Drugs / Abatacept
Abatacept Clinical Trials
DrugAbatacept is a selective T-cell co-stimulation modulator used for autoimmune and immune-mediated conditions including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and prophylaxis of acute graft-versus-host disease.
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Recruiting Phase 3
| Trial | Phase | Status | Sponsor | Started |
|---|---|---|---|---|
| Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis NCT05428488 | Phase 3 | Recruiting | University Hospital, Montpellier | Started 2022-11 |
| Abatacept in Immune Checkpoint Inhibitor Myocarditis NCT05335928 | Phase 3 | Recruiting | Massachusetts General Hospital | Started 2022-07 |
| A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications NCT04877288 | Phase 3 | Recruiting | Bristol-Myers Squibb | Started 2021-07 |
| Abatacept for the Treatment of Giant Cell Arteritis NCT04474847 | Phase 3 | Recruiting | University of Pennsylvania | Started 2021-03 |
| Study of COYA 302 for the Treatment of ALS NCT07161999 | Phase 2/3 | Recruiting | Coya Therapeutics | Started 2025-10 |
Recently started
| Trial | Phase | Status | Sponsor | Started |
|---|---|---|---|---|
| Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease NCT07616154 | Phase 2 | Recruiting | St. Jude Children's Research Hospital | Started 2026-09 |
| Partial Stem Cell Transplant for Sickle Cell Disease From Matched Donors NCT07599176 | Phase 1/2 | Recruiting | National Heart, Lung, and Blood Institute (NHLBI) | Started 2026-07 |
| Treatment of Antibody-Mediated Rejection (ABMR) With CarBel NCT06918990 | Phase 1 | Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | Started 2026-05 |
| Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO> NCT06291077 | Phase 4 | Recruiting | University Hospital, Rouen | Started 2026-04 |
| ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis NCT06680661 | Phase 2 | Suspended | Leland Metheny | Started 2026-04 |
Results recently posted
| Trial | Phase | Status | Sponsor | Results posted |
|---|---|---|---|---|
| Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression NCT04786067 | Phase 4 | Completed | University of Texas Southwestern Medical Center | Results posted 2026-08-14 |
| Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD) NCT01954979 | Phase 1/2 | Completed | Beth Israel Deaconess Medical Center | Results posted 2026-05-29 |
| Non-myeloablative Haploidentical HCT Study for Patients With Sickle Cell Disease, Including Compromised Organ Function NCT06145282 | Phase 1/2 | Active, not recruiting | National Heart, Lung, and Blood Institute (NHLBI) | Results posted 2026-04-29 |
| Subcutaneous Abatacept in Renal Transplant Recipients NCT05975450 | Phase 1 | Completed | Idelberto Badell | Results posted 2026-04-03 |
| Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA) NCT03841357 | Phase 3 | Completed | Duke University | Results posted 2026-01-23 |
Pipeline
Phase by status
| Phase | Recruiting | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 1 | — | 2 | 2 | 1 | — | 1 | — | 7 |
| Phase 1 | 2 | — | 21 | 1 | 1 | 1 | 3 | — | 29 |
| Phase 1/2 | 3 | 2 | 11 | 1 | 2 | — | 1 | — | 20 |
| Phase 2 | 11 | 3 | 44 | 12 | 4 | 1 | 6 | — | 81 |
| Phase 2/3 | 2 | 1 | 1 | 1 | — | — | — | — | 5 |
| Phase 3 | 6 | 2 | 38 | 2 | 1 | — | 3 | — | 52 |
| Phase 4 | 1 | — | 26 | 3 | 3 | — | 8 | — | 41 |
| Not applicable | — | — | 2 | — | 2 | — | — | — | 4 |
| Unknown | 2 | 2 | 17 | — | 1 | — | 6 | 2 | 30 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arthritis, Rheumatoid | — | 8 | 3 | 10 | 1 | 27 | 21 | 2 | 20 | 92 |
| Graft vs Host Disease | — | 2 | 4 | 6 | 1 | — | — | — | — | 13 |
| Diabetes Mellitus, Type 1 | 1 | — | 1 | 6 | — | — | — | 1 | — | 9 |
| Arthritis | — | — | 1 | 2 | — | 4 | — | — | 1 | 8 |
| Arthritis, Psoriatic | — | — | — | 2 | — | 2 | 2 | — | 2 | 8 |
| Arthritis, Juvenile | — | — | 1 | 1 | — | 5 | — | — | — | 7 |
| Lupus Erythematosus, Systemic | — | — | 1 | 5 | 1 | — | — | — | — | 7 |
| Anemia, Sickle Cell | — | 2 | 2 | 2 | — | — | — | — | — | 6 |
| Myelodysplastic Syndromes | — | — | 1 | 3 | 1 | 1 | — | — | — | 6 |
| Vasculitis | — | — | 1 | 2 | — | 2 | — | — | — | 5 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Bristol-Myers Squibb | 81 | 33 |
| 2 | National Institute of Allergy and Infectious Diseases (NIAID) | 17 | 0 |
| 3 | NYU Langone Health | 6 | 0 |
| 4 | Brigham and Women's Hospital | 5 | 0 |
| 5 | Duke University | 5 | 2 |
| 6 | Emory University | 5 | 0 |
| 7 | University of California, Los Angeles | 5 | 1 |
| 8 | Assistance Publique - Hôpitaux de Paris | 4 | 1 |
| 9 | Columbia University | 4 | 0 |
| 10 | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | 4 | 3 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Abatacept | 269 |
| 2 | Mycophenolic Acid | 29 |
| 3 | Tacrolimus | 28 |
| 4 | Methotrexate | 20 |
| 5 | tocilizumab | 19 |
| 6 | Adalimumab | 18 |
| 7 | Prednisone | 14 |
| 8 | Infliximab | 13 |
| 9 | Etanercept | 12 |
| 10 | Sirolimus | 12 |
Terminations
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT03457142 Terminated | Terminated | funding ended | 2024-11-06 |
| NCT03733067 Withdrawn | Withdrawn | No enrollment | 2023-11-30 |
| NCT03619876 Terminated | Terminated | Lack of funding | 2021-09-15 |
| NCT04472494 Terminated | Terminated | Slow accrual | 2021-09-13 |
| NCT04261023 Terminated | Terminated | The CI terminated ARCADIA early due to a number of reasons. These include the difficulty in recruiting and being placed on pause during the COVID pandemic, plus limited staffing at that time \& the need to considerably amend the eCRF MACRO system | 2021-03-15 |
| NCT01602302 Terminated | Terminated | low recruitment | 2020-11-19 |
| NCT04203875 Terminated | Terminated | Lack of eligible study participants. | 2020-07-23 |
| NCT02429934 Terminated | Terminated | Response rate in placebo group for primary outcome was 100% on interim analysis. | 2019-09-01 |
| NCT03059888 Terminated | Terminated | Mutual decision of sponsor and investigator due to logistical challenges | 2019-07-15 |
| NCT02134288 Terminated | Terminated | Drug unavailability due to a manufacturing transition. | 2019-01-18 |
Evidence
- Results reported
- 69.8%113 of 162 completed
- Published
- 7.4%12 of 162 completed
- Primary endpoint met
- 38.6%22 of 57 analyses
- Median months to report
- 16
Documents disclosed
Trial profile
- Median enrollment
- 59
- Median duration
- 43.3months
- Countries
- 50
- Study sites
- 2522
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 8
- Phase 1
- 24
- Phase 1/2
- 20
- Phase 2
- 42
- Phase 2/3
- 120
- Phase 3
- 235
- Phase 4
- 32
- Not applicable
- 10
- Unknown
- 506
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Boston | United States | 49 |
| 2 | New York | United States | 46 |
| 3 | Chicago | United States | 36 |
| 4 | Dallas | United States | 35 |
| 5 | Atlanta | United States | 34 |
| 6 | Los Angeles | United States | 34 |
| 7 | Birmingham | United States | 27 |
| 8 | Cincinnati | United States | 27 |
| 9 | Paris | France | 26 |
| 10 | San Francisco | United States | 25 |