Actively Recruiting
Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
Led by Sanofi · Updated on 2026-04-09
284
Participants Needed
91
Research Sites
288 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years at consent
- Chronic pruritus lasting at least 6 months before screening
- Chronic pruritus of unknown origin, excluding causes like dermatological, systemic, neuropathic, psychogenic, or drug-related
- Pruritus affecting at least two body areas: legs, arms, or trunk
- History of insufficient control with prior treatments
- Receiving optimal treatment for related conditions affecting pruritus (e.g., diabetes, iron deficiency)
- Severe itch with worst itch score of 7 or higher at screening on WI-NRS and "severe" rating on PGIS
- Average worst itch score of 7 or higher in the 7 days before run-in and Day 1
- "Severe" rating on PGIS of pruritus on Day 1
You will not qualify if you...
- Severe illnesses that would interfere with study participation
- Active tuberculosis, non-tuberculous mycobacterial infection, or history of incompletely treated tuberculosis without documented adequate treatment
- Diagnosed, suspected, or high risk of endoparasitic infection or recent use of antiparasitic drugs within 2 weeks before screening
- HIV infection
- Severe renal failure requiring dialysis
- Active infections needing systemic antibiotics, antivirals, or antifungals within 2 weeks before run-in
- Known or suspected immune deficiency
- Active cancer or cancer history within 5 years except certain treated skin or cervical cancers
- Allergy or intolerance to non-sedative antihistamines
- Prior participation in dupilumab clinical trials or previous treatment with dupilumab commercially
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 91 locations
1
Kern Allergy and Medical Research- Site Number : 8400016
Bakersfield, California, United States, 93301
Completed
2
Modena Allergy + Asthma- Site Number : 8400038
La Jolla, California, United States, 92037
Actively Recruiting
3
FoxHall Dermatology- Site Number : 8400042
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
4
Palm Harbor Dermatology- Site Number : 8400024
Belleair, Florida, United States, 32756
Actively Recruiting
5
University of Miami Hospital- Site Number : 8400011
Miami, Florida, United States, 33136
Actively Recruiting
6
Skin Care Physicians of Georgia - Macon- Site Number : 8400030
Macon, Georgia, United States, 31217
Actively Recruiting
7
Aeroallergy Research Laboratory- Site Number : 8400036
Savannah, Georgia, United States, 31406
Actively Recruiting
8
Dawes Fretzin Clinical Research- Site Number : 8400007
Indianapolis, Indiana, United States, 46256
Actively Recruiting
9
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031
Louisville, Kentucky, United States, 40241
Actively Recruiting
10
Tulane University School of Medicine- Site Number : 8400045
New Orleans, Louisiana, United States, 70112
Actively Recruiting
11
Johns Hopkins Hospital- Site Number : 8400020
Baltimore, Maryland, United States, 21287
Actively Recruiting
12
The Asthma and Allergy Center- Site Number : 8400014
Bellevue, Nebraska, United States, 68123
Actively Recruiting
13
Mount Sinai - Union Square- Site Number : 8400034
New York, New York, United States, 10003
Actively Recruiting
14
AXIS Clinicals - Fargo- Site Number : 8400037
Fargo, North Dakota, United States, 58103
Actively Recruiting
15
Optima Research - Boardman- Site Number : 8400039
Boardman, Ohio, United States, 44512
Actively Recruiting
16
Columbia Dermatology & Aesthetics- Site Number : 8400047
Columbia, South Carolina, United States, 29212
Actively Recruiting
17
National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032
North Charleston, South Carolina, United States, 29420
Actively Recruiting
18
Complete Dermatology - Sugar Land- Site Number : 8400046
Sugar Land, Texas, United States, 77479
Actively Recruiting
19
Investigational Site Number : 0320004
Rosario, Santa Fe Province, Argentina, 2000
Completed
20
Investigational Site Number : 0320008
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
21
Investigational Site Number : 0320005
Buenos Aires, Argentina, 1012
Actively Recruiting
22
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1023
Completed
23
Investigational Site Number : 0320006
Buenos Aires, Argentina, 1055
Actively Recruiting
24
Investigational Site Number : 0320007
Buenos Aires, Argentina, 1061
Actively Recruiting
25
Investigational Site Number : 0320002
Buenos Aires, Argentina, 1121
Actively Recruiting
26
Investigational Site Number : 0320003
Buenos Aires, Argentina, 1414
Actively Recruiting
27
Investigational Site Number : 1240001
Calgary, Alberta, Canada, T2G 1B1
Actively Recruiting
28
Investigational Site Number : 1240008
Edmonton, Alberta, Canada, T6G 1C3
Completed
29
Investigational Site Number : 1240002
London, Ontario, Canada, L6A 2C2
Actively Recruiting
30
Investigational Site Number : 1240003
Markham, Ontario, Canada, L3P 1X2
Completed
31
Investigational Site Number : 1240006
Toronto, Ontario, Canada, M4C 1L1
Actively Recruiting
32
Investigational Site Number : 1240005
Montreal, Quebec, Canada, H4A 3T2
Completed
33
Investigational Site Number : 1240004
Verdun, Quebec, Canada, H4G 2L8
Actively Recruiting
34
Investigational Site Number : 1560003
Beijing, China, 100191
Actively Recruiting
35
Investigational Site Number : 1560004
Chengdu, China, 610041
Actively Recruiting
