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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

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, California 91304
Contact:
SKYLINE-UC Trial Center

Site 023
La Jolla, California 92037
Contact:
SKYLINE-UC Trial Center

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

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

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

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

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

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

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

Site 003
Boston, Massachusetts 02114
Contact:
SKYLINE-UC Trial Center

Site 028
Rochester, Minnesota 55905
Contact:
SKYLINE-UC Trial Center

Site 037
New York, New York 10065
Contact:
SKYLINE-UC Trial Center

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

Site 041
Durham, North Carolina 27710
Contact:
SKYLINE-UC Trial Center

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

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

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

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

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

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

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

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

Site 019
Tacoma, Washington 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.