MedPath

Efavaleukin alfa

Generic Name
Efavaleukin alfa
Drug Type
Biotech
CAS Number
2049067-94-7
Unique Ingredient Identifier
YNH9K62UXU
Background

Efavaleukin alfa is a fusion protein consisting of interleukin mutein fused to the C-terminus of an immunoglobulin G Fc domain by way of a G4S linker. It is under investigation in clinical trial NCT03422627 (Safety and Efficacy of AMG 592 in Subjects With Steroid Refractory Chronic Graft Versus Host Disease).

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants

Phase 1
Completed
Conditions
Chronic Graft-versus-Host Disease (cGVHD)
Interventions
Other: Placebo
First Posted Date
2023-06-02
Last Posted Date
2023-06-02
Lead Sponsor
Amgen
Target Recruit Count
18
Registration Number
NCT05885451
Locations
🇦🇺

Research Site, Randwick, New South Wales, Australia

A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants

Phase 1
Completed
Conditions
Chronic Graft-versus-host Disease (cGVHD)
Interventions
Other: Placebo
First Posted Date
2023-05-24
Last Posted Date
2023-05-24
Lead Sponsor
Amgen
Target Recruit Count
64
Registration Number
NCT05873907
Locations
🇺🇸

Research Site, Aventura, Florida, United States

Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 2
Terminated
Conditions
Ulcerative Colitis
Interventions
First Posted Date
2023-01-05
Last Posted Date
2024-11-27
Lead Sponsor
Amgen
Target Recruit Count
92
Registration Number
NCT05672199
Locations
🇺🇸

Santa Maria Gastroenterology Medical Group, Santa Maria, California, United States

🇺🇸

Indian Health Service Health Research, Kissimmee, Florida, United States

🇺🇸

University of Kansas Medical Center, Kansas City, Kansas, United States

and more 22 locations

Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 2
Terminated
Conditions
Ulcerative Colitis
Interventions
First Posted Date
2021-08-03
Last Posted Date
2024-11-25
Lead Sponsor
Amgen
Target Recruit Count
224
Registration Number
NCT04987307
Locations
🇺🇸

Digestive Health Specialists of the Southeast, Dothan, Alabama, United States

🇺🇸

Birmingham Digestive Health Research, LLC, Homewood, Alabama, United States

🇺🇸

Arizona Health Research, Mesa, Arizona, United States

and more 197 locations

Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants

Phase 1
Completed
Conditions
Inflammatory Diseases
Interventions
First Posted Date
2021-08-03
Last Posted Date
2024-03-29
Lead Sponsor
Amgen
Target Recruit Count
32
Registration Number
NCT04987333
Locations
🇬🇧

Labcorp Clinical Research Unit - Leeds, Leeds, LDS, United Kingdom

Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

Phase 2
Terminated
Conditions
Active Systemic Lupus Erythematosus
Interventions
Drug: Placebo
Other: Standard of Care
First Posted Date
2020-12-23
Last Posted Date
2024-06-28
Lead Sponsor
Amgen
Target Recruit Count
168
Registration Number
NCT04680637
Locations
🇫🇷

Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil, Toulouse Cedex 9, France

🇯🇵

Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan

🇰🇷

Daegu Catholic Universtiy Medcial Center, Daegu, Korea, Republic of

and more 146 locations

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus

Phase 1
Completed
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2018-03-01
Last Posted Date
2023-07-19
Lead Sponsor
Amgen
Target Recruit Count
35
Registration Number
NCT03451422
Locations
🇺🇸

Metroplex Clinical Research Center, Dallas, Texas, United States

🇺🇸

Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States

🇵🇱

Clinical Research Center Spzoo Medic-R Spolka Komandytowa, Poznan, Poland

and more 12 locations

Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease

Phase 1
Terminated
Conditions
Chronic Graft Versus Host Disease cGVHD
Interventions
First Posted Date
2018-02-06
Last Posted Date
2023-11-22
Lead Sponsor
Amgen
Target Recruit Count
32
Registration Number
NCT03422627
Locations
🇺🇸

Texas Oncology Baylor, Dallas, Texas, United States

🇺🇸

Emory University, Atlanta, Georgia, United States

🇫🇷

Hôpital Saint Louis, Paris Cedex 10, France

and more 11 locations

Safety and Efficacy of Efavaleukin Alfa in Subjects With Active Rheumatoid Arthritis

Phase 1
Terminated
Conditions
Rheumatoid Arthritis RA
Interventions
First Posted Date
2018-01-25
Last Posted Date
2021-06-22
Lead Sponsor
Amgen
Target Recruit Count
36
Registration Number
NCT03410056
Locations
🇪🇸

Research Site, A Coruña, Galicia, Spain

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