Phase 3: testing Remibrutinib for Chronic Pruritus of Unknown Origin
The purpose of this phase 3 study is to establish the how well it works, whether it is safe and how hard side effects are to live with of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO).
Official registry: https://clinicaltrials.gov/study/NCT07700056 · Novartis Pharmaceuticals · enrollment listed as 180
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 Remibrutinib, or Placebo. The registry lists allocation as randomized. The purpose of this phase 3 study is to establish the how well it works, whether it is safe and how hard side effects are to live with of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO).
They plan to enroll about 180 people at 23 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
Interventions: Remibrutinib, Placebo
Primary outcome (registry wording): Proportion of participants achieving ≥4 point reduction from baseline in Worst itch Numerical Rating Scale (WI NRS)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Participants with chronic pruritus for at least 4 months prior to screening
- Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (e.g., excluding chronic pruritus related to primary dermatological or systemic conditions, neuropathic or psychogenic origin or secondary to drugs or other allergen exposures)
- Chronic pruritus must affect at least 2 of the following body areas: trunk, arms, or legs (cannot be unilateral and/or dermatomal in distribution)
- Participants with ongoing, severe chronic pruritus despite the use of emollients and who are candidates for systemic therapy
- Participants must have severe itch defined by a WI-NRS ≥7 at screening; score scale ranges from 0 to 10; higher score indicates worse itch
- Participants must have an average WI-NRS ≥7 over the 7 days prior to randomization/baseline visit
- The average WI-NRS score over the preceding 7 days prior to the randomization/baseline visit will be calculated based on the daily WI-NRS scores (0-10)
Who the registry excludes
- Any active skin conditions (e.g., atopic dermatitis, psoriasis, etc.) that may interfere with the assessment of CPUO
- Known systemic condition(s) or medication(s) that are considered by the investigator to be the primary cause of current pruritus
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
Public study contact (from the registry)
Novartis Pharmaceuticals
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
23 listed- Aller Vie Health-Cullman — Cullman, Alabama (recruiting)
- Driven Research — Miami, Florida (recruiting)
- Aeroallergy Research Laboratories — Savannah, Georgia (recruiting)
- Dawes Fretzin Clinical Rea Group — Indianapolis, Indiana (recruiting)
- Southern IN Clinical Trials — New Albany, Indiana (recruiting)
- Equity Medical — The Bronx, New York (recruiting)
- Optima Research-Boardman — Boardman, Ohio (recruiting)
- Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania (recruiting)
- National Allergy and Asthma Research LLS — North Charleston, South Carolina (recruiting)
- Austin Inst for Clinical Research — Pflugerville, Texas (recruiting)
+ 13 sites outside the US on the same record
FAQ about this NCT record
Is NCT07700056 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 NCT07700056?
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 NCT07700056?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary