Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab
Who is this study for? Child to adult patients with Chronic Spontaneous Urticaria
What treatments are being studied? Dupilumab
Status: Completed
Location: See all (98) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Objective: This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders) Secondary
Objectives: This study aimed to demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints This study aimed to demonstrate the efficacy of dupilumab on angioedema This study aimed to demonstrate the efficacy of dupilumab on urticaria control This study aimed to demonstrate improvement in health-related quality of life and overall disease status and severity This study aimed to evaluate the ability of dupilumab in reducing the proportion of participants who require treatment with oral corticosteroids (OCS) This study aimed to evaluate safety outcome measures This study aimed to evaluate immunogenicity of dupilumab
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 80
Healthy Volunteers: f
View:
• Study A and C: Participant were ≥6 years to 80 years of age at the time of signing the informed consent.
• Study B: Participant were ≥12 years (or the minimum legal age for adolescents in the country of the investigational site) to 80 years of age at the time of signing the informed consent
• Participants who had a diagnosis of CSU refractory to H1 antihistamines (H1-AH) at the time of randomization defined by
• Diagnosis of CSU\>6 months prior to screening visit
• Presence of itch and hives for \>6 consecutive weeks at any time prior to screening visit despite the use of H1-AH during that time period
• Used a study defined H1-antihistamine for CSU treatment
• During the 7 days before randomization:
⁃ UAS7≥16 ISS7≥ 8
• Study A and C: omalizumab naïve, Study B; intolerant or incomplete responder to omalizumab
• Participants were willing and able to complete a daily symptom e-Diary for the duration of the study
Locations
United States
California
California Allergy and Asthma Medical Group, Inc. Site Number : 8400019
Los Angeles
Florida
Sarasota Clinical Research Site Number : 8400017
Sarasota
Lenus Research & Medical Group Site Number : 8400001
Sweetwater
University of South Florida Site Number : 8400006
Tampa
Georgia
Aeroallergy Research Laboratories of Savannah, INC Site Number : 8400018
Savannah
Kentucky
Allergy & Asthma Specialists, PSC Site Number : 8400020
Owensboro
Maryland
Johns Hopkins University (Asthma and Allergy Center) Site Number : 8400016
Baltimore
Missouri
The Clinical Research Center, LLC Site Number : 8400009
St Louis
North Carolina
Immunocarolina LLC Site Number : 8400010
Charlotte
New York
UR Dermatology at College Town Site Number : 8400008
Rochester
Ohio
Bernstein Clinical Research Center Site Number : 8400014
Cincinnati
Oklahoma
Vital Prospects Clinical Research Institute, P.C. Site Number : 8400015
Tulsa
Pennsylvania
Allergy and Clinical Immunology Associates Site Number : 8400024
Pittsburgh
South Carolina
National Allergy and ENT Site Number : 8400011
Charleston
Texas
Pharmaceutical Research & Consulting, Inc. Site Number : 8400003
Dallas
STAAMP Research, LLC Site Number : 8400007
San Antonio
Other Locations
Argentina
Investigational Site Number : 0320001
Buenos Aires
Investigational Site Number : 0320004
Caba
Investigational Site Number : 0320008
Caba
Investigational Site Number : 0320005
Rosario
Investigational Site Number : 0320006
Rosario
Investigational Site Number : 0320007
Rosario
Investigational Site Number : 0320003
San Miguel De Tucumán
Canada
Investigational Site Number : 1240009
Calgary
Investigational Site Number : 1240010
Edmonton
Investigational Site Number : 1240014
Hamilton
Investigational Site Number : 1240013
Markham
Investigational Site Number : 1240003
Niagara Falls
Investigational Site Number : 1240004
Québec
Investigational Site Number : 1240011
Québec
Investigational Site Number : 1240016
Sherbrooke
Investigational Site Number : 1240002
Toronto
Investigational Site Number : 1240005
Toronto
Investigational Site Number : 1240006
Trois-rivières
Investigational Site Number : 1240007
Windsor
China
Investigational Site Number : 1560004
Beijing
Investigational Site Number : 1560010
Beijing
Investigational Site Number : 1560001
Chengdu
Investigational Site Number : 1560007
Guangzhou
Investigational Site Number : 1560002
Hangzhou
Investigational Site Number : 1560008
Hangzhou
Investigational Site Number : 1560006
Jinan
Investigational Site Number : 1560003
Shanghai
Investigational Site Number : 1560005
Wuxi
France
Investigational Site Number : 2500009
Calais
Investigational Site Number : 2500002
Lille
Investigational Site Number : 2500011
Mont-de-marsan
Investigational Site Number : 2500004
Nantes
Investigational Site Number : 2500003
Nice
Investigational Site Number : 2500012
Nice
Investigational Site Number : 2500006
Paris
Investigational Site Number : 2500005
Pierre-bénite
Germany
Investigational Site Number : 2760001
Berlin
Investigational Site Number : 2760010
Bramsche
Investigational Site Number : 2760006
Dresden
Investigational Site Number : 2760007
Kiel
Investigational Site Number : 2760008
Tübingen
Hungary
Investigational Site Number : 3480005
Debrecen
Investigational Site Number : 3480004
Szeged
Investigational Site Number : 3480003
Szolnok
Investigational Site Number : 3480002
Szombathely
Japan
Investigational Site Number : 3920005
Hiroshima
Investigational Site Number : 3920006
Itabashi-ku
Investigational Site Number : 3920007
Izumo-shi
Investigational Site Number : 3920011
Kagoshima
Investigational Site Number : 3920002
Kobe
Investigational Site Number : 3920004
Nagoya
Investigational Site Number : 3920009
Sapporo
Investigational Site Number : 3920001
Shinagawa-ku
Investigational Site Number : 3920003
Suita-shi
Investigational Site Number : 3920010
Tachikawa-shi
Investigational Site Number : 3920008
Yokohama
Investigational Site Number : 3920013
Yokohama
Russian Federation
Investigational Site Number : 6430008
Chelyabinsk
Investigational Site Number : 6430006
Kazan'
Investigational Site Number : 6430007
Krasnodar
Investigational Site Number : 6430002
Moscow
Investigational Site Number : 6430005
Moscow
Investigational Site Number : 6430010
Moscow
Investigational Site Number : 6430003
Saint Petersburg
Investigational Site Number : 6430009
Saratov
Investigational Site Number : 6430004
Smolensk
Investigational Site Number : 6430001
Stavropol
Spain
Investigational Site Number : 7240003
Barcelona
Investigational Site Number : 7240008
Barcelona
Investigational Site Number : 7240013
Burjassot - Valencia
Investigational Site Number : 7240004
Córdoba
Investigational Site Number : 7240010
Esplugues De Llobregat
Investigational Site Number : 7240014
L'hospitalet De Llobregat
Investigational Site Number : 7240005
Las Palmas De Gran Canaria
Investigational Site Number : 7240001
Madrid
Investigational Site Number : 7240006
Madrid
Investigational Site Number : 7240007
Madrid
Investigational Site Number : 7240002
Pamplona
Investigational Site Number : 7240012
Santiago De Compostela
Investigational Site Number : 7240011
Villarreal De Huerva
United Kingdom
Investigational Site Number : 8260002
London
Investigational Site Number : 8260001
Manchester
Time Frame
Start Date: 2019-12-11
Completion Date: 2024-10-25
Participants
Target number of participants: 397
Treatments
Experimental: Study A Dupilumab
Participants who were omalizumab naïve received dupilumab for 24 weeks as follows:~* 300 milligrams (mg) SC injection every 2 weeks (q2w) for adults and those adolescents who weighed \>=60 kilograms (kg) at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1,~* 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and~* 300 mg SC injection every 4 weeks (q4w) for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Placebo_comparator: Study A Placebo
Participants who were omalizumab naïve received placebo matched to dupilumab as subcutaneous (SC) injection including loading dose from Day 1 up to 24 weeks.
Experimental: Study B Dupilumab
Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows:~* 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or~* 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.
Placebo_comparator: Study B Placebo
Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.
Experimental: Study C Dupilumab
Participants who were omalizumab naïve received dupilumab for 24 weeks as follows:~* 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1,~* 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and~* 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Placebo_comparator: Study C Placebo
Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Sanofi