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)

Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome

Phase 2
Recruiting
Conditions
Sjogren's Syndrome
Interventions
Drug: Placebo
First Posted Date
2022-05-20
Last Posted Date
2022-12-19
Lead Sponsor
University Medical Center Groningen
Target Recruit Count
30
Registration Number
NCT05383677
Locations
🇳🇱

University Medical Centre Groningen, Groningen, Netherlands

Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab

Phase 1
Completed
Conditions
Healthy Participants Study
Interventions
Device: Autoinjector
Device: Accessorized Pre-Filled Syringe
First Posted Date
2022-04-21
Last Posted Date
2023-05-11
Lead Sponsor
AstraZeneca
Target Recruit Count
180
Registration Number
NCT05339100
Locations
🇬🇧

Research Site, Harrow, United Kingdom

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

Phase 3
Recruiting
Conditions
Lupus Nephritis
Interventions
Drug: Placebo
First Posted Date
2021-11-30
Last Posted Date
2025-04-25
Lead Sponsor
AstraZeneca
Target Recruit Count
360
Registration Number
NCT05138133
Locations
🇻🇳

Research Site, Hochiminh, Vietnam

Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)

Phase 3
Active, not recruiting
Conditions
Active Systemic Lupus Erythematosus
Interventions
First Posted Date
2021-06-18
Last Posted Date
2024-10-23
Lead Sponsor
AstraZeneca
Target Recruit Count
277
Registration Number
NCT04931563
Locations
🇹🇭

Research Site, Bangkok, Thailand

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Phase 3
Active, not recruiting
Conditions
Systemic Lupus Erythematosus
Interventions
Drug: Placebo
First Posted Date
2021-05-07
Last Posted Date
2024-11-19
Lead Sponsor
AstraZeneca
Target Recruit Count
367
Registration Number
NCT04877691
Locations
🇬🇧

Research Site, London, United Kingdom

Anifrolumab Early Access Program

Conditions
Systemic Lupus Erythematosus
First Posted Date
2021-02-11
Last Posted Date
2021-05-06
Lead Sponsor
AstraZeneca
Registration Number
NCT04750057

Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE

Early Phase 1
Recruiting
Conditions
Systemic Lupus Erythematosus (SLE)
Interventions
Drug: Standard of Care
First Posted Date
2021-01-27
Last Posted Date
2023-03-22
Lead Sponsor
Oklahoma Medical Research Foundation
Target Recruit Count
20
Registration Number
NCT04726553
Locations
🇺🇸

Yale University Medical Center, New Haven, Connecticut, United States

🇺🇸

New York University Medical Center, New York, New York, United States

🇺🇸

Columbia Unversity Medical Center, New York, New York, United States

and more 2 locations

A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)

Phase 2
Conditions
Rheumatoid Arthritis
Interventions
Drug: Placebos
First Posted Date
2018-02-19
Last Posted Date
2020-03-02
Lead Sponsor
Josef Smolen, Univ. Prof. Dr.
Target Recruit Count
24
Registration Number
NCT03435601
Locations
🇦🇹

Medizinische Universität Wien, Innere Medizin III, Abteilung für Rheumatologie, Wien, Austria

🇦🇹

Medizinische Universität Graz, Klinische Abteilung für Rheumatologie und Immunologie, Graz, Austria

🇦🇹

Krankenhaus Hietzing, 2. Medizinische Abteilung, Wien, Austria

A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations

Phase 2
Completed
Conditions
Systemic Lupus Erythematosus
Interventions
Drug: Placebo
First Posted Date
2016-11-15
Last Posted Date
2023-01-12
Lead Sponsor
AstraZeneca
Target Recruit Count
36
Registration Number
NCT02962960
Locations
🇵🇱

Research Site, Warszawa, Poland

A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects

First Posted Date
2015-11-10
Last Posted Date
2019-02-26
Lead Sponsor
AstraZeneca
Target Recruit Count
30
Registration Number
NCT02601625
Locations
🇺🇸

Research Site, Baltimore, Maryland, United States

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