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 · Has a placebo group

Conditions studied: Idiopathic Inflammatory Myositis

In brief

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.

Key facts

Study ID

NCT05669014

Run by

Amgen

People needed

12

Starts

2023-12-04

Expected to finish

2025-07-02

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Any condition that, in the opinion of the investigator or sponsor, would interfere with the evaluation of investigational product (IP) or interpretation of participant safety or study results.
• Weight > 160 kg (352 pounds) at screening.
• Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP.
• History of clinically meaningful cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to randomization; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities; or presence of clinically meaningful abnormality on electrocardiogram (ECG) if, in the opinion of the Investigator, it would increase the risk of study participation.
• History of cancer within the past 5 years except cutaneous basal cell or squamous cell carcinoma treated with curative therapy.
• Any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection (eg. hepatitis C).
• Known history of a primary immunodeficiency or an underlying condition, such as known human immunodeficiency virus (HIV) infection, or a positive result for HIV infection per central laboratory.
• All participants will undergo testing for hepatitis B virus serology as defined in the protocol.
• Active tuberculosis (TB), or a positive interferon gamma (IFN-γ) release assay (IGRA) test at screening, unless documented history of appropriate treatment for active or latent TB according to local guidelines.
• Any severe herpes virus family infection (including Epstein-Barr virus, cytomegalovirus [CMV]) at any time prior to randomization.
• Opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within 2 years prior to randomization.
• Significant organ system involvement or myositis damage (global muscle damage score > 5 on a 10 cm VAS scale on the MDI) that poses risks in the study or impedes assessments.
• Diagnosis of immune-mediated necrotizing myopathy (IMNM) [(positive 3-hydroxy-3-methylglutaryl-coenzyme A reductase (anti-HMGR), anti-signal recognition particle (anti- SRP), or antibody negative)], inclusion body myositis (IBM) (including positive anti-cytosolic 5'-nucleotidase 1A (anti cN1A), or drug-induced myositis.
• Current musculoskeletal, joint, or inflammatory disease, including significant joint contractures or calcinosis that in the opinion of the investigator, could interfere with the muscle strength assessments and confound the disease activity assessments.
• Wheelchair bound participants.
• Current inflammatory skin disease other than DM or ASIM that, in the opinion of the investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments.
• Severe interstitial lung disease where respiratory symptoms limit participant function or progressive pulmonary fibrosis.
• Myositis in overlap with another connective tissue disease that precludes the accurate assessment of a treatment response (for example, difficulty in assessing muscle strength in a scleroderma patient with associated myositis).

Where it is running

• 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

Full record on ClinicalTrials.gov

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