Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
Start Date
2/15/2022
Completion Date
8/25/2027
Summary
The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO. This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO. Study B design was to be adapted based on the results of Study A. For both Study A and B, after an up-to-4-week screening period, participants with severe pruritus (worst-itch numerical rating scale \[WI-NRS ≥7) will enter a 4-week run-in period and will be treated with a non-sedative antihistamine and an emollient (moisturizer). Participants with severe pruritus (WI-NRS ≥7) at baseline will be randomized (1:1) to be treated for 24 weeks with either dupilumab or matching placebo in addition to their non-sedative antihistamine and emollient regimen. The treatment period for both study A and B will be followed by a 12-week follow-up period.
Detailed Description
Study duration per participant will be up to 44 weeks for both Study A and Study B.
Eligibility Criteria
Age Range: 18 years to 90 years
Interventions
Dupilumab
Placebo
Fexofenadine (loratadine if not available)
Conditions
Locations
Kern Allergy and Medical Research- Site Number : 8400016
Bakersfield, California 93301
United States
Modena Allergy + Asthma- Site Number : 8400038
La Jolla, California 92037
United States
FoxHall Dermatology- Site Number : 8400042
Washington D.C., District of Columbia 20016
United States
Palm Harbor Dermatology- Site Number : 8400024
Belleair, Florida 32756
United States
University of Miami Hospital- Site Number : 8400011
Miami, Florida 33136
United States
Skin Care Physicians of Georgia - Macon- Site Number : 8400030
Macon, Georgia 31217
United States
Aeroallergy Research Laboratory- Site Number : 8400036
Savannah, Georgia 31406
United States
Dawes Fretzin Clinical Research- Site Number : 8400007
Indianapolis, Indiana 46256
United States
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031
Louisville, Kentucky 40241
United States
Tulane University School of Medicine- Site Number : 8400045
New Orleans, Louisiana 70112
United States
Johns Hopkins Hospital- Site Number : 8400020
Baltimore, Maryland 21287
United States
The Asthma and Allergy Center- Site Number : 8400014
Bellevue, Nebraska 68123
United States
Mount Sinai - Union Square- Site Number : 8400034
New York, New York 10003
United States
AXIS Clinicals - Fargo- Site Number : 8400037
Fargo, North Dakota 58103
United States
Optima Research - Boardman- Site Number : 8400039
Boardman, Ohio 44512
United States
Columbia Dermatology & Aesthetics- Site Number : 8400047
Columbia, South Carolina 29212
United States
National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032
North Charleston, South Carolina 29420
United States
Complete Dermatology - Sugar Land- Site Number : 8400046
Sugar Land, Texas 77479
United States
Investigational Site Number : 0320004
Rosario, Santa Fe Province 2000
Argentina
Investigational Site Number : 0320008
Rosario, Santa Fe Province 2000
Argentina
Investigational Site Number : 0320005
Buenos Aires, 1012
Argentina
Investigational Site Number : 0320001
Buenos Aires, 1023
Argentina
Investigational Site Number : 0320006
Buenos Aires, 1055
Argentina
Investigational Site Number : 0320007
Buenos Aires, 1061
Argentina
Investigational Site Number : 0320002
Buenos Aires, 1121
Argentina
Investigational Site Number : 0320003
Buenos Aires, 1414
Argentina
Investigational Site Number : 1240001
Calgary, Alberta T2G 1B1
Canada
Investigational Site Number : 1240008
Edmonton, Alberta T6G 1C3
Canada
Investigational Site Number : 1240002
London, Ontario L6A 2C2
Canada
Investigational Site Number : 1240003
Markham, Ontario L3P 1X2
Canada
Investigational Site Number : 1240006
Toronto, Ontario M4C 1L1
Canada
Investigational Site Number : 1240005
Montreal, Quebec H4A 3T2
Canada
Investigational Site Number : 1240004
Verdun, Quebec H4G 2L8
Canada
Investigational Site Number : 1560003
Beijing, 100191
China
Investigational Site Number : 1560004
Chengdu, 610041
China
