Recruiting

Phase 2

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

Sponsor:

Spyre Therapeutics, Inc.

Code:

NCT07012395

Conditions

Ulcerative Colitis

Inflammatory Bowel Diseases

Colitis

Colitis, Ulcerative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SPY001

SPY002

SPY003

Placebo

Study Details

Brief summary:

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

Study ID

NCT07012395

Start date

May 27, 2025

Status verified date

Jul, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

645 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

SPY001

Experimental

SPY002

Experimental

SPY003

Experimental

Placebo

Primary outcome measure

Part A: Change in Robarts Histopathology Index (RHI) [ Time Frame: Week 12 ]
Part B: Percentage of participants with clinical remission [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

SKYLINE-UC Trial Center

1-650-402-4238 info@skyline-uc.com

Locations

Site 024

Recruiting

Canoga Park, California, United States, 91304

Site 023

Recruiting

La Jolla, California, United States, 92037

Site 012

Recruiting

Lancaster, California, United States, 93534

Site 033

Recruiting

Colorado Springs, Colorado, United States, 91304

Site 007

Recruiting

Kissimmee, Florida, United States, 34741

029

Recruiting

Miami, Florida, United States, 33165

Site 038

Recruiting

Chicago, Illinois, United States, 60637

Site 006

Recruiting

Kansas City, Kansas, United States, 66160

Site 030

Recruiting

Louisville, Kentucky, United States, 40202

Site 035

Recruiting

Marrero, Louisiana, United States, 70072

Site 011

Recruiting

Glen Burnie, Maryland, United States, 21061

Site 003

Recruiting

Boston, Massachusetts, United States, 02114

Site 028

Recruiting

Rochester, Minnesota, United States, 55905

Site 037

Recruiting

New York, New York, United States, 10065

040

Recruiting

Chapel Hill, North Carolina, United States, 27599

Site 041

Recruiting

Durham, North Carolina, United States, 27710

Site 016

Recruiting

Winston-Salem, North Carolina, United States, 27103

Site 025

Recruiting

Providence, Rhode Island, United States, 02904

Site 017

Recruiting

Kingsport, Tennessee, United States, 37663

Site 013

Recruiting

Cedar Park, Texas, United States, 78613

Site 005

Recruiting

Garland, Texas, United States, 75246

Site 002

Recruiting

San Antonio, Texas, United States, 78229

Site 008

Recruiting

Southlake, Texas, United States, 76092

Site 009

Recruiting

Webster, Texas, United States, 77598

Site 004

Recruiting

Seattle, Washington, United States, 98195

Site 019

Recruiting

Tacoma, Washington, United States, 98405

Site 083

Recruiting

London, Ontario, Canada, G8H 3P7

Site 084

Recruiting

Toronto, Ontario, Canada, M5G1X5

Site 085

Recruiting

Greater Sudbury, Canada, P3C1X3

Site 086

Recruiting

London, Canada, N6K 1M6

More Information

Sponsor

Spyre Therapeutics, Inc.

Last update posted

Aug 25, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Spyre Therapeutics, Inc. on 2026-08-25.