Cholinergic Urticaria - Efficacy of Dupilumab

Sponsor: Charite University, Berlin, Germany
Study ID: NCT03749148
Phase: PHASE2
Status: Completed

Conditions

Cholinergic Urticaria

Eligibility Criteria

Sex: ALL
Age: 18 Years - 75 Years
Healthy Volunteers: Not accepted

Interventions

Dupilumab — DRUG
anti-IL4-Receptor alpha
Placebo — DRUG
Placebo

Study Details

The purpose of this study is to assess the efficacy in reducing disease activity and safety of Dupilumab in adult patients with cholinergic urticarial (CholU) who are symptomatic despite H1-antihistamine treatment (licensed dose).

Key Dates

Start date: Dec 10, 2018
Status verified: Sep 2023
Primary completion: Feb 28, 2023
Completion: Feb 28, 2023

Study Design

Enrollment: 48 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Active Comparator: Dupilumab
Dupilumab, s.c. administration 2 injections (600mg) as loading dose, 1 injection (300mg) every 14 days for a total of 16 weeks
Placebo Comparator: Placebo
matching Placebo, s.c. administration 2 injections as loading dose, 1 injection every 14 days for a total of 16 weeks

Primary Outcome Measure

cholinergic Urticaria activity score over 7 days (CholUAS7) [ Time Frame: Change from 7 days prior to baseline (Visit (V) 1) to 7 days prior to week 16 (V9)] ]