RecruitingPhase 1NCT07083960
Blood
Autoimmune Hemolytic Anemia
Also known as AIHA, warm AIHA, cold AIHA, Evans syndrome
Autoimmune hemolytic anemia is a heterogeneous group of acquired disorders in which autoantibodies directed against red blood cell surface antigens accelerate erythrocyte destruction by complement activation and phagocytosis in the reticulo
ORPHA:98375 ↗Prevalence 1-3 per 100,000 per yearOnset Any age; warm AIHA more common in adults; cold AIHA in older adults and post-infectious in childrenAcquired autoimmune
35
studies recruiting now
as of 7 Sept 2026
141
studies registered in total
as of 7 Sept 2026
21
countries with a recruiting site
as of 7 Sept 2026
5 Aug 2026
most recent study posted
among recruiting studies
Recruiting trials
RecruitingPhase 3NCT07086976
A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia
RecruitingNot applicableNCT07743242
Autoimmune Hemolytic Anemia and Its Clinical Implication on Antiphospholipid Syndrome
RecruitingPhase 2NCT07104565
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
RecruitingPhase 1NCT07748533
HY001N for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy.
Showing the 5 most recently updated recruiting studies, as recorded 7 Sept 2026. Live status on each study page.
See all 35 recruiting studiesWhere recruiting studies are running
Countries with at least one recruiting site among the studies above, 7 Sept 2026. Tap a country to search trials there.
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About Autoimmune Hemolytic Anemia
Autoimmune hemolytic anemia is a heterogeneous group of acquired disorders in which autoantibodies directed against red blood cell surface antigens accelerate erythrocyte destruction by complement activation and phagocytosis in the reticuloendothelial system. Warm AIHA involves IgG autoantibodies reactive at 37 degrees Celsius and accounts for approximately 70-80% of cases, while cold agglutinin disease involves IgM autoantibodies and cold hemolysins (paroxysmal cold hemoglobinuria) account for the remainder. When AIHA occurs with concurrent immune thrombocytopenia, the condition is called Evans syndrome and carries a more guarded prognosis.
Common clinical features
Rapidly developing anemia with pallor and fatigueJaundice and dark urine from hemolysisSplenomegaly from splenic red cell sequestrationPositive direct antiglobulin test (DAT/Coombs test)Elevated LDH, indirect bilirubin, and reticulocyte countReduced or absent haptoglobinCold-triggered acrocyanosis and Raynaud phenomenon in cold AIHAThrombocytopenia if concurrent Evans syndrome
From Orphanet’s phenotype annotations (CC BY 4.0). Not a complete list.
Treatments being studied
1 approved treatment and 23 in clinical development, from Open Targets (CC BY 4.0). Not medical advice.
Approved: Sutimlimab (Enjaymo)
Phase 3Fostamatinib Disodium (Tavalisse)
Phase 3Cyclosporine (Capimune)
Phase 3Prednisolone (Cortalone)
Phase 3Ianalumab
Phase 3Parsaclisib
Phase 3Obexelimab
Phase 3Rilzabrutinib
Phase 3Rituximab (Blitzima)
+ 15 more in development
Before you apply
Things trial teams commonly ask about for Autoimmune Hemolytic Anemia. Not eligibility rules; those are set by each study.
- Direct antiglobulin test (DAT) specificity (IgG, complement C3d, or both) and thermal amplitude of the causative antibody distinguish warm from cold AIHA and determine eligibility for specific trials targeting complement or B-cell pathways.
- Primary versus secondary AIHA (secondary to lymphoma, SLE, or other autoimmune disease) affects eligibility; most trials require exclusion of active malignancy and documentation of underlying conditions.
- Prior treatment history including corticosteroids, rituximab, splenectomy, and immunosuppressants with response assessment and duration is critical for second-line trial qualification.
Related conditions
Information, not medical advice. Trial listings are shown as recorded on ClinicalTrials.gov; whether any study is right for you is a decision for you and your clinicians, and eligibility is decided by each research team. Disease information from Orphanet (CC BY 4.0).