EFFICACY/FUTILITY clinical trial stops

Phase I Non-CNS Tumor trial by Genmab. Stop reason: EFFICACY/FUTILITY.

After reviewing all available data from Part 1 of the trial, the Sponsor has decided not to proceed to Part 2 (randomized Phase 2) of the trial due to lack of efficacy

Phase II Angioimmunoblastic T-cell Lymphoma trial by Alliance for Clinical Trials in Oncology. Stop reason: EFFICACY/FUTILITY.

Interim Analysis

Phase III COVID trial by University of Minnesota. Stop reason: EFFICACY/FUTILITY.

Stopped for futility - no safety issues.

Phase I Recurrent Acute Myeloid Leukemia trial by City of Hope Medical Center. Stop reason: EFFICACY/FUTILITY.

Pending Interim Analysis

Phase I Advanced Colorectal Carcinoma trial by University of California, Davis. Stop reason: EFFICACY/FUTILITY.

For internal interim analysis

Phase II Crohn's Disease trial by Pfizer. Stop reason: EFFICACY/FUTILITY.

The study was prematurely discontinued due to a lack of efficacy in sub-study 1

Unknown Diabetes Type 2 trial by Richmond Pharmacology Limited. Stop reason: EFFICACY/FUTILITY.

The study is being terminated early on the grounds of futility, as continuation of the study is no longer considered scientifically or operationally justified.

Phase II Hidradenitis Suppurativa trial by Insmed Incorporated. Stop reason: EFFICACY/FUTILITY.

Lack of Efficacy

Phase I Prostatic Neoplasms trial by Eli Lilly and Company. Stop reason: EFFICACY/FUTILITY.

The study was terminated early as related study I3Y-MC-JPCM (NCT03706365) did not meet its primary endpoint.

Phase III Acute Major Bleeding trial by Octapharma. Stop reason: EFFICACY/FUTILITY.

Following Interim Analysis IDMEAC concluded:1-No safety concerns 2-Suspend enrolment: Futility based on treatment effect size at interim analysis. Enrollment was suspended on 22DEC25. Study was terminated FEB2026. Final analysis is planned in Q2 2026

Phase III Pre-Eclampsia trial by The University of Texas Medical Branch, Galveston. Stop reason: EFFICACY/FUTILITY.

Futility of the study

Phase III Recurrent Uterine Corpus Sarcoma trial by National Cancer Institute (NCI). Stop reason: EFFICACY/FUTILITY.

The study was targeted to accrue 130 patients, but closed early for futility.

Phase I Pancreatic Cancer Metastatic trial by HonorHealth Research Institute. Stop reason: EFFICACY/FUTILITY.

The study was terminated early per the recommendation of the Data and Safety Monitoring Board (DSMB) after a planned interim analysis met pre-specified criteria for futility.

Phase III MPOX trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: EFFICACY/FUTILITY.

DSMB recommendation due to statistical futility

Phase III Asthma trial by University of Arizona. Stop reason: EFFICACY/FUTILITY.

The AZ-SWED trial was stopped by the National Heart, Lung, and Blood Institute (NHLBI) due to futility

Phase IV Surgical Site Infection trial by The University of Texas Medical Branch, Galveston. Stop reason: EFFICACY/FUTILITY.

Futility

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 III Brain Injuries trial by University Hospital, Brest. Stop reason: EFFICACY/FUTILITY.

interim analysis - Results ongoing

Phase II Dementia With Lewy Bodies trial by Georgetown University. Stop reason: EFFICACY/FUTILITY.

Interim analysis was performed for 442 patients who completed Part I of the PROSEEK study-(CLR\_18\_06); it did not show evidence of treatment benefit in patients receiving Vodobatinib.

Phase III Depressive Disorder, Major trial by Janssen Research & Development, LLC. Stop reason: EFFICACY/FUTILITY.

Early study termination due to insufficient efficacy.

