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A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis

StatusCompleted
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Results posted: Oct 1, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 25 of 27 entries
    • Site details revised at 4 of 45 sites
  2. Primary endpoints: 2 to 9
    • Secondary endpoints: 9 to 27
    v19
  3. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 231 to confirmed 272
    • Study completion date changed from estimate of Jan 2026 to Nov 27, 2025
    v18
  4. Primary completion date changed from estimate of Nov 2025 to Nov 6, 2025
    • Study completion date: Dec 2025 to Jan 2026
    v17
  5. Re-verified, no change to tracked fieldsv16
Show 14 earlier versionsHide 14 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 45 of 45 sites
    v15
  2. Study sites: 39 to 45v14
  3. Study sites: 32 to 39v13
  4. Study sites: 30 to 32v12
  5. Study sites: 26 to 30v11
  6. Study sites: 12 to 26v10
  7. Eligibility criteria revised
    • Site contacts updated at 3 of 12 sites
    v9
  8. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 12 of 12 sites
    v8
  9. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 12 of 12 sites
    v7
  10. Study description expanded, about 27 words
    • Site details revised at 4 of 12 sites
    v6
  11. Study sites: 9 to 12v5
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 9
    • Start date changed from estimate of Feb 2023 to Feb 28, 2023
    • Eligibility criteria revised
    v4
  13. Study Status, Contacts/Locations, Referencesv3
  14. Study title shortened, about 2 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
Trial Details
NCT Number NCT05721573
Lead Sponsor Abcuro, Inc.
Collaborators: Syneos Health
Conditions
(from sponsor)		 Inclusion Body Myositis
Related terms Muscular Diseases, Myositis, Myositis, Inclusion Body, Nervous System Diseases, Neuromuscular Diseases
Enrollment 272 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov