Testing Dupilumab with Fexofenadine (loratadine if not against a placebo for pruritus
Official title: Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
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)
- Phase 3
- 2 groups
- Sites in Calgary, Edmonton and 5 more cities
- Recruiting
Interventions
- Medication
Dupilumab
Injection solution subcutaneous
- Medication
Placebo
Injection solution SC
- Medication
Fexofenadine (loratadine if not available)
Tablet or capsule Oral
Canadian Sites (7)
4 of 7 recruiting
- Recruiting
Investigational Site Number : 1240001
Calgary, Alberta
- Recruiting
Investigational Site Number : 1240002
London, Ontario
- Recruiting
Investigational Site Number : 1240006
Toronto, Ontario
- Recruiting
Investigational Site Number : 1240004
Verdun, Quebec
- Completed
Investigational Site Number : 1240008
Edmonton, Alberta
- Completed
Investigational Site Number : 1240003
Markham, Ontario
- Completed
Investigational Site Number : 1240005
Montreal, Quebec
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants must have a history of severe itch and a worst itch score of ≥7 at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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.
- +Participant must be 18 (or the legal age of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → at baselineBaselineYour starting measurements, taken before treatment begins.Read more → (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, armsArmOne of the groups in a study, each receiving something different.Read more →, or trunk.
- +History of insufficient controlControl groupThe group a new treatment is measured against.Read more → 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 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
- −History of hypersensitivity or intolerance to non-sedative antihistamines.
- −HIV infection.
- −Participants are excluded from the study if any of the following criteria apply:
- −Severe concomitant illness(es) that, in the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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 visitScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −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 visitBaselineYour starting measurements, taken before treatment begins.Read more →, except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
- −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 trialInterventional studyA study where participants are given something to see what happens.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Dupilumab, together with one or more of: Fexofenadine (loratadine if not available).
Registry label: A: Dupilumab
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo, together with one or more of: Fexofenadine (loratadine if not available).
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 90 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 284 people.
The study is currently expected to finish around August 2027.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 24.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 24 — measured over Baseline to Week 24.
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12 — measured over Baseline to Week 12.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05263206 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About DupilumabDrug
Injection solution subcutaneous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Injection solution SC
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Fexofenadine (loratadine if not available)Drug
Tablet or capsule Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 90 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 90 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 24.
The study as a whole is currently expected to finish around 2027-08-25.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 284 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 8 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; London, Ontario, Canada; Markham, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 2 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (1)
Mount Sinai - Union Square- Site Number : 8400034
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.