Phase I Distal Bile Duct Adenocarcinoma trial by City of Hope Medical Center. Stop reason: EFFICACY/FUTILITY.

Pending Interim analysis

Phase I Recurrent Acute Lymphoblastic Leukemia trial by City of Hope Medical Center. Stop reason: EFFICACY/FUTILITY.

Pending Interim Analysis

Phase II Dermatitis, Atopic trial by Janssen Research & Development, LLC. Stop reason: EFFICACY/FUTILITY.

Terminated: futility criteria met at interim efficacy analysis.

Phase II Melanoma trial by Yale University. Stop reason: EFFICACY/FUTILITY.

Lack of activity in the drugs

Phase I Pancreatic Cancer trial by James Cleary, MD, PhD. Stop reason: EFFICACY/FUTILITY.

Efficacy concerns.

Phase II Kaposi Sarcoma trial by Institut National de la Santé Et de la Recherche Médicale, France. Stop reason: EFFICACY/FUTILITY.

results from interim analysis conducted to study interruption

Phase II Anatomic Stage IV Breast Cancer AJCC v8 trial by Alliance for Clinical Trials in Oncology. Stop reason: EFFICACY/FUTILITY.

Interim analysis

Phase III Chronic Intracranial Subdural Hematoma trial by University Hospital, Montpellier. Stop reason: EFFICACY/FUTILITY.

successfull Interim Analysis

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

Study terminated due to lack of efficacy.

Phase III ALS trial by Tanabe Pharma America, Inc.. Stop reason: EFFICACY/FUTILITY.

Futility was met.

Phase III ALS trial by Tanabe Pharma America, Inc.. Stop reason: EFFICACY/FUTILITY.

Futility Analysis of parent study MT-1186-A02 was met.

Phase II Severe Preeclampsia trial by AMAG Pharmaceuticals, Inc.. Stop reason: EFFICACY/FUTILITY.

Following a recommendation from the Data and Safety Monitoring Board (DSMB), the study was stopped early for futility. There were no safety concerns raised.

Phase II COVID-19 trial by Inmune Bio, Inc.. Stop reason: EFFICACY/FUTILITY.

Futility

Phase III Central Retinal Artery Occlusion trial by University Hospital Tuebingen. Stop reason: EFFICACY/FUTILITY.

Stopped after prespecified interim analysis due to futility

Phase III Amyotrophic Lateral Sclerosis trial by Stichting TRICALS Foundation. Stop reason: EFFICACY/FUTILITY.

The planned interim analysis showed no survival benefit of taking the drug when compared with placebo.

Phase II HER2-positive Breast Cancer trial by Washington University School of Medicine. Stop reason: EFFICACY/FUTILITY.

Futility

Phase III Non-small Cell Lung Cancer trial by BeiGene. Stop reason: EFFICACY/FUTILITY.

This decision was conducted by the sponsor based on lack of efficacy and not driven by safety concerns.

Phase II Secondary Acute Myeloid Leukemia trial by University of Michigan Rogel Cancer Center. Stop reason: EFFICACY/FUTILITY.

Interim Analysis per Protocol

Phase II Sjogren's Syndrome trial by Amgen. Stop reason: EFFICACY/FUTILITY.

The study was terminated by sponsor due to meeting pre-defined criteria for futility.

Phase III COVID-19 trial by South African National Blood Service. Stop reason: EFFICACY/FUTILITY.

No benefit seen in 2 published inpatient RCTs (but had limitations). Press release from inpatient Recovery trial with large number of endpoints showed no benefit. CCP collected from survivors of original strain infection had no neutralisation

Phase III Multiple Sclerosis trial by Amsterdam UMC, location VUmc. Stop reason: EFFICACY/FUTILITY.

In line with the study protocol, due to slow recruitment, a futility analysis has been performed in the first quarter of 2025 by an independent statistician. The result of the analysis was restricted to a "no-go".

