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New drug for stubborn hives passes blood pressure check in phase 3 trial

NCT ID NCT05795153

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a drug called remibrutinib in 144 adults with chronic spontaneous urticaria (hives lasting over 6 months) that standard antihistamines couldn't control. Participants took a 25 mg tablet twice daily for up to 12 weeks. The main goal was to see if the drug affected blood pressure, using a 24-hour monitor. The study also tracked overall safety and how well the drug controlled hives.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remibrutinib (a drug taken as a tablet twice daily)
What this could lead to
If successful, this could confirm that remibrutinib is a safe and effective option for people with chronic hives that don't respond to standard antihistamines.
What could go wrong
This is a completed Phase 3 study, but it primarily measured blood pressure changes, not long-term effectiveness or safety. The results may not apply to all patients, and side effects are still being evaluated.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

144 people

The number who actually took part.

Started

Apr 2023

Finished

Apr 2024

Lead sponsor

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

18 to 99 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Signed informed consent obtained prior to participation in the study * Male and female adult participants \>= 18 years of age * CSU duration for \>= 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation). * Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of baseline (Day 1) * Documentation of hives within three months before baseline (either at screening and/or at baseline (Day 1); or documented in the participants' medical history). * Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the protocol * Participants had no more than 2 missing UPDD entries (either morning or evening) in the 7 days prior to baseline (Day 1). Key Exclusion Criteria: * Participants unable to tolerate 24-hour ambulatory blood pressure measurement using automatic ABPM device * Ongoing or past history of hypertension and/or SBP \>= 140 or =\< 90 OR DBP \>= 90 or =\< 60 mmHg at screening * Participants working night shifts * Participants taking/requiring medications prohibited by the protocol (including those known to interfere with blood pressure assessments in the study) * Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the Investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria Chronic Urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic spontaneous urticaria

Contacts and locations

Locations

  • Acuro Research Inc

    Little Rock, Arkansas, 72205, United States

  • Allergy Asthma and Clinical Research

    Oklahoma City, Oklahoma, 73120, United States

  • Allergy Asthma and amp Sinus Ctr S C

    Greenfield, Wisconsin, 53228, United States

  • Allergy and Asthma Specialist P S C

    Owensboro, Kentucky, 42301, United States

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241, United States

  • Endeavor Health

    Glenview, Illinois, 60077, United States

  • Finlay Medical Research

    Greenacres City, Florida, 33467, United States

  • Florida Ctr Allergy Asthma Research

    Aventura, Florida, 33180, United States

  • Novartis Investigative Site

    Nueve de Julio, Buenos Aires, B6500BWQ, Argentina

  • Novartis Investigative Site

    Sourigues, Buenos Aires, B1837, Argentina

  • Novartis Investigative Site

    Santa Fe, Rosario, S2000DBS, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000JKR, Argentina

  • Novartis Investigative Site

    Calgary, Alberta, T2M 1A6, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H2V 2K1, Canada

  • Novartis Investigative Site

    Angers, 49933, France

  • Novartis Investigative Site

    Antony, 92160, France

  • Novartis Investigative Site

    Brest, 29609, France

  • Novartis Investigative Site

    Montpellier, 34295, France

  • Novartis Investigative Site

    Paris, 75970, France

  • Novartis Investigative Site

    Reims, 51100, France

  • Novartis Investigative Site

    Saint-Mandé, 94160, France

  • Novartis Investigative Site

    Toulouse, 31400, France

  • Novartis Investigative Site

    Bramsche, Lower Saxony, 49565, Germany

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06108, Germany

  • Novartis Investigative Site

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    Hanover, 30625, Germany

  • Novartis Investigative Site

    Marburg, 35039, Germany

  • Novartis Investigative Site

    Singapore, 308205, Singapore

  • Novartis Investigative Site

    Komárno, 945 01, Slovakia

  • Novartis Investigative Site

    Levice, 934 01, Slovakia

  • Novartis Investigative Site

    Nové Zámky, 940 34, Slovakia

  • Novartis Investigative Site

    Daegu, Dalseo Gu, 41931, South Korea

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 16499, South Korea

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Alicante, Valencia, 03010, Spain

  • Novartis Investigative Site

    Valencia, Valencia, 46014, Spain

  • Novartis Investigative Site

    Madrid, 28006, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Izmir, 35140, Turkey (Türkiye)

  • Novartis Investigative Site

    Kayseri, 38070, Turkey (Türkiye)

  • Novartis Investigative Site

    Samsun, 55139, Turkey (Türkiye)

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • Western Sky Medical Research

    El Paso, Texas, 79924, United States

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