Your session is about to expire
← Back to Search
Monoclonal Antibodies
Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohort 1 : baseline (day 1) and pre-dose at weeks 1, 2, 4, 8, and 12; cohorts 2 and 3: baseline (day 1) and pre-dose at weeks 1, 2, 4, 8, 12, and 24
Awards & highlights
No Placebo-Only Group
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
- Autoimmune Hemolytic Anemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cohort 1 : baseline (day 1) and pre-dose at weeks 1, 2, 4, 8, and 12; cohorts 2 and 3: baseline (day 1) and pre-dose at weeks 1, 2, 4, 8, 12, and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort 1 : baseline (day 1) and pre-dose at weeks 1, 2, 4, 8, and 12; cohorts 2 and 3: baseline (day 1) and pre-dose at weeks 1, 2, 4, 8, 12, and 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A: Number of Participants With PCSA: Clinical Chemistry And Electrolyte Parameters
Part A: Number of Participants With Potentially Clinically Significant Abnormality (PCSA): Hematology
Part A: Number of Participants With Potentially Clinically Significant Abnormality: Urinalysis
+3 moreSecondary study objectives
Part A: Absolute Change From Baseline In Haptoglobin at 1, 2, 4, 8, 12, and 24 Weeks
Part A: Absolute Change From Baseline In Lactate Dehydrogenase (LDH) at 1, 2, 4, 8, 12, and 24 Weeks
Part A: Absolute Change From Baseline In Reticulocytes at 1, 2, 4, 8, 12, and 24 Weeks
+26 moreSide effects data
From 2023 Phase 1 & 2 trial • 351 Patients • NCT0108425250%
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
6%
Back Pain
6%
Pain
6%
Sinusitis
6%
Upper Respiratory Tract Infection
6%
Dizziness
6%
Abnormal Dreams
6%
Herpes Simplex
6%
Groin Pain
6%
Abdominal Pain
6%
Abdominal Pain Upper
6%
Gastrointestinal Pain
6%
Otitis Media
6%
Myelodysplastic Syndrome
6%
Meningitis Bacterial
6%
Constipation
6%
Acute Kidney Injury
6%
Bradycardia
6%
Glossodynia
6%
Stomatitis
6%
Respiratory Tract Infection
6%
Balance Disorder
6%
Dry Mouth
6%
Gastrooesophageal Reflux Disease
6%
Disease Progression
6%
Influenza Like Illness
6%
Malaise
6%
Cytokine Release Syndrome
6%
Bronchitis
6%
Limb Discomfort
6%
Muscle Spasms
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Head Discomfort
6%
Peripheral Sensory Neuropathy
6%
Agitation
6%
Bradyphrenia
6%
Depression
6%
Insomnia
6%
Irritability
6%
Productive Cough
6%
Throat Lesion
6%
Dermatitis Contact
6%
Hypertension
6%
Onychoclasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Isatuximab <=1 mg/kg Q2W
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Phase 1: Isatuximab 20mg/kg QW
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 20 mg/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
Awards & Highlights
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: Part B: Isatuximab up to 560 mg SC Q2W x6Experimental Treatment1 Intervention
Participants were planned to receive 6 doses of Isatuximab up to 560 mg (4 mL) via SC injection Q2W through Day 71
Group II: Part A: Cohort 3: Isatuximab 560 mg SC Q2W x6Experimental Treatment1 Intervention
Participants received 6 doses of Isatuximab 560 mg (4 mL) via SC injection Q2W through Day 71.
Group III: Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6Experimental Treatment1 Intervention
Participants received 6 doses of Isatuximab 280 mg (2 mL) via SC injection Q2W through Day 71.
Group IV: Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2Experimental Treatment1 Intervention
Participants received 2 doses of Isatuximab 140 milligrams (mg) (1 milliliter \[mL\]) via subcutaneous (SC) injection every 2 weeks (Q2W) on Day 1 and Day 15.
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
2,216 Previous Clinical Trials
4,047,624 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
877 Previous Clinical Trials
2,022,808 Total Patients Enrolled