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A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

Study acronym: SKYLINE-UC
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jun 2026 → Jun 2027
See other at-risk trials from Spyre Therapeutics, Inc.

Record History

  1. Study sites: 271 to 273
  2. Trial sites expanded: 267 → 271 locations Eligibility criteria expanded, about 6 words · Secondary endpoints: details revised at 7 of 7 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 7 of 7 entries
  3. Trial sites expanded: 259 → 267 locationsv43
  4. Trial sites expanded: 253 → 259 locationsv42
  5. Primary completion pushed from Jun 2026 to Jun 2027 Trial sites expanded: 243 → 253 locations · Study description expanded, about 12 wordsv41 Show 2 more changesShow less
    • Trial sites expanded: 243 → 253 locations
    • Study description expanded, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  6. Trial sites expanded: 234 → 243 locationsv40
  7. Trial sites expanded: 223 → 234 locationsv39
  8. Trial sites expanded: 206 → 223 locationsv38
  9. Trial sites expanded: 191 → 206 locationsv37
  10. Trial sites expanded: 175 → 191 locationsv36
  11. Trial sites expanded: 162 → 175 locationsv35
  12. Trial sites expanded: 148 → 162 locationsv34
  13. Trial sites expanded: 143 → 148 locationsv33
  14. Trial sites expanded: 129 → 143 locationsv32
  15. Study sites: 126 to 129v31
  16. Study sites: 119 to 126v30
  17. Study sites: 108 to 119v29
  18. Study sites: 105 to 108v28
  19. Study sites: 101 to 105v27
  20. Study sites: 94 to 101v26
  21. Study sites: 90 to 94v25
  22. Study sites: 89 to 90v24
  23. Study sites: 83 to 89v23
  24. Study sites: 79 to 83v22
  25. Study sites: 72 to 79v21
  26. Study sites: 59 to 72v20
  27. Study sites: 54 to 59v19
  28. Study sites: 53 to 54v18
  29. Study sites: 52 to 53v17
  30. Study sites: 49 to 52v16
  31. Study sites: 43 to 49v15
  32. Study sites: 37 to 43v14
  33. Study sites: 33 to 37v13
  34. Study sites: 24 to 33v12
  35. Study sites: 19 to 24v11
  36. Study sites: 15 to 19v10
  37. Study sites: 14 to 15v9
  38. Site contacts updated at 1 of 14 sitesv8
  39. Study sites: 13 to 14v7
  40. Study sites: 11 to 13v6
  41. Site details revised at 1 of 11 sitesv5
  42. Study sites: 10 to 11v4
  43. Study sites: 8 to 10v3
  44. Enrollment target: 35 to 645 Primary endpoints: 1 to 2 · Study sites: 6 to 8 · Completion date: Jun 2027 to Mar 2028 · 3 morev2 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 6 to 8
    • Completion date: Jun 2027 to Mar 2028
    • Interventions: SPY001 (Drug) to Placebo (Other), SPY001 (Drug), SPY002 (Drug), SPY003 (Drug)
    • Secondary endpoints: 2 to 7
    • Study arms: 1 to 13

    See this version in full on ClinicalTrials.gov ↗

  45. 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 Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.
Trial Details
NCT Number NCT07012395
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