Can a new pill silence the itch of chronic hives?

NCT ID NCT05107115

Completed Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

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.

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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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