Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)

PHASE3CompletedINTERVENTIONAL
Enrollment

397

Participants

Timeline

Start Date

December 11, 2019

Primary Completion Date

August 1, 2024

Study Completion Date

October 25, 2024

Conditions
Chronic Spontaneous Urticaria
Interventions
DRUG

Dupilumab SAR231893

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

DRUG

non sedating H1-antihistamine

Pharmaceutical form:Tablet Route of administration: oral administration

Trial Locations (98)

2000

Investigational Site Number : 0320006, Rosario

4031

Investigational Site Number : 3480005, Debrecen

5000

Investigational Site Number : 3480003, Szolnok

6720

Investigational Site Number : 3480004, Szeged

9700

Investigational Site Number : 3480002, Szombathely

10117

Investigational Site Number : 2760001, Berlin

12540

Investigational Site Number : 7240011, Villarreal de Huerva

14004

Investigational Site Number : 7240004, Córdoba

14642

UR Dermatology at College Town Site Number : 8400008, Rochester

15241

Allergy and Clinical Immunology Associates Site Number : 8400024, Pittsburgh

15702

Investigational Site Number : 7240012, Santiago de Compostela

21224

Johns Hopkins University (Asthma and Allergy Center) Site Number : 8400016, Baltimore

24148

Investigational Site Number : 2760007, Kiel

28027

Investigational Site Number : 7240007, Madrid

28040

Investigational Site Number : 7240001, Madrid

28041

Investigational Site Number : 7240006, Madrid

28277

Immunocarolina LLC Site Number : 8400010, Charlotte

29420

National Allergy and ENT Site Number : 8400011, Charleston

31008

Investigational Site Number : 7240002, Pamplona

31406

Aeroallergy Research Laboratories of Savannah, INC Site Number : 8400018, Savannah

33172

Lenus Research & Medical Group Site Number : 8400001, Sweetwater

33613

University of South Florida Site Number : 8400006, Tampa

34239

Sarasota Clinical Research Site Number : 8400017, Sarasota

35010

Investigational Site Number : 7240005, Las Palmas de Gran Canaria

40000

Investigational Site Number : 2500011, Mont-de-Marsan

42301

Allergy & Asthma Specialists, PSC Site Number : 8400020, Owensboro

44093

Investigational Site Number : 2500004, Nantes

45236

Bernstein Clinical Research Center Site Number : 8400014, Cincinnati

46100

Investigational Site Number : 7240013, Burjassot - Valencia

49565

Investigational Site Number : 2760010, Bramsche

59037

Investigational Site Number : 2500002, Lille

62107

Investigational Site Number : 2500009, Calais

63141

The Clinical Research Center, LLC Site Number : 8400009, St Louis

69495

Investigational Site Number : 2500005, Pierre-Bénite

72076

Investigational Site Number : 2760008, Tübingen

74136

Vital Prospects Clinical Research Institute, P.C. Site Number : 8400015, Tulsa

75231

Pharmaceutical Research & Consulting, Inc. Site Number : 8400003, Dallas

75970

Investigational Site Number : 2500006, Paris

78229

STAAMP Research, LLC Site Number : 8400007, San Antonio

90025

California Allergy and Asthma Medical Group, Inc. Site Number : 8400019, Los Angeles

100045

Investigational Site Number : 1560010, Beijing

100050

Investigational Site Number : 1560004, Beijing

115522

Investigational Site Number : 6430005, Moscow

Investigational Site Number : 6430010, Moscow

123182

Investigational Site Number : 6430002, Moscow

193231

Investigational Site Number : 6430003, Saint Petersburg

200040

Investigational Site Number : 1560003, Shanghai

214002

Investigational Site Number : 1560005, Wuxi

214006

Investigational Site Number : 6430004, Smolensk

250013

Investigational Site Number : 1560006, Jinan

310006

Investigational Site Number : 1560002, Hangzhou

310016

Investigational Site Number : 1560008, Hangzhou

350020

Investigational Site Number : 6430007, Krasnodar

355030

Investigational Site Number : 6430001, Stavropol

410028

Investigational Site Number : 6430009, Saratov

420064

Investigational Site Number : 6430006, Kazan'

454048

Investigational Site Number : 6430008, Chelyabinsk

510630

Investigational Site Number : 1560007, Guangzhou

610041

Investigational Site Number : 1560001, Chengdu

C1023AAB

Investigational Site Number : 0320008, CABA

C1414AIF

Investigational Site Number : 0320004, CABA

S2000BRH

Investigational Site Number : 0320007, Rosario

S2000JKR

Investigational Site Number : 0320005, Rosario

T4000AXL

Investigational Site Number : 0320003, San Miguel de Tucumán

C1121ABE

Investigational Site Number : 0320001, Buenos Aires

T2J 7E1

Investigational Site Number : 1240009, Calgary

T6G 1C3

Investigational Site Number : 1240010, Edmonton

L8L 3C3

Investigational Site Number : 1240014, Hamilton

L3P 1X3

Investigational Site Number : 1240013, Markham

L2H 1H5

Investigational Site Number : 1240003, Niagara Falls

M3B 3S6

Investigational Site Number : 1240005, Toronto

M5G 1E2

Investigational Site Number : 1240002, Toronto

N8X 2G1

Investigational Site Number : 1240007, Windsor

J1G 1X9

Investigational Site Number : 1240016, Sherbrooke

G8T 7A1

Investigational Site Number : 1240006, Trois-Rivières

G1V 4W2

Investigational Site Number : 1240004, Québec

G1W 4R4

Investigational Site Number : 1240011, Québec

06000

Investigational Site Number : 2500012, Nice

06200

Investigational Site Number : 2500003, Nice

01307

Investigational Site Number : 2760006, Dresden

734-8551

Investigational Site Number : 3920005, Hiroshima

060-0807

Investigational Site Number : 3920009, Sapporo

650-0017

Investigational Site Number : 3920002, Kobe

890-0063

Investigational Site Number : 3920011, Kagoshima

221-0825

Investigational Site Number : 3920013, Yokohama

236-0004

Investigational Site Number : 3920008, Yokohama

565-0871

Investigational Site Number : 3920003, Suita-shi

693-8501

Investigational Site Number : 3920007, Izumo-shi

173-8610

Investigational Site Number : 3920006, Itabashi-ku

141-8625

Investigational Site Number : 3920001, Shinagawa-Ku

190-0023

Investigational Site Number : 3920010, Tachikawa-shi

454-8509

Investigational Site Number : 3920004, Nagoya

08003

Investigational Site Number : 7240003, Barcelona

08036

Investigational Site Number : 7240008, Barcelona

08907

Investigational Site Number : 7240014, L'Hospitalet de Llobregat

08950

Investigational Site Number : 7240010, Esplugues de Llobregat

E1 1BB

Investigational Site Number : 8260002, London

M23 9QZ,

Investigational Site Number : 8260001, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT04180488 - Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID) | Biotech Hunter | Biotech Hunter