Daxdilimab

Generic Name: Daxdilimab

Drug Type: Biotech

CAS Number: 2245966-28-1

Unique Ingredient Identifier: CNI3N6QR71

Background: Daxdilimab is under investigation in clinical trial NCT04526912 (Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection).

Clinical Trials

A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)

Phase 2

Active, not recruiting

Conditions: Idiopathic Inflammatory Myositis

Interventions: Drug: Daxdilimab
Drug: Placebo

First Posted Date: 2022-12-30

Last Posted Date: 2024-12-11

Lead Sponsor: Amgen

Target Recruit Count: 12

Registration Number: NCT05669014

Locations: 🇺🇸
Advanced Research Center, Inc., Anaheim, California, United States
🇧🇷
Centro Mineiro de Pesquisa - CMiP, Juiz De Fora, Minas Gerais, Brazil
🇧🇷
LMK Servicos Medicos SS, Porto Alegre, Rio Grande Do Sul, Brazil

and more 6 locations

Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus

Phase 2

Active, not recruiting

Conditions: Discoid Lupus Erythematosus

Interventions: Drug: Placebo
Drug: Daxdilimab

First Posted Date: 2022-10-24

Last Posted Date: 2025-03-12

Lead Sponsor: Amgen

Target Recruit Count: 99

Registration Number: NCT05591222

Locations: 🇺🇸
Wallace Medical Group, Beverly Hills, California, United States
🇺🇸
Arkansas Research Trials, North Little Rock, Arkansas, United States
🇺🇸
The Center for Dermatology Clinical Research, Fremont, California, United States

and more 65 locations

Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)

Phase 2

Terminated

Conditions: Lupus Nephritis

Interventions: Drug: Placebo (Normal Saline)
Drug: Daxdilimab

First Posted Date: 2022-09-15

Last Posted Date: 2025-03-24

Lead Sponsor: Amgen

Target Recruit Count: 19

Registration Number: NCT05540665

Locations: 🇦🇷
Clinica Mayo de U.M.C.B. S.R.L, San Miguel De Tucumán, Argentina
🇧🇷
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME, Salvador, Bahia, Brazil
🇧🇷
Irmandade Da Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil

and more 48 locations

Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study

Phase 2

Terminated

Conditions: Systemic Lupus Erythematosus

Interventions: Biological: Daxdilimab

First Posted Date: 2022-06-24

Last Posted Date: 2024-05-03

Lead Sponsor: Amgen

Target Recruit Count: 155

Registration Number: NCT05430854

Locations: 🇬🇷
Kianous Stavros, Thessaloníki, Greece
🇬🇷
Athens General Hospital 'G Gennimatas, Athens, Greece
🇬🇷
University General Hospital of Larissa, Larisa, Greece

and more 49 locations

Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata

Phase 2

Completed

Conditions: Alopecia Areata

Interventions: Biological: Daxdilimab

First Posted Date: 2022-05-10

Last Posted Date: 2025-01-07

Lead Sponsor: Amgen

Target Recruit Count: 30

Registration Number: NCT05368103

Locations: 🇨🇦
The Centre for Clinical Trials, Oakville, Ontario, Canada
🇨🇦
Innovaderm Research, Montréal, Quebec, Canada
🇨🇦
Centre de Recherche Saint-Louis (Quebec), Quebec, Canada

and more 10 locations

Study of VIB7734 for the Treatment of Moderate to Severely Active SLE

Phase 2

Completed

Conditions: Lupus Erythematosus, Systemic

Interventions: Drug: VIB7734
Other: Placebo

First Posted Date: 2021-06-14

Last Posted Date: 2024-07-23

Lead Sponsor: Amgen

Target Recruit Count: 214

Registration Number: NCT04925934

Locations: 🇺🇸
Millennium Research, Ormond Beach, Florida, United States
🇺🇸
Inland Rheumatology Clinical Trials Incorporated, Upland, California, United States
🇺🇸
Clinical Research of West Florida Inc - Clearwater, Clearwater, Florida, United States

and more 64 locations

Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection

Phase 1

Terminated

Conditions: Acute Lung Injury

Interventions: Drug: VIB7734
Drug: Placebo

First Posted Date: 2020-08-26

Last Posted Date: 2021-12-17

Lead Sponsor: Viela Bio

Target Recruit Count: 10

Registration Number: NCT04526912

Locations: 🇺🇸
Research Site, Cleveland, Ohio, United States

A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis

Phase 1

Completed

Conditions: Systemic Sclerosis
Cutaneous Lupus Erythematosus
Polymyositis
Systemic Lupus Erythematosus
Sjogren's Syndrome
Dermatomyositis

Interventions: Drug: VIB7734
Drug: Placebo

First Posted Date: 2019-01-25

Last Posted Date: 2024-12-13

Lead Sponsor: Amgen

Target Recruit Count: 31

Registration Number: NCT03817424

Locations: 🇪🇸
Viela Bio Investigative Site, Sevilla, Spain

A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases

Phase 1

Completed

Conditions: Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc

Interventions: Biological: MEDI7734
Biological: Placebo

First Posted Date: 2016-05-23

Last Posted Date: 2024-12-13

Lead Sponsor: Amgen

Target Recruit Count: 36

Registration Number: NCT02780674

Locations: 🇺🇸
Research Site, Duncansville, Pennsylvania, United States

Drug Development Updates

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