Immunology & Autoimmune clinical trial failures

Phase II Frailty trial by University of Rochester. Stop reason: OTHER/UNKNOWN.

The study has been suspended by the IRB pending review of a study-related issue

Phase II Crohn's Disease trial by AstraZeneca. Stop reason: OPERATIONAL.

Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.

Phase II Rheumatoid Arthritis trial by Eli Lilly and Company. Stop reason: EFFICACY/FUTILITY.

The interim analysis data failed to demonstrate the intended treatment effect.

Phase I Relapsed/Refractory Autoimmune Diseases trial by Nanjing Legend Biotech Co.. Stop reason: OTHER/UNKNOWN.

pipeline adjustment

Phase II Rheumatoid Arthritis (RA) trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OPERATIONAL.

The study was closed due to continued enrollment hurdles.

Early Phase I Rheumatoid Arthritis trial by Institute of Hematology & Blood Diseases Hospital, China. Stop reason: OPERATIONAL.

Due to the sponsor's adjustment of the research and development strategy for this clinical trial, this study was prematurely terminated, and no subjects were recruited for this study

Phase IV Spondylitis, Ankylosing trial by Johnson & Johnson Taiwan Ltd. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Early Phase I Systemic Sclerosis (SSc) trial by RenJi Hospital. Stop reason: OTHER/UNKNOWN.

company's decision

Phase IV Osteo Arthritis Knee trial by University of Calgary. Stop reason: OPERATIONAL.

The study has been stopped due to logistical reasons at the clinical site.

Early Phase I Systemic Lupus Erythematosus trial by The Affiliated Hospital of Xuzhou Medical University. Stop reason: OTHER/UNKNOWN.

Internal decision.

Phase II Rheumatoid Arthritis trial by BeiGene. Stop reason: SAFETY.

Sponsor has concluded that patients are unlikely to derive sufficient benefit from treatment with BGB-45035 to support continuation of the clinical development program due to unfavored benefit/risk profile.

Phase IV Post Operative Pain trial by Baptist Health South Florida. Stop reason: OPERATIONAL.

Study discontinued due to feasibility challenges related to participant recruitment

Phase I Rheumatoid Arthritis trial by Gilead Sciences. Stop reason: EFFICACY/FUTILITY.

Study terminated due to lack of efficacy.

Phase I Autoimmune Hemolytic Anemia trial by University Hospital, Bordeaux. Stop reason: OTHER/UNKNOWN.

target number of inclusion not reached

Phase IV PANDAS trial by Massachusetts General Hospital. Stop reason: OPERATIONAL.

Low recruitment

Phase II Discoid Lupus Erythematosus trial by Amgen. Stop reason: OPERATIONAL.

Sponsor business decision, not related to safety concerns.

Phase IV Rheumatoid Arthritis trial by Platelet and Thrombosis Research, LLC. Stop reason: OPERATIONAL.

Our group moved from Inova Heart and Vascular institute to Sinai Hospital with Platelet and Thrombosis, LLC taking over sponsorship. Study was then IRB approved at Sinai on March, 2020 but closed prior to any additional enrolment due to COVID.

Phase II Acute Respiratory Distress Syndrome trial by ImmunityBio, Inc.. Stop reason: OTHER/UNKNOWN.

New protocol developed

Phase II Granulomatosis With Polyangiitis trial by Mayo Clinic. Stop reason: OPERATIONAL.

Funding was withdrawn by sponsor.

Phase I Rheumatoid Arthritis trial by Robert Flavell, MD, PhD. Stop reason: OPERATIONAL.

Lapse in study funding.

Phase IV ANCA Associated Vasculitis trial by Guy's and St Thomas' NHS Foundation Trust. Stop reason: OPERATIONAL.

Recruitment was terminated early by the funder due to study sites' inability to recruit sufficient number of participants.

Phase I Arthritis, Psoriatic trial by Enlivex Therapeutics Ltd.. Stop reason: OPERATIONAL.

reprioritization

Unknown Osteoarthritis Thumb trial by Kettering Health Network. Stop reason: OPERATIONAL.

Due to lack of enrollment, challenging follow-up, and lack of funding.

Phase II Osteoarthritis trial by OrthoCarolina Research Institute, Inc.. Stop reason: OPERATIONAL.

Principal Investigator left the lead site. New Principal Investigator was not selected. Project was discontinued.

Phase II Systemic Lupus Erythematosus trial by Provention Bio, a Sanofi Company. Stop reason: OPERATIONAL.

Termination for Strategic Reasons

Phase II Human Immunodeficiency Virus trial by ANRS, Emerging Infectious Diseases. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II Osteoarthritis trial by Novartis Pharmaceuticals. Stop reason: EFFICACY/FUTILITY.

Study early terminated due to lack of effect (did not meet primary/ secondary endpoints). This decision was not linked to safety concerns

Phase III Crohn's Disease trial by AstraZeneca. Stop reason: OPERATIONAL.

Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.

Phase III Osteoarthritis of the Knee trial by Biosplice Therapeutics, Inc.. Stop reason: OPERATIONAL.

Study was terminated by Sponsor based on a business decision not due to safety. The study report was finalized without any statistical analysis.

Phase II Osteoarthritis, Knee trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Unknown Spondyloarthritis trial by Assistance Publique - Hôpitaux de Paris. Stop reason: OPERATIONAL.

The study of the long term antibody response is no longer relative due to the introduction of Covid vaccine.

Phase II Combined Immunodeficiencies trial by Assistance Publique - Hôpitaux de Paris. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II Rheumatoid Arthritis trial by Incannex Healthcare Ltd. Stop reason: OPERATIONAL.

Recruitment challenges

Phase III Osteoarthritis, Knee trial by Biosplice Therapeutics, Inc.. Stop reason: OPERATIONAL.

Study OA-07 was designed to be conducted until the Sponsor closed it. Study OA-07 was administratively closed at Visit 6E (Week 100), with no safety concerns, one year into the open-label study as described in the protocol.

Phase IV Kidney Transplant Immunosuppression trial by CAMC Health System. Stop reason: OTHER/UNKNOWN.

The PI is relocating to another State/ another hospital

Phase I T Cell Non-Hodgkin Lymphoma trial by Autolus Limited. Stop reason: OTHER/UNKNOWN.

Only Phase I of the study was conducted.

Phase II Lupus Erythematosus, Systemic trial by Pfizer. Stop reason: OPERATIONAL.

Pfizer has made an internal business decision to not continue this study. This decision was not due to safety concerns or clinical effect reasons or requests from any regulatory authorities.

Phase II Knee Osteoarthritis trial by Biosplice Therapeutics, Inc.. Stop reason: OPERATIONAL.

The study was terminated early due to COVID-19 pandemic-related issues (e.g., temporary site closures impacting data collection). No formal Statistical Analysis Plan was prepared, and the study report was finalized without any statistical analysis.

Phase II Lupus Nephritis trial by Janssen Research & Development, LLC. Stop reason: OPERATIONAL.

Business Decision

Phase II Chronic Knee Pain trial by Campbell Clinic. Stop reason: REGULATORY.

unable to obtain IND approval from FDA

Phase I Sclerosis, Multiple trial by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Stop reason: OPERATIONAL.

Early termination due to operational feasibility reasons, resulting from a slow recruitment rate and logistical and financial difficulties that prevent reaching the planned sample size within the study schedule.

Phase II Human Immunodeficiency Virus trial by Rhode Island Hospital. Stop reason: OTHER/UNKNOWN.

The study was initiated but no participants were enrolled.

Phase II Cutaneous Lupus Erythematosus (CLE) trial by Gilead Sciences. Stop reason: OPERATIONAL.

Sponsor Decision

Phase I Autoimmune Hemolytic Anemia trial by Institute of Hematology & Blood Diseases Hospital, China. Stop reason: EFFICACY/FUTILITY.

Did not meet the anticipated outcome.

Phase III Adolescent Lupus Nephritis trial by Aurinia Pharmaceuticals Inc.. Stop reason: SAFETY.

DSMB recommendation

Phase III Adolescent Lupus Nephritis trial by Aurinia Pharmaceuticals Inc.. Stop reason: SAFETY.

DSMB recommendation

Phase IV Arthritis Knee trial by F. Johannes Plate. Stop reason: OTHER/UNKNOWN.

withdrawn

Early Phase I Systemic Lupus Erythematosus trial by Nanjing Bioheng Biotech Co., Ltd.. Stop reason: OTHER/UNKNOWN.

