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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

Summary

This trial is testing the safety and effectiveness of isatuximab injections in adults with warm Autoimmune Hemolytic Anemia (wAIHA). The medication works by attaching to immune cells and helping to stop them from destroying red blood cells. The study aims to see if this treatment can reduce symptoms and improve patient outcomes.

Eligible Conditions
  • Warm Autoimmune Hemolytic Anemia

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

Side effects data

From 2023 Phase 1 & 2 trial • 351 Patients • NCT01084252
54%
Infusion Related Reaction
38%
Nausea
38%
Cough
29%
Diarrhoea
29%
Upper Respiratory Tract Infection
29%
Back Pain
25%
Fatigue
21%
Chills
21%
Dyspnoea
21%
Oedema Peripheral
21%
Pyrexia
21%
Insomnia
17%
Pneumonia
17%
Vomiting
17%
Headache
17%
Chest Discomfort
17%
Dehydration
17%
Myalgia
17%
Oropharyngeal Pain
13%
Productive Cough
13%
Bone Pain
13%
Non-Cardiac Chest Pain
13%
Oral Candidiasis
13%
Constipation
13%
Decreased Appetite
13%
Hypercalcaemia
13%
Hypokalaemia
13%
Arthralgia
13%
Musculoskeletal Pain
13%
Nasal Congestion
13%
Anaemia
8%
Peripheral Sensory Neuropathy
8%
Upper-Airway Cough Syndrome
8%
Abdominal Pain Upper
8%
Dysphagia
8%
Nasopharyngitis
8%
Asthenia
8%
Influenza Like Illness
8%
Fall
8%
Blood Creatinine Increased
8%
Dyspnoea Exertional
8%
Muscle Spasms
8%
Pain In Extremity
8%
Restless Legs Syndrome
8%
Hypertension
8%
Hypotension
8%
Malaise
4%
Lacrimation Increased
4%
Flank Pain
4%
Influenza
4%
Sinus Congestion
4%
Urinary Tract Infection
4%
Pneumonia Viral
4%
Infective Aortitis
4%
Pneumonia Mycoplasmal
4%
Sepsis
4%
Aortic Aneurysm
4%
Cerebral Haemorrhage
4%
Anaphylactic Reaction
4%
Herpes Zoster
4%
Septic Shock
4%
Pathological Fracture
4%
Spinal Cord Compression
4%
Bronchospasm
4%
Musculoskeletal Chest Pain
4%
Dry Eye
4%
Dry Mouth
4%
Gastrooesophageal Reflux Disease
4%
Toothache
4%
Pneumonia Aspiration
4%
Hypoaesthesia
4%
Varicella Zoster Virus Infection
4%
Neutropenia
4%
Pain
4%
Peripheral Swelling
4%
Procedural Pain
4%
Hyperkalaemia
4%
Neutrophil Count Decreased
4%
Hypocalcaemia
4%
Epistaxis
4%
Dizziness
4%
Dysgeusia
4%
Agitation
4%
Anxiety
4%
Depression
4%
Acute Kidney Injury
4%
Rhinorrhoea
4%
Sneezing
4%
Throat Irritation
4%
Throat Tightness
4%
Hyperhidrosis
4%
Flushing
4%
Pneumonia Respiratory Syncytial Viral
4%
Spinal Column Stenosis
4%
Pelvic Pain
4%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Phase 1: Isatuximab 20mg/kg QW
Phase 1: Isatuximab 1mg/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

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,173 Previous Clinical Trials
3,516,482 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
866 Previous Clinical Trials
2,020,201 Total Patients Enrolled
~2 spots leftby Sep 2025
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