Phase III Radial Artery Occlusion trial by Ottawa Heart Institute Research Corporation. Stop reason: EFFICACY/FUTILITY.

Assessment for futility

Phase II Recurrent Waldenstrom Macroglobulinemia trial by Mayo Clinic. Stop reason: EFFICACY/FUTILITY.

Discontinued after interim analysis for futility; no treatment successes observed in the first 12 patients

Phase II Triple Negative Breast Cancer trial by MedSIR. Stop reason: EFFICACY/FUTILITY.

The interim analysis of the STAR-221 study showed that the domvanalimab combination did not improve overall survival compared to standard of care. No new relevant safety concerns were identified.

Phase III Refractory IPA trial by Pulmocide Ltd. Stop reason: EFFICACY/FUTILITY.

The study was terminated by the Sponsor based on a sample size recalculation interim analysis which showed a numerically lower favorable response rate and a numerically higher mortality rate in the opelconazole arm compared to the control arm.

Phase IV Total Shoulder Arthroplasty trial by Johnny K. Lee. Stop reason: EFFICACY/FUTILITY.

Due to resource limitations and the lack of difference observed between study groups after the interim analysis, the study was halted prematurely.

Phase II Fibrodysplasia Ossificans Progressiva trial by Clementia Pharmaceuticals Inc.. Stop reason: EFFICACY/FUTILITY.

Following the planned FALKON Part A primary analysis, the study did not meet its primary endpoint of reducing heterotopic ossification (HO) volume compared with placebo and met predefined futility criteria.

Phase II Pancreatic Cancer trial by Cancer Trials Ireland. Stop reason: EFFICACY/FUTILITY.

Study terminated due to futility

Phase IV Laparoscopic Surgery trial by Peking University First Hospital. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to substantial protocol amendments involving changes in the target population and primary endpoint, rendering previously collected data incompatible with the revised study objective.

Phase II Pancreatic Diseases trial by Mayo Clinic. Stop reason: EFFICACY/FUTILITY.

study paused for interim analysis

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 I Thyroid Cancer trial by SOTIO Biotech AG. Stop reason: EFFICACY/FUTILITY.

Due to lack of efficacy shown at the time of the interim analysis.

Phase IV Hemorrhage trial by Assistance Publique - Hôpitaux de Paris. Stop reason: EFFICACY/FUTILITY.

reason of halt prematurely: futility of the trial

Phase II Diffuse Cutaneous Systemic Sclerosis trial by Amgen. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to meeting pre-defined criteria for futility.

Phase III Carcinoma, Renal Cell trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

As the study did not meet it's primary endpoint a decision was made to terminate the study.

Phase II Relapsed Plasmablastic Lymphoma trial by Jacob Soumerai, MD. Stop reason: EFFICACY/FUTILITY.

The study was closed given lack of efficacy and plans to publish this negative study.

Phase II Idiopathic Pulmonary Fibrosis 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 I Metastatic Prostate Cancer trial by Epizyme, Inc.. Stop reason: EFFICACY/FUTILITY.

The study was terminated early as Sponsor decided to discontinue the development of tazemetostat in metastatic castration resistant prostate cancer and the primary endpoint was not met for this study. There were no safety concerns.

Phase II Metastatic Colorectal Cancer trial by National Cancer Institute (NCI). Stop reason: EFFICACY/FUTILITY.

Interim analysis indicated limited efficacy

Phase I Cervical Cancer trial by Sun Yat-sen University. Stop reason: EFFICACY/FUTILITY.

Five patients were enrolled in the study, but no treatment response was observed and all the patients had the best of response of prgressive disease. Given the lack of efficacy, the trial was terminated.

Phase II Copd trial by McGill University Health Centre/Research Institute of the McGill University Health Centre. Stop reason: EFFICACY/FUTILITY.

Clinical trial discontinued for reason pertaining to lack of efficacy.

Phase II Uveal Melanoma trial by Dana-Farber Cancer Institute. Stop reason: EFFICACY/FUTILITY.

This was a Simon two stage design trial that terminated after the first stage due to lack of response.

Phase II Alzheimer's Disease trial by Alector Inc.. Stop reason: EFFICACY/FUTILITY.

Parent study failed to meet the primary endpoint and there were no treatment effects that favored AL002 on secondary clinical and functional endpoints.

Phase II Ulcerative Colitis trial by Genentech, Inc.. Stop reason: EFFICACY/FUTILITY.

Based on a futility analysis, which suggested that the Moonglow study was unlikely to meet its primary endpoint.

Phase III Infectious Pneumonia trial by Dompé Farmaceutici S.p.A. Stop reason: EFFICACY/FUTILITY.

The study was stopped due to futility as per protocol

Phase II Colorectal Cancer trial by Inspirna, Inc.. Stop reason: EFFICACY/FUTILITY.

At the time of the primary analysis, results did not meet the primary endpoint

Phase I Hepatitis B, Chronic trial by GlaxoSmithKline. Stop reason: EFFICACY/FUTILITY.

Following the primary phase (24 weeks post last vaccination) the predefined efficacy endpoint was not met. Noting the lack of efficacy and with the objective to prioritize participants' safety GSK has decided on the early termination of the study.

Phase III Nasal Polyposis trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

The study has a double-blind period and an open-label period. The study did not meet its primary endpoints after the primary LSLV and the decision was taken to terminate the study early.

Phase III Depressive Disorder, Major trial by Janssen Research & Development, LLC. Stop reason: EFFICACY/FUTILITY.

Early study termination due to insufficient efficacy.

Phase IV Urinary Retention trial by Antonio Nocito, MD. Stop reason: EFFICACY/FUTILITY.

The study was terminated prematurely following a pre-planned interim analysis demonstrating futility

Phase II Advanced Renal Cell Carcinoma trial by Michael B. Atkins, MD. Stop reason: EFFICACY/FUTILITY.

Interim Analysis

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 Nonalcoholic Steatohepatitis (NASH) trial by Galmed Research and Development, Ltd.. Stop reason: EFFICACY/FUTILITY.

Interim analysis results from the open-label part of the study. The double blind portion of the study will be resumed once the study will continue.

Phase III COVID-19 trial by Queen's Medical Center. Stop reason: EFFICACY/FUTILITY.

RECOVERY Trial results - no efficacy

Phase II IgG4 Related Disease trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: EFFICACY/FUTILITY.

The study was terminated early based on disease flare/lack of efficacy in the early phase of the trial.

Early Phase I Large Granular Lymphocyte Leukemia trial by H. Lee Moffitt Cancer Center and Research Institute. Stop reason: EFFICACY/FUTILITY.

lack of efficacy/futility

Phase I Pancreatic Ductal Adenocarcinoma trial by Boehringer Ingelheim. Stop reason: EFFICACY/FUTILITY.

Primary endpoint not met

Phase II HNSCC trial by Flamingo Therapeutics NV. Stop reason: EFFICACY/FUTILITY.

Interim analysis was negative

Phase I Neoplasms trial by Teva Branded Pharmaceutical Products R&D LLC. Stop reason: EFFICACY/FUTILITY.

Study was terminated early due to futility.

Phase II Dry Age-related Macular Degeneration trial by Gyroscope Therapeutics Limited. Stop reason: EFFICACY/FUTILITY.

Terminated for interim analysis demonstrating futility (trial highly unlikely to meet efficacy outcome). The trial is not ending early because of medical problems or concerns.

Phase I Dry Age-related Macular Degeneration trial by Gyroscope Therapeutics Limited. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to the interim analysis demonstrating lack of treatment efficacy.

Phase II Dry Age-related Macular Degeneration trial by Gyroscope Therapeutics Limited. Stop reason: EFFICACY/FUTILITY.

Terminated for interim analysis demonstrating futility (trial highly unlikely to meet efficacy outcome). The trial is not ending early because of medical problems or concerns.

Phase I Ulcerative Colitis (UC) trial by Vial Australia Pty Ltd. Stop reason: EFFICACY/FUTILITY.

Study terminated based on interim analysis results indicating the primary pharmacokinetic endpoint was unlikely to be met.

Phase I Pancreatic Cancer trial by Takeda. Stop reason: EFFICACY/FUTILITY.

Clinical Futility of TAK 500 met. No further development with this compound

Phase III Leukemia, Myeloid, Acute trial by Delta-Fly Pharma, Inc.. Stop reason: EFFICACY/FUTILITY.

The data met the protocol-specified criteria for futility of the investigational treatment.

Phase II Recurrent Grade 1 Follicular Lymphoma trial by City of Hope Medical Center. Stop reason: EFFICACY/FUTILITY.

Pending Interim Analysis

Phase III Frontotemporal Dementia trial by Alector Inc.. Stop reason: EFFICACY/FUTILITY.

The trial did not meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR® plus NACC FTLD-SB)

Phase III Neurodegenerative Diseases trial by Alector Inc.. Stop reason: EFFICACY/FUTILITY.

The AL001-CS-302 study was terminated because its Phase 3 placebo-controlled parent study (AL001-3) failed to meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer's

Phase II HIV1 Infection trial by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba. Stop reason: EFFICACY/FUTILITY.

No response regarding coverage of treatments by social security and the DGOS

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

In December 2023, Novartis decided to terminate the sabatolimab clinical development program early after Phase II (MDS1) and Phase III (MDS2) studies failed to meet their primary objectives. The termination was not due to safety concerns.

Phase III Myelodysplastic Syndromes trial by Novartis Pharmaceuticals. Stop reason: EFFICACY/FUTILITY.

In December 2023, Novartis decided to terminate the sabatolimab clinical development program early after Phase II (MDS1) and Phase III (MDS2) studies failed to meet their primary objectives. The termination was not due to safety concerns.

Phase II Ulcerative Colitis trial by Amgen. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to meeting a prespecified futility rule and not related to any safety concerns.

Phase II Glioblastoma trial by Incyte Corporation. Stop reason: EFFICACY/FUTILITY.

Recruitment ceased after a pre-planned futility interim analysis indicated a low probability to confer a clinically meaningful improvement in objective response when compared to currently available therapies. There were no safety related concerns.

Phase II Glioblastoma trial by Weill Medical College of Cornell University. Stop reason: EFFICACY/FUTILITY.

Pending results of interim analysis

Phase II Recent Onset type1 Diabetes trial by Dompé Farmaceutici S.p.A. Stop reason: EFFICACY/FUTILITY.

The study was stopped due to futility as per protocol

Phase III Light Chain (AL) Amyloidosis trial by Prothena Biosciences Ltd.. Stop reason: EFFICACY/FUTILITY.

The AFFIRM-AL clinical trial did not meet its primary endpoint.

Phase II Oropharynx Squamous Cell Carcinoma trial by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Stop reason: EFFICACY/FUTILITY.

unmet primary endpoint

Phase II Irritable Bowel Syndrome With Diarrhea trial by CinPhloro Pharma, LLC. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to lack of efficacy compared to placebo.

Phase III Cytomegalovirus Infection trial by ModernaTX, Inc.. Stop reason: EFFICACY/FUTILITY.

The Sponsor decided to terminate the study after it did not meet the primary efficacy endpoint at final analysis. The safety profile was consistent with prior studies, and no safety concerns were raised by the Data and Safety Monitoring Board.

Phase III Acute Respiratory Failure trial by Fred Hutchinson Cancer Center. Stop reason: EFFICACY/FUTILITY.

due to increased mortality and futility analyses