Clinical trials: AIHA - Warm Autoimmune Hemolytic Anemia
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.
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
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
Warm Antibody Autoimmune Hemolytic Anemia
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA
The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
- Trial name
- NCT03764618
- Testing
- Fostamatinib disodium
- Where
- 102 sites in United States, Australia and 20 more
- Volunteers
- 90 people
- Sponsor
- Rigel Pharmaceuticals
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 (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
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 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
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
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
A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
- Trial name
- NCT05786573
- Testing
- Obexelimab
- Where
- 7 sites in Italy, Poland and 3 more
- Volunteers
- 134 people
- Sponsor
- Zenas BioPharma (USA), LLC
Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD)
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in…
- Conditions
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA), End-stage Renal Disease (ESRD)
- Trial name
- BIVV009-01 (NCT02502903)
- Testing
- BIV009
- Where
- Austria
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Bioverativ, a Sanofi company
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 (wAIHA)
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)
This study will evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
- Trial name
- NCT04691570
- Testing
- ANX005
- Where
- 4 sites in United States, Australia and 2 more
- Volunteers
- 7 people
- Sponsor
- Annexon, Inc.
Warm Autoimmune Hemolytic Anemia (wAIHA)
Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)
All participants will receive rilzabrutinib orally. The screening period is up to 28 days, followed by a treatment period of 24 weeks for Part A.
- Trial name
- LUMINA 2 (NCT05002777)
- Testing
- rilzabrutinib
- Where
- 27 sites in United States, Austria and 7 more
- Volunteers
- 22 people
- Sponsor
- Sanofi
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.
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 Autoimmune Hemolytic Anemia
A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)
This main study objective was to evaluate the safety and tolerability of intravenous (IV) SYNT001 (ALXN1830) in participants with WAIHA.
- Trial name
- NCT03075878
- Testing
- ALXN1830
- Where
- 10 sites in United States, Jordan
- Volunteers
- 8 people
- 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
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