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A Study to Investigate the Efficacy and Safety of Brivekimig in Adult Participants With Ulcerative Colitis

Study acronym: COLOR UC
StatusActive, Not Recruiting
PhasePhase 2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: estimated 99 to confirmed 105
  2. Enrollment closed, study ongoing Study sites: 67 to 66 · Eligibility criteria expanded, about 32 words · Secondary endpoints: 25 to 13 · 1 more Show 4 more changesShow less
    • Study sites: 67 to 66
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: 25 to 13
    • Study title revised
  3. Study sites: 66 to 67v16
  4. Study sites: 65 to 66v15
  5. Study sites: 62 to 65v14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 52 to 62v13
  2. Eligibility criteria shortened, about 12 words Secondary endpoints: details revised at 21 of 25 entriesv12 Show 1 more changeShow less
    • Secondary endpoints: details revised at 21 of 25 entries

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 45 to 52v11
  4. Study sites: 33 to 45v10
  5. Study sites: 24 to 33v9
  6. Study sites: 14 to 24v8
  7. Study sites: 10 to 14v7
  8. Re-verified, no change to tracked fieldsv6
  9. Study sites: 9 to 10v5
  10. Study sites: 8 to 9v4
  11. Study sites: 6 to 8 Start date changed from estimate of Jul 15, 2025 to Jul 7, 2025v3 Show 1 more changeShow less
    • Start date changed from estimate of Jul 15, 2025 to Jul 7, 2025
  12. Trial status: Not Yet Recruiting to Recruiting Start date: Jun 3, 2025 to Jul 15, 2025 · Study sites: 0 to 6v2 Show 2 more changesShow less
    • Start date: Jun 3, 2025 to Jul 15, 2025
    • Study sites: 0 to 6
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sanofi
284 trials monitored
See 12 trials at risk
Ulcerative Colitis
587 trials monitored
See 34 trials at risk
This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Ulcerative Colitis. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Ulcerative Colitis. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.
Trial Details
NCT Number NCT06975722
Lead Sponsor Sanofi
Conditions Ulcerative Colitis
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov