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Bruton's Tyrosine Kinase (BTK) Inhibitor

Rilzabrutinib for Autoimmune Hemolytic Anemia

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower
Participants who have previously failed to maintain a sustained response after treatment with corticosteroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after week 1 of treatment to week 24 in part a and week 75 in part b
Awards & highlights

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.

Who is the study for?
Adults with warm autoimmune hemolytic anemia (wAIHA) who haven't responded well to steroids can join this trial. They should be relatively healthy, have a BMI between 17.5 and 40, and up-to-date vaccinations. Participants must use approved contraception methods and not have other serious illnesses or recent treatments with experimental drugs.Check my eligibility
What is being tested?
The trial is testing rilzabrutinib's effectiveness for wAIHA patients over two parts: initial treatment for 24 weeks (Part A), then potentially continuing for another year if they respond well (Part B). It's an open-label study, meaning everyone knows they're taking the drug, which is given orally.See study design
What are the potential side effects?
Specific side effects of rilzabrutinib aren't listed here, but generally could include reactions at the medication site, digestive issues, fatigue or allergic reactions. Any severe or unacceptable side effects may lead to discontinuation from the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most of my daily activities but not heavy physical work.
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My condition did not improve after steroid treatment.
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I showed improvement with rilzabrutinib treatment in Part A.
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I have been diagnosed with wAIHA or SLE-related wAIHA, with only skin and muscle symptoms.
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I did not improve long-term after steroid treatment.
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I have completed a 24-week treatment period.
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I have been diagnosed with wAIHA or lupus-related wAIHA, without severe lupus symptoms.
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I can do most of my daily activities but not heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after week 1 of treatment to week 24 in part a and week 75 in part b
This trial's timeline: 3 weeks for screening, Varies for treatment, and after week 1 of treatment to week 24 in part a and week 75 in part b for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemoglobin
Part B: Proportion of participants who maintain durable response achieved during Part A or achieve a durable response during Part B and have a hemoglobin response
Secondary outcome measures
Change from baseline in FACIT-Fatigue scale score
Frequency of rescue therapy (any wAIHA-directed therapy other than predniso[lo]ne or transfusion) received
Incidence of treatment emergent adverse events (TEAEs), serious TEAEs, adverse events of special interest (AESIs)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RilzabrutinibExperimental Treatment1 Intervention
Oral rilzabrutinib 400 mg BID

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,158 Previous Clinical Trials
3,514,326 Total Patients Enrolled

Media Library

rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05002777 — Phase 2
Autoimmune Hemolytic Anemia Research Study Groups: Rilzabrutinib
Autoimmune Hemolytic Anemia Clinical Trial 2023: rilzabrutinib Highlights & Side Effects. Trial Name: NCT05002777 — Phase 2
rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05002777 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Utah
How old are they?
18 - 65
What site did they apply to?
Investigational Site Number 3800001
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby May 2024