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RECRUITING Phase 3

Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)

NCT05263206 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Dupilumab
  • DRUG Fexofenadine (loratadine if not available)

Study Locations (20)

California

  • Kern Allergy and Medical Research- Site Number : 8400016 — Bakersfield
  • Modena Allergy + Asthma- Site Number : 8400038 — La Jolla

Florida

  • Palm Harbor Dermatology- Site Number : 8400024 — Belleair
  • University of Miami Hospital- Site Number : 8400011 — Miami

Georgia

  • Skin Care Physicians of Georgia - Macon- Site Number : 8400030 — Macon
  • Aeroallergy Research Laboratory- Site Number : 8400036 — Savannah

South Carolina

  • Columbia Dermatology & Aesthetics- Site Number : 8400047 — Columbia
  • National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032 — North Charleston

Santa Fe Province

  • Investigational Site Number : 0320004 — Rosario
  • Investigational Site Number : 0320008 — Rosario

District of Columbia

  • FoxHall Dermatology- Site Number : 8400042 — Washington D.C.

Indiana

  • Dawes Fretzin Clinical Research- Site Number : 8400007 — Indianapolis

Kentucky

  • Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031 — Louisville

Trial Details

FieldValue
Enrollment Target 284 participants
Start Date 2022-02-15
Est. Completion 2027-08-25
Phase Phase 3

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05263206

The ClinicalTrials.gov registry entry for NCT05263206 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 284 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pruritus appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05263206 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05263206 about?

NCT05263206 is a clinical study titled "Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)". 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 participan...

What is the current status of trial NCT05263206?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 284 participants. The study started on 2022-02-15. Estimated completion is 2027-08-25.

What conditions does trial NCT05263206 study?

This clinical trial studies the following conditions: Pruritus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05263206?

The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG), Fexofenadine (loratadine if not available) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05263206?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05263206 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial