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Monoclonal Antibodies

Caplacizumab + Immunosuppression for Thrombotic Thrombocytopenic Purpura (MAYARI Trial)

Phase 3
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with a clinical diagnosis of iTTP and a French TMA score of 1 or 2.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up overall study period from day 1 to day 168 (treatment period + 12 weeks of follow-up)
Awards & highlights

MAYARI Trial Summary

This trial will test a drug and therapy to treat a rare blood disorder in men and women aged 18-80. Treatment duration is up to 24 weeks with daily assessments during hospitalization and weekly visits for assessments during ongoing treatment.

Who is the study for?
Adults aged 18-80 with immune-mediated thrombotic thrombocytopenic purpura (iTTP) can join this trial. They must have a specific score indicating iTTP severity, not be pregnant or breastfeeding, and agree to use contraception. Those with certain health conditions or high platelet counts are excluded.Check my eligibility
What is being tested?
The study tests caplacizumab combined with immunosuppressive therapy in treating iTTP without using plasma exchange first. It's an open-label Phase 3 trial focusing on whether patients achieve remission within a maximum of 24 weeks.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to corticosteroids and anti-CD20 antibody, as well as those specific to caplacizumab which could involve bleeding issues or other infusion-related reactions.

MAYARI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have iTTP with a low to moderate risk score.

MAYARI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overall study period from day 1 to day 168 (treatment period + 12 weeks of follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and overall study period from day 1 to day 168 (treatment period + 12 weeks of follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving Remission without requiring therapeutic plasma exchange (TPE).
Secondary outcome measures
Proportion of participants achieving Clinical Response
Proportion of participants achieving Remission
Proportion of participants refractory to therapy
+6 more

MAYARI Trial Design

1Treatment groups
Experimental Treatment
Group I: Caplacizumab & immunosuppressive therapy without 1st-line TPEExperimental Treatment3 Interventions
All participants will receive open label caplacizumab daily and immunosuppressive therapy (corticosteroid +/-anti-CD20 therapy antibody [rituximab or biosimilar]) without first line TPE
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Caplacizumab
2011
Completed Phase 3
~350
Corticosteroids
2003
Completed Phase 4
~8270

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,919 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,778 Total Patients Enrolled

Media Library

anti-CD20 antibody (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05468320 — Phase 3
Thrombotic Thrombocytopenic Purpura Research Study Groups: Caplacizumab & immunosuppressive therapy without 1st-line TPE
Thrombotic Thrombocytopenic Purpura Clinical Trial 2023: anti-CD20 antibody Highlights & Side Effects. Trial Name: NCT05468320 — Phase 3
anti-CD20 antibody (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05468320 — Phase 3

Frequently Asked Questions

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

Are applicants below the age of 25 eligible for participation in this experiment?

"In accordance with the eligibility prerequisites, prospective participants must be aged 18 or over and no older than 80 years old."

Answered by AI

Is enrollment currently open for this research study?

"Per the data showcased on clinicaltrials.gov, this investigation is actively enrolling volunteers and has been open since November 21st 2022. This study was most recently revised on February 15th 2023."

Answered by AI

How many participants are included in this research project?

"Indeed, the online clinicaltrials.gov resource verifies that this medical study is currently enrolling patients. Initially posted on November 21st 2022 and most recently edited on February 15th 2023, the trial requires 61 participants to be recruited at a single location."

Answered by AI

How perilous is the combination of Caplacizumab and immunosuppressive therapy prior to initial TPE for patients?

"Both the efficacy and safety of Caplacizumab & immunosuppressive therapy without initial TPE have been established through Phase 3 trials, leading to a score of 3."

Answered by AI

Would I be eligible to participate in this research?

"The research team is looking to enrol 61 individuals between the ages of 18 and 80 that have been diagnosed with thrombotic thrombocytopenic purpura."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura
2022. "Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05468320.
~18 spots leftby Dec 2024
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