Actively Recruiting
Master Protocol of Two Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Studies to Evaluate the Efficacy and Safety of Dupilumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)
Led by Sanofi · Updated on 2026-06-08
284
Participants Needed
92
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of dupilumab in adults aged 18 to 90 years who have chronic pruritus of unknown origin (CPUO). This study consists of two parallel, double-blind, placebo-controlled Phase 3 trials (Study A and Study B) designed to assess dupilumab treatment effects, with Study B's design adapting based on Study A's results. Participants must have severe itch lasting at least six months and confirmed by specific scoring systems. After up to a 4-week screening period, participants enter a 4-week run-in phase where they receive a non-sedative antihistamine and moisturizer. Those with severe itch scores are then randomly assigned to receive either dupilumab or placebo injections subcutaneously every two weeks for 24 weeks, alongside the antihistamine and moisturizer. Following treatment, a 12-week follow-up period monitors participants. Participants will be involved for up to 44 weeks total, including screening, run-in, treatment, and follow-up. Researchers will assess improvements in itch severity using the Worst-Itch Numerical Rating Scale (WI-NRS) and other measures such as quality of life, sleep disturbance, anxiety, and depression scores. Safety will be monitored through adverse event tracking and antibody development against dupilumab during and after treatment.
CONDITIONS
Brief 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 the time of consent
- Chronic pruritus lasting at least 6 months before screening
- Chronic pruritus of unknown origin, excluding known dermatological, systemic, neuropathic, psychogenic causes, or drug-induced
- Pruritus affecting at least two of the following areas: legs, arms, or trunk
- History of insufficient control of chronic pruritus with prior treatments
- Receiving optimal treatment for other conditions affecting pruritus (e.g., diabetes, iron deficiency)
- Severe itch with a worst itch numerical rating scale (WI-NRS) score of 7 or higher at screening and Day 1
- Severe pruritus rating on Patient Global Impression of Severity (PGIS) at screening and Day 1
- Average worst itch score of 7 or higher in the 7 days before run-in and before Day 1
You will not qualify if you...
- Severe illnesses that may negatively impact study participation
- Active tuberculosis, non-tuberculous mycobacterial infection, or incompletely treated tuberculosis without documented adequate treatment
- Diagnosed or suspected endoparasitic infection or recent antiparasitic drug use within 2 weeks before screening
- HIV infection
- Severe renal failure requiring dialysis
- Active infection needing systemic antibiotics, antivirals, or antifungals within 2 weeks before run-in
- Known or suspected immunodeficiency
- Active cancer or history of cancer within 5 years, except certain treated skin or cervical cancers
- History of allergic reaction or intolerance to non-sedative antihistamines
- Previous participation in dupilumab clinical trials or prior treatment with commercial dupilumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive subcutaneous injections of either Dupilumab or placebo every 2 weeks, alongside non-sedative antihistamines and moisturizer, to evaluate the efficacy and safety for chronic pruritus of unknown origin.
Regular visits every 2 weeks during treatment
Duration - Up to 12 weeks after treatment
Participants are monitored for safety and treatment-emergent effects after completing the treatment phase.
Visits for safety monitoring up to Week 36
Trial Site Locations
Total: 92 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 : 3480010
Gyula, Hungary, 5700
Actively Recruiting
54
Investigational Site Number : 3480003
Szeged, Hungary, 6720
Actively Recruiting
55
Investigational Site Number : 3480011
Székesfehérvár, Hungary, 8000
Actively Recruiting
56
Investigational Site Number : 3480002
Zalaegerszeg, Hungary, 8900
Actively Recruiting
57
Azienda Ospedaliero-Universitaria di Ferrara-Site Number : 3800007
Cona, Ferrara, Italy, 44124
Actively Recruiting
58
AUSL Toscana Centro - Presidio Ospedaliero "Piero Palagi-"Site Number : 3800005
Florence, Firenze, Italy, 50125
Actively Recruiting
59
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Site Number : 3800003
Milan, Milano, Italy, 20122
Actively Recruiting
60
Investigational Site Number : 3800002
Rozzano, Milano, Italy, 20089
Actively Recruiting
61
Investigational Site Number : 3800006
Naples, Napoli, Italy, 80131
Actively Recruiting
62
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001
Rome, Roma, Italy, 00168
Actively Recruiting
63
Azienda Ospedaliero Universitaria delle Marche-Site Number : 3800004
Ancona, Italy, 60126
Actively Recruiting
64
Investigational Site Number : 3920007
Urayasu, Chiba, Japan, 279-0011
Actively Recruiting
65
Investigational Site Number : 3920003
Obihiro, Hokkaido, Japan, 080-0013
Actively Recruiting
66
Investigational Site Number : 3920006
Sapporo, Hokkaido, Japan, 060-0063
Actively Recruiting
67
Investigational Site Number : 3920004
Habikino, Osaka, Japan, 583-8588
Actively Recruiting
68
Investigational Site Number : 3920002
Sakai, Osaka, Japan, 593-8324
Actively Recruiting
69
Investigational Site Number : 3920005
Izumo, Shimane, Japan, 693-8501
Actively Recruiting
70
Investigational Site Number : 3920001
Tachikawa, Tokyo, Japan, 190-0023
Actively Recruiting
71
Investigational Site Number : 6160001
Krakow, Lesser Poland Voivodeship, Poland, 30-033
Actively Recruiting
72
Investigational Site Number : 6160007
Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
Actively Recruiting
73
Investigational Site Number : 6160003
Wroclaw, Lower Silesian Voivodeship, Poland, 51-318
Active, Not Recruiting
74
Investigational Site Number : 6160003
Wroclaw, Lower Silesian Voivodeship, Poland, 51-503
Actively Recruiting
75
Investigational Site Number : 6160008
Warsaw, Masovian Voivodeship, Poland, 01-142
Actively Recruiting
76
Investigational Site Number : 6160005
Warsaw, Masovian Voivodeship, Poland, 02-172
Actively Recruiting
77
Investigational Site Number : 4100003
Busan, Busan, South Korea, 49241
Completed
78
Investigational Site Number : 4100004
Ansan-si, Gyeonggi-do, South Korea, 15355
Completed
79
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi, South Korea, 03080
Completed
80
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea, 03722
Completed
81
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, South Korea, 05030
Actively Recruiting
82
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea, 07441
Completed
83
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi, South Korea, 07804
Actively Recruiting
84
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona], Spain, 08003
Actively Recruiting
85
Investigational Site Number : 7240006
Barcelona, Catalunya [Cataluña], Spain, 08041
Actively Recruiting
86
Investigational Site Number : 7240001
Pontevedra, Pontevedra [Pontevedra], Spain, 36002
Actively Recruiting
87
Investigational Site Number : 7240005
Alicante, Spain, 03010
Actively Recruiting
88
Investigational Site Number : 7240004
Córdoba, Spain, 14004
Actively Recruiting
89
Investigational Site Number : 1580003
Kaohsiung City, Taiwan, 833
Actively Recruiting
90
Investigational Site Number : 1580004
New Taipei City, Taiwan, 235
Actively Recruiting
91
Investigational Site Number : 1580001
Taipei, Taiwan, 100
Actively Recruiting
92
Investigational Site Number : 1580002
Taoyuan City, Taiwan, 333
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free number for US & Canada)
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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