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COMPLETED
NCT05669014
PHASE2

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)

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1. To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. 2. To evaluate the effect of daxdilimab compared with placebo on skin symptoms at Week 24. 3. To evaluate the effect of daxdilimab on decreasing the use of corticosteroid at Week 24. Other secondary objectives include: 1. To characterize the pharmacokinetics (PK) and immunogenicity of daxdilimab in participants. 2. To evaluate the safety and tolerability of daxdilimab in participants.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Daxdilimab Subcutaneous Injection in Adult Participants With Inadequately Controlled Dermatomyositis or Anti-synthetase Inflammatory Myositis.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2023-12-04

Completion Date

2025-07-02

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

DRUG

Daxdilimab

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

DRUG

Placebo

Participants will be administered identically matching placebo by SC injection.

Locations (9)

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

Revmatologicky ustav

Prague, Praha, Hlavní Mesto, Czechia

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

Mexico City, Mexico

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

Monterrey, Mexico

Hospital Quironsalud Infanta Luisa

Seville, Spain

Aintree University Hospital - NWCRN - PPDS

Liverpool, Merseyside, United Kingdom

Western General Hospital Edinburgh - PPDS

Edinburgh, Midlothian, United Kingdom