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PEGASUSNCT07747467

A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 7 months later, enrollment reduced 50%.

See at-risk trials from GlaxoSmithKline

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 16 → 8 participants Show 5 more changesShow less
    • Primary and study completion dates pushed to Mar 21, 2029
    • Recruitment opened
    • Eligibility criteria expanded, about 31 words
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 10, 2026 to Sep 3, 2026
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Number of Participants with Adverse Events (AEs)
Timeframe: Up to 34 weeks
Number of Participants with Serious AEs (SAEs)
Timeframe: Up to 34 weeks
Number of Participants who Discontinue Study Intervention due to AEs
Timeframe: Up to 34 weeks
Number of Participants with Clinically Significant Changes in Laboratory Readings
Timeframe: Up to 34 weeks
Number of Participants with Clinically Significant Changes in Vital Signs
Timeframe: Up to 34 weeks
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings
Timeframe: Up to 34 weeks

Arms and interventions

AletekitugExperimental

Participants will receive Aletekitug.

Biologicals: Aletekitug (GSK1070806)

Sites

1 site in 1 country

  • GSK Investigational SiteOxford, United Kingdom