Remibrutinib for Severe Chronic Pruritus of Unknown Origin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a global phase 3, randomized, double-blind, placebo-controlled study in adults with severe chronic pruritus of unknown origin. Participants are assigned to remibrutinib or placebo for 24 weeks, followed by open-label remibrutinib for 28 weeks and a 4-week safety follow-up. The trial includes a screening period (up to 4 weeks), a double-blind treatment period, an open-label treatment period where placebo non-responders switch to remibrutinib at Week 24, and a safety assessment period. Primary focus is on safety, tolerability, and efficacy in reducing itch as measured by WI-NRS scores, with ongoing monitoring for adverse events. Enrollment spans multiple global sites, with certain centers in the United States identified as study locations.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Participant must be ≥ 18 years of age, at the time of signing the informed consent.
* 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).
* Participants must have PGIS of pruritus scored as 3 "severe" at screening and baseline visits.

Key Exclusion Criteria:

* 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.
* Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the clinical trial as per Investigator´s assessment. These infectious diseases include but are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected HIV infection.
* 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.
* Significant bleeding risk or coagulation disorders. History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAIDs), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion). Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
* History or current hepatic disease, including but not limited to, acute or chronic hepatitis, cirrhosis or hepatic failure or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening.

Where it's running

• Aller Vie Health-Cullman
  Cullman, Alabama, United States Recruiting
• Driven Research
  Miami, Florida, United States Recruiting
• Aeroallergy Research Laboratories
  Savannah, Georgia, United States Recruiting
• Dawes Fretzin Clinical Rea Group
  Indianapolis, Indiana, United States Recruiting
• Southern IN Clinical Trials
  New Albany, Indiana, United States Recruiting
• Equity Medical
  The Bronx, New York, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remibrutinib for Severe Chronic Pruritus of Unknown Origin in Adults

  We’re testing whether remibrutinib can help adults with severe, unexplained itching that hasn’t gone away with moisturizers.

  Recruiting at 12 sites Phase 3 Novartis · Fremont, California and 11 other locations · NCT07811869

• Nocturnal ScratchSense ring: test of automatic scratch detection in adults with itchy skin

  This study tests whether the Replior ScratchSense ring can accurately detect and measure nighttime scratching in adults with itchy skin conditions.

  Recruiting Replior AB · Grenoble · NCT07909967

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Remibrutinib and omalizumab-based treatment approach for adults with chronic spontaneous urticaria not well controlled by antihistamines

  This trial tests a sequencing plan using remibrutinib and omalizumab to see if it helps adults with chronic spontaneous urticaria that isn’t well controlled by second-generation antihistamines.

  Recruiting at 10 sites Phase 3 Novartis · London, Ontario and 9 other locations · NCT07816328

• Remibrutinib for IgE-mediated peanut, milk, and egg allergy

  This study tests whether remibrutinib can help people with peanut, milk, or egg allergies by comparing it to placebo over 52 weeks.

  Recruiting at 22 sites Phase 3 Novartis · Birmingham, Alabama and 21 other locations · NCT07768371

• Brain Imaging and Immune Changes During Remibrutinib in Relapsing MS

  This study tests how remibrutinib affects brain inflammation in people with relapsing MS who are also on ocrelizumab.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT07758270

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.