TerminatedPhase 2

Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)

Stopped: Study discontinuation based on strategic sponsor decision; not driven by any safety concerns.

United States, France, Germany8 participantsStarted 2021-09-09

Plain-language summary

Primary Objectives: * Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA * Part B: To evaluate the efficacy of the selected dose in adults with wAIHA Secondary Objectives: * Part A (Cohorts 2 and 3 only) * To evaluate the efficacy of isatuximab in adults with wAIHA * To evaluate the durability of response to isatuximab and time to response * To evaluate the impact of isatuximab treatment on fatigue Part B * To evaluate the safety and tolerability of isatuximab in adults with wAIHA * To evaluate the durability of response to isatuximab and time to response * To evaluate the impact of isatuximab treatment on fatigue Parts A (all Cohorts) and B * To evaluate the effect of isatuximab on markers of hemolysis * To characterize the pharmacokinetic profile of isatuximab in adults with wAIHA * To evaluate the immunogenicity of isatuximab

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Hemoglobin level \<10 g/dL at screening.
✓. Hemolysis (haptoglobin ≤40 mg/dL and total or indirect/unconjugated bilirubin above the upper limit of normal).
✓. Positive direct antiglobulin test (DAT) (IgG or IgG + complement C3d pattern or IgM warm autoantibodies (positive dual DAT)).

What they're measuring

Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) And Treatment Emergent Serious Adverse Events (TESAEs)

Timeframe: From first dose of study drug (Day 1) up to 30 days after last study intervention administration, approximately 101 days

Part A: Number of Participants With Potentially Clinically Significant Abnormality (PCSA): Hematology

Timeframe: From first dose of study drug (Day 1) up to end of study, approximately 169 days

Part A: Number of Participants With PCSA: Clinical Chemistry And Electrolyte Parameters

Timeframe: From first dose of study drug (Day 1) up to end of study, approximately 169 days

Part A: Number of Participants With Potentially Clinically Significant Abnormality: Urinalysis

Timeframe: From first dose of study drug (Day 1) up to end of study, approximately 169 days

Part A: Number of Participants With Potentially Clinically Significant Abnormality: Vital Signs

Timeframe: From first dose of study drug (Day 1) up to end of study, approximately 169 days

Part B: Overall Response Rate (Response [R] Or Complete Response [CR]) At Day 85

Timeframe: Day 85

Trial details

NCT IDNCT04661033

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-26

Results submitted2024-06-06

View on ClinicalTrials.gov More Warm Autoimmune Hemolytic Anemia (wAIHA) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Hemoglobin level \<10 g/dL at screening.
✓. Hemolysis (haptoglobin ≤40 mg/dL and total or indirect/unconjugated bilirubin above the upper limit of normal).
✓. Positive direct antiglobulin test (DAT) (IgG or IgG + complement C3d pattern or IgM warm autoantibodies (positive dual DAT)).