NCT05669014View on ClinicalTrials.gov

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)

PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 4, 2023

Primary Completion Date

July 2, 2025

Study Completion Date

July 2, 2025

Conditions
Idiopathic Inflammatory Myositis
Interventions
DRUG

Daxdilimab

Participants will be administered daxdilimab by subcutaneous (SC) injection.

DRUG

Placebo

Participants will be administered identically matching placebo by SC injection.

Trial Locations (9)

41010

Hospital Quironsalud Infanta Luisa, Seville

64000

Accelerium, S. de R.L. de C.V. - PPDS, Monterrey

92805-5854

Advanced Research Center, Inc., Anaheim

36010-570

Centro Mineiro de Pesquisa - CMiP, Juiz de Fora

90480-000

LMK Servicos Medicos SS, Porto Alegre

128 00

Revmatologicky ustav, Prague

Unknown

Unidad de Investigacion de las Enfermedades Reumaticas S.A. De C.V., Mexico City

L9 7AL

Aintree University Hospital - NWCRN - PPDS, Liverpool

EH4 2XU

Western General Hospital Edinburgh - PPDS, Edinburgh

Sponsors

Lead Sponsor

Amgen
All Listed Sponsors
lead

Amgen

INDUSTRY

NCT05669014 - 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) | Biotech Hunter | Biotech Hunter