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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05263206




Registration number
NCT05263206
Ethics application status
Date submitted
22/02/2022
Date registered
2/03/2022
Date last updated
20/08/2025

Titles & IDs
Public title
Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
Scientific title
Master Protocol of Two Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Studies to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Chronic Pruritus of Unknown Origin (CPUO)
Secondary ID [1] 0 0
U1111-1253-9888
Secondary ID [2] 0 0
EFC16973
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pruritus 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab
Treatment: Drugs - Placebo
Treatment: Drugs - Fexofenadine (loratadine if not available)

Experimental: Dupilumab - Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer

Placebo comparator: Placebo - Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer


Treatment: Drugs: Dupilumab
Injection solution subcutaneous

Treatment: Drugs: Placebo
Injection solution SC

Treatment: Drugs: Fexofenadine (loratadine if not available)
Tablet or capsule Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by =4 from baseline to Week 24
Timepoint [1] 0 0
Baseline to Week 24
Primary outcome [2] 0 0
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by =4 from baseline to Week 12
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Study A; Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by =4 from baseline to Week 12
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Study A: Proportion of participants who scored "none" or "mild" in Patient Global Impression of Severity (PGIS) of pruritus at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by =4 from baseline over time until Week 24
Timepoint [3] 0 0
Baseline to Week 24
Secondary outcome [4] 0 0
Study A: Time to first response of WI-NRS =4 points reduction from baseline by Week 24
Timepoint [4] 0 0
Baseline to Week 24
Secondary outcome [5] 0 0
Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24
Timepoint [5] 0 0
Baseline to Week 24
Secondary outcome [6] 0 0
Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 24
Timepoint [6] 0 0
Baseline to Week 24
Secondary outcome [7] 0 0
Study A: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12
Timepoint [8] 0 0
Baseline to Week 12
Secondary outcome [9] 0 0
Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 12
Timepoint [9] 0 0
Baseline to Week 12
Secondary outcome [10] 0 0
Study A: Absolute change from baseline in weekly average of daily sleep disturbance numerical rating scale (NRS) at Week 24
Timepoint [10] 0 0
Baseline to Week 24
Secondary outcome [11] 0 0
Study A: Percent change from baseline in weekly average of daily sleep disturbance NRS at Week 24
Timepoint [11] 0 0
Baseline to Week 24
Secondary outcome [12] 0 0
Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 24
Timepoint [12] 0 0
Baseline to Week 24
Secondary outcome [13] 0 0
Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 24
Timepoint [13] 0 0
Baseline to Week 24
Secondary outcome [14] 0 0
Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 24
Timepoint [14] 0 0
Baseline to Week 24
Secondary outcome [15] 0 0
Study A: Absolute change from baseline in weekly average of daily sleep disturbance NRS at Week 12
Timepoint [15] 0 0
Baseline to Week 12
Secondary outcome [16] 0 0
Study A: Percent change from baseline in weekly average of daily sleep disturbance NRS at Week 12
Timepoint [16] 0 0
Baseline to Week 12
Secondary outcome [17] 0 0
Study A: Change from baseline in DLQI score at Week 12
Timepoint [17] 0 0
Baseline to Week 12
Secondary outcome [18] 0 0
Study A: Change from baseline in the ItchyQoL score at Week 12
Timepoint [18] 0 0
Baseline to Week 12
Secondary outcome [19] 0 0
Study A: Change from baseline in HADS total score at Week 12
Timepoint [19] 0 0
Baseline to Week 12
Secondary outcome [20] 0 0
Study A: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through end of study (EOS)
Timepoint [20] 0 0
Baseline to Week 36
Secondary outcome [21] 0 0
Study A: Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab
Timepoint [21] 0 0
Baseline to Week 36
Secondary outcome [22] 0 0
Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 24
Timepoint [22] 0 0
Week 24
Secondary outcome [23] 0 0
Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12
Timepoint [23] 0 0
Week 12
Secondary outcome [24] 0 0
Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 12
Timepoint [24] 0 0
Baseline to Week 12
Secondary outcome [25] 0 0
Study B: Percent change from baseline in weekly average of daily WI-NRS at Week 12
Timepoint [25] 0 0
Baseline to Week 12
Secondary outcome [26] 0 0
Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 24
Timepoint [26] 0 0
Baseline to Week 24
Secondary outcome [27] 0 0
Study B: Percentage change from baseline in weekly average of daily WI-NRS at Week 24
Timepoint [27] 0 0
Baseline to Week 24
Secondary outcome [28] 0 0
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by =4 from baseline, sustained from Week 19 through Week 24
Timepoint [28] 0 0
Baseline to Week 19 through Week 24
Secondary outcome [29] 0 0
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by =5 from baseline to Week 24
Timepoint [29] 0 0
Baseline to Week 24
Secondary outcome [30] 0 0
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by =4 from baseline to Week 24
Timepoint [30] 0 0
Baseline to Week 24
Secondary outcome [31] 0 0
Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 24
Timepoint [31] 0 0
Week 24
Secondary outcome [32] 0 0
Study B: Time to first response of WI-NRS =4 points reduction from baseline by Week 24
Timepoint [32] 0 0
Baseline to Week 24
Secondary outcome [33] 0 0
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by =5 from baseline to Week 12
Timepoint [33] 0 0
Baseline to Week 12
Secondary outcome [34] 0 0
Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 12
Timepoint [34] 0 0
Week 12
Secondary outcome [35] 0 0
Study B: Absolute change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24
Timepoint [35] 0 0
Baseline to Week 12 and Week 24
Secondary outcome [36] 0 0
Study B: Percent change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24
Timepoint [36] 0 0
Baseline to Week 12 and Week 24
Secondary outcome [37] 0 0
Study B: Change from baseline in DLQI score at Week 12 and Week 24
Timepoint [37] 0 0
Baseline to Week 12 and Week 24
Secondary outcome [38] 0 0
Study B: Change from baseline in the ItchyQoL score at Week 12 and Week 24
Timepoint [38] 0 0
Baseline to Week 12 and Week 24
Secondary outcome [39] 0 0
Study B: Change from baseline in HADS total score at Week 12 and Week 24
Timepoint [39] 0 0
Baseline to Week 12 and Week 24
Secondary outcome [40] 0 0
Study B: Percentage of participants experiencing TEAEs or SAEs from baseline through EOS
Timepoint [40] 0 0
Baseline to Week 36
Secondary outcome [41] 0 0
Study B: Incidence of treatment-emergent ADA against dupilumab
Timepoint [41] 0 0
Baseline to Week 36

Eligibility
Key inclusion criteria
* Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent.
* 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.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:

* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/08/2027
Actual
Sample size
Target
284
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Investigational Site Number : 0320003 - Birtinya
Recruitment hospital [2] 0 0
Investigational Site Number : 0320007 - Maroochydore
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
China
State/province [17] 0 0
Beijing
Country [18] 0 0
China
State/province [18] 0 0
Chengdu
Country [19] 0 0
China
State/province [19] 0 0
Chongqing
Country [20] 0 0
China
State/province [20] 0 0
Guangzhou
Country [21] 0 0
China
State/province [21] 0 0
Hangzhou
Country [22] 0 0
China
State/province [22] 0 0
Shanghai
Country [23] 0 0
China
State/province [23] 0 0
Suzhou
Country [24] 0 0
China
State/province [24] 0 0
Wuhan
Country [25] 0 0
Croatia
State/province [25] 0 0
Ferrara
Country [26] 0 0
Germany
State/province [26] 0 0
Ohio
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Mainz
Country [29] 0 0
Greece
State/province [29] 0 0
Santa Fe
Country [30] 0 0
Hungary
State/province [30] 0 0
Budapest
Country [31] 0 0
Hungary
State/province [31] 0 0
Debrecen
Country [32] 0 0
Hungary
State/province [32] 0 0
Szeged
Country [33] 0 0
Hungary
State/province [33] 0 0
Zalaegerszeg
Country [34] 0 0
Italy
State/province [34] 0 0
Ancona
Country [35] 0 0
Italy
State/province [35] 0 0
Firenze
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Italy
State/province [37] 0 0
Napoli
Country [38] 0 0
Italy
State/province [38] 0 0
Roma
Country [39] 0 0
Italy
State/province [39] 0 0
Como
Country [40] 0 0
Japan
State/province [40] 0 0
Chiba
Country [41] 0 0
Japan
State/province [41] 0 0
Hokkaido
Country [42] 0 0
Japan
State/province [42] 0 0
Osaka
Country [43] 0 0
Japan
State/province [43] 0 0
Shimane
Country [44] 0 0
Poland
State/province [44] 0 0
Lesser Poland Voivodeship
Country [45] 0 0
Poland
State/province [45] 0 0
Lower Silesian Voivodeship
Country [46] 0 0
Poland
State/province [46] 0 0
Masovian Voivodeship
Country [47] 0 0
Slovakia
State/province [47] 0 0
South Carolina
Country [48] 0 0
South Korea
State/province [48] 0 0
Busan
Country [49] 0 0
South Korea
State/province [49] 0 0
Gyeonggi-do
Country [50] 0 0
South Korea
State/province [50] 0 0
Seoul-teukbyeolsi
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona [Barcelona]
Country [52] 0 0
Spain
State/province [52] 0 0
Catalunya [Cataluña]
Country [53] 0 0
Spain
State/province [53] 0 0
Pontevedra [Pontevedra]
Country [54] 0 0
Spain
State/province [54] 0 0
Alicante
Country [55] 0 0
Spain
State/province [55] 0 0
Córdoba
Country [56] 0 0
Taiwan
State/province [56] 0 0
Kaohsiung City
Country [57] 0 0
Taiwan
State/province [57] 0 0
New Taipei City
Country [58] 0 0
Taiwan
State/province [58] 0 0
Taipei
Country [59] 0 0
Taiwan
State/province [59] 0 0
Taoyuan
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Leicestershire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05263206