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Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Trial sites expanded: 90 → 98 locations Primary completion moved earlier from Apr 2028 to Dec 2027 · Completion pushed from Jan 2029 to May 2030 · Eligibility criteria expanded, about 29 words · 1 more Show 4 more changesShow less
    • Primary completion moved earlier from Apr 2028 to Dec 2027
    • Completion pushed from Jan 2029 to May 2030
    • Eligibility criteria expanded, about 29 words
    • Study description revised
  3. Trial sites expanded: 66 → 90 locations Study description expanded, about 1 wordv11 Show 1 more changeShow less
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Trial sites expanded: 57 → 66 locationsv10
  5. Trial sites expanded: 52 → 57 locationsv9
  6. Trial sites expanded: 40 → 52 locationsv8
  7. Study sites: 21 to 40v7
  8. Primary endpoints revised (3) Study sites: 5 to 21 · Eligibility criteria shortened, about 10 words · Secondary endpoints revised (10) · 1 morev6 Show 4 more changesShow less
    • Study sites: 5 to 21
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints revised (10)
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  9. Lead sponsor: GALE Therapeutics Inc. to Xencor, Inc. Primary completion date: Oct 2026 to Apr 2028 · Primary endpoints: 4 to 3 · Enrollment target: 300 to 270 · 6 morev5 Show 9 more changesShow less
    • Primary completion date: Oct 2026 to Apr 2028
    • Primary endpoints: 4 to 3
    • Enrollment target: 300 to 270
    • Study sites: 2 to 5
    • Completion date: Oct 2027 to Jan 2029
    • Eligibility criteria expanded, about 54 words
    • Secondary endpoints: 26 to 10
    • Study description shortened, about 20 words
    • Collaborators shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  10. Trial status: Not Yet Recruiting to Recruiting Site details revised at 2 of 2 sitesv4 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  11. Study sites revised (2)v3 See this version in full on ClinicalTrials.gov ↗
  12. Primary endpoints revised (4) Start date: Oct 7, 2024 to Oct 10, 2024 · Interventions: Placebo (Drug), XbAb942 (Biological) to Placebo (Drug), XmAb942 (Biological) · Secondary endpoints: 38 to 26 · 1 morev2 Show 4 more changesShow less
    • Start date: Oct 7, 2024 to Oct 10, 2024
    • Interventions: Placebo (Drug), XbAb942 (Biological) to Placebo (Drug), XmAb942 (Biological)
    • Secondary endpoints: 38 to 26
    • Study description shortened, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  13. 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.
Xencor
10 trials monitored
See all monitored trials
Ulcerative Colitis
587 trials monitored
See 34 trials at risk
The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).
Trial Details
NCT Number NCT06619990
Lead Sponsor Xencor, Inc.
Conditions Ulcerative Colitis (UC)
Enrollment 270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov