Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06284954 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: empacific
StatusActive, Not Recruiting
PhasePhase 2
Sponsorargenx
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: estimated 42 to confirmed 3 Primary completion date: Jul 18, 2025 to Nov 2026 · Trial status: Recruiting to Active, Not Recruiting · Study sites: 27 to 28 · 1 morev16 Show 4 more changesShow less
    • Primary completion date: Jul 18, 2025 to Nov 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 27 to 28
    • Completion date: Jan 20, 2028 to Nov 2026
  2. Study sites: 24 to 27v15
  3. Study sites: 20 to 24v14
  4. Study sites: 16 to 20v13
  5. Study sites: 14 to 16v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 13 to 14v11
  2. Study sites: 12 to 13v10
  3. Study sites: 6 to 12v9
  4. Study sites: 3 to 6v8
  5. Study sites: 1 to 3v7
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Sep 2024 to Aug 20, 2024v6 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2024 to Aug 20, 2024
  7. Enrollment target: 80 to 42 Eligibility criteria expanded, about 25 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 25 words

    See this version in full on ClinicalTrials.gov ↗

  8. Start date: May 10, 2024 to Sep 2024 Primary endpoints revised (2) · Secondary endpoints: details revised at 1 of 1 entry · Study arms: 4 to 2v4 Show 3 more changesShow less
    • Primary endpoints revised (2)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study arms: 4 to 2

    See this version in full on ClinicalTrials.gov ↗

  9. Eligibility criteria expanded, about 19 wordsv3 See this version in full on ClinicalTrials.gov ↗
  10. Eligibility criteria shortened, about 58 words Study title shortened, about 6 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Argenx
56 trials monitored
See 2 trials at risk
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).
Trial Details
NCT Number NCT06284954
Lead Sponsor argenx
Conditions Dermatomyositis, Myositis
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov