AzTrials
AzTrials

Immunoglobulin G4 Related DiseasePhase 3RILIEFNCT07190196

A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease

A Phase 3 study testing Rilzabrutinib and Glucocorticoid in people with Immunoglobulin G4 Related Disease, run by Sanofi at 95 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase 3, parallel group, 2-arm, randomized, double blind, placebo-controlled, 52-week treatment study to assess the efficacy and safety of rilzabrutinib as a treatment for adult patients with active IgG4-RD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Immunoglobulin G4 Related Disease
What is being tested?
Rilzabrutinib and Glucocorticoid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
95 sitesin 19 countries
Study dates
26 Sep 2025to 25 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have a clinical diagnosis of IgG4-RD confirmed by the Adjudication Committee.
  • Participants meeting Step 1 Entry criteria of 2019 ACR/EULAR classification criteria for IgG4-RD and Total inclusion points are ≥20
  • Participants with active disease in at least 1 organ system, excluding lymph nodes, with active disease defined by an IgG4-RD Responder Index organ/site activity score ≥2 based on the manifestations of disease activity in the last 28 days.
  • Participants with history or current involvement of at least 1 organ/site (excluding lymph nodes) affected with IgG4-RD.
  • Participants with active IgG4-RD controlled for at least 2 weeks while on a stable dose of GC.
  • Participants willing to taper off GC after starting IMP.
Show all 9Show fewer
  • Participants willing and able to participate in repeated study protocol mandated or clinically indicated imaging procedures to assess IgG4-RD such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), or ultrasound.
  • Participants who have an up-to-date vaccination status as per local guidelines. The last dose of live vaccines should be received at least 30 days before Day 1.
  • 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

  • Meet any Step 2 Exclusion criteria from the 2019 ACR/EULAR classification criteria for IgG4-RD.
  • History of retroperitoneal fibrosis, sclerosing mesenteritis, fibrosing mediastinitis, or other overwhelmingly fibrotic expression of IgG4-RD that is the sole disease manifestation.
  • Active malignancy or history of malignancy within 5 years before Day 1, except completely treated in situ carcinoma of the cervix, completely treated, and resolved nonmetastatic squamous or basal cell carcinoma of the skin.
  • Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator.
  • History of serious infections with the potential for recurrence (as judged by the 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).
  • Current or chronic history of liver disease unrelated to IgG4-RD.
Show all 14Show fewer
  • Refractory nausea and vomiting, malabsorption, external biliary shunt, bariatric surgery, or significant bowel resection that would preclude adequate rilzabrutinib/placebo absorption.
  • History of solid organ transplant.
  • Planned major surgical procedure during the participation in this study.
  • History of drug abuse within the previous 12 months.
  • Alcoholism or excessive alcohol use, defined as regular consumption of more than approximately 3 standard drinks per day.
  • Prior participation in any rilzabrutinib studies or other BTK inhibitor studies.
  • History of treatment with an investigational drug within 6 months or 5 half-lives of the investigational drug, whichever is longer.
  • Laboratory abnormalities at the screening visit identified by the central laboratory The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

95 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended (Toll free for US & Canada) contact

