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Compares treatment options for Autoimmune Haemolytic Anaemia
Official title A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia
ClinicalTrials.gov ID: NCT07086976
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 autoimmune haemolytic anaemia.
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 parallel-group, Phase 3, double-blind, 2-arm study to investigate the efficacy, safety, PK and PD of oral rilzabrutinib in achieving durable Hb response (DHR) compared with placebo in approximately 90 male and female participants ≥ 18 years of age with a confirmed diagnosis of primary wAIHA. Following a 4-week screening period, eligible participants will be randomized in a 2:1 ratio to receive rilzabrutinib or placebo in primary analysis period (PAP) for a duration of up to 24 weeks.
- Phase 3: a large, late-stage study
- Time commitment: about 8 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Male and female participants with a documented (confirmed) diagnosis of primary wAIHA for at least 6 months.
- Participants who have previously failed to maintain a sustained response after treatment with CS (CS-resistance [defined as failure to obtain...
- Participants with Eastern Cooperative Oncology Group (ECOG) performance status Grade 2 or lower.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in...
You likely can't join if
- Participants with clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise...
- Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial...
- Participants with symptomatic herpes zoster within 3 months prior to screening.
- Participants with mixed wAIHA, or secondary wAIHA from any cause including drugs, Evans Syndrome, lymphoproliferative disorders (low count monoclonal...
- Participants with history of myelodysplastic syndrome.
- Participants with uncontrolled or active HBV infection or Active HCV infection.
See the full eligibility criteria
- Male and female participants with a documented (confirmed) diagnosis of primary wAIHA for at least 6 months.
- Participants who have previously failed to maintain a sustained response after treatment with CS (CS-resistance [defined as failure to obtain hemoglobin response within 3 weeks on at least 1 mg/kg or 60 mg prednisone or...
- Participants with Eastern Cooperative Oncology Group (ECOG) performance status Grade 2 or lower.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participants with 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...
- 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...
- Participants with symptomatic herpes zoster within 3 months prior to screening.
- Participants with mixed wAIHA, or secondary wAIHA from any cause including drugs, Evans Syndrome, lymphoproliferative disorders (low count monoclonal B-cell lymphocytosis is allowed), infectious or autoimmune disease...
- Participants with history of myelodysplastic syndrome.
- Participants with uncontrolled or active HBV infection or Active HCV infection.
- HIV infection.
- Participants with history of solid organ transplant.
- Participants with a history of active or latent tuberculosis (TB).
- Splenectomy within 12 weeks before screening and planned surgery during the PAP.
- Concurrent treatment with other experimental/investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to treatment start. Participants who previously received treatment with BTK inhibitors for...
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. The above information is not intended...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Duarte, California, United States
- Los Angeles, California, United States
- Stanford, California, United States
- Torrance, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Tamarac, Florida, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- The Bronx, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Memphis, Tennessee, United States
+ 70 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 study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Phoenix, Arizona, United States; Tucson, Arizona, United States; Duarte, California, United States; Los Angeles, California, United States; Stanford, California, United States; Torrance, California, United States and 84 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.