Actively Recruiting
A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
Led by Sanofi · Updated on 2026-05-04
124
Participants Needed
68
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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. Study details include: The study duration will be up to 60 weeks, including a 4 to 6-week screening period, 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).
CONDITIONS
Official Title
A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have an adjudicated clinical diagnosis of IgG4-RD
- Participants meeting Step 1 Entry criteria of 2019 ACR/EULAR classification criteria for IgG4-RD with total points of 20 or more
- Participants with active disease at screening in at least one organ system (excluding lymph nodes) with a Responder Index total activity score of 2 or higher
- Participants with history or current involvement of at least one organ affected by IgG4-RD (excluding lymph nodes)
- Participants with active IgG4-RD controlled for at least 2 weeks on a stable dose of glucocorticoids
- Participants willing to taper off glucocorticoids after starting the investigational medicinal product
- Participants willing and able to undergo repeated imaging procedures (CT, MRI, PET, or ultrasound) to assess disease
- Participants who have up-to-date vaccinations according to local guidelines, with live vaccines given at least 30 days before Day 1
- Participants using contraception according to local regulations for clinical study participation
You will not qualify if you...
- 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 mainly fibrotic forms of IgG4-RD as the sole disease
- Active cancer or cancer history within 5 years, except certain treated skin or cervical cancers
- Known or suspected immune deficiency or history of serious or recurrent infections
- Recent serious infection within 4 weeks before first dose or active moderate to severe infection at screening
- Current or chronic liver disease unrelated to IgG4-RD
- Conditions impairing absorption of rilzabrutinib or placebo such as nausea, vomiting, malabsorption, biliary shunt, bariatric surgery, or bowel resection
- History of solid organ transplant
- Planned major surgery during the study
- History of drug abuse in the past 12 months
- Excessive alcohol use defined as more than 3 standard drinks daily
- Previous participation in rilzabrutinib or other BTK inhibitor studies
- Treatment with investigational drugs within 6 months or 5 drug half-lives before starting
- Laboratory abnormalities identified at screening by central laboratory
AI-Screening
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Trial Site Locations
Total: 68 locations
1
San Jose Clinical Trials- Site Number : 8400016
San Jose, California, United States, 95128
Actively Recruiting
2
Solace Clinical Research - Tustin- Site Number : 8400020
Tustin, California, United States, 92780
Actively Recruiting
3
Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400002
Margate, Florida, United States, 33063
Actively Recruiting
4
Schiff Center for Liver Diseases/University of Miami- Site Number : 8400010
Miami, Florida, United States, 33136
Actively Recruiting
5
Vitalia Medical Research - Margate- Site Number : 8400025
Palm Beach Gardens, Florida, United States, 33410
Actively Recruiting
6
Primeway Clinical Research- Site Number : 8400019
Fayetteville, Georgia, United States, 30214
Actively Recruiting
7
Mayo Clinic in Rochester - Minnesota- Site Number : 8400017
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
Cleveland Clinic - Cleveland- Site Number : 8400001
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
Ohio State University Wexner Medical Center - Site Number : 8400024
Columbus, Ohio, United States, 43210
Actively Recruiting
10
Paramount Medical Research and Consulting LLC- Site Number : 8400018
Middleburg Heights, Ohio, United States, 44140
Actively Recruiting
11
Stryde Research- Site Number : 8400011
Plano, Texas, United States, 75093
Actively Recruiting
12
Epic Medical Research - Red Oak- Site Number : 8400003
Red Oak, Texas, United States, 75154
Actively Recruiting
13
Digestive Health Research of North Texas- Site Number : 8400021
Wichita Falls, Texas, United States, 76301
Actively Recruiting
14
Velocity Clinical Research - Seattle- Site Number : 8400005
Seattle, Washington, United States, 98105
Actively Recruiting
15
Investigational Site Number : 0320005
Berazategui, Buenos Aires, Argentina, 1886
Actively Recruiting
16
Investigational Site Number : 0320002
Resistencia, Chaco Province, Argentina, 3500
Actively Recruiting
17
Investigational Site Number : 0320004
Buenos Aires, Argentina, 1015
Actively Recruiting
18
Investigational Site Number : 0560001
Leuven, Belgium, 3000
Actively Recruiting
19
Investigational Site Number : 1240001
Sherbrooke, Quebec, Canada, J1G 2E8
Actively Recruiting
20
Investigational Site Number : 1520005