800-633-1610 ext. option 6

contact-us@sanofi.com

95 sites in 19 countries

United States21 sites, 21 recruiting

  • Emory University School of Medicine - Atlanta- Site Number : 8400013

    Atlanta, Georgia, 30322

    Recruiting

  • Massachusetts General Hospital- Site Number : 8400008

    Boston, Massachusetts, 02114

    Recruiting

  • Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400035

    Charlotte, North Carolina, 28207

    Recruiting

  • Cleveland Clinic - Cleveland- Site Number : 8400001

    Cleveland, Ohio, 44195

    Danielle Haas, 216-385-2438, haasd2@ccf.org

    James Fernandez

    Recruiting

  • Ohio State University Wexner Medical Center- Site Number : 8400024

    Columbus, Ohio, 43215

    Recruiting

  • Henry Ford Hospital- Site Number : 8400009

    Detroit, Michigan, 48202

    Recruiting

  • Primeway Clinical Research- Site Number : 8400019

    Fayetteville, Georgia, 30214

    Celine Lalu, 678-368-7197, celinek@primewayclinicalresearch.com

    Charlita Worthy

    Recruiting

  • Kaiser Permanente - Fontana Medical Center- Site Number : 8400015

    Fontana, California, 92335

    Recruiting

  • Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400002

    Margate, Florida, 33063

    Ana Auza, 954-669-1052, auza@ictresearch.com

    Jigar Shah

    Recruiting

  • Paramount Medical Research and Consulting LLC- Site Number : 8400018

    Middleburg Heights, Ohio, 44140

    Jackie Wittenmyer, 440-826-0742, jwittenmyer5@yahoo.com

    Isam Diab

    Recruiting

  • Icahn School of Medicine at Mount Sinai- Site Number : 8400014

    New York, New York, 10029

    Recruiting

  • Vitalia Medical Research - Margate- Site Number : 8400025

    Palm Beach Gardens, Florida, 33410

    Delano Brooks, 561-975-3684, dbrooks@vitaliaresearch.com

    Clifford Stermer

    Recruiting

  • Stryde Research- Site Number : 8400011

    Plano, Texas, 75093

    Jayshree Chouhan, 214-407-8640, jchouhan@stryderesearch.com

    Rahul Patel

    Recruiting

  • Epic Medical Research - Red Oak- Site Number : 8400003

    Red Oak, Texas, 75154

    Siby Spurgeon, 972-777-6956, sspurgeon@epicmedresearch.com

    Sunny Patel

    Recruiting

  • Mayo Clinic in Rochester - Minnesota- Site Number : 8400017

    Rochester, Minnesota, 55905

    Christian Coy, 507-284-2175, coy.christian@mayo.edu

    Motaz Ashkar

    Recruiting

  • University of California Davis Health- Site Number : 8400012

    Sacramento, California, 95817

    Recruiting

  • San Jose Clinical Trials- Site Number : 8400016

    San Jose, California, 95128

    Sara Viznyuk, 408-443-3542, sviznyuk@sanjosetrials.com

    Slawomir Wojtowicz-Praga

    Recruiting

  • Velocity Clinical Research - Seattle- Site Number : 8400005

    Seattle, Washington, 98105

    Christeen DeNeui, 206-536-3030, cdeneui@velocityclinical.com

    Kris Kowdley

    Recruiting

  • Tampa General Hospital - Tampa - General Circle- Site Number : 8400027

    Tampa, Florida, 33606

    Recruiting

  • Solace Clinical Research - Tustin- Site Number : 8400020

    Tustin, California, 92780

    Hikyhe Ogannesian, 562-652-0005, hikyhe@salacecr.com

    Roger Kornu

    Recruiting

  • Digestive Health Research of North Texas- Site Number : 8400021

    Wichita Falls, Texas, 76301

    Sarah Sparkman, 940-222-6675, Sarah.sparkman@objective.health

    Vanya Wagler

    Recruiting

Other trials in United States

Japan11 sites, 11 recruiting

  • Investigational Site Number : 3920008

    Bunkyo, Tokyo, 113-8677

    Recruiting

  • Investigational Site Number : 3920003

    Hirakata, Osaka, 573-1191

    Recruiting

  • Hiroshima University Hospital-Site Number : 3920007

    Hiroshima, Hiroshima, 734-8551

    Shintaro Hirata, +81-82-257-5555, shirata@hiroshima-u.ac.jp

    Shintaro Hirata

    Recruiting

  • Kanazawa Medical University Hospital-Site Number : 3920002

    Kahoku, Uchinada, Ishikawa-ken, 920-0293

    Yasufumi Masaki, +81-76-286-3511, yasum1macky1@gmail.com

    Yasufumi Masaki

    Recruiting

  • Investigational Site Number : 3920001

    Kanazawa, Ishikawa-ken, 920-8641

    Recruiting

  • Investigational Site Number : 3920004

    Kitakyushu, Fukuoka, 807-8556

    Recruiting

  • Kobe University Hospital-Site Number : 3920010

    Kobe, Hyōgo, 650-0017

    Yuzo Kodama, +81-78-382-5111, kodama@med.kobe-u.ac.jp

    Yuzo Kodama

    Recruiting

  • The Institute of Medical Science, The University of Tokyo-Site Number : 3920006

