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New pill could offer relief for chronic hives sufferers

NCT ID NCT06042478

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study tests a new daily pill, remibrutinib, for adults with chronic spontaneous urticaria (long-term hives and itching) that antihistamines don't control well. About 470 participants will receive either remibrutinib, a placebo, or an active control (omalizumab injections) for up to 52 weeks, with an optional year-long extension. The goal is to see if the pill reduces hives and itching better than placebo and works as well as the standard injectable treatment.

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

470 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

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 100 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.

Inclusion Criteria: * Male and female adult participants ≥18 years of age at the time of signing the informed consent. * CSU duration for ≥ 6 months prior to screening. * Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of randomization, defined as: * The presence of itch and hives for ≥6 consecutive weeks prior to screening, despite the use of second-generation H1-AH during this time period. * UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0- 21) ≥ 6 during the 7 days prior to randomization (Day 1). * Documentation of hives within three months before randomization. * Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol. * Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1). Exclusion Criteria: * Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies. * Significant bleeding risk or coagulation disorders. * History of gastrointestinal bleeding. * Requirement for anti-platelet or anti-coagulant medication. * History or current hepatic disease. * 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. * Evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. * Documented history of anaphylaxis. * Pregnant or nursing (lactating) women.

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria Chronic Urticaria 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

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414AIF, Argentina

  • Novartis Investigative Site

    Mendoza, Mendoza Province, 5500, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, 2000, Argentina

  • Novartis Investigative Site

    Bahía Blanca, B8000JRB, Argentina

  • Novartis Investigative Site

    CABA, C1012AAY, Argentina

  • Novartis Investigative Site

    Capital Federal, C1023AAB, Argentina

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

  • Novartis Investigative Site

    Alphaville Barueri, São Paulo, 06454-010, Brazil

  • Novartis Investigative Site

    Santo André, São Paulo, 09060-870, Brazil

  • Novartis Investigative Site

    Sorocaba, São Paulo, 18040-425, Brazil

  • Novartis Investigative Site

    Sofia, 1421, Bulgaria

  • Novartis Investigative Site

    Sofia, 1431, Bulgaria

  • Novartis Investigative Site

    Varna, 9009, Bulgaria

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1C3, Canada

  • Novartis Investigative Site

    Hamilton, Ontario, L8L 3C3, Canada

  • Novartis Investigative Site

    Hamilton, Ontario, L8S 1G5, Canada

  • Novartis Investigative Site

    London, Ontario, N6H 5L5, Canada

  • Novartis Investigative Site

    Niagara Falls, Ontario, L2H 1H5, Canada

  • Novartis Investigative Site

    Québec, Quebec, G1V 4W2, Canada

  • Novartis Investigative Site

    Verdun, Quebec, H4G 3E7, Canada

  • Novartis Investigative Site

    Brno, 602 00, Czechia

  • Novartis Investigative Site

    Plzen Bolevec, 32300, Czechia

  • Novartis Investigative Site

    Prague, 100 34, Czechia

  • Novartis Investigative Site

    Nice, France, 06000, France

  • Novartis Investigative Site

    Grenoble, 38043, France

  • Novartis Investigative Site

    La Rochelle, 17019, France

  • Novartis Investigative Site

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    Rouen, 76031, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    Hamburg, Free and Hanseatic City of Hamburg, 22391, Germany

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Stade, Lower Saxony, 21682, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120, Germany

  • Novartis Investigative Site

    Bad Bentheim, 48455, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Bochum, 44791, Germany

  • Novartis Investigative Site

    Bochum, 44793, Germany

  • Novartis Investigative Site

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    Lübeck, 23538, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    München, 80377, Germany

  • Novartis Investigative Site

    Münster, 48149, Germany

  • Novartis Investigative Site

    Osnabrück, 49074, Germany

  • Novartis Investigative Site

    Tübingen, 72076, Germany

  • Novartis Investigative Site

    Kaposvár, 7400, Hungary

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380016, India

  • Novartis Investigative Site

    Bangalore, Karnataka, 560004, India

  • Novartis Investigative Site

    Belagavi, Karnataka, 590010, India

  • Novartis Investigative Site

    Mysore, Karnataka, 570001, India

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440012, India

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440015, India

  • Novartis Investigative Site

    Nashik, Maharashtra, 422101, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334003, India

  • Novartis Investigative Site

    Hyderabad, Telangana, 500004, India

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001, India

  • Novartis Investigative Site

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Modena, MO, 41124, Italy

  • Novartis Investigative Site

    Roma, RM, 00186, Italy

  • Novartis Investigative Site

    Siena, SI, 53100, Italy

  • Novartis Investigative Site

    Muar town, Johor, 84000, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Novartis Investigative Site

    Ipoh, Perak, 30450, Malaysia

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    Petaling Jaya, Selangor, 46150, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Wilayah Persekutuan, 62502, Malaysia

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44638, Mexico

  • Novartis Investigative Site

    Cuauhtémoc, Mexico City, 06100, Mexico

  • Novartis Investigative Site

    Villahermosa, Tabasco, 86035, Mexico

  • Novartis Investigative Site

    Mérida, Yucatán, 97070, Mexico

  • Novartis Investigative Site

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    Krosno, Krosno, 38-400, Poland

  • Novartis Investigative Site

    Gdansk, 80-214, Poland

  • Novartis Investigative Site

    Gdansk, 80-546, Poland

  • Novartis Investigative Site

    Trnava, Slovakia, 917 02, Slovakia

  • Novartis Investigative Site

    Bardejov, 085 01, Slovakia

  • Novartis Investigative Site

    Kežmarok, 060 01, Slovakia

  • Novartis Investigative Site

    Svidník, 089 01, Slovakia

  • Novartis Investigative Site

    Ansan, Gyeonggi-do, 425-801, South Korea

  • Novartis Investigative Site

    Busan, 49241, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Granada, Andalusia, 18014, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Las Palmas GC, 35010, Spain

  • Novartis Investigative Site

    Valencia, 46015, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110, Thailand

  • Novartis Investigative Site

    Khon Kaen, THA, 40002, Thailand

  • Novartis Investigative Site

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

  • Novartis Investigative Site

    Sakarya, Adapazari, 54290, Turkey (Türkiye)

  • Novartis Investigative Site

    Aydin, Efeler, 09100, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Denizli, Kinikli, 20070, Turkey (Türkiye)

  • Novartis Investigative Site

    Birmingham, B9 5SS, United Kingdom

  • Novartis Investigative Site

    Hanoi, Vietnam, 100000, Vietnam

  • Novartis Investigative Site

    Ho Chi Minh City, 700000, Vietnam

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