BridgeMD
Tests treatment safety and results 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)
ClinicalTrials.gov ID: NCT05263206
What this study is testing
What is Dupilumab?
Dupilumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pruritus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
- 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...
- 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.
You likely can't join if
- 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...
- 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).
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bakersfield, California, United States
- La Jolla, California, United States
- Washington D.C., District of Columbia, United States
- Belleair, Florida, United States
- Miami, Florida, United States
- Macon, Georgia, United States
- Savannah, Georgia, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Bellevue, Nebraska, United States
- New York, New York, United States
- Fargo, North Dakota, United States
- Boardman, Ohio, United States
- Columbia, South Carolina, United States
- North Charleston, South Carolina, United States
- Sugar Land, Texas, United States
- Rosario, Santa Fe Province, Argentina
- Buenos Aires, Argentina
+ 58 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bakersfield, California, United States; La Jolla, California, United States; Washington D.C., District of Columbia, United States; Belleair, Florida, United States; Miami, Florida, United States; Macon, Georgia, United States and 72 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.