12 completed, 5 terminated, 3 recruiting. 19 Phase 2, 3 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 19 | Completed 12, Terminated 4, Recruiting 3 |
| Phase 1 | 3 | Completed 2, Terminated 1 |
| Phase 3 | 2 | Recruiting 1, Terminated 1 |
Follow clazakizumab: new trials by email Literature Review of clazakizumab trials Research Report on clazakizumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event Clazakizumab, Placebo - Atherosclerosis, Cardiovascular Disease | Phase 2 | Recruiting | Eli Lilly and Company | 120 | 2026-08-27 | 2026-11-03 |
| Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD) CSL300, Placebo - End Stage Kidney Disease | Phase 2 / Phase 3 | Recruiting | CSL Behring | 3110 | 2024-04-27 | 2026-09-21 |
| Improving Physical Function in Older Adults Using an Anti-inflammation Drug: The RIGHT Study Clazakizumab, Placebo - Inflammation, Frailty | Phase 2 | Completed | Anne B. Newman | 29 | 2023-08-01 | 2026-06-11 |
| Clazakizumab vs. Placebo - COVID-19 Infection Clazakizumab, Placebo - COVID-19 Infection | Phase 2 | Recruiting | The Methodist Hospital Research Institute | 60 | 2020-07-13 | 2020-07-31 |
| Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection Clazakizumab, Placebo - COVID-19 | Phase 2 | Terminated | Columbia University | 1 | 2020-05-18 | 2022-04-08 |
| Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19) Clazakizumab - COVID-19 | Phase 2 | Completed | Cedars-Sinai Medical Center | 17 | 2020-04-28 | 2024-02-08 |
| A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection Clazakizumab 25 mg, Clazakizumab 12.5 mg, Placebo - COVID-19 | Phase 2 | Completed | NYU Langone Health | 178 | 2020-03-31 | 2022-06-14 |
| PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study MCT, Clazakizumab, Broncho-Vaxom - Asthma | Phase 2 | Completed | University of North Carolina, Chapel Hill | 950 | 2019-12-19 | 2026-04-01 |
| Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients Clazakizumab, Physiologic saline solution - Antibody-mediated Rejection | Phase 3 | Terminated | CSL Behring | 194 | 2019-10-14 | 2025-07-23 |
| Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant Clazakizumab - Kidney Failure, Chronic, End-Stage Renal Disease | Phase 1 / Phase 2 | Completed | Stanley Jordan, MD | 20 | 2018-02-27 | 2026-10-30 |
| Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant Clazakizumab - Antibody-mediated Rejection, Kidney Transplant; Complications | Phase 1 / Phase 2 | Completed | Stanley Jordan, MD | 10 | 2018-02-21 | 2025-05-06 |
| A Pilot Trial of Clazakizumab in Late ABMR Clazakizumab / Clazakizumab, Placebo / Clazakizumab - Antibody-mediated Rejection | Phase 2 | Completed | Medical University of Vienna | 20 | 2018-01-16 | 2020-09-09 |
| Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease Placebo matching with BMS-945429, BMS-945429 - Crohn's Disease | Phase 2 | Terminated | CSL Behring | 72 | 2012-06-01 | 2021-12-03 |
| Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis Clazakizumab, Placebo (Matching with Clazakizumab) - Rheumatoid Arthritis | Phase 2 | Completed | CSL Behring | 143 | 2012-06-01 | 2021-05-12 |
| Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD) ALD518 - Acute GvHD | Phase 1 / Phase 2 | Terminated | CSL Behring | 3 | 2012-03-01 | 2021-02-17 |
| Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy Placebo matching BMS-945429, BMS-945429 - Arthritis, Psoriatic | Phase 2 | Completed | CSL Behring | 165 | 2011-12-01 | 2021-11-05 |
| Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects ALD518, 0.9% saline - Oral Mucositis | Phase 2 | Terminated | CSL Behring | 76 | 2011-07-01 | 2021-05-11 |
| Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate BMS-945429 Placebo, BMS-945429, Methotrexate - Rheumatoid Arthritis | Phase 2 | Completed | CSL Behring | 418 | 2011-06-01 | 2021-12-06 |
| Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis ALD518, Infusion without ALD518' - Arthritis, Rheumatoid | Phase 2 | Completed | CSL Behring | 127 | 2008-10-01 | 2020-07-09 |
| Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia ALD518, Infusion of 0.9% Saline without ALD518 - NSCLC, Fatigue | Phase 2 | Completed | CSL Behring | 124 | 2008-09-01 | 2020-07-09 |
COVID-19 (4) · Arthritis, Rheumatoid (3) · Atherosclerosis (2) · Coronavirus Infections (2) · Kidney Failure, Chronic (2) · Arthritis, Psoriatic (1) · Asthma (1) · Cachexia (1) · Cardiovascular Diseases (1) · Coronary Artery Disease (1) · Crohn Disease (1) · Diabetes Mellitus (1) · Diabetes Mellitus, Type 2 (1) · Fatigue (1) · Frailty (1)
CSL Behring (10) · Stanley Jordan, MD (2) · Anne B. Newman (1) · Cedars-Sinai Medical Center (1) · Columbia University (1) · Eli Lilly and Company (1) · Medical University of Vienna (1) · NYU Langone Health (1) · The Methodist Hospital Research Institute (1) · University of North Carolina, Chapel Hill (1)
United States (17) · Canada (9) · Germany (7) · Hungary (6) · Italy (6) · Poland (6) · Argentina (5) · Australia (5) · Austria (5) · Czechia (5) · France (5) · Mexico (5) · Japan (4) · Netherlands (4) · Russia (4)
Stanley Jordan, MD (2) · Anastasia Ivanova, PhD (1) · Anne B. Newman, MD, MPH (1) · Bernd Jilma, MD (1) · Bonnie Lonze, MD (1) · David J. Cohen, MD (1) · Howard Huang, MD (1) · Javier San Martin, MD FRCP (1) · Jeffrey Smith, MD FRCP (1) · Jeffrey Smith, MD, FRCP (1) · Jeffrey TL Smith, MD FRCP (1)
PMID 23136551, PMID 26138593, PMID 27059799, PMID 29622697, PMID 30254251, PMID 30635033, PMID 31958792, PMID 32167524, PMID 32181911, PMID 32192578, PMID 32253449, PMID 34153143, PMID 34473343, PMID 35497778, PMID 35583232, PMID 35969004, PMID 36382130, PMID 36550562, PMID 37322595, PMID 38796655, PMID 39102302, PMID 40444214, PMID 41518612
2017 (1), 2018 (1), U24HL138998 (1)