologne
Modality: Monoclonal Antibodies

Drugs: dupilumab
Conditions: localized scleroderma

Overview

Phase 2, randomised, double-blind trial in localized scleroderma comparing Dupilumab with Placebo (2 arms). Primary endpoint: Localized Scleroderma Cutaneous Assessment Tool target lesion at 24 weeks. Started May 2020; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Dupilumab
Dupilumab 600mg loading dose, then 300mg q2w
Placebo
Matching placebo q2w

Endpoints

Primary

Localized Scleroderma Cutaneous Assessment Tool target lesion24 weeks

Secondary

modified Localized Scleroderma Skin Severity Index all lesions48 weeks
Localized Scleroderma Skin Damage Index all lesions48 weeks
Number of lesions48 weeks
Dermatology Life Quality Index48 weeks
RNA sequencing24 weeks
Reverse Transcription quantitative Polymerase Chain Reaction24 weeks
Adverse events48 weeks
Physical examination48 weeks

Beyond the preview

Go deeper on NCT04200755.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT04200755.