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Monoclonal Antibodies

Isatuximab SAR650984 for Autoimmune Hemolytic Anemia

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 more

Secondary 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 more

Side effects data

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

54%

Infusion Related Reaction

42%

Cough

38%

Nausea

29%

Diarrhoea

29%

Upper Respiratory Tract Infection

29%

Back Pain

29%

Fatigue

25%

Insomnia

21%

Chills

21%

Dyspnoea

21%

Headache

21%

Oedema Peripheral

21%

Pyrexia

21%

Arthralgia

17%

Pneumonia

17%

Constipation

17%

Vomiting

17%

Chest Discomfort

17%

Dehydration

17%

Myalgia

17%

Oropharyngeal Pain

13%

Bone Pain

13%

Productive Cough

13%

Non-Cardiac Chest Pain

13%

Oral Candidiasis

13%

Decreased Appetite

13%

Hypercalcaemia

13%

Hypokalaemia

13%

Nasal Congestion

13%

Anaemia

Upper-Airway Cough Syndrome

Peripheral Sensory Neuropathy

Sinus Congestion

Abdominal Pain Upper

Dysphagia

Nasopharyngitis

Influenza

Asthenia

Influenza Like Illness

Fall

Blood Creatinine Increased

Dyspnoea Exertional

Muscle Spasms

Pain In Extremity

Restless Legs Syndrome

Hypertension

Hypotension

Malaise

Bronchitis

Spinal Stenosis

Flank Pain

Pneumonia Viral

Urinary Tract Infection

Pneumonia Aspiration

Lacrimation Increased

Infective Aortitis

Pneumonia Mycoplasmal

Sepsis

Aortic Aneurysm

Cerebral Haemorrhage

Anaphylactic Reaction

Herpes Zoster

Septic Shock

Pathological Fracture

Spinal Cord Compression

Bronchospasm

Musculoskeletal Chest Pain

Dry Eye

Dry Mouth

Gastrooesophageal Reflux Disease

Toothache

Hypoaesthesia

Varicella Zoster Virus Infection

Neutropenia

Pain

Peripheral Swelling

Procedural Pain

Hyperkalaemia

Neutrophil Count Decreased

Hypocalcaemia

Epistaxis

Muscular Weakness

Dizziness

Dysgeusia

Agitation

Anxiety

Depression

Acute Kidney Injury

Rhinorrhoea

Sneezing

Throat Irritation

Throat Tightness

Hyperhidrosis

Flushing

Pneumonia Respiratory Syncytial Viral

Spinal Column Stenosis

Pelvic Pain

100%

80%

60%

40%

20%

Study treatment Arm

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

Phase 1: Isatuximab 20mg/kg QW

Phase 1: Isatuximab <=1 mg/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 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

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