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

NCT ID: NCT07012395

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

645 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-27

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ulcerative Colitis Inflammatory Bowel Diseases Colitis Colitis, Ulcerative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention Specific Appendix - SPY001: Part A

Participants will receive open-label dose of SPY001

Group Type EXPERIMENTAL

SPY001

Intervention Type DRUG

Experimental

Intervention Specific Appendix - SPY002: Part A

Participants will receive open-label dose of SPY002

Group Type EXPERIMENTAL

SPY002

Intervention Type DRUG

Experimental

Intervention Specific Appendix - SPY003: Part A

Participants will receive open-label dose of SPY003

Group Type EXPERIMENTAL

SPY003

Intervention Type DRUG

Experimental

Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B

Participants will receive double-blind dosing regimen 1 of SPY001

Group Type EXPERIMENTAL

SPY001

Intervention Type DRUG

Experimental

Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B

Participants will receive double-blind dosing regimen 2 of SPY001

Group Type EXPERIMENTAL

SPY001

Intervention Type DRUG

Experimental

Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B

Participants will receive double-blind dosing regimen 1 of SPY002

Group Type EXPERIMENTAL

SPY002

Intervention Type DRUG

Experimental

Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B

Participants will receive double-blind dosing regimen 2 of SPY002

Group Type EXPERIMENTAL

SPY002

Intervention Type DRUG

Experimental

Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B

Participants will receive double-blind dosing regimen 1 of SPY003

Group Type EXPERIMENTAL

SPY003

Intervention Type DRUG

Experimental

Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B

Participants will receive double-blind dosing regimen 2 of SPY003

Group Type EXPERIMENTAL

SPY003

Intervention Type DRUG

Experimental

Intervention Specific Appendix - SPY120: Part B

Participants will receive double-blind dose of SPY001 and SPY002

Group Type EXPERIMENTAL

SPY001

Intervention Type DRUG

Experimental

SPY002

Intervention Type DRUG

Experimental

Intervention Specific Appendix - SPY130: Part B

Participants will receive double-blind dose of SPY001 and SPY003

Group Type EXPERIMENTAL

SPY001

Intervention Type DRUG

Experimental

SPY003

Intervention Type DRUG

Experimental

Intervention Specific Appendix - SPY230: Part B

Participants will receive double-blind dose of SPY002 and SPY003

Group Type EXPERIMENTAL

SPY002

Intervention Type DRUG

Experimental

SPY003

Intervention Type DRUG

Experimental

Placebo: Part B

Participants will receive matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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SPY001

Experimental

Intervention Type DRUG

SPY002

Experimental

Intervention Type DRUG

SPY003

Experimental

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Other Intervention Names

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SPY001-001 SPY002-091 SPY003-207

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spyre Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SKYLINE-UC Study Director

Role: STUDY_DIRECTOR

Spyre Therapeutics

Locations

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Site 024

Canoga Park, California, United States

Site Status RECRUITING

Site 012

Lancaster, California, United States

Site Status RECRUITING

Site 033

Colorado Springs, Colorado, United States

Site Status RECRUITING

Site 007

Kissimmee, Florida, United States

Site Status RECRUITING

029

Miami, Florida, United States

Site Status RECRUITING

Site 035

Marrero, Louisiana, United States

Site Status RECRUITING

Site 011

Glen Burnie, Maryland, United States

Site Status RECRUITING

040

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Site 016

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Site 025

Providence, Rhode Island, United States

Site Status RECRUITING

Site 017

Kingsport, Tennessee, United States

Site Status RECRUITING

Site 013

Cedar Park, Texas, United States

Site Status RECRUITING

Site 005

Garland, Texas, United States

Site Status RECRUITING

Site 002

San Antonio, Texas, United States

Site Status RECRUITING

Site 008

Southlake, Texas, United States

Site Status RECRUITING

Site 009

Webster, Texas, United States

Site Status RECRUITING

Site 019

Tacoma, Washington, United States

Site Status RECRUITING

Site 483

Sarajevo, , Bosnia and Herzegovina

Site Status RECRUITING

Site 083

London, Ontario, Canada

Site Status RECRUITING

Site 584

Kutaisi, , Georgia

Site Status RECRUITING

Site 589

Marneuli, , Georgia

Site Status RECRUITING

Site 581

Tbilisi, , Georgia

Site Status RECRUITING

Site 588

Tbilisi, , Georgia

Site Status RECRUITING

Site 583

Tbilisi, , Georgia

Site Status RECRUITING

Site 586

Tbilisi, , Georgia

Site Status RECRUITING

Site 582

Tbilisi, , Georgia

Site Status RECRUITING

Site 587

Tbilisi, , Georgia

Site Status RECRUITING

Site 590

Tbilisi, , Georgia

Site Status RECRUITING

Site 585

Tbilisi, , Georgia

Site Status RECRUITING

Site 713

Chisinau, , Moldova

Site Status RECRUITING

Site 711

Chisinau, , Moldova

Site Status RECRUITING

Site 712

Chisinau, , Moldova

Site Status RECRUITING

Site 714

Chisinau, , Moldova

Site Status RECRUITING

Site 715

Chisinau, , Moldova

Site Status RECRUITING

Site 802

Belgrade, , Serbia

Site Status RECRUITING

Site 807

Belgrade, , Serbia

Site Status RECRUITING

Site 803

Belgrade, , Serbia

Site Status RECRUITING

Site 806

Užice, , Serbia

Site Status RECRUITING

Site 801

Zrenjanin, , Serbia

Site Status RECRUITING

Site 355

Daejeon, , South Korea

Site Status RECRUITING

Site 362

Seoul, , South Korea

Site Status RECRUITING

Site 906

Ivano-Frankivsk, , Ukraine

Site Status RECRUITING

Site 902

Kyiv, , Ukraine

Site Status RECRUITING

Site 904

Kyiv, , Ukraine

Site Status RECRUITING

Site 905

Kyiv, , Ukraine

Site Status RECRUITING

Site 913

Kyiv, , Ukraine

Site Status RECRUITING

Site 911

Kyiv, , Ukraine

Site Status RECRUITING

Site 903

Kyiv, , Ukraine

Site Status RECRUITING

Site 901

Lutsk, , Ukraine

Site Status RECRUITING

Site 909

Lviv, , Ukraine

Site Status RECRUITING

Site 914

Poltava, , Ukraine

Site Status RECRUITING

Site 908

Vinnytsia, , Ukraine

Site Status RECRUITING

Site 907

Vinnytsia, , Ukraine

Site Status RECRUITING

Countries

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United States Bosnia and Herzegovina Canada Georgia Moldova Serbia South Korea Ukraine

Central Contacts

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SKYLINE-UC Trial Center

Role: CONTACT

Phone: 1-650-402-4238

Email: [email protected]

Facility Contacts

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SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

Skyline-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE- UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC Trial Center

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

SKYLINE-UC

Role: primary

Other Identifiers

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SPY123-201

Identifier Type: -

Identifier Source: org_study_id