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A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Primary and study completion pushed from Feb 2027 to Oct 2028v3
  3. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 27 to 60 · Start date changed from estimate of Feb 2026 to Feb 24, 2026 · Interventions: XmAb13676 (Biological) to XmAb657 (Biological) · 5 morev2 Show 8 more changesShow less
    • Enrollment target: 27 to 60
    • Start date changed from estimate of Feb 2026 to Feb 24, 2026
    • Interventions: XmAb13676 (Biological) to XmAb657 (Biological)
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
    • Study description expanded, about 1 word
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
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Scleroderma
305 trials monitored
See 10 trials at risk
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.
Trial Details
NCT Number NCT07284797
Lead Sponsor Xencor, Inc.
Conditions Healthy, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjögren's Disease
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov