Dupilumab in Chronic Spontaneous Urticaria

Sponsor
Charite University, Berlin, Germany
Study ID
NCT03749135
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Spontaneous Urticaria
  • Recurrent Angioedema

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 chronic spontaneous urticaria (CSU) who are symptomatic despite H1-antihistamine treatment.

Key Dates

First listed
Nov 21, 2018
Start date
Nov 12, 2018
Status verified
Feb 2022
Primary completion
Jul 7, 2021
Completion
Jul 7, 2021

Study Design

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

Arms

  • Active Comparator: Dupilumab
    Dupilumab (anti-IL4Ra), s.c. administration
  • Placebo Comparator: Placebo Comparator
    matching Placebo, s.c. administration

Primary Outcome Measure

Urticaria activity score over 7 days (UAS7) [ Time Frame: Change from 7 days prior to baseline (Visit (V) 1) to 7 days prior to week 16 (V9) ]

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