Status:
COMPLETED
Dupilumab in Chronic Spontaneous Urticaria
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Sanofi
Proinnovera GmbH
Conditions:
Chronic Spontaneous Urticaria
Recurrent Angioedema
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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-antih...
Detailed Description
Treatment with Dupilumab has been shown to reduce clinically significant exacerbations and to improve skin symptom control as well as quality of life in moderate to severe atopic dermatitis patients a...
Eligibility Criteria
Inclusion
- Diagnosis: chronic spontaneous urticaria (defined as ongoing disease)
- Patient is informed about study procedures and medications and has given written informed consent before any assessment.
- Patient is able to communicate with the investigator, understands and complies with the requirements of the study.
- Male or Female
- Patient is 18-75 years of age
- Patient is diagnosed with moderate to severe CSU and refractory to standard of care treatment at the time of randomization, as defined by the following:
- The presence of itch and hives for more than 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine
- Urticaria activity score UAS7 score (range 0-42) equal or more than 16, 7 days prior to randomization (Day 1)
- CSU diagnosis for 6 months
- Willing and able to complete a daily symptom diary for the duration of the study and adhere to the study visit schedules.
- Patients must not have more than one missing diary entry in the 7 days prior to randomization. Re-screening may be considered.
- Women of childbearing potential have to agree to use an acceptable form of contraception (as determined by the site investigator) and have to continue its use for the duration of the study.
Exclusion
- Patients whose urticaria is solely due to inducible urticaria.
- Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
- Any other active skin disease associated with chronic itching that might confound the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, etc.)
- Patients who have received concomitant prohibited medication within the last 3 months prior to screening
- Anti-IgE therapy (e.g. omalizumab)
- Routine (daily or every other day during 5 or more consecutive days) doses of systemic corticosteroids or other immunosuppressants
- Intravenous immunoglobulins
- Biological therapy
- Systemic immunosuppressants
- Live/attenuated vaccines
- Other investigational drug
- History of anaphylactic shock
- Active helminthic parasite infection or treatment of helminthic parasites within 6 months of screening
Key Trial Info
Start Date :
November 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03749135
Start Date
November 12 2018
End Date
July 7 2021
Last Update
February 2 2022
Active Locations (6)
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1
Universitätsklinikum Giessen und Marburg
Marburg, Hesse, Germany, 35043
2
Hautklinik Universitätsklinikum Münster
Münster, NRW, Germany, Germany, 48149
3
Hautklinik der Universitätsmedizin Mainz Clinical Research Center
Mainz, Rheinland-Pfalz, Germany, Germany, 55101
4
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany, 01307