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Rilzabrutinib for Autoimmune Hemolytic Anemia
Study Summary
This trial is testing a drug to see if it's effective, safe, and has the right amount of the drug in patients' bodies when taken orally for wAIHA. The trial will last about 137 weeks total, and will have two parts. Part A is 24 weeks long, and Part B is 52 weeks long.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My condition did not improve after steroid treatment.I showed improvement with rilzabrutinib treatment in Part A.I can do most of my daily activities but not heavy physical work.I haven't had cancer, except for certain skin cancers, in the last 5 years.I have been diagnosed with myelodysplastic syndrome.I have been diagnosed with wAIHA or SLE-related wAIHA, with only skin and muscle symptoms.I have a type of anemia caused by my immune system attacking my red blood cells, but I don't have a confirmed autoimmune disease.I am HIV positive.I received treatment for wAIHA during Part A of the study.I did not improve long-term after steroid treatment.You have received all the necessary vaccinations according to local guidelines.Your weight is within a healthy range based on your height (BMI between 17.5 and 40 kg/m2).You need to follow the local regulations for contraception during the study, whether you are a man or a woman.You have allergies to any of the study medications or their ingredients.I have completed a 24-week treatment period.I have been diagnosed with wAIHA or lupus-related wAIHA, without severe lupus symptoms.I can do most of my daily activities but not heavy physical work.
- Group 1: Rilzabrutinib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has rilzabrutinib been granted sanction by the Federal Drug Administration (FDA)?
"Our team at Power judged that rilzabrutinib is a moderately safe treatment option, scoring it with a 2. This assessment was based on the fact that Phase 2 trials have yielded some evidence of its safety but not much related to efficacy."
How many individuals are being accepted as participants in this research experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, this therapeutic experiment was initiated December 7th 2021 and recently updated October 28th 2022. They are currently seeking 20 participants from 3 locations for enrollment in the trial."
Are there any vacancies available in this trial for prospective participants?
"As per current information on clinicaltrials.gov, this study is actively seeking participants. The medical trial was posted on December 7th 2021 and most recently updated on October 28th 2022."
Who else is applying?
What state do they live in?
How old are they?
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What portion of applicants met pre-screening criteria?
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