New drug targets mystery itch that Won't go away
NCT ID NCT07700056
First seen Jul 13, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This phase 3 trial tests whether remibrutinib, an oral drug, can reduce severe itching in adults who have had chronic itch for at least 4 months with no known cause. Participants receive either remibrutinib or a placebo for 52 weeks. The main goal is to see if more people on the drug achieve a meaningful reduction in itch intensity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- remibrutinib
- What this could lead to
- If effective, remibrutinib could offer a new treatment option for people suffering from severe chronic itch with no identifiable cause.
- What could go wrong
- This is a phase 3 trial, but the drug may not work better than placebo. Side effects are possible, and the cause of the itch is unknown, so results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aeroallergy Research Laboratories
RECRUITINGSavannah, Georgia, 31406, United States
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Austin Inst for Clinical Research
RECRUITINGPflugerville, Texas, 78660, United States
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Dawes Fretzin Clinical Rea Group
RECRUITINGIndianapolis, Indiana, 46256, United States
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Novartis Investigative Site
RECRUITINGTachikawa, Tokyo, 1900023, Japan
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Optima Research-Boardman
RECRUITINGBoardman, Ohio, 44512, United States
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