Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
NCT ID: NCT05263206
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
284 participants
INTERVENTIONAL
2022-02-15
2027-08-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dupilumab
Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer
Dupilumab
Injection solution subcutaneous
Fexofenadine (loratadine if not available)
Tablet or capsule Oral
Placebo
Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer
Placebo
Injection solution SC
Fexofenadine (loratadine if not available)
Tablet or capsule Oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dupilumab
Injection solution subcutaneous
Placebo
Injection solution SC
Fexofenadine (loratadine if not available)
Tablet or capsule Oral
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants with chronic pruritus for at least 6 months before the screening visit.
* Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs).
* Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk.
* History of insufficient control of the chronic pruritus with prior treatment.
* Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency).
* Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient Global Impression of Severity (PGIS) of pruritus scored "severe" at screening.
* Participants must have an average worst itch score of ≥7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS.
* Participants scored "severe" in the PGIS of pruritus on Day 1.
Exclusion Criteria
* Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study.
* Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent.
* Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit.
* HIV infection.
* Severe renal failure (dialysis).
* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit.
* Known or suspected immunodeficiency.
* Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
* History of hypersensitivity or intolerance to non-sedative antihistamines.
* Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kern Allergy and Medical Research- Site Number : 8400016
Bakersfield, California, United States
Modena Allergy + Asthma- Site Number : 8400038
La Jolla, California, United States
FoxHall Dermatology- Site Number : 8400042
Washington D.C., District of Columbia, United States
Palm Harbor Dermatology- Site Number : 8400024
Belleair, Florida, United States
University of Miami Hospital- Site Number : 8400011
Miami, Florida, United States
Skin Care Physicians of Georgia - Macon- Site Number : 8400030
Macon, Georgia, United States
Aeroallergy Research Laboratory- Site Number : 8400036
Savannah, Georgia, United States
Dawes Fretzin Clinical Research- Site Number : 8400007
Indianapolis, Indiana, United States
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031
Louisville, Kentucky, United States
Tulane University Health Sciences Center- Site Number : 8400045
New Orleans, Louisiana, United States
Johns Hopkins Hospital- Site Number : 8400020
Baltimore, Maryland, United States
The Asthma and Allergy Center- Site Number : 8400014
Bellevue, Nebraska, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8400034
New York, New York, United States
AXIS Clinicals - Fargo- Site Number : 8400037
Fargo, North Dakota, United States
Optima Research - Boardman- Site Number : 8400039
Boardman, Ohio, United States
Columbia Dermatology & Aesthetics- Site Number : 8400047
Columbia, South Carolina, United States
National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032
North Charleston, South Carolina, United States
Complete Dermatology - Sugar Land- Site Number : 8400046
Sugar Land, Texas, United States
Investigational Site Number : 0320004
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320008
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320005
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320006
Buenos Aires, , Argentina
Investigational Site Number : 0320007
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320003
Buenos Aires, , Argentina
Investigational Site Number : 1240001
Calgary, Alberta, Canada
Investigational Site Number : 1240008
Edmonton, Alberta, Canada
Investigational Site Number : 1240002
London, Ontario, Canada
Investigational Site Number : 1240003
Markham, Ontario, Canada
Investigational Site Number : 1240006
Toronto, Ontario, Canada
Investigational Site Number : 1240005
Montreal, Quebec, Canada
Investigational Site Number : 1240004
Verdun, Quebec, Canada
Investigational Site Number : 1560003
Beijing, , China
Investigational Site Number : 1560004
Chengdu, , China
Investigational Site Number : 1560009
Chongqing, , China
Investigational Site Number : 1560006
Guangzhou, , China
Investigational Site Number : 1560005
Guangzhou, , China
Investigational Site Number : 1560002
Hangzhou, , China
Investigational Site Number : 1560001
Shanghai, , China
Investigational Site Number : 1560011
Suzhou, , China
Investigational Site Number : 1560008
Wuhan, , China
Investigational Site Number : 2760002
Berlin, , Germany
Investigational Site Number : 2760003
Mainz, , Germany
Investigational Site Number : 3480001
Budapest, , Hungary
Investigational Site Number : 3480009
Budapest, , Hungary
Investigational Site Number : 3480005
Debrecen, , Hungary
Investigational Site Number : 3480003
Szeged, , Hungary
Investigational Site Number : 3480002
Zalaegerszeg, , Hungary
Investigational Site Number : 3800004
Torette, Ancona, Italy
Investigational Site Number : 3800007
Cona, Ferrara, Italy
Investigational Site Number : 3800005
Florence, Firenze, Italy
Investigational Site Number : 3800003
Milan, Milano, Italy
Investigational Site Number : 3800002
Rozzano, Milano, Italy
Investigational Site Number : 3800006
Naples, Napoli, Italy
Investigational Site Number : 3800001
Rome, Roma, Italy
Investigational Site Number : 3920007
Urayasu, Chiba, Japan
Investigational Site Number : 3920003
Obihiro, Hokkaido, Japan
Investigational Site Number : 3920006
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920004
Habikino, Osaka, Japan
Investigational Site Number : 3920002
Sakai, Osaka, Japan
Investigational Site Number : 3920005
Izumo, Shimane, Japan
Investigational Site Number : 3920001
Tachikawa, Tokyo, Japan
Investigational Site Number : 6160001
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160007
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160003
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160003
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160008
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160005
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 4100003
Busan, Busan, South Korea
Investigational Site Number : 4100004
Ansan-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240001
Pontevedra, Pontevedra [Pontevedra], Spain
Investigational Site Number : 7240005
Alicante, , Spain
Investigational Site Number : 7240004
Córdoba, , Spain
Investigational Site Number : 1580003
Kaohsiung City, , Taiwan
Investigational Site Number : 1580004
New Taipei City, , Taiwan
Investigational Site Number : 1580001
Taipei, , Taiwan
Investigational Site Number : 1580002
Taoyuan, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Trial Transparency email recommended (Toll free number for US & Canada)
Role: CONTACT
Related Links
Access external resources that provide additional context or updates about the study.
EFC16973 Chronic Pruritus of Unknown Origin Website
EFC16973 Plain Language Results Summary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1253-9888
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-508879-36-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-508879-36
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-004315-76
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC16973
Identifier Type: -
Identifier Source: org_study_id