← Back to Search

Monoclonal Antibodies

Isatuximab SAR650984 for Autoimmune Hemolytic Anemia

Phase 1 & 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through day 169

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through day 169

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

Side effects data

From 2023 Phase 1 & 2 trial • 351 Patients • NCT01084252

50%

Fatigue

38%

Anaemia

31%

Infusion Related Reaction

31%

Headache

25%

Nausea

25%

Chills

25%

Pyrexia

19%

Cough

19%

Diarrhoea

13%

Oedema Peripheral

13%

Contusion

13%

Vision Blurred

13%

Hypercalcaemia

13%

Thrombocytopenia

13%

Vomiting

13%

Urinary Tract Infection

13%

Blood Creatinine Increased

13%

Lymphocyte Count Decreased

13%

Bone Pain

13%

Pain In Extremity

13%

Dysgeusia

13%

Dyspnoea

Upper Respiratory Tract Infection

Groin Pain

Pain

Herpes Simplex

Dizziness

Sinusitis

Back Pain

Abnormal Dreams

Abdominal Pain

Abdominal Pain Upper

Gastrointestinal Pain

Otitis Media

Myelodysplastic Syndrome

Meningitis Bacterial

Constipation

Acute Kidney Injury

Bradycardia

Glossodynia

Stomatitis

Respiratory Tract Infection

Balance Disorder

Dry Mouth

Gastrooesophageal Reflux Disease

Disease Progression

Influenza Like Illness

Malaise

Cytokine Release Syndrome

Bronchitis

Limb Discomfort

Muscle Spasms

Musculoskeletal Chest Pain

Myalgia

Head Discomfort

Peripheral Sensory Neuropathy

Agitation

Bradyphrenia

Depression

Insomnia

Irritability

Productive Cough

Throat Lesion

Dermatitis Contact

Hypertension

Onychoclasis

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1: Isatuximab 1mg/kg Q2W

Phase 1: Isatuximab 20mg/kg QW

Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W

Phase 1: Isatuximab 3mg/kg Q2W

Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)

Phase 1: Isatuximab 20mg/kg Q2W

Phase 2 Stage 2: Isatuximab Alone

Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W

Phase 1: Isatuximab 5mg/kg Q2W

Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W

Phase 2 Stage 2: Isatuximab + Dexamethasone

Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W

Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)

Phase 1: Isatuximab 10mg/kg QW

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 SAR650984

2015

Completed Phase 2

~580

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,163 Previous Clinical Trials

3,512,472 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

857 Previous Clinical Trials

2,019,291 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.