A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

Conditions

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SPY001 — DRUG
  Experimental
• SPY002 — DRUG
  Experimental
• SPY003 — DRUG
  Experimental
• Placebo — OTHER
  Placebo

Study Details

This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.

Key Dates

Start date

May 27, 2025

Status verified

Jun 2026

Primary completion

Jun 30, 2026

Completion

Mar 31, 2028

Study Design

Enrollment

645 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Intervention Specific Appendix - SPY001: Part A
  Participants will receive open-label dose of SPY001
• Experimental: Intervention Specific Appendix - SPY002: Part A
  Participants will receive open-label dose of SPY002
• Experimental: Intervention Specific Appendix - SPY003: Part A
  Participants will receive open-label dose of SPY003
• Experimental: Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B
  Participants will receive double-blind dosing regimen 1 of SPY001
• Experimental: Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B
  Participants will receive double-blind dosing regimen 2 of SPY001
• Experimental: Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B
  Participants will receive double-blind dosing regimen 1 of SPY002
• Experimental: Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B
  Participants will receive double-blind dosing regimen 2 of SPY002
• Experimental: Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B
  Participants will receive double-blind dosing regimen 1 of SPY003
• Experimental: Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B
  Participants will receive double-blind dosing regimen 2 of SPY003
• Experimental: Intervention Specific Appendix - SPY120: Part B
  Participants will receive double-blind dose of SPY001 and SPY002
• Experimental: Intervention Specific Appendix - SPY130: Part B
  Participants will receive double-blind dose of SPY001 and SPY003
• Experimental: Intervention Specific Appendix - SPY230: Part B
  Participants will receive double-blind dose of SPY002 and SPY003
• Placebo Comparator: Placebo: Part B
  Participants will receive matching placebo

Primary Outcome Measure

Part A: Change in Robarts Histopathology Index (RHI) [ Time Frame: Week 12 ]

Central Contacts

• SKYLINE-UC Trial Center
  1-650-402-4238
  [email protected]

Locations (25)

Find similar trials in Canoga Park, CA

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