Concepción, Biobio, Chile, 4070038
Actively Recruiting
21
Centro de estudios G y C-Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile, 7500504
Actively Recruiting
22
Investigational Site Number : 1520006
Santiago, Reg Metropolitana de Santiago, Chile, 8207257
Actively Recruiting
23
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile, 8320325
Actively Recruiting
24
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile, 8330032
Actively Recruiting
25
Investigational Site Number : 1560008
Beijing, China, 100034
Actively Recruiting
26
Investigational Site Number : 1560004
Beijing, China, 100050
Actively Recruiting
27
Investigational Site Number : 1560001
Beijing, China, 100730
Actively Recruiting
28
Investigational Site Number : 1560012
Chengdu, China, 610041
Actively Recruiting
29
Investigational Site Number : 1560010
Hangzhou, China, 310009
Actively Recruiting
30
Investigational Site Number : 1560003
Jiazhuang, China, 050000
Actively Recruiting
31
Investigational Site Number : 1560013
Taiyuan, China, 030001
Actively Recruiting
32
Investigational Site Number : 1560005
Taiyuan, China, 030032
Actively Recruiting
33
Investigational Site Number : 1560011
Wuhan, China, 430030
Actively Recruiting
34
Investigational Site Number : 1560009
Yantai, China, 264001
Actively Recruiting
35
AP-HP - Hôpital Beaujon-Site Number : 2500002
Clichy, France, 92110
Active, Not Recruiting
36
Investigational Site Number : 2500001
Marseille, France, 13885
Actively Recruiting
37
CHU Bordeaux - Hôpital Haut Leveque-Site Number : 2500003
Pessac, France, 33600
Active, Not Recruiting
38
Investigational Site Number : 2760001
Berlin, Germany, 13353
Actively Recruiting
39
Investigational Site Number : 2760003
Erlangen, Germany, 91054
Actively Recruiting
40
Rabin MC, Outpatient Clinics Building-Site Number : 3760001
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
41
Sourasky Rheumatology Dept, Rishonim Building-Site Number : 3760005
Tel Aviv, Central District, Israel, 6423906
Actively Recruiting
42
AOU Meyer IRCCS-Site Number : 3800003
Florence, Firenze, Italy, 50139
Actively Recruiting
43
IRCCS Ospedale San Raffaele-Site Number : 3800001
Milan, Lombardy, Italy, 20132
Actively Recruiting
44
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B.Rossi-Site Number : 3800002
Verona, Veneto, Italy, 37134
Actively Recruiting
45
Hiroshima University Hospital-Site Number : 3920007
Hiroshima, Hiroshima, Japan, 734-8551
Actively Recruiting
46
Investigational Site Number : 3920011
Sapporo, Hokkaido, Japan, 060-8543
Actively Recruiting
47
Kanazawa Medical University Hospital-Site Number : 3920002
Kahoku, Uchinada, Ishikawa-ken, Japan, 920-0293
Actively Recruiting
48
Investigational Site Number : 3920001
Kanazawa, Ishikawa-ken, Japan, 920-8641
Actively Recruiting
49
Investigational Site Number : 3920003
Hirakata, Osaka, Japan, 573-1191
Actively Recruiting
50
Investigational Site Number : 3920008
Bunkyo-ku, Tokyo, Japan, 113-8677
Actively Recruiting
51
The Institute of Medical Science, The University of Tokyo-Site Number : 3920006
Minato-ku, Tokyo, Japan, 108-8639
Actively Recruiting
52
Erasmus Medisch Centrum-Site Number : 5280001
Rotterdam, South Holland, Netherlands, 3015 GD
Active, Not Recruiting
53
UMCG-Site Number : 5280002
Groningen, Netherlands, 9713 GZ
Active, Not Recruiting
54
Malopolskie Badania Kliniczne sp. z. o.o.-Site Number : 6160001
Krakow, Lesser Poland Voivodeship, Poland, 30-002
Actively Recruiting
55
Investigational Site Number : 6160002
Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
Actively Recruiting
56
Uniwersyteckie Centrum Kliniczne, Centrum Wsparcia Badan Klinicznych UCK Osrodek Badan Wczesnych Faz-Site Number : 6160003
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Actively Recruiting
57
Investigational Site Number : 6820002
Riyadh, Saudi Arabia, 12372
Actively Recruiting
58
Investigational Site Number : 6820001
Riyadh, Saudi Arabia, 12713
Actively Recruiting
59
Investigational Site Number : 4100002
Suwon, Gyeonggi-do, South Korea, 16499
Actively Recruiting
60
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea, 03080
Actively Recruiting
61
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
62
Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], Spain, 08041
Actively Recruiting
63
Investigational Site Number : 7240004
Madrid, Spain, 28034
Actively Recruiting
64
Investigational Site Number : 7520001
Huddinge, Sweden, 141 57
Actively Recruiting
65
Investigational Site Number : 7520002
Uppsala, Sweden, 751 85
Actively Recruiting
66
Investigational Site Number : 1580001
Taipei, Taiwan, 10016
Actively Recruiting
67
Investigational Site Number : 1580002
Taoyuan City, Taiwan, 333
Actively Recruiting
68
Investigational Site Number : 8260004
Norwich, Norfolk, United Kingdom, NR4 7UY
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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