Clinical trials: Warm Autoimmune Hemolytic Anemia
Warm Antibody Autoimmune Hemolytic Anemia
HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA. Phase III Study(Part A): Confirmation of Efficacy safety and of HMPL-523 in adult patients with wAIHA.
- Trial name
- wAIHA (NCT05535933)
- Testing
- HMPL-523(300mg PO QD)
- Where
- 39 sites in China
- Volunteers
- 111 people
- Sponsor
- Hutchmed
Immune Thrombocytopenia
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
- Trial name
- NCT07104565
- Testing
- INCA000585
- Where
- 39 sites in United States, Australia and 5 more
- Volunteers
- 56 people
- Sponsor
- Incyte Corporation
Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (WAIHA)
A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
A Phase 1b/2a, open-label dose escalation and dose expansion study of subcutaneously (SC) administered velinotamig for the treatment of adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune…
- Trial name
- NCT07738822
- Testing
- Velinotamig specified dose on specified days.
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Cullinan Therapeutics Inc.
AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia
OM336 in Autoimmune Cytopenias
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, ITP - Immune Thrombocytopenia
- Trial name
- NCT07083960
- Testing
- OM336
- Where
- 7 sites in United States, Australia
- Volunteers
- 32 people
- Sponsor
- Lakefront Biotherapeutics West LLC
Warm Autoimmune Hemolytic Anemia
Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)
The purpose of this post-trial access (PTA) program is to provide nipocalimab for the treatment of participants with Warm Autoimmune Hemolytic Anemia (wAIHA) who are experiencing clinical benefit after completing 28-weeks…
- Trial name
- NCT05221619
- Testing
- Nipocalimab
- Sponsor
- Janssen Research & Development, LLC
Warm Autoimmune Hemolytic Anemia
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
- Trial name
- ENERGY (NCT04119050)
- Testing
- M281
- Where
- 171 sites in United States, Brazil and 17 more
- Volunteers
- 118 people
- Sponsor
- Janssen Research & Development, LLC
Warm Autoimmune Hemolytic Anemia
Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic Anemia
This is a Phase 2, multiple ascending, dose-finding, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, health-related quality of life, tolerability, pharmacokinetic, pharmacodynamic, and…
- Trial name
- NCT04956276
- Testing
- ALXN1830
- Where
- United States
- Sponsor
- Alexion Pharmaceuticals, Inc.
Warm Autoimmune Hemolytic Anemia (wAIHA)
Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),
- Trial name
- PATHWAY (NCT05073458)
- Testing
- parsaclisinib
- Where
- 56 sites in United States, Austria and 11 more
- Volunteers
- 13 people
- Sponsor
- Incyte Corporation
Warm Antibody Autoimmune Hemolytic Anemia
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
- Trial name
- SOAR (NCT02612558)
- Testing
- Fostamatinib 150 mg bid
- Where
- 36 sites in United States, Canada
- Volunteers
- 26 people
- Sponsor
- Rigel Pharmaceuticals
Warm Antibody Autoimmune Hemolytic Anemia
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
The primary objective of this study is: To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
- Trial name
- NCT04138927
- Testing
- Fostamatinib disodium
- Where
- 37 sites in United States, Australia and 16 more
- Volunteers
- 90 people
- Sponsor
- Rigel Pharmaceuticals
Primary Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after…
- Trial name
- VAY RE-HIT (NCT07039422)
- Testing
- Ianalumab
- Sponsor
- Novartis Pharmaceuticals
Warm Autoimmune Hemolytic Anemia
To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).
This is a Phase 2 non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 in patients with Warm Autoimmune Hemolytic Anemia.
- Trial name
- ASCEND-WAIHA (NCT04253236)
- Testing
- RVT-1401 680 mg/weekly, RVT-1401 340 mg/weekly
- Where
- 21 sites in United States, Israel and 4 more
- Volunteers
- 5 people
- Sponsor
- Immunovant Sciences GmbH
Warm Autoimmune Hemolytic Anemia (wAIHA)
Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)
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…
- Trial name
- NCT04661033
- Testing
- Isatuximab SAR650984
- Where
- 6 sites in United States, France and 4 more
- Volunteers
- 8 people
- Sponsor
- Sanofi
Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenia
An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias (RUBY-4)
The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and…
- Conditions
- Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease
- Trial name
- NCT05757570
- Testing
- Povetacicept
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 30 people
- Sponsor
- Alpine Immune Sciences Inc, A Subsidiary of Vertex
Warm Autoimmune Hemolytic Anemia
ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).
- Trial name
- NCT04256148
- Testing
- ALXN1830
- Where
- United States
- Sponsor
- Alexion Pharmaceuticals, Inc.
Autoimmune Haemolytic Anaemia
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
This is a parallel-group, Phase 3, double-blind, 2-arm study to investigate the efficacy, safety, PK and PD of oral rilzabrutinib in achieving durable Hb response (DHR) compared with placebo in approximately 90 male and female…
- Trial name
- LUMINA 3 (NCT07086976)
- Testing
- rilzabrutinib
- Where
- 105 sites in United States, Argentina and 16 more
- Volunteers
- 90 people
- Sponsor
- Sanofi
Autoimmune Thrombocytopenia, Warm Autoimmune Haemolytic Anaemia
IASO-782 in Autoimmune Hematological Diseases
This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases.
- Trial name
- NCT06534021
- Testing
- IASO-782 injection
- Where
- 2 sites in China
- Volunteers
- 16 people
- Sponsor
- Shanghai IASO Biotechnology Co., Ltd
Warm Autoimmune Hemolytic Anemia (WAIHA), ITP - Immune Thrombocytopenia
Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
This is a single-arm, open-label, multicenter, ascending dose Phase 1/2 trial evaluating the safety and preliminary efficacy of CTX112 or Zugocabtagene geleucel (zugo-cel) in adult participants with relapsed/refractory primary…
- Conditions
- Warm Autoimmune Hemolytic Anemia (WAIHA), ITP - Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Immune Thrombocytopenic Purpura
- Trial name
- NCT07549698
- Testing
- CTX112
- Where
- 12 sites in United States, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- CRISPR Therapeutics AG
Warm Autoimmune Hemolytic Anemia (wAIHA)
A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.
- Trial name
- VAYHIA (NCT05648968)
- Testing
- Ianalumab
- Where
- 53 sites in United States, Argentina and 14 more
- Volunteers
- 90 people
- Sponsor
- Novartis Pharmaceuticals
Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease
Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).
- Trial name
- NCT03226678
- Testing
- APL-2
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Apellis Pharmaceuticals, Inc.