    Minato-ku, Tokyo, 108-8639

    Motohisa Yamamoto, +81-3-3443-8111, mocha0422jp@yahoo.co.jp

    Motohisa Yamamoto

    Recruiting

  • Investigational Site Number : 3920005

    Nagaoka, Niigata, 940-2108

    Recruiting

  • Investigational Site Number : 3920011

    Sapporo, Hokkaido, 060-8543

    Recruiting

  • Investigational Site Number : 3920009

    Tokyo, 160-8582

    Recruiting

Other trials in Japan

China10 sites, 10 recruiting

  • Investigational Site Number : 1560008

    Beijing, 100034

    Recruiting

  • Investigational Site Number : 1560004

    Beijing, 100050

    Recruiting

  • Investigational Site Number : 1560001

    Beijing, 100730

    Recruiting

  • Investigational Site Number : 1560012

    Chengdu, 610041

    Recruiting

  • Investigational Site Number : 1560010

    Hangzhou, 310009

    Recruiting

  • Investigational Site Number : 1560003

    Jiazhuang, 050000

    Recruiting

  • Investigational Site Number : 1560013

    Taiyuan, 030001

    Recruiting

  • Investigational Site Number : 1560005

    Taiyuan, 030032

    Recruiting

  • Investigational Site Number : 1560011

    Wuhan, 430030

    Recruiting

  • Investigational Site Number : 1560009

    Yantai, 264001

    Recruiting

Other trials in China

France7 sites, 5 recruiting

  • AP-HP - Hôpital Beaujon-Site Number : 2500002

    Clichy, 92110

    Active, not recruiting

  • Investigational Site Number : 2500004

    Dijon, 21000

    Recruiting

  • Investigational Site Number : 2500005

    Lille, 59037

    Recruiting

  • Investigational Site Number : 2500006

    Lyon, 69004

    Recruiting

  • Investigational Site Number : 2500001

    Marseille, 13885

    Recruiting

  • CHU Bordeaux - Hôpital Haut Leveque-Site Number : 2500003

    Pessac, 33600

    Active, not recruiting

  • Investigational Site Number : 2500007

    Suresnes, 92151

    Recruiting

Other trials in France

Argentina5 sites, 5 recruiting

  • Investigational Site Number : 0320005

    Berazategui, Buenos Aires, 1886

    Recruiting

  • Investigational Site Number : 0320004

    Buenos Aires, 1015

    Recruiting

  • Investigational Site Number : 0320002

    Buenos Aires, 1180

    Recruiting

  • Investigational Site Number : 0320006

    Buenos Aires, 1181

    Recruiting

  • Investigational Site Number : 0320003

    San Isidro, Buenos Aires, B1643CRO

    Recruiting

Other trials in Argentina

Chile5 sites, 5 recruiting

  • Investigational Site Number : 1520005

    Concepción, Biobio, 4070038

    Recruiting

  • Investigational Site Number : 1520006

    Puente Alto, Reg Metropolitana de Santiago, 8207257

    Recruiting

  • Centro de estudios G y C-Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500504

