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A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

Study acronym: JASMINE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later May 14, 2027 → Jan 10, 2028
See other at-risk trials from AstraZeneca

Record History

  1. Primary completion pushed from May 14, 2027 to Jan 10, 2028 Completion pushed from Aug 4, 2028 to Apr 9, 2029 · Study sites: 236 to 237 · Eligibility criteria expanded, about 18 words · 2 more Show 5 more changesShow less
    • Completion pushed from Aug 4, 2028 to Apr 9, 2029
    • Study sites: 236 to 237
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 9 of 15 entries
    • Publications: details revised at 1 of 1 entry
  2. Study sites: 234 to 236v21
  3. Trial sites expanded: 228 → 234 locationsv20
  4. Study sites: 226 to 228 Eligibility criteria shortened, about 4 wordsv19 Show 1 more changeShow less
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 220 to 226v18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 218 to 220v17
  2. Study sites: 217 to 218v16
  3. Study sites: 216 to 217v15
  4. Study sites: 214 to 216v14
  5. Study sites: 209 to 214v13
  6. Study sites: 201 to 209v12
  7. Study sites: 191 to 201v11
  8. Study sites: 184 to 191v10
  9. Study sites: 178 to 184v9
  10. Study sites: 175 to 178v8
  11. Study sites: 166 to 175 Secondary endpoints: 11 to 15v7 Show 1 more changeShow less
    • Secondary endpoints: 11 to 15

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 165 to 166v6
  13. Study sites: 161 to 165v5
  14. Study sites: 159 to 161 Primary completion date: May 6, 2027 to May 14, 2027 · Completion date: Jul 27, 2028 to Aug 4, 2028v4 Show 2 more changesShow less
    • Primary completion date: May 6, 2027 to May 14, 2027
    • Completion date: Jul 27, 2028 to Aug 4, 2028
  15. Study sites: 150 to 159 Primary completion date: May 7, 2027 to May 6, 2027 · Completion date: Jul 28, 2028 to Jul 27, 2028v3 Show 2 more changesShow less
    • Primary completion date: May 7, 2027 to May 6, 2027
    • Completion date: Jul 28, 2028 to Jul 27, 2028
  16. Trial status: Not Yet Recruiting to Recruiting Primary completion date: May 14, 2027 to May 7, 2027 · Completion date: Aug 4, 2028 to Jul 28, 2028 · Start date changed from estimate of Jun 27, 2024 to Jun 20, 2024 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: May 14, 2027 to May 7, 2027
    • Completion date: Aug 4, 2028 to Jul 28, 2028
    • Start date changed from estimate of Jun 27, 2024 to Jun 20, 2024
    • Site details revised at 150 of 150 sites
  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.
AstraZeneca
727 trials monitored
See 61 trials at risk
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.
Trial Details
NCT Number NCT06455449
Lead Sponsor AstraZeneca
Conditions Polymyositis, Dermatomyositis
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov