Warm Autoimmune Hemolytic Anemia

Immunology
6
Pipeline Programs
4
Companies
50
Clinical Trials
2 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
2
0
2
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2100%
+ 2 programs with unclassified modality

On Market (2)

Approved therapies currently available

Roche
RITUXANApproved
rituximab
Roche
CD20-directed Cytolytic Antibody [EPC]intravenous1997
Roche
RITUXAN HYCELAApproved
rituximab and hyaluronidase
Roche
Endoglycosidase [EPC]subcutaneous2017

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Roche
RocheSTAVANGER NORWAY, Norway
1 program
1
1
RITUXAN HYCELA(rituximab)Phase 3Monoclonal Antibody5 trials
Active Trials
NCT06186648Recruiting40Est. Mar 2027
NCT06047080Active Not Recruiting1,130Est. Dec 2030
NCT05798156Active Not Recruiting125Est. Sep 2028
+2 more trials
Zenas BioPharma
Zenas BioPharmaWALTHAM, MA
1 program
1
ObexelimabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT05786573Active Not Recruiting134Est. Aug 2026
Apellis Pharmaceuticals
Apellis PharmaceuticalsAustralia - Hawthorn East
1 program
1
APL-2Phase 21 trial
Active Trials
NCT03226678Completed24Est. Sep 2022
Immunovant
ImmunovantDURHAM, NC
1 program
1
RVT-1401 680 mg/weeklyPhase 21 trial
Active Trials
NCT04253236TerminatedEst. Apr 2021

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Rocherituximab
Rocherituximab
Rocherituximab
Rocherituximab
Rocherituximab
Zenas BioPharmaObexelimab
Rocherituximab
Rocherituximab
Rocherituximab
Rocherituximab
Rocherituximab
Rocherituximab
Rocherituximab
Rocherituximab
Rocherituximab

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 8,440 patients across 50 trials

NCT01382940Rocherituximab

A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis

Start: Jul 2011Est. completion: Jan 2013351 patients
Phase 4Completed
NCT01271010Rocherituximab

A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status

Start: Jun 2011Est. completion: May 201689 patients
Phase 4Terminated
NCT00502853Rocherituximab

A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.

Start: Oct 2007Est. completion: Jul 201010 patients
Phase 4Completed
NCT00934648Rocherituximab

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Start: Oct 2007Est. completion: Nov 201015 patients
Phase 4Completed
NCT00504777Rocherituximab

A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

Start: Jul 2007Est. completion: Mar 201036 patients
Phase 4Completed
NCT05786573Zenas BioPharmaObexelimab

A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)

Start: Sep 2023Est. completion: Aug 2026134 patients
Phase 3Active Not Recruiting
NCT06047080Rocherituximab

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

Start: Sep 2023Est. completion: Dec 20301,130 patients
Phase 3Active Not Recruiting
NCT02406092Rocherituximab

Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A

Start: Oct 2015Est. completion: Jun 2021139 patients
Phase 3Completed
NCT02005471Rocherituximab

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Start: Mar 2014Est. completion: Aug 2022389 patients
Phase 3Completed
NCT01987505Rocherituximab

MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma

Start: Nov 2013Est. completion: Apr 2017140 patients
Phase 3Completed
NCT01724021Rocherituximab

A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a

Start: Dec 2012Est. completion: Jan 2015743 patients
Phase 3Completed
NCT01649856Rocherituximab

A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma

Start: Aug 2012Est. completion: Sep 2016572 patients
Phase 3Completed
NCT01461928Rocherituximab

A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab

Start: Dec 2011Est. completion: Jun 2018692 patients
Phase 3Completed
NCT01181154Rocherituximab

Rituximab in Auto-Immune Hemolytic Anemia

Start: Mar 2011Est. completion: Jan 201632 patients
Phase 3Completed
NCT01332994Rocherituximab

A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis

Start: Mar 2011Est. completion: Feb 2014519 patients
Phase 3Completed
NCT01200758Rocherituximab

A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma

Start: Feb 2011Est. completion: Oct 2017410 patients
Phase 3Completed
NCT00502840Rocherituximab

A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

Start: Jul 2007Est. completion: Sep 2011193 patients
Phase 3Completed
NCT02079532Rocherituximab

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor

Start: Nov 2006Est. completion: Nov 2010302 patients
Phase 3Completed
NCT00422383Rocherituximab

A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

Start: Feb 2006Est. completion: Mar 2013378 patients
Phase 3Completed
NCT02569996Rocherituximab

A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma

Start: Jul 2005Est. completion: Aug 2013124 patients
Phase 3Completed
NCT00503425Rocherituximab

A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy.

Start: Jun 2005Est. completion: May 2013215 patients
Phase 3Completed
NCT00435955Rocherituximab

Comparison of High-Dose Chemotherapy + Rituximab and CHOP + Rituximab in High-Risk Follicular Lymphoma

Start: Mar 2000240 patients
Phase 3Unknown
NCT00432653Rocherituximab

Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis

Start: Mar 2007Est. completion: Nov 200920 patients
Phase 2/3Unknown
NCT06186648Rocherituximab

Evaluation of Treatment by Glofitamab in Combination With Rituximab or Obinutuzumab Plus CHOP in Patients With RIchter Syndrome

Start: Mar 2024Est. completion: Mar 202740 patients
Phase 2Recruiting
NCT05798156Rocherituximab

Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP

Start: Mar 2023Est. completion: Sep 2028125 patients
Phase 2Active Not Recruiting
NCT04980222Rocherituximab

A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma

Start: Mar 2022Est. completion: Sep 202646 patients
Phase 2Active Not Recruiting
NCT04253236ImmunovantRVT-1401 680 mg/weekly

To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).

Start: Aug 2020Est. completion: Apr 2021
Phase 2Terminated
NCT03226678Apellis PharmaceuticalsAPL-2

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)

Start: Aug 2017Est. completion: Sep 202224 patients
Phase 2Completed
NCT01238692Rocherituximab

A Phase II Study of Oral Panobinostat (LBH589) and Rituximab to Treat Diffuse Large B Cell Lymphoma (DLBCL)

Start: Nov 2010Est. completion: Dec 201642 patients
Phase 2Completed
NCT01144403Rocherituximab

A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.

Start: Jun 2010Est. completion: Aug 20148 patients
Phase 2Terminated
NCT00656812Rocherituximab

Rituximab Plus 2CdA in Patients With Advanced or Relapsed Mucosa Associated Lymphoid Tissue (MALT) Lymphoma

Start: May 2008Est. completion: Sep 201140 patients
Phase 2Completed
NCT00475423Rocherituximab

A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.

Start: May 2007Est. completion: Aug 2011122 patients
Phase 2Completed
NCT00472225Rocherituximab

Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease

Start: May 2007Est. completion: May 200942 patients
Phase 2Unknown
NCT00324467Rocherituximab

Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment

Start: Aug 2006Est. completion: Dec 2021150 patients
Phase 2Unknown
NCT00664599Rocherituximab

Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease

Start: Apr 2006Est. completion: Jan 200820 patients
Phase 2Completed
NCT00169156Rocherituximab

A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma

Start: Dec 2005Est. completion: Nov 201227 patients
Phase 2Completed
NCT01153971Rocherituximab

A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas

Start: Jul 2005Est. completion: Sep 201047 patients
Phase 2Completed
NCT00127569Rocherituximab

Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy

Start: May 2003Est. completion: Jan 200625 patients
Phase 2Terminated
NCT00204659Rocherituximab

Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Start: Mar 2003Est. completion: Sep 200830 patients
Phase 2Completed
NCT00965289Rocherituximab

High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma

Start: Apr 2002Est. completion: Jun 200942 patients
Phase 2Completed
NCT00126243Rocherituximab

Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin's Lymphoma

Start: Jan 1999Est. completion: Oct 200360 patients
Phase 2Terminated
NCT01388959Rocherituximab

A Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma

Start: Nov 1998Est. completion: Apr 200440 patients
Phase 2Completed
NCT01998893Rocherituximab

A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma

Start: Jan 1997Est. completion: Feb 200838 patients
Phase 2Completed
NCT05533775Rocherituximab

A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma

Start: Nov 2022Est. completion: Nov 203265 patients
Phase 1/2Recruiting
NCT03135262Rocherituximab

A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Start: Jun 2017Est. completion: Apr 202029 patients
Phase 1/2Terminated
NCT02611323Rocherituximab

A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)

Start: Mar 2016Est. completion: Aug 2022133 patients
Phase 1/2Completed
NCT02624986Rocherituximab

A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants

Start: Dec 2015Est. completion: May 201925 patients
Phase 1/2Terminated
NCT02055820Rocherituximab

A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL

Start: Nov 2013Est. completion: Jun 2019267 patients
Phase 1/2Completed
NCT00363350Rocherituximab

Rituximab Treatment in Sjogren's Syndrome

Start: Aug 2006Est. completion: Oct 200830 patients
Phase 1/2Completed
NCT04790903Rocherituximab

A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)

Start: Jul 2021Est. completion: May 202450 patients
Phase 1Terminated

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 8,440 patients
4 companies competing in this space

Related Indications

Rheumatoid Arthritis(475)Psoriasis(206)Ulcerative Colitis(151)Atopic Dermatitis(144)Crohn's Disease(140)Systemic Lupus Erythematosus(85)Arthritis, Rheumatoid(61)Plaque Psoriasis(53)Crohn Disease(49)Ankylosing Spondylitis(33)