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Can a new pill silence the itch of chronic hives?

NCT ID NCT05107115

Disease control Sponsor: Sanofi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial is testing whether an experimental oral drug called rilzabrutinib can reduce the itching and hives in adults with chronic spontaneous urticaria (CSU) — a condition where hives appear without a clear trigger — even when standard antihistamines haven't helped. Participants will receive one of three doses of rilzabrutinib or a placebo for 12 weeks, and those who finish may continue on the drug for up to 40 more weeks. The study tracks changes in itch and hive severity to see if the drug offers meaningful relief.

What this could mean

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

Active substance
rilzabrutinib
What this could lead to
If rilzabrutinib works, it could offer a new oral treatment option for people with chronic hives that don't respond to antihistamines, potentially reducing itch and hive severity.
What could go wrong
This is an early-phase trial, so the drug may not prove more effective than placebo. Possible side effects are still being evaluated, and results may not apply to all patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

160 people

The number who actually took part.

Started

Nov 2021

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 80 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: * Participants who had a diagnosis of CSU refractory to H1-AH at the time of randomization * Diagnosis of CSU ≥3 months prior to screening visit (Visit 1). * The presence of itch and hives for ≥6 consecutive weeks at any time prior to screening visit (Visit 1) despite the use of H1-AH during this time period. * Participants using a study defined H1-AH for CSU treatment. For participants on stable doses of non-study-approved H1-AH, investigators may switch participants to an equivalent dose of a study-approved H1-AH maintenance medication. * Participants who were omalizumab naïve OR omalizumab-incomplete responders. * Participants must be willing and able to complete a daily symptom e-diary for the duration of the study. * During the 7 days before randomization: UAS7 ≥16 and ISS7 ≥8. * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Clearly defined underlying etiology for CUs other than CSU (main manifestation being physical urticaria). * Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes. * Participants with active atopic dermatitis (AD). * Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study. * Known or suspected immunodeficiency, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator. * History of serious infections requiring intravenous (IV) therapy with the potential for recurrence (as judged by the Site Investigator) with less than 4 weeks interval between resolution of serious infection and first dose of study drug, or currently active moderate to severe infection at Screening (Grade 2 or higher), including active coronavirus disease 2019 (COVID-19). * Live vaccine except Bacille Calmette Guerin-vaccination within 28 days prior to Day 1 or plan to receive one during the trial; Bacille Calmette Guerin-vaccination within 12 months prior to Screening. * Active malignancy or history of malignancy within 5 years. * Conditions that may predispose the participant to excessive bleeding * Any participant with an uncontrolled disease state as judged by the Investigator, such as asthma, psoriasis, or inflammatory bowel disease, etc. that are typically treated with oral or parenteral corticosteroids * Previous use of a BTK inhibitor. * Had received any investigational drug (or is currently using an investigational device) within the 30 days before Day 1, or at least 5 times the respective elimination half-life time (whichever is longer). * Previous exposure to another investigative drug for CSU. * Positive for human immunodeficiency virus (HIV) antibody test. * Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with positive DNA test result at screening or within 3 months prior to the screening visit. * Positive hepatitis C antibody test result at screening or within 3 months prior to the screening visit. * Tuberculosis infection. * Any of significant laboratory abnormalities and ECG findings at the screening visit. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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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

  • Investigational Site Number : 0320001

    Buenos Aires, C1121ABE, Argentina

  • Investigational Site Number : 0320002

    CABA, Buenos Aires, C1414AIF, Argentina

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, S2000JKR, Argentina

  • Investigational Site Number : 0320004

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320005

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320006

    CABA, Buenos Aires, C1055AAO, Argentina

  • Investigational Site Number : 1240002

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Investigational Site Number : 1240003

    Québec, G1V 4W2, Canada

  • Investigational Site Number : 1240004

    Toronto, Ontario, M5G 1E2, Canada

  • Investigational Site Number : 1240005

    Toronto, Ontario, M3B 3S6, Canada

  • Investigational Site Number : 1240006

    Montreal, Quebec, H4A 3T2, Canada

  • Investigational Site Number : 1240009

    Red Deer, Alberta, T4P 1K4, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1520004

    Osorno, Los Lagos Region, 5310644, Chile

  • Investigational Site Number : 1580001

    Taipei, 10002, Taiwan

  • Investigational Site Number : 1580002

    Hsinchu, 30059, Taiwan

  • Investigational Site Number : 1580003

    Taichung, 40201, Taiwan

  • Investigational Site Number : 1580004

    Kaohsiung City, 833, Taiwan

  • Investigational Site Number : 2760001

    Dresden, 01307, Germany

  • Investigational Site Number : 2760002

    Berlin, 12200, Germany

  • Investigational Site Number : 2760004

    Mainz, 55131, Germany

  • Investigational Site Number : 2760005

    Kiel, 24105, Germany

  • Investigational Site Number : 3000001

    Athens, 12462, Greece

  • Investigational Site Number : 3000002

    Athens, 16121, Greece

  • Investigational Site Number : 3000003

    Thessaloniki, 56403, Greece

  • Investigational Site Number : 3000004

    N. Efkarpia, 56429, Greece

  • Investigational Site Number : 3800001

    Milan, Lombardy, 20122, Italy

  • Investigational Site Number : 3800002

    Ancona, 60126, Italy

  • Investigational Site Number : 3800005

    Catania, Italy

  • Investigational Site Number : 3920001

    Sagamihara-shi, Kanagawa, 252-0392, Japan

  • Investigational Site Number : 3920002

    Sapporo, Hokkaido, 063-0005, Japan

  • Investigational Site Number : 3920003

    Tachikawa-shi, Tokyo, 190-0014, Japan

  • Investigational Site Number : 3920004

    Nagoya, 454-8509, Japan

  • Investigational Site Number : 3920005

    Chikushino-shi, Fukuoka, 818-0083, Japan

  • Investigational Site Number : 3920006

    Izumo-shi, Shimane, 693-8501, Japan

  • Investigational Site Number : 3920007

    Yokohama, Kanagawa, 221-0825, Japan

  • Investigational Site Number : 4100002

    Busan, Busan, 49241, South Korea

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 06973, South Korea

  • Investigational Site Number : 4100004

    Yeongdeunpo-gu, Seoul-teukbyeolsi, Hyllm University Med, South Korea

  • Investigational Site Number : 4100005

    Ansan-si, Gyeonggi-do, 15355, South Korea

  • Investigational Site Number : 5280001

    Utrecht, 3584 CX, Netherlands

  • Investigational Site Number : 5280002

    Rotterdam, 3015 GD, Netherlands

  • Investigational Site Number : 6160001

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Investigational Site Number : 6160004

    Krakow, 31-011, Poland

  • Investigational Site Number : 6160005

    Lodz, 91-211, Poland

  • Investigational Site Number : 6160006

    Wroclaw, 50-566, Poland

  • Investigational Site Number : 6160007

    Wroclaw, Lower Silesian Voivodeship, 53-673, Poland

  • Investigational Site Number : 6160008

    Krakow, 30-438, Poland

  • Investigational Site Number : 6160009

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Investigational Site Number : 6430001

    Stavropol, 355020, Russia

  • Investigational Site Number : 6430002

    Moscow, 123182, Russia

  • Investigational Site Number : 6430005

    Moscow, 115522, Russia

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08003, Spain

  • Investigational Site Number : 7240002

    Córdoba, 14004, Spain

  • Investigational Site Number : 7240004

    Seville, Andalusia, 41009, Spain

  • Investigational Site Number : 7240005

    Alicante, 03010, Spain

  • Investigational Site Number : 7240006

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240008

    Barcelona / Sabadell, Catalunya [Cataluña], 08208, Spain

  • Investigational Site Number :0320001

    Buenos Aires, C1121ABE, Argentina

  • Investigational Site Number :0320002

    CABA, Buenos Aires, C1414AIF, Argentina

  • Investigational Site Number :0320003

    Rosario, Santa Fe Province, S2000JKR, Argentina

  • Investigational Site Number :0320004

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number :0320005

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number :0320006

    CABA, Buenos Aires, C1055AAO, Argentina

  • Investigational Site Number :1240002

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Investigational Site Number :1240003

