Phase 3: testing Dupilumab for Pruritus
The main objective of the study is to assess how well it works and safety of dupilumab given up to 24 weeks in adults with CPUO. This is a master protocol which includes 2 parallel-treatment, neither you nor the study doctors know who gets the real treatment, 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.
Official registry: https://clinicaltrials.gov/study/NCT05263206 · Sanofi · enrollment listed as 284
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Dupilumab, Placebo, or Fexofenadine (loratadine if not available). The registry lists allocation as randomized. The main objective of the study is to assess how well it works and safety of dupilumab given up to 24 weeks in adults with CPUO.
They plan to enroll about 284 people at 94 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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)
Interventions: Dupilumab, Placebo, Fexofenadine (loratadine if not available)
Primary outcome (registry wording): 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
Who it is for (from inclusion criteria)
- Ages 18 Years to 90 Years
- 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
Who the registry excludes
- 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
- 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
Public study contact (from the registry)
Trial Transparency email recommended (Toll free number for US & Canada)
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
94 listed- Kern Allergy and Medical Research- Site Number : 8400016 — Bakersfield, California (completed)
- Modena Allergy + Asthma- Site Number : 8400038 — La Jolla, California (recruiting)
- FoxHall Dermatology- Site Number : 8400042 — Washington D.C., District of Columbia (recruiting)
- Palm Harbor Dermatology- Site Number : 8400024 — Belleair, Florida (recruiting)
- University of Miami Hospital- Site Number : 8400011 — Miami, Florida (recruiting)
- Skin Care Physicians of Georgia - Macon- Site Number : 8400030 — Macon, Georgia (recruiting)
- Aeroallergy Research Laboratory- Site Number : 8400036 — Savannah, Georgia (recruiting)
- Treasure Valley Medical Research- Site Number : 8400049 — Boise, Idaho (recruiting)
- Dawes Fretzin Clinical Research- Site Number : 8400007 — Indianapolis, Indiana (recruiting)
- Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031 — Louisville, Kentucky (recruiting)
- Tulane University School of Medicine- Site Number : 8400045 — New Orleans, Louisiana (recruiting)
- Johns Hopkins Hospital- Site Number : 8400020 — Baltimore, Maryland (recruiting)
+ 75 sites outside the US on the same record
FAQ about this NCT record
Is NCT05263206 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05263206?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05263206?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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