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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)

NCT05669014 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-03

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2025-07-02
Completion
2025-07-02
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Czechia
  • Mexico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05669014 on ClinicalTrials.gov