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Compares treatment options for Immunoglobulin G4 Related Disease
Official title A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
ClinicalTrials.gov ID: NCT07190196
What this study is testing
What is Rilzabrutinib?
Rilzabrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for immunoglobulin g4 related disease.
Also referred to as SAR444671.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 and Total inclusion points are ≥20
- Participants with active disease at screening in at least one organ system, excluding lymph nodes, as an IgG4-RD Responder Index total activity score...
- 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.
You likely can't join if
- 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...
- Active malignancy or history of malignancy within 5 years before Day 1, except completely treated in situ carcinoma of the cervix, completely...
- Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis...
- History of serious infections with the potential for recurrence (as judged by the Investigator), with less than 4 weeks interval between resolution...
- Current or chronic history of liver disease unrelated to IgG4-RD.
See the full eligibility criteria
- 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 and Total inclusion points are ≥20
- Participants with active disease at screening in at least one organ system, excluding lymph nodes, as an IgG4-RD Responder Index total activity score ≥ 2
- 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.
- 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...
- 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.
- 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...
- Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or...
- 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...
- Current or chronic history of liver disease unrelated to IgG4-RD.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Fontana, California, United States
- San Jose, California, United States
- Tustin, California, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Palm Beach Gardens, Florida, United States
- Atlanta, Georgia, United States
- Fayetteville, Georgia, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Middleburg Heights, Ohio, United States
- Plano, Texas, United States
- Red Oak, Texas, United States
- Wichita Falls, Texas, United States
- Seattle, Washington, United States
- Berazategui, Buenos Aires, Argentina
- San Isidro, Buenos Aires, Argentina
- Resistencia, Chaco Province, Argentina
+ 52 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fontana, California, United States; San Jose, California, United States; Tustin, California, United States; Margate, Florida, United States; Miami, Florida, United States; Palm Beach Gardens, Florida, United States and 66 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.