36
Investigational Site Number : 1560009
Chongqing, China, 400016
Actively Recruiting
37
Investigational Site Number : 1560006
Guangzhou, China, 510018
Actively Recruiting
38
Investigational Site Number : 1560005
Guangzhou, China, 510080
Actively Recruiting
39
Investigational Site Number : 1560002
Hangzhou, China, 310006
Actively Recruiting
40
Investigational Site Number : 1560001
Shanghai, China, 200040
Actively Recruiting
41
Investigational Site Number : 1560011
Suzhou, China, 215006
Actively Recruiting
42
Investigational Site Number : 1560008
Wuhan, China, 430022
Actively Recruiting
43
Investigational Site Number : 2500001
Brest, France, 29200
Actively Recruiting
44
Investigational Site Number : 2500003
Nice, France, 06202
Actively Recruiting
45
Investigational Site Number : 2760005
Bad Bentheim, Germany, 48455
Actively Recruiting
46
Investigational Site Number : 2760002
Berlin, Germany, 12203
Actively Recruiting
47
Investigational Site Number : 2760004
Frankfurt, Germany, 60590
Actively Recruiting
48
Investigational Site Number : 2760003
Mainz, Germany, 55131
Actively Recruiting
49
Investigational Site Number : 2760001
Münster, Germany, 48149
Actively Recruiting
50
Investigational Site Number : 3480001
Budapest, Hungary, 1036
Actively Recruiting
51
Investigational Site Number : 3480009
Budapest, Hungary, 1066
Actively Recruiting
52
Investigational Site Number : 3480005
Debrecen, Hungary, 4031
Actively Recruiting
53
Investigational Site Number : 3480003
Szeged, Hungary, 6720
Actively Recruiting
54
Investigational Site Number : 3480011
Székesfehérvár, Hungary, 8000
Actively Recruiting
55
Investigational Site Number : 3480002
Zalaegerszeg, Hungary, 8900
Actively Recruiting
56
Azienda Ospedaliero-Universitaria di Ferrara-Site Number : 3800007
Cona, Ferrara, Italy, 44124
Actively Recruiting
57
AUSL Toscana Centro - Presidio Ospedaliero "Piero Palagi-"Site Number : 3800005
Florence, Firenze, Italy, 50125
Actively Recruiting
58
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Site Number : 3800003
Milan, Milano, Italy, 20122
Actively Recruiting
59
Investigational Site Number : 3800002
Rozzano, Milano, Italy, 20089
Actively Recruiting
60
Investigational Site Number : 3800006
Naples, Napoli, Italy, 80131
Actively Recruiting
61
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001
Rome, Roma, Italy, 00168
Actively Recruiting
62
Azienda Ospedaliero Universitaria delle Marche-Site Number : 3800004
Ancona, Italy, 60126
Actively Recruiting
63
Investigational Site Number : 3920007
Urayasu, Chiba, Japan, 279-0011
Actively Recruiting
64
Investigational Site Number : 3920003
Obihiro, Hokkaido, Japan, 080-0013
Actively Recruiting
65
Investigational Site Number : 3920006
Sapporo, Hokkaido, Japan, 060-0063
Actively Recruiting
66
Investigational Site Number : 3920004
Habikino, Osaka, Japan, 583-8588
Actively Recruiting
67
Investigational Site Number : 3920002
Sakai, Osaka, Japan, 593-8324
Actively Recruiting
68
Investigational Site Number : 3920005
Izumo, Shimane, Japan, 693-8501
Actively Recruiting
69
Investigational Site Number : 3920001
Tachikawa, Tokyo, Japan, 190-0023
Actively Recruiting
70
Investigational Site Number : 6160001
Krakow, Lesser Poland Voivodeship, Poland, 30-033
Actively Recruiting
71
Investigational Site Number : 6160007
Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
Actively Recruiting
72
Investigational Site Number : 6160003
Wroclaw, Lower Silesian Voivodeship, Poland, 51-318
Active, Not Recruiting
73
Investigational Site Number : 6160003
Wroclaw, Lower Silesian Voivodeship, Poland, 51-503
Actively Recruiting
74
Investigational Site Number : 6160008
Warsaw, Masovian Voivodeship, Poland, 01-142
Actively Recruiting
75
Investigational Site Number : 6160005
Warsaw, Masovian Voivodeship, Poland, 02-172
Actively Recruiting
76
Investigational Site Number : 4100003
Busan, Busan, South Korea, 49241
Completed
77
Investigational Site Number : 4100004
Ansan-si, Gyeonggi-do, South Korea, 15355
Completed
78
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi, South Korea, 03080
Completed
79
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea, 03722
Completed
80
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, South Korea, 05030
Actively Recruiting
81
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea, 07441
Completed
82
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi, South Korea, 07804
Actively Recruiting
83
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona], Spain, 08003
Actively Recruiting
84
Investigational Site Number : 7240006
Barcelona, Catalunya [Cataluña], Spain, 08041
Actively Recruiting
85
Investigational Site Number : 7240001
Pontevedra, Pontevedra [Pontevedra], Spain, 36002
Actively Recruiting
86
Investigational Site Number : 7240005
Alicante, Spain, 03010
Actively Recruiting
87
Investigational Site Number : 7240004
Córdoba, Spain, 14004
Actively Recruiting
88
Investigational Site Number : 1580003
Kaohsiung City, Taiwan, 833
Actively Recruiting
89
Investigational Site Number : 1580004
New Taipei City, Taiwan, 235
Actively Recruiting
90
Investigational Site Number : 1580001
Taipei, Taiwan, 100
Actively Recruiting
91
Investigational Site Number : 1580002
Taoyuan City, Taiwan, 333
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free number for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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