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Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD

Study acronym: SKYLINE-LTE
StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 59 → 70 locations
  2. Minor Trial sites expanded: 52 → 59 locations Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 1 of 1 entry Show 2 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 1 entry
  3. Minor Trial sites expanded: 47 → 52 locationsv11
  4. Minor Trial sites expanded: 41 → 47 locationsv10
  5. Minor Trial sites expanded: 34 → 41 locationsv9
  6. Minor Trial sites expanded: 16 → 34 locationsv8
  7. Minor Study sites: 15 to 16v7
  8. Minor Trial sites expanded: 9 → 15 locationsv6
  9. Minor Trial sites expanded: 6 → 9 locationsv5
  10. Minor Study sites: 5 to 6v4
  11. Minor Trial sites expanded: 1 → 5 locationsv3
  12. Notable Primary endpoint(s) modified Secondary endpoint revisedv2 Show 1 more changeShow less
  13. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
Trial Details
NCT Number NCT07652294
Lead Sponsor Spyre Therapeutics, Inc.
Conditions Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
Enrollment 645 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov