Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine (RILECSU)

July 14, 2026 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1121ABE
        • Investigational Site Number :0320001
      • Buenos Aires, Argentina, C1121ABE
        • Investigational Site Number : 0320001
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1055AAO
        • Investigational Site Number : 0320006
      • CABA, Buenos Aires, Argentina, C1055AAO
        • Investigational Site Number :0320006
      • CABA, Buenos Aires, Argentina, C1414AIF
        • Investigational Site Number : 0320002
      • CABA, Buenos Aires, Argentina, C1414AIF
        • Investigational Site Number :0320002
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320005
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320004
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number :0320004
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number :0320005
      • Rosario, Santa Fe Province, Argentina, S2000JKR
        • Investigational Site Number : 0320003
      • Rosario, Santa Fe Province, Argentina, S2000JKR
        • Investigational Site Number :0320003
  • Canada
      • Québec, Canada, G1V 4W2
        • Investigational Site Number : 1240003
      • Québec, Canada, G1V 4W2
        • Investigational Site Number :1240003
    • Alberta
      • Calgary, Alberta, Canada, T2W 4X9
        • Investigational Site Number :1240010
      • Red Deer, Alberta, Canada, T4P 1K4
        • Investigational Site Number :1240009
      • Red Deer, Alberta, Canada, T4P 1K4
        • Investigational Site Number : 1240009
    • Ontario
      • Toronto, Ontario, Canada, M3B 3S6
        • Investigational Site Number :1240005
      • Toronto, Ontario, Canada, M5G 1E2
        • Investigational Site Number :1240004
      • Toronto, Ontario, Canada, M3B 3S6
        • Investigational Site Number : 1240005
      • Toronto, Ontario, Canada, M5G 1E2
        • Investigational Site Number : 1240004
    • Quebec
      • Montreal, Quebec, Canada, H4A 3T2
        • Investigational Site Number :1240006
      • Montreal, Quebec, Canada, H4A 3T2
        • Investigational Site Number : 1240006
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Investigational Site Number : 1240002
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Investigational Site Number :1240002
  • Chile
    • Los Lagos Region
      • Osorno, Los Lagos Region, Chile, 5310644
        • Investigational Site Number : 1520004
      • Osorno, Los Lagos Region, Chile, 5310644
        • Investigational Site Number :1520004
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Chile, 7640881
        • Investigational Site Number : 1520001
      • Santiago, Reg Metropolitana de Santiago, Chile, 8420383
        • Investigational Site Number : 1520002
      • Santiago, Reg Metropolitana de Santiago, Chile, 7640881
        • Investigational Site Number :1520001
      • Santiago, Reg Metropolitana de Santiago, Chile, 7750000
        • Investigational Site Number :1520003
      • Santiago, Reg Metropolitana de Santiago, Chile
        • Investigational Site Number :1520002
  • Germany
      • Berlin, Germany, 10117
        • Investigational Site Number :2760002
      • Berlin, Germany, 12200
        • Investigational Site Number : 2760002
      • Dresden, Germany, 01307
        • Investigational Site Number :2760001
      • Dresden, Germany, 01307
        • Investigational Site Number : 2760001
      • Kiel, Germany, 24105
        • Investigational Site Number :2760005
      • Kiel, Germany, 24105
        • Investigational Site Number : 2760005
      • Mainz, Germany, 55131
        • Investigational Site Number :2760004
      • Mainz, Germany, 55131
        • Investigational Site Number : 2760004
  • Greece
      • Athens, Greece, 12462
        • Investigational Site Number :3000001
      • Athens, Greece, 16121
        • Investigational Site Number :3000002
      • Athens, Greece, 16121
        • Investigational Site Number : 3000002
      • Athens, Greece, 12462
        • Investigational Site Number : 3000001
      • N. Efkarpia, Greece, 56429
        • Investigational Site Number :3000004
      • N. Efkarpia, Greece, 56429
        • Investigational Site Number : 3000004
      • Thessaloniki, Greece, 56429
        • Investigational Site Number :3000003
      • Thessaloniki, Greece, 56403
        • Investigational Site Number : 3000003
  • Italy
      • Ancona, Italy, 60126
        • Investigational Site Number :3800002
      • Ancona, Italy, 60126
        • Investigational Site Number : 3800002
      • Catania, Italy
        • Investigational Site Number :3800005
      • Catania, Italy
        • Investigational Site Number : 3800005
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Investigational Site Number : 3800001
      • Milan, Lombardy, Italy, 20122
        • Investigational Site Number :3800001
      • Milan, Lombardy, Italy, 20161
        • Investigational Site Number :3800004
  • Japan
      • Nagoya, Japan, 454-8509
        • Investigational Site Number : 3920004
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 454-8509
        • Investigational Site Number :3920004
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-0083
        • Investigational Site Number :3920005
      • Chikushino-shi, Fukuoka, Japan, 818-0083
        • Investigational Site Number : 3920005
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 063-0005
        • Investigational Site Number : 3920002
      • Sapporo, Hokkaido, Japan, 063-0005
        • Investigational Site Number :3920002
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 252-0392
        • Investigational Site Number :3920001
      • Sagamihara-shi, Kanagawa, Japan, 252-0392
        • Investigational Site Number : 3920001
      • Yokohama, Kanagawa, Japan, 221-0825
        • Investigational Site Number : 3920007
      • Yokohama, Kanagawa, Japan, 221-0825
        • Investigational Site Number :3920007
    • Shimane
      • Izumo-shi, Shimane, Japan, 693-8501
        • Investigational Site Number :3920006
      • Izumo-shi, Shimane, Japan, 693-8501
        • Investigational Site Number : 3920006
    • Tokyo
      • Tachikawa-shi, Tokyo, Japan, 190-0014
        • Investigational Site Number :3920003
      • Tachikawa-shi, Tokyo, Japan, 190-0014
        • Investigational Site Number : 3920003
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Investigational Site Number :5280002
      • Rotterdam, Netherlands, 3015 GD
        • Investigational Site Number : 5280002
      • Utrecht, Netherlands, 3584 CX
        • Investigational Site Number :5280001
      • Utrecht, Netherlands, 3584 CX
        • Investigational Site Number : 5280001
  • Poland
      • Krakow, Poland, 30-438
        • Investigational Site Number :6160008
      • Krakow, Poland, 31-011
        • Investigational Site Number :6160004
      • Krakow, Poland, 31-302
        • Investigational Site Number :6160003
      • Krakow, Poland, 30-438
        • Investigational Site Number : 6160008
      • Krakow, Poland, 31-011
        • Investigational Site Number : 6160004
      • Lodz, Poland, 91-211
        • Investigational Site Number :6160005
      • Lodz, Poland, 91-211
        • Investigational Site Number : 6160005
      • Wroclaw, Poland, 50-566
        • Investigational Site Number :6160006
      • Wroclaw, Poland, 50-566
        • Investigational Site Number : 6160006
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-088
        • Investigational Site Number :6160007
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-673
        • Investigational Site Number : 6160007
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Investigational Site Number : 6160001
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Investigational Site Number :6160001
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Investigational Site Number : 6160009
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Investigational Site Number :6160009
  • Russia
      • Moscow, Russia, 115522
        • Investigational Site Number : 6430005
      • Moscow, Russia, 115522
        • Investigational Site Number :6430005
      • Moscow, Russia, 115522
        • Investigational Site Number :6430006
      • Moscow, Russia, 123182
        • Investigational Site Number : 6430002
      • Moscow, Russia, 123182
        • Investigational Site Number :6430002
      • Saint Petersburg, Russia, 193231
        • Investigational Site Number :6430003
      • Smolensk, Russia, 214006
        • Investigational Site Number :6430004
      • Stavropol, Russia, 355020
        • Investigational Site Number : 6430001
      • Stavropol, Russia, 355020
        • Investigational Site Number :6430001
  • South Korea
    • Busan
      • Busan, Busan, South Korea, 49241
        • Investigational Site Number : 4100002
      • Busan, Busan, South Korea, 602-739
        • Investigational Site Number :4100002
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, South Korea, 15355
        • Investigational Site Number : 4100005
      • Ansan-si, Gyeonggi-do, South Korea, 15355
        • Investigational Site Number :4100005
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 03080
        • Investigational Site Number :4100001
      • Seoul, Seoul-teukbyeolsi, South Korea, 06973
        • Investigational Site Number : 4100003
      • Seoul, Seoul-teukbyeolsi, South Korea, 06973
        • Investigational Site Number :4100003
      • Yeongdeunpo-gu, Seoul-teukbyeolsi, South Korea, Hyllm University Med
        • Investigational Site Number : 4100004
      • Yeongdeunpo-gu, Seoul-teukbyeolsi, South Korea, Hyllm University Med
        • Investigational Site Number :4100004
  • Spain
      • Alicante, Spain, 03010
        • Investigational Site Number :7240005
      • Alicante, Spain, 03010
        • Investigational Site Number : 7240005
      • Córdoba, Spain, 14004
        • Investigational Site Number :7240002
      • Córdoba, Spain, 14004
        • Investigational Site Number : 7240002
    • Andalusia
      • Seville, Andalusia, Spain, 41009
        • Investigational Site Number : 7240004
      • Seville, Andalusia, Spain, 41009
        • Investigational Site Number :7240004
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08003
        • Investigational Site Number :7240001
      • Barcelona, Barcelona [Barcelona], Spain, 08003
        • Investigational Site Number : 7240001
    • Catalunya [Cataluña]
      • Barcelona / Sabadell, Catalunya [Cataluña], Spain, 08208
        • Investigational Site Number :7240008
      • Barcelona / Sabadell, Catalunya [Cataluña], Spain, 08208
        • Investigational Site Number : 7240008
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Investigational Site Number :7240007
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Investigational Site Number :7240006
      • Pamplona, Navarre, Spain, 31008
        • Investigational Site Number : 7240006
      • Pamplona, Navarre, Spain, 31008
        • Investigational Site Number :7240003
  • Taiwan
      • Hsinchu, Taiwan, 30059
        • Investigational Site Number : 1580002
      • Hsinchu, Taiwan, 30059
        • Investigational Site Number :1580002
      • Kaohsiung City, Taiwan, 833
        • Investigational Site Number : 1580004
      • Kaohsiung City, Taiwan, 833
        • Investigational Site Number :1580004
      • Taichung, Taiwan, 402
        • Investigational Site Number :1580003
      • Taichung, Taiwan, 40201
        • Investigational Site Number : 1580003
      • Taipei, Taiwan, 10002
        • Investigational Site Number :1580001
      • Taipei, Taiwan, 10002
        • Investigational Site Number : 1580001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: placebo
Tablet, oral use
Experimental: Rilzabrutinib dose A
dose A
Drug: rilzabrutinib
Tablet, oral use
Other Names:
  • PRN1008/SAR444671
Experimental: Rilzabrutinib dose B
dose B
Drug: rilzabrutinib
Tablet, oral use
Other Names:
  • PRN1008/SAR444671
Experimental: Rilzabrutinib dose C
dose C
Drug: rilzabrutinib
Tablet, oral use
Other Names:
  • PRN1008/SAR444671

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 12
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.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Weekly Urticaria Activity Score at Week 4
Time Frame: Baseline and 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.
Baseline and Week 4
Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12
Time Frame: Baseline and 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.
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
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.
At Week 12
Percentage of Participants With Weekly Urticaria Activity Score Equal to 0 at Week 12
Time Frame: 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.
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
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.
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)
Plasma samples were collected at specified timepoints for evaluation of rilzabrutinib pharmacokinetic (PK) concentrations.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2021

Primary Completion (Actual)

July 19, 2023

Study Completion (Actual)

April 23, 2024

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI17224 (Other Identifier: Sanofi Identifier)
  • U1111-1263-4226 (Registry Identifier: ICTRP)
  • 2021-002609-93 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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