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Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia
EU CTIS ID: 2023-509441-13-00
What this study is testing
Part A: To evaluate the efficacy of rilzabrutinib in adult patients with wAIHA Part B: To evaluate the long-term efficacy of rilzabrutinib in patients with wAIHA
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female patients with a confirmed diagnosis of primary wAIHA or systemic lupus erythematosus (SLE)-associated wAIHA (without other SLE-related manifestations apart from cutaneous and musculoskeletal manifestations)
- Participants who have previously failed to maintain a sustained response after treatment with corticosteroids
- Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower
- Up-to-date vaccination status as per local guideline
- Body mass index (BMI) >17.5 and <40 kg/m2
- All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
You likely can't join if
- Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his or her participation in the study as determined by the Investigator
- Part B only: Presence of unacceptable side effect(s) or toxicity associated with rilzabrutinib such that there is an unfavorable risk-benefit assessment for continued treatment with rilzabrutinib in the opinion of the Investigator and/or Sponsor
- Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years
- Secondary wAIHA from any cause including drugs, lymphoproliferative disorders (low-count monoclonal B-cell lymphocytosis is allowed), infectious or autoimmune disease, or active hematologic malignancies. Participants with positive antinuclear antibodies but without a definitive diagnosis of an autoimmune disease are allowed
- Myelodysplastic syndrome
- Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV DNA
See the full eligibility criteria
- Male and female patients with a confirmed diagnosis of primary wAIHA or systemic lupus erythematosus (SLE)-associated wAIHA (without other SLE-related manifestations apart from cutaneous and musculoskeletal manifestations)
- Participants who have previously failed to maintain a sustained response after treatment with corticosteroids
- Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower
- Up-to-date vaccination status as per local guideline
- Body mass index (BMI) >17.5 and <40 kg/m2
- All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Core Part B: Evidence of treatment efficacy to rilzabrutinib as defined by achieving overall response during Part A
- Core Part B: - Completion of Part A treatment period (24 weeks)
- Extended Part B: Completion of Core Part B period.
- Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his or her participation in the study as determined by the Investigator
- Part B only: Presence of unacceptable side effect(s) or toxicity associated with rilzabrutinib such that there is an unfavorable risk-benefit assessment for continued treatment with rilzabrutinib in the opinion of the Investigator and/or Sponsor
- Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years
- Secondary wAIHA from any cause including drugs, lymphoproliferative disorders (low-count monoclonal B-cell lymphocytosis is allowed), infectious or autoimmune disease, or active hematologic malignancies. Participants with positive antinuclear antibodies but without a definitive diagnosis of an autoimmune disease are allowed
- Myelodysplastic syndrome
- Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV DNA
- HIV infection
- Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 half-lives, whichever is greater, prior to treatment start
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
- Part B only: Participants who receive any therapy during Part A known to be active in wAIHA
The study team makes the final eligibility decision.
Where it's taking place
- China
- United Kingdom
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; United Kingdom; United States. 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 EU CTIS; the study team decides eligibility.