Dupilumab in Chronic Spontaneous Urticaria

NCT03749135 | Completed Phase 2

• 2 other identifiers: D-001-012017-004458-41
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 6

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-antihistamine treatment.

Conditions

Chronic Spontaneous Urticaria; Recurrent Angioedema

Keywords

hives; itch

Outcome Measures

Primary Outcomes (1)

• Urticaria activity score over 7 days (UAS7)

  0-42 Points total range over 7 days, higher values equal more disease activity

  Change from 7 days prior to baseline (Visit (V) 1) to 7 days prior to week 16 (V9)

Secondary Outcomes (6)

• Itch severity score (ISS7; 0 - no pruritus; 21 - most severe pruritus), hive severity score (HSS7; 0 - no hives; 21 - max. hive severity)

  Change from 7 days prior to baseline (Visit (V) 1) to 7 days prior to week 16 (V9)

• Global assessment for disease activity

  Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)

• urticaria control test (UCT; 16 - complete disease control; 0 - strong symptoms), dermatological quality of life (DLQI; 0 - no impairment; 30 - max. impairment), chronic urticaria quality of life (Cu2-QoL; 23 - no impairment; 115 - max. impairment)

  Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)

• Responder rates (regarding disease activity and quality of live (QoL))

  Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)

• rate of angioedema burdened days angioedema activity score (AAS; 0 - lowest disease activity; 15 - highest disease activity) angioedema quality of life (AE-Qol; 0 - no impairment; 100 - worst impairment)

  Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)]

Study Arms (2)

Dupilumab

ACTIVE COMPARATOR

Dupilumab (anti-IL4Ra), s.c. administration

Drug: Dupilumab

Placebo Comparator

PLACEBO COMPARATOR

matching Placebo, s.c. administration

Drug: Placebo

Interventions

Dupilumab DRUG

anti-IL4-Receptor alpha

Dupilumab

Placebo DRUG

Placebo

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Sanofi: collaborator
• Proinnovera GmbH: collaborator

Study Sites (6)

Universitätsklinikum Giessen und Marburg

Marburg, Hesse, 35043, Germany

Location

Hautklinik Universitätsklinikum Münster

Münster, NRW, Germany, 48149, Germany

Location

Hautklinik der Universitätsmedizin Mainz Clinical Research Center

Mainz, Rheinland-Pfalz, Germany, 55101, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Location

Universitätsmedizin Leipzig, Klinik für Dermatologie, Venerologie und Allergologie

Leipzig, Saxony, 04103, Germany

Location

Charite University, Berlin, Germany

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Chronic Urticaria; Angioedema; Urticaria; Pruritus

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Skin Manifestations; Signs and Symptoms

Study Officials

• Marcus Maurer, Prof.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomized, double blind, placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director Prof. Dr. med. Marcus Maurer

Model Details: This is a Phase 2a multicenter, randomized, double blind, placebo controlled, parallel group, two-arm, proof-of-concept investigator-initiated trial

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: November 21, 2018
• Study Start: November 12, 2018
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: February 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)