    Québec, G1V 4W2, Canada

  • Investigational Site Number :1240004

    Toronto, Ontario, M5G 1E2, Canada

  • Investigational Site Number :1240005

    Toronto, Ontario, M3B 3S6, Canada

  • Investigational Site Number :1240006

    Montreal, Quebec, H4A 3T2, Canada

  • Investigational Site Number :1240009

    Red Deer, Alberta, T4P 1K4, Canada

  • Investigational Site Number :1240010

    Calgary, Alberta, T2W 4X9, Canada

  • Investigational Site Number :1520001

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number :1520002

    Santiago, Reg Metropolitana de Santiago, Chile

  • Investigational Site Number :1520003

    Santiago, Reg Metropolitana de Santiago, 7750000, Chile

  • Investigational Site Number :1520004

    Osorno, Los Lagos Region, 5310644, Chile

  • Investigational Site Number :1580001

    Taipei, 10002, Taiwan

  • Investigational Site Number :1580002

    Hsinchu, 30059, Taiwan

  • Investigational Site Number :1580003

    Taichung, 402, Taiwan

  • Investigational Site Number :1580004

    Kaohsiung City, 833, Taiwan

  • Investigational Site Number :2760001

    Dresden, 01307, Germany

  • Investigational Site Number :2760002

    Berlin, 10117, Germany

  • Investigational Site Number :2760004

    Mainz, 55131, Germany

  • Investigational Site Number :2760005

    Kiel, 24105, Germany

  • Investigational Site Number :3000001

    Athens, 12462, Greece

  • Investigational Site Number :3000002

    Athens, 16121, Greece

  • Investigational Site Number :3000003

    Thessaloniki, 56429, Greece

  • Investigational Site Number :3000004

    N. Efkarpia, 56429, Greece

  • Investigational Site Number :3800001

    Milan, Lombardy, 20122, Italy

  • Investigational Site Number :3800002

    Ancona, 60126, Italy

  • Investigational Site Number :3800004

    Milan, Lombardy, 20161, Italy

  • Investigational Site Number :3800005

    Catania, Italy

  • Investigational Site Number :3920001

    Sagamihara-shi, Kanagawa, 252-0392, Japan

  • Investigational Site Number :3920002

    Sapporo, Hokkaido, 063-0005, Japan

  • Investigational Site Number :3920003

    Tachikawa-shi, Tokyo, 190-0014, Japan

  • Investigational Site Number :3920004

    Nagoya, Aichi-ken, 454-8509, Japan

  • Investigational Site Number :3920005

    Chikushino-shi, Fukuoka, 818-0083, Japan

  • Investigational Site Number :3920006

    Izumo-shi, Shimane, 693-8501, Japan

  • Investigational Site Number :3920007

    Yokohama, Kanagawa, 221-0825, Japan

  • Investigational Site Number :4100001

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number :4100002

    Busan, Busan, 602-739, South Korea

  • Investigational Site Number :4100003

    Seoul, Seoul-teukbyeolsi, 06973, South Korea

  • Investigational Site Number :4100004

    Yeongdeunpo-gu, Seoul-teukbyeolsi, Hyllm University Med, South Korea

  • Investigational Site Number :4100005

    Ansan-si, Gyeonggi-do, 15355, South Korea

  • Investigational Site Number :5280001

    Utrecht, 3584 CX, Netherlands

  • Investigational Site Number :5280002

    Rotterdam, 3015 GD, Netherlands

  • Investigational Site Number :6160001

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Investigational Site Number :6160003

    Krakow, 31-302, Poland

  • Investigational Site Number :6160004

    Krakow, 31-011, Poland

  • Investigational Site Number :6160005

    Lodz, 91-211, Poland

  • Investigational Site Number :6160006

    Wroclaw, 50-566, Poland

  • Investigational Site Number :6160007

    Wroclaw, Lower Silesian Voivodeship, 50-088, Poland

  • Investigational Site Number :6160008

    Krakow, 30-438, Poland

  • Investigational Site Number :6160009

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Investigational Site Number :6430001

    Stavropol, 355020, Russia

  • Investigational Site Number :6430002

    Moscow, 123182, Russia

  • Investigational Site Number :6430003

    Saint Petersburg, 193231, Russia

  • Investigational Site Number :6430004

    Smolensk, 214006, Russia

  • Investigational Site Number :6430005

    Moscow, 115522, Russia

  • Investigational Site Number :6430006

    Moscow, 115522, Russia

  • Investigational Site Number :7240001

    Barcelona, Barcelona [Barcelona], 08003, Spain

  • Investigational Site Number :7240002

    Córdoba, 14004, Spain

  • Investigational Site Number :7240003

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number :7240004

    Seville, Andalusia, 41009, Spain

  • Investigational Site Number :7240005

    Alicante, 03010, Spain

  • Investigational Site Number :7240006

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number :7240007

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Investigational Site Number :7240008

    Barcelona / Sabadell, Catalunya [Cataluña], 08208, Spain

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