14 completed, 14 recruiting, 5 active not recruiting, 3 unknown. 13 Phase 3, 11 Phase 2, 4 Phase 1, 2 Phase 4, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Recruiting 5, Active not recruiting 4, Completed 4 |
| Phase 2 | 11 | Completed 6, Recruiting 3, Unknown 2 |
| Phase 1 | 4 | Completed 4 |
| Phase 4 | 2 | Recruiting 2 |
| Early Phase 1 | 1 | Unknown 1 |
Follow anifrolumab: new trials by email Literature Review of anifrolumab trials Research Report on anifrolumab
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 |
|---|---|---|---|---|---|---|
| Saphnelo Use in Females of Child-bearing Potential Anifrolumab - Systemic Lupus Erythematosus | Not yet recruiting | AstraZeneca | 26000000 | 2026-10-01 | 2026-02-25 | |
| A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus Anifrolumab + APFS - Systemic Lupus Erythematosus | Phase 2 | Recruiting | AstraZeneca | 24 | 2026-08-31 | 2026-09-22 |
| Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment Anifrolumab - Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus | Phase 3 | Recruiting | AstraZeneca | 1072 | 2026-08-31 | 2026-10-02 |
| A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus Anifrolumab - Lupus Erythematosus, Systemic | Phase 3 | Recruiting | AstraZeneca | 417 | 2026-08-31 | 2026-10-22 |
| Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial) Anifrolumab - Antiphospholipid Syndrome (APS) | Phase 2 | Recruiting | National and Kapodistrian University of Athens | 20 | 2026-04-29 | 2026-06-02 |
| PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis LUPKYNIS, belimumab, obinutuzumab or anifrolumab, mycophenolic acid analog (MPAA) - Lupus Nephritis | Phase 4 | Recruiting | Aurinia Pharmaceuticals Inc. | 150 | 2026-04-22 | 2026-08-03 |
| A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus Anifrolumab - Systemic Lupus Erythematosus | Phase 3 | Recruiting | AstraZeneca | 245 | 2026-04-13 | 2026-09-25 |
| Anifrolumab Malignancy and Serious Infections Study Anifrolumab - Systemic Lupus Erythematosus | Recruiting | AstraZeneca | 3506 | 2026-01-26 | 2026-09-16 | |
| Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users Anifrolumab - Systemic Lupus Erythematosus | Phase 4 | Recruiting | AstraZeneca | 16 | 2026-01-16 | 2026-09-16 |
| Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. Anifrolumab - Lupus Erythematosus, Systemic | Recruiting | AstraZeneca | 218 | 2025-12-31 | 2026-09-21 | |
| The Anifrolumab PRIM Program Anifrolumab - Systemic Lupus Erythematosus | Recruiting | AstraZeneca | 240 | 2025-11-07 | 2026-09-11 | |
| Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users Anifrolumab - Systemic Lupus Erythematosus | Recruiting | AstraZeneca | 442 | 2025-07-01 | 2026-09-02 | |
| Establishing the Salience of Type 1 Interferon Pathway Blockade in the Central Mechanisms of SLE Related Fatigue Anifrolumab - Systemic Lupus Erythematosus | Not yet recruiting | NHS Greater Glasgow and Clyde | 20 | 2025-03-17 | 2025-01-29 | |
| Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus Anifrolumab - Lupus Erythematosus, Systemic | Active not recruiting | AstraZeneca | 105 | 2025-02-28 | 2026-09-18 | |
| Pharmacokinetic and Safety Study of Subcutaneous and Intravenous Anifrolumab Delivered in Healthy Adult Participants Anifrolumab - Healthy Volunteers | Phase 1 | Completed | AstraZeneca | 24 | 2024-10-21 | 2025-03-19 |
| A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus Anifrolumab, Placebo - Cutaneous Lupus Erythematosus | Phase 3 | Active not recruiting | AstraZeneca | 339 | 2024-06-29 | 2026-07-29 |
| Anifrolumab for Hidradenitis Suppurativa Anifrolumab - Hidradenitis Suppurativa, Acne Inversa | Phase 2 | Completed | University of North Carolina, Chapel Hill | 15 | 2024-06-21 | 2026-08-03 |
| A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis) Anifrolumab (blinded), Placebo, Anifrolumab (unblinded, open label) - Polymyositis, Dermatomyositis | Phase 3 | Recruiting | AstraZeneca | 240 | 2024-06-20 | 2026-09-24 |
| An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants Anifrolumab, Placebo - Systemic Lupus Erythematosus | Phase 3 | Recruiting | AstraZeneca | 100 | 2024-03-14 | 2026-09-30 |
| The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD anifrolumab, Placebo - Systemic Lupus Erythematosus, Cardiovascular Disease | Phase 2 | Recruiting | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | 45 | 2023-12-07 | 2026-09-18 |
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Lupus Erythematosus, Systemic (22) · Lupus Nephritis (3) · Immune System Diseases (2) · Scleroderma, Diffuse (2) · Antiphospholipid Syndrome (1) · Arthritis, Rheumatoid (1) · Autoimmune Diseases (1) · Cardiovascular Diseases (1) · Connective Tissue Diseases (1) · Dermatomyositis (1) · Hidradenitis (1) · Hidradenitis Suppurativa (1) · Infections (1) · Lung Diseases, Interstitial (1) · Lupus Erythematosus, Cutaneous (1)
AstraZeneca (28) · MedImmune LLC (3) · Aurinia Pharmaceuticals Inc. (1) · Josef Smolen, Univ. Prof. Dr. (1) · NHS Greater Glasgow and Clyde (1) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (1) · National and Kapodistrian University of Athens (1) · Oklahoma Medical Research Foundation (1) · University Medical Center Groningen (1) · University of North Carolina, Chapel Hill (1)
United States (23) · Poland (15) · Germany (14) · Mexico (13) · South Korea (12) · France (11) · Japan (11) · Spain (11) · Taiwan (11) · Argentina (10) · China (10) · Hungary (10) · Italy (10) · United Kingdom (10) · Brazil (9)
Christopher Sayed, MD (1) · Cristina Arriens, M.D. (1) · Darin Brimhall, MD (1) · Hendrika Bootsma (1) · Herbert Hutman, MD (1) · Joan T Merrill, M.D. (1) · Kenneth Kalunian, MD (1) · Lilia Pineda, MD (1) · Mariana J Kaplan, M.D. (1) · Neil Basu, MD, PhD (1) · Raj Tummala, MD (1) · Roberta Weiss, MD (1) · Stephen Yoo, M.D. (1) · Syd Philips (1)
PMID 33687069, PMID 33913260, PMID 33977796, PMID 34528084, PMID 35157371, PMID 35338035, PMID 35580976, PMID 36018235, PMID 36690388, PMID 41144892, PMID 42175562, PMID 24559157, PMID 28130918, PMID 29420200, PMID 30538817, PMID 31660791, PMID 31851795, PMID 32909675, PMID 33225631, PMID 35144924, PMID 36369793, PMID 37528520, PMID 37607780, PMID 37706527, PMID 38229377, PMID 38279367, PMID 40297385, PMID 40324450, PMID 41217519, PMID 41663906
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