Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Spyre Therapeutics, Inc.
Study ID
NCT07652294
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SPY001 — DRUG
    Experimental
  • SPY002 — DRUG
    Experimental
  • SPY003 — DRUG
    Experimental

Study Details

This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).

Key Dates

Start date
Jun 8, 2026
Status verified
Jun 2026
Primary completion
Mar 2, 2029
Completion
Jan 3, 2030

Study Design

Enrollment
645 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SPY001 Dosing Regimen 1
    Participants will receive SPY001
  • Experimental: SPY002 Dosing Regimen 1
    Participants will receive SPY002
  • Experimental: SPY003 Dosing Regimen 1
    Participants will receive SPY003
  • Experimental: SPY001 Dosing Regimen 2
    Participants will receive SPY001
  • Experimental: SPY002 Dosing Regimen 2
    Participants will receive SPY002
  • Experimental: SPY003 Dosing Regimen 2
    Participants will receive SPY003
  • Experimental: SPY001 & SPY002
    Participants will receive SPY001 and SPY002
  • Experimental: SPY001 & SPY003
    Participants will receive SPY001 and SPY003
  • Experimental: SPY002 & SPY003
    Participants will receive SPY002 and SPY003
  • Experimental: SPY002 Dosing Regimen 3
    Participants will receive SPY002

Primary Outcome Measure

To assess the safety and tolerability of study drug treatment regimens [ Time Frame: Week 96 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Study Site 002San AntonioTexas78229-

Find similar trials in San Antonio, TX

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Study· San Antonio, TX

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