    Iván Gónzalez, +56 9 93459808, ivangonzalez44@yahoo.com

    Iván Gónzalez

    Recruiting

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8320325

    Recruiting

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8330032

    Recruiting

Other trials in Chile

Germany5 sites, 5 recruiting

  • Investigational Site Number : 2760001

    Berlin, 13353

    Recruiting

  • Investigational Site Number : 2760003

    Erlangen, 91054

    Recruiting

  • Investigational Site Number : 2760007

    Hanover, 30625

    Recruiting

  • Investigational Site Number : 2760004

    Minden, 32429

    Recruiting

  • Investigational Site Number : 2760006

    Ulm, 89081

    Recruiting

Other trials in Germany

Israel4 sites, 4 recruiting

  • Investigational Site Number : 3760006

    Kefar Sava, 4428164

    Recruiting

  • Investigational Site Number : 3760003

    Nahariya, 2210001

    Recruiting

  • Rabin MC, Outpatient Clinics Building-Site Number : 3760001

    Petah Tikva, Central District, 4941492

    Elisheva Pokroy Shapira, elisheva@clalit.org.il

    Elisheva Pokroy Shapira

    Recruiting

  • Sourasky Rheumatology Dept, Rishonim Building-Site Number : 3760005

    Tel Aviv, Central District, 6423906

    Yael Lahat Goldstein, yaellah@tlvmc.gov.il

    Yael Lahat Goldstein

    Recruiting

Other trials in Israel

Spain4 sites, 4 recruiting

  • Investigational Site Number : 7240001

    Barcelona, Catalunya [Cataluña], 08035

    Recruiting

  • Investigational Site Number : 7240002

    Barcelona, Catalunya [Cataluña], 08041

    Recruiting

  • Investigational Site Number : 7240004

    Madrid, Madrid, Comunidad de, 28034

    Recruiting

  • Investigational Site Number : 7240007

    Seville, Andalusia, 41013

    Recruiting

Other trials in Spain

Italy3 sites, 3 recruiting

  • AOU Meyer IRCCS-Site Number : 3800003

    Florence, Firenze, 50139

    Ilaria Fibbi, +39 055 5662 905, ilaria.fibbi@meyer.it

    Prof. Augusto Vaglio, augusto.vaglio@meyer.it

    Recruiting

  • IRCCS Ospedale San Raffaele-Site Number : 3800001

    Milan, Lombardy, 20132

    Prof. Lorenzo Dagna, +39 02 2643 3828, dagna.trials@hsr.it

    Prof. Lorenzo Dagna

    Recruiting

  • Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B.Rossi-Site Number : 3800002

    Verona, Veneto, 37134

    Dr. Luigi Ziviani, '+39 0458126616, luigi.ziviani@crc.vr.it

    Prof. Luca Frulloni, luca.frulloni@univr.it

    Recruiting

Other trials in Italy

Poland3 sites, 3 recruiting

  • Uniwersyteckie Centrum Kliniczne, Centrum Wsparcia Badan Klinicznych UCK Osrodek Badan Wczesnych Faz-Site Number : 6160003

    Gdansk, Pomeranian Voivodeship, 80-214

    Anna Masiak, 48585844466, obkwf@uck.gda.pl

    Anna Masiak

    Recruiting

  • Malopolskie Badania Kliniczne sp. z. o.o.-Site Number : 6160001

    Krakow, Lesser Poland Voivodeship, 30-002

    Piotr Krawiec, +48 575 105 288, biuro@MBK.CLINIC

    Bogdan Batko

    Recruiting

  • Investigational Site Number : 6160002

    Wroclaw, Lower Silesian Voivodeship, 50-556

    Recruiting

Other trials in Poland

Taiwan3 sites, 3 recruiting

  • Investigational Site Number : 1580004

    Kaohsiung City, 833

    Recruiting

  • Investigational Site Number : 1580001

    Taipei, 100

    Recruiting

  • Investigational Site Number : 1580002

    Taoyuan City, 333

    Recruiting

Other trials in Taiwan

United Kingdom3 sites, 3 recruiting

  • Investigational Site Number : 8260002

    London, London, City of, W2 1NY

    Recruiting

  • Investigational Site Number : 8260004

    Norwich, Norfolk, NR4 7UY

    Recruiting

  • Investigational Site Number : 8260001

    Oxford, Oxfordshire, OX3 9DU

    Recruiting

Other trials in United Kingdom

Canada2 sites, 2 recruiting

  • Investigational Site Number : 1240004

    Montreal, Quebec, H2L 4M1

    Recruiting

  • Investigational Site Number : 1240001

    Sherbrooke, Quebec, J1G 2E8

    Recruiting

Other trials in Canada

Netherlands2 sites

  • UMCG-Site Number : 5280002

    Groningen, 9713 GZ

    Active, not recruiting

  • Erasmus Medisch Centrum-Site Number : 5280001

    Rotterdam, South Holland, 3015 GD

    Active, not recruiting

Other trials in Netherlands

Saudi Arabia2 sites, 2 recruiting

  • Investigational Site Number : 6820002

    Riyadh, 12372

    Recruiting

  • Investigational Site Number : 6820001

    Riyadh, 12713

    Recruiting

Other trials in Saudi Arabia

South Korea2 sites, 2 recruiting

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03080

    Recruiting

  • Investigational Site Number : 4100002

    Suwon, Gyeonggi-do, 16499

    Recruiting

Other trials in South Korea

Sweden2 sites, 2 recruiting

  • Investigational Site Number : 7520001

    Huddinge, 141 57

    Recruiting

  • Investigational Site Number : 7520002

    Uppsala, 751 85

    Recruiting

Other trials in Sweden

Belgium1 site, 1 recruiting

  • Investigational Site Number : 0560001

    Leuven, 3000

    Recruiting

Other trials in Belgium

About this study

Official title: A Randomized, Phase 3, Double-blind, 52-week Study to Evaluate the Efficacy and Safety of Rilzabrutinib (SAR444671) Compared to Placebo in Adult Participants With Active IgG4-related Disease

This is a Phase 3, parallel group, 2-arm, randomized, double blind, placebo-controlled, 52-week treatment study to assess the efficacy and safety of rilzabrutinib as a treatment for adult patients with active IgG4-RD.

