NCT05669014 is a Phase 2 clinical trial of Daxdilimab in Idiopathic Inflammatory Myositis, sponsored by Amgen.

Who is sponsoring NCT05669014?

NCT05669014 is sponsored by Amgen.

What drugs are being tested in NCT05669014?

Interventions in NCT05669014: Daxdilimab, Placebo.

What condition does NCT05669014 study?

NCT05669014 studies Idiopathic Inflammatory Myositis.

Is NCT05669014 still recruiting?

NCT05669014 is currently completed. Last updated 3 November 2025.

Last reviewed 2025-11-03 · How we verify

NCT05669014

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Completed Phase 2 Last updated 3 November 2025

What this trial tests

Phase 2 trial testing Daxdilimab in Idiopathic Inflammatory Myositis in 12 participants. Completed in 2 July 2025.

Timeline

4 December 2023

Primary endpoint
2 July 2025

2 July 2025

Quick facts

Lead sponsor	Amgen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	4 December 2023
Primary completion	2 July 2025
Estimated completion	2 July 2025
Sites	9 locations across Brazil, United Kingdom, Mexico, United States, Spain, Czechia

Drugs / interventions tested

Daxdilimab — full drug profile →
Placebo

Conditions studied

Idiopathic Inflammatory Myositis — all drugs for Idiopathic Inflammatory Myositis →

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 75, any sex, with Idiopathic Inflammatory Myositis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Dermatomyositis: Practical Guidance and Unmet Needs.
Cassard L, Seraly N, Riegert M, Patel A, et al · · 2024 · cited 14× · PMID 38464459 · DOI 10.2147/itt.s381472
Immune-Mediated Necrotizing Myopathy (IMNM): A Story of Antibodies.
Julien S, Challier I, Malleter M, Jouen F, et al · · 2024 · cited 8× · PMID 38390873 · DOI 10.3390/antib13010012
Clinical pearls and promising therapies in myositis.
Connolly CM, Paik JJ. · · 2023 · cited 8× · PMID 37158055 · DOI 10.1080/1744666x.2023.2212162

Verify or expand the search:

Other trials of Daxdilimab

Trials testing the same drug.

NCT05540665 — Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN) · Phase 2 · terminated
NCT05591222 — Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus · Phase 2 · terminated
NCT05430854 — Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study · Phase 2 · terminated
NCT05368103 — Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata · Phase 2 · completed

Other recruiting trials for Idiopathic Inflammatory Myositis

Currently open trials in the same condition.

NCT05454527 — Follow-up of Patients With Inflammatory Myopathies Associated With a Biobank · recruiting

Other Amgen trials

Trials by the same sponsor.

NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05669014 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 3 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05669014.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing