Chronic Spontaneous UrticariaPhase 2RILECSUNCT05107115
Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine
A Phase 2 study testing rilzabrutinib in people with Chronic Spontaneous Urticaria, run by Sanofi at 128 sites in 13 countries.
Trial summary
The first phase of this study will be a parallel, 12-week treatment, Phase 2, double-blind, 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 (rilzabrutinib), i.e. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- rilzabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 128 sitesin 13 countries
- Study dates
- 24 Nov 2021to 23 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
128 sites in 13 countries.
128 sites in 13 countries
Poland15 sites
Investigational Site Number : 6160001
Gdansk, Pomeranian Voivodeship, 80-214
Investigational Site Number :6160001
Gdansk, Pomeranian Voivodeship, 80-214
Investigational Site Number : 6160009
Gdansk, Pomeranian Voivodeship, 80-546
Investigational Site Number :6160009
Gdansk, Pomeranian Voivodeship, 80-546
Investigational Site Number : 6160008
Krakow, 30-438
Investigational Site Number :6160008
Krakow, 30-438
Investigational Site Number : 6160004
Krakow, 31-011
Investigational Site Number :6160004
Krakow, 31-011
Investigational Site Number :6160003
Krakow, 31-302
Investigational Site Number : 6160005
Lodz, 91-211
Investigational Site Number :6160005
Lodz, 91-211
Investigational Site Number :6160007
Wroclaw, Lower Silesian Voivodeship, 50-088
Investigational Site Number : 6160007
Wroclaw, Lower Silesian Voivodeship, 53-673
Investigational Site Number : 6160006
Wroclaw, 50-566
Investigational Site Number :6160006
Wroclaw, 50-566
Japan14 sites
Investigational Site Number : 3920005
Chikushino-shi, Fukuoka, 818-0083
Investigational Site Number :3920005
Chikushino-shi, Fukuoka, 818-0083
Investigational Site Number : 3920006
Izumo-shi, Shimane, 693-8501
Investigational Site Number :3920006
Izumo-shi, Shimane, 693-8501
Investigational Site Number :3920004
Nagoya, Aichi-ken, 454-8509
Investigational Site Number : 3920004
Nagoya, 454-8509
Investigational Site Number : 3920001
Sagamihara-shi, Kanagawa, 252-0392
Investigational Site Number :3920001
Sagamihara-shi, Kanagawa, 252-0392
Investigational Site Number : 3920002
Sapporo, Hokkaido, 063-0005
Investigational Site Number :3920002
Sapporo, Hokkaido, 063-0005
Investigational Site Number : 3920003
Tachikawa-shi, Tokyo, 190-0014
Investigational Site Number :3920003
Tachikawa-shi, Tokyo, 190-0014
Investigational Site Number : 3920007
Yokohama, Kanagawa, 221-0825
Investigational Site Number :3920007
Yokohama, Kanagawa, 221-0825
Spain14 sites
Investigational Site Number : 7240005
Alicante, 03010
Investigational Site Number :7240005
Alicante, 03010
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], 08003
Investigational Site Number :7240001
Barcelona, Barcelona [Barcelona], 08003
Investigational Site Number : 7240008
Barcelona / Sabadell, Catalunya [Cataluña], 08208
Investigational Site Number :7240008
Barcelona / Sabadell, Catalunya [Cataluña], 08208
Investigational Site Number : 7240002
Córdoba, 14004
Investigational Site Number :7240002
Córdoba, 14004
Investigational Site Number : 7240006
Pamplona, Navarre, 31008
Investigational Site Number :7240003
Pamplona, Navarre, 31008
Investigational Site Number :7240006
Pamplona, Navarre, 31008
Investigational Site Number :7240007
Pozuelo de Alarcón, Madrid, 28223
Investigational Site Number : 7240004
Seville, Andalusia, 41009
Investigational Site Number :7240004
Seville, Andalusia, 41009
Canada13 sites
Investigational Site Number :1240010
Calgary, Alberta, T2W 4X9
Investigational Site Number : 1240006
Montreal, Quebec, H4A 3T2
Investigational Site Number :1240006
Montreal, Quebec, H4A 3T2
Investigational Site Number : 1240003
Québec, G1V 4W2
Investigational Site Number :1240003
Québec, G1V 4W2
Investigational Site Number : 1240009
Red Deer, Alberta, T4P 1K4
Investigational Site Number :1240009
Red Deer, Alberta, T4P 1K4
Investigational Site Number : 1240005
Toronto, Ontario, M3B 3S6
Investigational Site Number :1240005
Toronto, Ontario, M3B 3S6
Investigational Site Number : 1240004
Toronto, Ontario, M5G 1E2
Investigational Site Number :1240004
Toronto, Ontario, M5G 1E2
Investigational Site Number : 1240002
Trois-Rivières, Quebec, G8T 7A1
Investigational Site Number :1240002
Trois-Rivières, Quebec, G8T 7A1
Argentina12 sites
Investigational Site Number : 0320001
Buenos Aires, C1121ABE
Investigational Site Number :0320001
Buenos Aires, C1121ABE
Investigational Site Number : 0320006
CABA, Buenos Aires, C1055AAO
Investigational Site Number :0320006
CABA, Buenos Aires, C1055AAO
Investigational Site Number : 0320002
CABA, Buenos Aires, C1414AIF
Investigational Site Number :0320002
CABA, Buenos Aires, C1414AIF
Investigational Site Number : 0320004
Rosario, Santa Fe Province, 2000
Investigational Site Number : 0320005
Rosario, Santa Fe Province, 2000
Investigational Site Number :0320004
Rosario, Santa Fe Province, 2000
Investigational Site Number :0320005
Rosario, Santa Fe Province, 2000
Investigational Site Number : 0320003
Rosario, Santa Fe Province, S2000JKR
Investigational Site Number :0320003
Rosario, Santa Fe Province, S2000JKR
Russia9 sites
Investigational Site Number : 6430005
Moscow, 115522
Investigational Site Number :6430005
Moscow, 115522
Investigational Site Number :6430006
Moscow, 115522
Investigational Site Number : 6430002
Moscow, 123182
Investigational Site Number :6430002
Moscow, 123182
Investigational Site Number :6430003
Saint Petersburg, 193231
Investigational Site Number :6430004
Smolensk, 214006
Investigational Site Number : 6430001
Stavropol, 355020
Investigational Site Number :6430001
Stavropol, 355020
South Korea9 sites
Investigational Site Number : 4100005
Ansan-si, Gyeonggi-do, 15355
Investigational Site Number :4100005
Ansan-si, Gyeonggi-do, 15355
Investigational Site Number : 4100002
Busan, Busan, 49241
Investigational Site Number :4100002
Busan, Busan, 602-739
Investigational Site Number :4100001
Seoul, Seoul-teukbyeolsi, 03080
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, 06973
Investigational Site Number :4100003
Seoul, Seoul-teukbyeolsi, 06973
Investigational Site Number : 4100004
Yeongdeunpo-gu, Seoul-teukbyeolsi, Hyllm University Med
Investigational Site Number :4100004
Yeongdeunpo-gu, Seoul-teukbyeolsi, Hyllm University Med
Germany8 sites
Investigational Site Number :2760002
Berlin, 10117
Investigational Site Number : 2760002
Berlin, 12200
Investigational Site Number : 2760001
Dresden, 01307
Investigational Site Number :2760001
Dresden, 01307
Investigational Site Number : 2760005
Kiel, 24105
Investigational Site Number :2760005
Kiel, 24105
Investigational Site Number : 2760004
Mainz, 55131
Investigational Site Number :2760004
Mainz, 55131
Greece8 sites
Investigational Site Number : 3000001
Athens, 12462
Investigational Site Number :3000001
Athens, 12462
Investigational Site Number : 3000002
Athens, 16121
Investigational Site Number :3000002
Athens, 16121
Investigational Site Number : 3000004
N. Efkarpia, 56429
Investigational Site Number :3000004
N. Efkarpia, 56429
Investigational Site Number : 3000003
Thessaloniki, 56403
Investigational Site Number :3000003
Thessaloniki, 56429
Taiwan8 sites
Investigational Site Number : 1580002
Hsinchu, 30059
Investigational Site Number :1580002
Hsinchu, 30059
Investigational Site Number : 1580004
Kaohsiung City, 833
Investigational Site Number :1580004
Kaohsiung City, 833
Investigational Site Number : 1580003
Taichung, 40201
Investigational Site Number :1580003
Taichung, 402
Investigational Site Number : 1580001
Taipei, 10002
Investigational Site Number :1580001
Taipei, 10002
Chile7 sites
Investigational Site Number : 1520004
Osorno, Los Lagos Region, 5310644
Investigational Site Number :1520004
Osorno, Los Lagos Region, 5310644
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 7640881
Investigational Site Number :1520001
Santiago, Reg Metropolitana de Santiago, 7640881
Investigational Site Number :1520003
Santiago, Reg Metropolitana de Santiago, 7750000
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 8420383
Investigational Site Number :1520002
Santiago, Reg Metropolitana de Santiago
Italy7 sites
Investigational Site Number : 3800002
Ancona, 60126
Investigational Site Number :3800002
Ancona, 60126
Investigational Site Number : 3800005
Catania
Investigational Site Number :3800005
Catania
Investigational Site Number : 3800001
Milan, Lombardy, 20122
Investigational Site Number :3800001
Milan, Lombardy, 20122
Investigational Site Number :3800004
Milan, Lombardy, 20161
Netherlands4 sites
Investigational Site Number : 5280002
Rotterdam, 3015 GD
Investigational Site Number :5280002
Rotterdam, 3015 GD
Investigational Site Number : 5280001
Utrecht, 3584 CX
Investigational Site Number :5280001
Utrecht, 3584 CX
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Phase 2 Study of Rilzabrutinib Followed by an Open-label Extension Phase in Patients With Moderate-to-severe Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment
The first phase of this study will be a parallel, 12-week treatment, Phase 2, double-blind, 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 (rilzabrutinib), i.e. dose A, B and C, compared with placebo for decreasing the frequency and severity of itch and urticaria in male and female participants aged 18 years inclusive or older with CSU.
After completion of the double-blind phase of the study, participants will be given the option of enrolling in the 40-week open label extension (OLE) phase of the study. Participants will receive open-label rilzabrutinib at dose B or dose C (the dose may be modified based on the 12-week safety and efficacy data). Due to the fact that some participants may be receiving rilzabrutinib for the first time, all participants will be monitored at Week 14, Week 16, Week 20, and Week 24. Afterwards, participants will be monitored at Week 36 and Week 52.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- rilzabrutinib, placebo
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rilzabrutinibDrug
Also called PRN1008/SAR444671
Tablet, oral use
placeboDrug
Tablet, oral use
| Study group | Role | What they receive |
|---|---|---|
| Rilzabrutinib dose A | Experimental | dose A Receives: Drug: rilzabrutinib |
| Rilzabrutinib dose B | Experimental | dose B Receives: Drug: rilzabrutinib |
| Rilzabrutinib dose C | Experimental | dose C Receives: Drug: rilzabrutinib |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12
The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day.
Measured: Baseline and Week 12
Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12
The ISS represents the itch severity on a scale and was recorded by the participant in their e-diary ranging from 0 (None) to 3 (intense). The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch. Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day.
Measured: Baseline and Week 12
Secondary outcomes (6)
Change From Baseline in Weekly Urticaria Activity Score at Week 4
The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Baseline is defined as the sum of the 7 measurements obtained within the 7 days prior to randomization.
Measured: Baseline and Week 4
Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12
The HSS7 represents hive severity score on a scale recorded on e-diary ranging from 0 (None) to 3 (more than 50 hives). A weekly score (HSS7) was sum of the average daily scores of the previous 7 days. The possible range of the weekly score was 0-21 (highest hives activity). Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day.
Measured: Baseline and Week 12
Percentage of Participants With Weekly Urticaria Activity Score Less Than or Equal to (≤)6 at Week 12
The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Here, a score ≤6 indicates well-controlled disease.
Measured: At Week 12
Percentage of Participants With Weekly Urticaria Activity Score Equal to 0 at Week 12
The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Here, score 0 indicates an absence of both itches and hives and a complete resolution of chronic spontaneous urticaria (CSU) symptoms.
Measured: At Week 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs), and Withdrawals Due to Treatment-Emergent Adverse Events
Adverse event (AE): any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of study treatment (on Day 1) to last administration of study treatment + 7 days. SAE: any AE that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. An AESI was an TEAE (serious or nonserious) of scientific and medical concern specific to Sponsor's product or program.
Measured: From first dose of study treatment (Day 1) up to last dose of study treatment + 7 days, approximately 13 weeks for DB period and approximately 41 weeks for OLE period
Plasma Concentration of Rilzabrutinib
Plasma samples were collected at specified timepoints for evaluation of rilzabrutinib pharmacokinetic (PK) concentrations.
Measured: Pre-dose and 2 hours post-dose at Day 1 and Week 4; pre-dose at Week 12 (DB period); pre-dose and 2 hours post-dose at Week 16; pre-dose at Weeks 20, 24 and 52 (OLE period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start24 Nov 2021
- Primary completion19 Jul 2023
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107115
- Sponsor's protocol ID
- DRI17224
- Other IDs
- U1111-1263-4226, DRI17224, 2021-002609-93
- Acronym
- RILECSU
- Status last verified
- Apr 2025
- First submitted
- 27 Oct 2021
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Gimenez-Arnau A, Ferrucci S, Ben-Shoshan M, Mikol V, Lucats L, Sun I, Mannent L, Gereige J. Rilzabrutinib in Antihistamine-Refractory Chronic Spontaneous Urticaria: The RILECSU Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):679-687. doi: 10.1001/jamadermatol.2025.0733.
PubMed 40266575
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Phase 2 Study of Rilzabrutinib Followed by an Open-label Extension Phase in Patients With Moderate-to-severe Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment
- ClinicalTrials.gov ID
- NCT05107115
- Acronym / sponsor ID
- RILECSU / DRI17224
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The first phase of this study will be a parallel, 12-week treatment, Phase 2, double-blind, 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 (rilzabrutinib), i.e. dose A, B and C, compared with placebo for decreasing the frequency and severity of itch and urticaria in male and female participants aged 18 years inclusive or older with CSU.
After completion of the double-blind phase of the study, participants will be given the option of enrolling in the 40-week open label extension (OLE) phase of the study. Participants will receive open-label rilzabrutinib at dose B or dose C (the dose may be modified based on the 12-week safety and efficacy data). Due to the fact that some participants may be receiving rilzabrutinib for the first time, all participants will be monitored at Week 14, Week 16, Week 20, and Week 24. Afterwards, participants will be monitored at Week 36 and Week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rilzabrutinib dose A | Experimental | Drug: rilzabrutinibdose A |
| Rilzabrutinib dose B | Experimental | Drug: rilzabrutinibdose B |
| Rilzabrutinib dose C | Experimental | Drug: rilzabrutinibdose C |
| Placebo | Placebo comparator | Drug: placeboMatching placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rilzabrutinibAlso: PRN1008/SAR444671Tablet, oral use | Drug | Rilzabrutinib dose A, Rilzabrutinib dose B, Rilzabrutinib dose C |
| placeboTablet, oral use | Drug | Placebo |
Primary outcome
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12
Time frame: Baseline and Week 12
The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day.
Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12
Time frame: Baseline and Week 12
The ISS represents the itch severity on a scale and was recorded by the participant in their e-diary ranging from 0 (None) to 3 (intense). The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch. Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day.
6 secondary outcomes
Change From Baseline in Weekly Urticaria Activity Score at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12
Time frame: Baseline and Week 12
Percentage of Participants With Weekly Urticaria Activity Score Less Than or Equal to (≤)6 at Week 12
Time frame: At Week 12
Percentage of Participants With Weekly Urticaria Activity Score Equal to 0 at Week 12
Time frame: At Week 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs), and Withdrawals Due to Treatment-Emergent Adverse Events
Time frame: From first dose of study treatment (Day 1) up to last dose of study treatment + 7 days, approximately 13 weeks for DB period and approximately 41 weeks for OLE period
Plasma Concentration of Rilzabrutinib
Time frame: Pre-dose and 2 hours post-dose at Day 1 and Week 4; pre-dose at Week 12 (DB period); pre-dose and 2 hours post-dose at Week 16; pre-dose at Weeks 20, 24 and 52 (OLE period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40266575Gimenez-Arnau A, Ferrucci S, Ben-Shoshan M, Mikol V, Lucats L, Sun I, Mannent L, Gereige J. Rilzabrutinib in Antihistamine-Refractory Chronic Spontaneous Urticaria: The RILECSU Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):679-687. doi: 10.1001/jamadermatol.2025.0733.
- DRI17224 Plain language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
128 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rilzabrutinib in people with Chronic Spontaneous Urticaria, run by Sanofi at 128 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 128 sites in Poland, Japan, Spain, Canada, Argentina and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05107115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.