Investigational Site Number : 1560009
Chongqing, 400016
China
Investigational Site Number : 1560006
Guangzhou, 510018
China
Investigational Site Number : 1560005
Guangzhou, 510080
China
Investigational Site Number : 1560002
Hangzhou, 310006
China
Investigational Site Number : 1560001
Shanghai, 200040
China
Investigational Site Number : 1560011
Suzhou, 215006
China
Investigational Site Number : 1560008
Wuhan, 430022
China
Investigational Site Number : 2500001
Brest, 29200
France
Investigational Site Number : 2500003
Nice, 06202
France
Investigational Site Number : 2500004
Reims, 51100
France
Investigational Site Number : 2760005
Bad Bentheim, 48455
Germany
Investigational Site Number : 2760002
Berlin, 12203
Germany
Investigational Site Number : 2760004
Frankfurt, 60590
Germany
Investigational Site Number : 2760003
Mainz, 55131
Germany
Investigational Site Number : 2760001
Münster, 48149
Germany
Investigational Site Number : 3480001
Budapest, 1036
Hungary
Investigational Site Number : 3480009
Budapest, 1066
Hungary
Investigational Site Number : 3480005
Debrecen, 4031
Hungary
Investigational Site Number : 3480010
Gyula, 5700
Hungary
Investigational Site Number : 3480003
Szeged, 6720
Hungary
Investigational Site Number : 3480011
Székesfehérvár, 8000
Hungary
Investigational Site Number : 3480002
Zalaegerszeg, 8900
Hungary
Azienda Ospedaliero-Universitaria di Ferrara-Site Number : 3800007
Cona, Ferrara 44124
Italy
AUSL Toscana Centro - Presidio Ospedaliero "Piero Palagi-"Site Number : 3800005
Florence, Firenze 50125
Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Site Number : 3800003
Milan, Milano 20122
Italy
Investigational Site Number : 3800002
Rozzano, Milano 20089
Italy
Investigational Site Number : 3800006
Naples, Napoli 80131
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001
Rome, Roma 00168
Italy
Azienda Ospedaliero Universitaria delle Marche-Site Number : 3800004
Ancona, 60126
Italy
Investigational Site Number : 3920007
Urayasu, Chiba 279-0011
Japan
Investigational Site Number : 3920003
Obihiro, Hokkaido 080-0013
Japan
Investigational Site Number : 3920006
Sapporo, Hokkaido 060-0063
Japan
Investigational Site Number : 3920004
Habikino, Osaka 583-8588
Japan
Investigational Site Number : 3920002
Sakai, Osaka 593-8324
Japan
Investigational Site Number : 3920005
Izumo, Shimane 693-8501
Japan
Investigational Site Number : 3920001
Tachikawa, Tokyo 190-0023
Japan
Investigational Site Number : 6160001
Krakow, Lesser Poland Voivodeship 30-033
Poland
Investigational Site Number : 6160007
Wroclaw, Lower Silesian Voivodeship 50-566
Poland
Investigational Site Number : 6160003
Wroclaw, Lower Silesian Voivodeship 51-318
Poland
Investigational Site Number : 6160003
Wroclaw, Lower Silesian Voivodeship 51-503
Poland
Investigational Site Number : 6160008
Warsaw, Masovian Voivodeship 01-142
Poland
Investigational Site Number : 6160005
Warsaw, Masovian Voivodeship 02-172
Poland
Investigational Site Number : 4100003
Busan, Busan 49241
South Korea
Investigational Site Number : 4100004
Ansan-si, Gyeonggi-do 15355
South Korea
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi 03080
South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi 03722
South Korea
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi 05030
South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi 07441
South Korea
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi 07804
South Korea
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona] 08003
Spain
Investigational Site Number : 7240006
Barcelona, Catalunya [Cataluña] 08041
Spain
Investigational Site Number : 7240001
Pontevedra, Pontevedra [Pontevedra] 36002
Spain
Investigational Site Number : 7240005
Alicante, 03010
Spain
Investigational Site Number : 7240004
Córdoba, 14004
Spain
Investigational Site Number : 1580003
Kaohsiung City, 833
Taiwan
Investigational Site Number : 1580004
New Taipei City, 235
Taiwan
Investigational Site Number : 1580001
Taipei, 100
Taiwan
Investigational Site Number : 1580002
Taoyuan City, 333
Taiwan