A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis

Part of paid clinical trials in Oceanside, California.

Sponsor
argenx
Study ID
NCT06284954
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Dermatomyositis
  • Myositis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empasiprubart IV — BIOLOGICAL
    Intravenous infusion with Empasiprubart IV
  • Placebo IV — OTHER
    Intravenous infusion with Placebo IV

Study Details

This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).

Key Dates

Start date
Aug 20, 2024
Status verified
Sep 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
3 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empasiprubart
    Patients receiving Empasiprubart IV
  • Placebo Comparator: Placebo
    Patients receiving Placebo IV

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 90 weeks ]

Locations (9)

FacilityCityStateZIPSite coordinators
Profound Research LLCOceansideCalifornia92056-
Omega Research Debary, LLCDeBaryFlorida32713-
University of Florida Health (UF) - Endocrinology - Medical Specialties - Medical PlazaGainesvilleFlorida32610-
Homestead Associates in Research, Inc.HomesteadFlorida33033-
Life Clinical TrialsMargateFlorida33063-
Advance Medical Research CenterMiamiFlorida33135-
Integral Rheumatology and Immunology Specialists (IRIS)PlantationFlorida33324-
D and H Tamarac Research, LLC CenterTamaracFlorida33321-
Wright State Physicians Health CenterDaytonOhio45324-

Find similar trials in Oceanside, CA

By research site
Profound Research LLC· Oceanside, CAOmega Research Debary, LLC· DeBary, FLUniversity of Florida Health (UF) - Endocrinology - Medical Specialties - Medical Plaza· Gainesville, FLHomestead Associates in Research, Inc.· Homestead, FLLife Clinical Trials· Margate, FLAdvance Medical Research Center· Miami, FL

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