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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening - Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis) - Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2

Exclusion Criteria

  • Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined - Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction - Failed 4 or more approved or investigational advanced therapy classes

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention Specific Appendix - SPY001: Part A 		Participants will receive open-label dose of SPY001
  • Drug: SPY001
    Experimental
    Other names:
    • SPY001-001
Experimental
Intervention Specific Appendix - SPY002: Part A 		Participants will receive open-label dose of SPY002
  • Drug: SPY002
    Experimental
    Other names:
    • SPY002-091
Experimental
Intervention Specific Appendix - SPY003: Part A 		Participants will receive open-label dose of SPY003
  • Drug: SPY003
    Experimental
    Other names:
    • SPY003-207
Experimental
Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B 		Participants will receive double-blind dosing regimen 1 of SPY001
  • Drug: SPY001
    Experimental
    Other names:
    • SPY001-001
Experimental
Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B 		Participants will receive double-blind dosing regimen 2 of SPY001
  • Drug: SPY001
    Experimental
    Other names:
    • SPY001-001
Experimental
Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B 		Participants will receive double-blind dosing regimen 1 of SPY002
  • Drug: SPY002
    Experimental
    Other names:
    • SPY002-091
Experimental
Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B 		Participants will receive double-blind dosing regimen 2 of SPY002
  • Drug: SPY002
    Experimental
    Other names:
    • SPY002-091
Experimental
Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B 		Participants will receive double-blind dosing regimen 1 of SPY003
  • Drug: SPY003
    Experimental
    Other names:
    • SPY003-207
Experimental
Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B 		Participants will receive double-blind dosing regimen 2 of SPY003
  • Drug: SPY003
    Experimental
    Other names:
    • SPY003-207
Experimental
Intervention Specific Appendix - SPY120: Part B 		Participants will receive double-blind dose of SPY001 and SPY002
  • Drug: SPY001
    Experimental
    Other names:
    • SPY001-001
  • Drug: SPY002
    Experimental
    Other names:
    • SPY002-091
Experimental
Intervention Specific Appendix - SPY130: Part B 		Participants will receive double-blind dose of SPY001 and SPY003
  • Drug: SPY001
    Experimental
    Other names:
    • SPY001-001
  • Drug: SPY003
    Experimental
    Other names:
    • SPY003-207
Experimental
Intervention Specific Appendix - SPY230: Part B 		Participants will receive double-blind dose of SPY002 and SPY003
  • Drug: SPY002
    Experimental
    Other names:
    • SPY002-091
  • Drug: SPY003
    Experimental
    Other names:
    • SPY003-207
Placebo Comparator
Placebo: Part B 		Participants will receive matching placebo
  • Other: Placebo
    Placebo

Recruiting Locations

Site 024
Canoga Park 5333913, California 5332921 91304
Contact:
SKYLINE-UC Trial Center

Site 012
Lancaster 5364940, California 5332921 93534
Contact:
SKYLINE-UC Trial Center

Site 033
Colorado Springs 5417598, Colorado 5417618 91304
Contact:
SKYLINE-UC Trial Center

Site 007
Kissimmee 4160983, Florida 4155751 34741
Contact:
SKYLINE-UC Trial Center

029
Miami 4164138, Florida 4155751 33165
Contact:
SKYLINE-UC Trial Center

Site 006
Kansas City 4273837, Kansas 4273857 66160
Contact:
SKYLINE-UC Trial Center

Site 035
Marrero 4332628, Louisiana 4331987 70072
Contact:
SKYLINE-UC Trial Center

Site 011
Glen Burnie 4356188, Maryland 4361885 21061
Contact:
Skyline-UC Trial Center

040
Chapel Hill 4460162, North Carolina 4482348 27599
Contact:
SKYLINE-UC Trial Center

Site 016
Winston-Salem 4499612, North Carolina 4482348 27103
Contact:
SKYLINE-UC Trial Center

Site 025
Providence 5224151, Rhode Island 5224323 02904
Contact:
SKYLINE- UC Trial Center

Site 017
Kingsport 4634662, Tennessee 4662168 37663
Contact:
SKYLINE-UC Trial Center

Site 013
Cedar Park 4679867, Texas 4736286 78613
Contact:
SKYLINE-UC Trial Center

Site 005
Garland 4693003, Texas 4736286 75246
Contact:
SKYLINE-UC Trial Center

Site 002
San Antonio 4726206, Texas 4736286 78229
Contact:
SKYLINE-UC Trial Center

Site 008
Southlake 4733313, Texas 4736286 76092
Contact:
SKYLINE-UC Trial Center

Site 009
Webster 4740423, Texas 4736286 77598
Contact:
SKYLINE-UC Trial Center

Site 019
Tacoma 5812944, Washington 5815135 98405
Contact:
SKYLINE-UC Trial Center

More Details

Status
Recruiting
Sponsor
Spyre Therapeutics, Inc.

Study Contact

SKYLINE-UC Trial Center
1-650-402-4238
info@skyline-uc.com

Detailed Description

This platform study will evaluate the efficacy and safety of investigational treatments, including 3 monotherapies and 3 combination therapies, for moderately to severely active UC in adults. The study will progress in two parts. Part A is the open-label portion of the study assessing safety and preliminary efficacy of monotherapies. Part B, which will be open for enrollment after Part A, is the randomized, placebo-controlled portion of the study assessing the safety and efficacy of the 6 interventions (3 monotherapies and 3 combinations) compared to placebo. Intervention arms will be added to the study over time and may complete at different times.