MedPath

Anifrolumab

Generic Name
Anifrolumab
Brand Names
Saphnelo
Drug Type
Biotech
CAS Number
1326232-46-5
Unique Ingredient Identifier
38RL9AE51Q
Background

Anifrolumab, or MEDI-546, is a type 1 interferon receptor (IFNAR) inhibiting IgG1κ monoclonal antibody indicated in the treatment of adults with moderate to severe systemic lupus erythematosus. The standard therapy for systemic lupus erythematosus consists of antimalarials like hydroxychloroquine, glucocorticoids like dexamethasone, and disease modifying antirheumatic drugs like methotrexate.

Three monoclonal antibodies (anifrolumab, rontalizumab, and sifalimumab) that target the type 1 interferon pathway entered clinical trials as potential treatments for systemic lupus erythematosus, but so far only anifrolumab has been approved.

The design of early clinical trials of anti-interferon treatments such as anifrolumab, rontalizumab, and sifalimumab have come under criticism. The design of the clinical trials use different definitions of autoantibody positivity, making comparison between trials difficult; all trials involve large portions of patients also using corticosteroids, which may alter patient responses in the experimental and placebo groups; and patient populations were largely homogenous, which may have increased the odds of success of the trial.

Anifrolumab has also been investigated for the treatment of Scleroderma.

Anifrolumab was granted FDA approval on 30 July 2021.

Indication

Anifrolumab is indicated in the treatment of adults with moderate to severe systemic lupus erythematosus.

Associated Conditions
Moderate Systemic Lupus Erythematosus (SLE), Severe Systemic Lupus Erythematosus (SLE)

The Anifrolumab PRIM Program

Not yet recruiting
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2025-01-28
Last Posted Date
2025-02-25
Lead Sponsor
AstraZeneca
Target Recruit Count
240
Registration Number
NCT06795893

Establishing the Salience of Type 1 Interferon Pathway Blockade in the Central Mechanisms of SLE Related Fatigue

Not yet recruiting
Conditions
Systemic Lupus Erythematosus
First Posted Date
2025-01-20
Last Posted Date
2025-01-29
Lead Sponsor
NHS Greater Glasgow and Clyde
Target Recruit Count
20
Registration Number
NCT06784076

Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

Recruiting
Conditions
Lupus Erythematosus, Systemic
Interventions
First Posted Date
2024-11-04
Last Posted Date
2025-05-20
Lead Sponsor
AstraZeneca
Target Recruit Count
100
Registration Number
NCT06673043
Locations
🇵🇱

Research Site, Wroclaw, Poland

Pharmacokinetic and Safety Study of Subcutaneous and Intravenous Anifrolumab Delivered in Healthy Adult Participants

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2024-10-28
Last Posted Date
2025-03-19
Lead Sponsor
AstraZeneca
Target Recruit Count
24
Registration Number
NCT06662123
Locations
🇨🇳

Research Site, Wuhan, China

Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

Recruiting
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2024-10-26
Last Posted Date
2025-05-13
Lead Sponsor
AstraZeneca
Target Recruit Count
442
Registration Number
NCT06659029
Locations
🇺🇸

Research Site, Las Vegas, Nevada, United States

Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users

Phase 4
Recruiting
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2024-09-19
Last Posted Date
2025-03-14
Lead Sponsor
AstraZeneca
Target Recruit Count
16
Registration Number
NCT06594068
Locations
🇺🇸

Research Site, Las Vegas, Nevada, United States

Anifrolumab for Hidradenitis Suppurativa

Phase 2
Recruiting
Conditions
Hidradenitis
Acne Inversa
Hidradenitis Suppurativa
Interventions
First Posted Date
2024-04-18
Last Posted Date
2024-07-24
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
15
Registration Number
NCT06374212
Locations
🇺🇸

UNC Dermatology and Skin Cancer Center, Chapel Hill, North Carolina, United States

Efficacy and Tolerance of the Association of ANIFROLUMAB (300mg) IV Every Four Weeks and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo

Phase 2
Recruiting
Conditions
Vitiligo
Interventions
First Posted Date
2023-06-26
Last Posted Date
2023-12-22
Lead Sponsor
University Hospital, Bordeaux
Target Recruit Count
48
Registration Number
NCT05917561
Locations
🇫🇷

Centre Hospitalier Universitaire de Nice, Nice, France

🇫🇷

Centre Hospitalier Universitaire de Toulouse, Toulouse, France

🇫🇷

CHU de Bordeaux, Bordeaux, France

and more 1 locations

An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants

Phase 3
Active, not recruiting
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2023-04-28
Last Posted Date
2025-04-11
Lead Sponsor
AstraZeneca
Target Recruit Count
100
Registration Number
NCT05835310
Locations
🇬🇧

Research Site, Southampton, United Kingdom

The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD

Phase 2
Recruiting
Conditions
Premature Atherosclerosis
Cardiovascular Disease
Systemic Lupus Erythematosus
Interventions
Other: Placebo
First Posted Date
2022-06-30
Last Posted Date
2025-05-16
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Target Recruit Count
45
Registration Number
NCT05440422
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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