Monoclonal Antibodies

Isatuximab SAR650984 for Autoimmune Hemolytic Anemia

Investigational Site Number :8400001, Los Angeles, CA
Isatuximab SAR650984Phase 1 & 2Waitlist AvailableResearch Sponsored by Sanofi

Study Summary

This trial is testing a new drug, isatuximab, for people with wAIHA (warm autoimmune hemolytic anemia). The primary objectives are to evaluate the safety and tolerability of isatuximab and the efficacy of the selected dose. Secondary objectives include evaluating the durability of response to isatuximab and the impact of isatuximab treatment on fatigue.

Eligible Conditions
  • Warm Autoimmune Hemolytic Anemia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have tried at least one therapy in addition to corticosteroids, but it did not work well enough.
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Both men and women must use birth control methods during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 169
This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 169 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A To assess safety and tolerability
Part B -To evaluate overall response rate (R) or complete response (CR) at Day 85
Secondary outcome measures
Part A (All Cohorts) and B -Change from baseline in LDH
Part A (All Cohorts) and B -Change from baseline in haptoglobin
Part A (All Cohorts) and B -Change from baseline in reticulocytes
+10 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Isatuximab Part BExperimental Treatment1 Intervention
Isatuximab dose subcutaneous (SC) every 2 weeks x 6 doses
Group II: Isatuximab Part A/Cohort 3 (optional)Experimental Treatment1 Intervention
Isatuximab dose subcutaneous (SC) every 2 weeks x 2 doses
Group III: Isatuximab Part A/Cohort 2Experimental Treatment1 Intervention
Isatuximab dose subcutaneous (SC) every 2 weeks x 6 doses
Group IV: Isatuximab Part A/Cohort 1Experimental Treatment1 Intervention
Isatuximab dose subcutaneous (SC) every 2 weeks x 2 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
FDA approved

Find a site

Who is running the clinical trial?

SanofiLead Sponsor
2,102 Previous Clinical Trials
3,093,719 Total Patients Enrolled
Clinical Sciences & OperationsStudy Director
Sanofi
834 Previous Clinical Trials
1,653,307 Total Patients Enrolled

Frequently Asked Questions

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

What is the unique aspect of this clinical trial?

"Over the past decade, there have been 46 ongoing trials for Isatuximab SAR650984 in 358 cities and 39 countries. The first study began in 2010 and was sponsored by Sanofi. That initial Phase 1 & 2 trial included 351 participants and completed drug approval stages one and two. In the 10 years since then, an additional 287 studies have concluded."

Answered by AI

How many individuals are included in the analysis of this experiment?

"That is correct. According to the information available on clinicaltrials.gov, this trial has 23 open spots at 4 different sites. The first posting was on September 9th, 2021 and there have been no changes since October 4th, 2022."

Answered by AI

Are there any other human tests similar to this one that have been completed for Isatuximab SAR650984?

"The first study involving isatuximab SAR650984 occurred in 2010 at site 604001. To date, there have been 287 completed studies with 46 currently active trials; a significant portion of these are based in Philadelphia, Pennsylvania."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)
2021. "Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04661033.
~3 spots leftby Oct 2024
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