The purpose of this study is to measure time to adjudicated IgG4-RD clinical disease flare, and other relevant efficacy endpoints including flare-free rate, control of IgG4-RD disease activity, use of GC rescue and safety parameters such as treatment-emergent adverse events, clinical laboratory values and electrocardiograms (ECG) in participants aged 18 years and above, diagnosed with IgG4-RD and treated with rilzabrutinib tablets over a 52-week placebo-controlled period.

Read more

Study details include:

The study duration will be up to 60 weeks, including a Screening period of 4 to 6 weeks, a 52-week double blind treatment period, and 2 weeks of follow up (plus an optional OLE of 108 weeks).

The number of visits will be 16 (plus an optional 9 visits during the OLE).

Being tested
Rilzabrutinib, Placebo, Glucocorticoid
Medical subject headings
Immunoglobulin G4-Related Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RilzabrutinibDrug

    Also called SAR444671

    Pharmaceutical form:Tablet-Route of administration:Oral

  • PlaceboDrug

    Pharmaceutical form:Tablet-Route of administration:Oral

  • GlucocorticoidDrug

    Pharmaceutical form:Tablet, solution, suspension formulations according to local standard practices-Route of administration:Oral

Study groups in NCT07190196
Study groupRoleWhat they receive
RilzabrutinibExperimentalRilzabrutinib
Receives: Drug: Rilzabrutinib; Drug: Glucocorticoid
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo; Drug: Glucocorticoid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first adjudicated clinical disease flare treated by the investigator during the Blinded Treatment period

    The Adjudication Committee will include internationally recognized independent experts in diagnosis and management of patients with IgG4-RD, blinded to participant, investigator, and site identifiers

    Measured: Until Week 52

Secondary outcomes (12)

  1. Proportion of participants without IgG4-RD adjudicated clinical disease flare and off glucocorticoids and immunomodulators

    Measured: At Week 52

  2. Proportion of participants without IgG4-RD adjudicated clinical disease flare and off glucocorticoids

    Measured: At Week 52

  3. Annualized rate of clinical disease flares

    Measured: At Week 52

  4. Change in IgG4-RD RI total activity scores from baseline to Week 52

    Measured: From baseline to Week 52

  5. Proportion of participants in complete remission at Week 52

    Defined by an IgG4-RD RI total activity score = 0 or absence of evident disease activity assessed by the Investigator

    Measured: At Week 52

  6. Percent change in IgG4-RD RI total activity scores from baseline to Week 52

    Measured: From baseline to Week 52

  7. Change in IgG4-RD RI total activity scores from baseline to Week 12

    Measured: From baseline to Week 12

  8. Percent change in IgG4-RD RI total activity scores from baseline at Week 12

    Measured: From baseline to Week 12

  9. Proportion of participants with reduction of ≥2 points from the baseline IgG4-RD RI total activity score

    Measured: At Week 12, Week 24, and Week 52

  10. Cumulative glucocorticoid dose for treatment of IgG4-RD

    Measured: At Week 52

  11. Proportion of participants with potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population

    Measured: Until Week 160

  12. Proportion of participants with TEAEs, AESIs, SAEs in the Safety Population

    Measured: Until Week 160

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start26 Sep 2025
  3. Primary completion28 Jun 2028 (estimated)
  4. Study completion25 Dec 2030 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07190196
Sponsor's protocol ID
EFC17359
Other IDs
U1111-1316-0266, 2025-521398-15, 2025
Acronym
RILIEF
Status last verified
Oct 2026
First submitted
17 Sep 2025
Last updated
20 Oct 2026
Results posted
No
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rilzabrutinib and Glucocorticoid in people with Immunoglobulin G4 Related Disease, run by Sanofi at 95 sites in 19 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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Japan, China, France, Argentina and 14 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first adjudicated clinical disease flare treated by the investigator during the Blinded Treatment period (time frame: Until Week 52). 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 NCT07190196.

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 20 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in