R\&D strategy adjustment

Phase III RSV Immunisation trial by Sanofi Pasteur, a Sanofi Company. Stop reason: OPERATIONAL.

Sponsor decision

Phase III RSV Immunisation trial by Sanofi Pasteur, a Sanofi Company. Stop reason: OPERATIONAL.

Sponsor decision

Early Phase I SLE trial by Nanjing Bioheng Biotech Co., Ltd.. Stop reason: OTHER/UNKNOWN.

R\&D strategy adjustment

Phase III RSV Immunization trial by Sanofi Pasteur, a Sanofi Company. Stop reason: OPERATIONAL.

Sponsor decision

Phase II Rheumatoid Arthritis trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OPERATIONAL.

The study is being closed early due to insufficient participant enrollment across study sites.

Early Phase I Systemic Lupus Erythematosus (SLE) trial by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Stop reason: OTHER/UNKNOWN.

The collaborating party has adjusted its R\&D strategy and terminated the study.

Phase II Lupus Nephritis trial by Alexion Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Sponsor Decision.

Phase I Shoulder Osteoarthritis trial by Shane A. Shapiro. Stop reason: OPERATIONAL.

Lack of enrollment and funding for study.

Phase I Diabetes Mellitus, Type 1 trial by Camillo Ricordi and Jay Skyler. Stop reason: OPERATIONAL.

Study withdrawn prior to enrollment due to funding issues

Phase III Systemic Lupus Erythematosus trial by Vor Biopharma. Stop reason: OPERATIONAL.

Business decision

Phase III Systemic Lupus Erythematosus trial by Vor Biopharma. Stop reason: OPERATIONAL.

Sponsor business decision

Phase II Juvenile Idiopathic Arthritis (JIA) trial by Hope Biosciences Research Foundation. Stop reason: OPERATIONAL.

In the time that the site has been active, there have been 0 patients enrolled despite our best efforts. It is clear that it is not feasible to conduct this study at this time; therefore, we have withdrawn this study.

Phase II Arthritis trial by AHS Cancer Control Alberta. Stop reason: OPERATIONAL.

Challenges in meeting the enrollment target

Phase II Osteoarthritis of Hip trial by Pacira Pharmaceuticals, Inc. Stop reason: OPERATIONAL.

Study was stopped due to business decision and lack of enrollment. There were no safety concerns.

Phase II Lupus Nephritis trial by Kezar Life Sciences, Inc.. Stop reason: OPERATIONAL.

Sponsor Decision.

Phase II Rheumatoid Arthritis trial by Eli Lilly and Company. Stop reason: SAFETY.

Study terminated due to an unfavourable benefit-risk profile observed in interim data analysis.

Phase I Rheumatoid Arthritis trial by Philogen S.p.A.. Stop reason: OTHER/UNKNOWN.

Study redesigned and registered under NCT07245992 (Protocol n° PH-F8IL10INTRA-03/24)

Phase I Severe Combined Immune Deficiency (SCID) trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OPERATIONAL.

Lack of accrual

Phase III Lyme Arthritis trial by Desiree Neville, MD. Stop reason: OTHER/UNKNOWN.

Study with overlapping patient population

Phase IV Systemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to Surgery trial by Washington University School of Medicine. Stop reason: OTHER/UNKNOWN.

PI moved to a different institution.

Phase I Severe Combined Immunodeficiency Disease, X-linked trial by St. Jude Children's Research Hospital. Stop reason: OTHER/UNKNOWN.

voluntary hold

Phase II Pain trial by GlaxoSmithKline. Stop reason: EFFICACY/FUTILITY.

The study met futility criteria at pre-planned interim analysis, showing no clinical efficacy of the investigational drug. Based on the lack of efficacy at the interim data review, the sponsor decided to terminate the study.

Phase III Warm Autoimmune Hemolytic Anemia (wAIHA) trial by Incyte Corporation. Stop reason: OPERATIONAL.

A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.

Phase II Knee Osteoarthritis trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase III Immunocompromised trial by Regeneron Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

Emerging SARS-CoV2 variants impacting susceptibility to study drug

Phase II Lupus Nephritis trial by Alexion Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Sponsor Decision.

Phase I Meningococcal Immunisation trial by Sanofi Pasteur, a Sanofi Company. Stop reason: OPERATIONAL.

Sponsor decision. Termination decision not related to any safety concern.

Phase III Rheumatoid Arthritis trial by Abu Dhabi Stem Cells Center. Stop reason: OTHER/UNKNOWN.

Decision of the local healthcare authority

Phase I Systemic Lupus Erythematosus trial by GlaxoSmithKline. Stop reason: OTHER/UNKNOWN.

The trial was temporarily halted due to findings in new non-clinical studies necessitating further investigation.

Phase I Juvenile Idiopathic Arthritis trial by Duke University. Stop reason: OPERATIONAL.

Funding expired

Unknown Intermetatarsal Bursitis trial by Rigshospitalet, Denmark. Stop reason: OTHER/UNKNOWN.

The study was stopped due to health-related issues in the research group, that hindered inrolement of patients.

Phase I Systemic Lupus Erythematosus trial by Caribou Biosciences, Inc.. Stop reason: OPERATIONAL.

Sponsor Strategic Pipeline Prioritization with Focus on CB-010 and CB-011 Oncology Programs

Phase I Immune System Disorder trial by Sanofi. Stop reason: SAFETY.

Terminated due to non-safety reasons

Phase I Myositis trial by National Institute of Mental Health (NIMH). Stop reason: EFFICACY/FUTILITY.

due to difficulty with participant recruitment and data futility

Phase I Immune Thrombocytopenia trial by Hutchmed. Stop reason: OPERATIONAL.

Sponsor decision

Phase I Autoimmune Haemolytic Anaemia trial by Bioverativ, a Sanofi company. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II Osteoarthritis, Knee trial by Wake Forest University Health Sciences. Stop reason: OPERATIONAL.

Data from the initial participants were analyzed to support an NIH grant submission, leading to NIH funding of a new protocol to expand on the initial results.

Phase II Systemic Lupus Erythematosus trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OPERATIONAL.

The study was closed due to slow enrollment.

Phase III Influenza Immunization trial by Sanofi Pasteur, a Sanofi Company. Stop reason: OPERATIONAL.

Sponsor decision to prematurely stop the study. This decision was made without any safety concerns.

Unknown Interstitial Lung Disease trial by McGill University Health Centre/Research Institute of the McGill University Health Centre. Stop reason: OPERATIONAL.

Slow recruitment

Phase I Autoimmune Diseases trial by GlaxoSmithKline. Stop reason: OPERATIONAL.

Sponsor decision

Phase II Axial Spondyloarthritis trial by The University of Texas Health Science Center, Houston. Stop reason: OPERATIONAL.

lack of recruitment

Phase I Sedation trial by University of Wisconsin, Madison. Stop reason: OTHER/UNKNOWN.

IND application was not approved

Phase II Osteoarthritis, Knee trial by Wake Forest University Health Sciences. Stop reason: OPERATIONAL.

Study was not initiated; no subjects enrolled. A replacement study will be submitted

Phase II Systemic Lupus Erythematosus trial by Merck Sharp & Dohme LLC. Stop reason: OPERATIONAL.

Business Reasons

Phase I Arthritis, Rheumatoid trial by Crystal Lederhos Smith. Stop reason: OPERATIONAL.

This study was put on clinical hold with the FDA prior to beginning enrollment due to insufficient preclinical evidence.

Unknown Monocompartimental Tibiofemoral Osteoarthritis trial by Istituto Ortopedico Rizzoli. Stop reason: OPERATIONAL.

Patient enrollment was proceeding slower than planned

Phase I Osteo Arthritis Knee trial by Sadat City University. Stop reason: OPERATIONAL.

Institutional and funding constrains

Phase I Rheumatoid Arthritis trial by Sadat City University. Stop reason: OPERATIONAL.

Institutional and funding constrains

Phase I Osteoarthritis trial by Sadat City University. Stop reason: OPERATIONAL.

Institutional and funding constrains

Early Phase I Relapsed/Refractory Autoimmune Diseases trial by Nanjing Legend Biotech Co.. Stop reason: OTHER/UNKNOWN.

Discontinue further development of LCAR-AIO program

Phase I Knee Osteoarthritis trial by University of Missouri-Columbia. Stop reason: OTHER/UNKNOWN.

Principal Investigator is Retiring.