Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD (SKYLINE-LTE)

September 11, 2026 updated by: Spyre Therapeutics, Inc.

A Study to Evaluate the Long-term Safety and Efficacy of Long-acting Antibodies as Single Agents and in Combinations in Participants With Inflammatory Bowel Disease

This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study) who have completed Part A and are deemed to be receiving clinical benefit, completed Part B, or met escape criteria in Part B. The primary aim of this LTE study is to characterize the long-term safety of various investigational drugs, to offer participants the option to extend treatment if they are clinically benefiting, or if they have not achieved sufficient clinical benefit (particularly placebo insufficient responders), to offer the opportunity to receive investigational drug.

Study Type

Interventional

Enrollment (Estimated)

645

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Site 103
  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Site 206
  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Site 471
  • Czechia
      • Brno, Czechia, 615 00
        • Site 531
  • Georgia
      • Kutaisi, Georgia, 4600
        • Site 584
      • Tbilisi, Georgia, 0144
        • Site 586
      • Tbilisi, Georgia, 0144
        • Site 583
      • Tbilisi, Georgia, 0102
        • Site 581
      • Tbilisi, Georgia, 0114
        • Site 588
      • Tbilisi, Georgia, 0159
        • Site 582
  • Greece
      • Athens, Greece, 106 76
        • Site 634
  • Hungary
      • Budapest, Hungary, H-1088
        • Site 651
  • Italy
    • Verona
      • Negrar, Verona, Italy, 37024
        • Site 672
  • Jordan
      • Amman, Jordan, 11196
        • Site 424
      • Irbid, Jordan, 21110
        • Site 422
  • Moldova
      • Chisinau, Moldova, MD-2025
        • Site 711
  • Poland
      • Bydgoszcz, Poland, 85-229
        • Site 753
      • Bydgoszcz, Poland, 85-794
        • Site 732
      • Poznan, Poland, 60-309
        • Site 740
      • Rzeszów, Poland, 35-326
        • Site 736
      • Sopot, Poland, 81-756
        • Site 744
      • Szczecin, Poland, 71-434
        • Site 737
      • Tychy, Poland, 43-100
        • Site 752
      • Warsaw, Poland, 02-172
        • Site 754
      • Warsaw, Poland, 04-501
        • Site 731
      • Wroclaw, Poland, 52-416
        • Site 738
      • Wroclaw, Poland, 54-239
        • Site 742
      • Wroclaw, Poland, 53-149
        • Site 734
  • Romania
      • Timișoara, Romania, 300239
        • Site 788
  • Serbia
      • Belgrade, Serbia, 11000
        • Site 802
      • Zrenjanin, Serbia, 23000
        • Site 801
  • Slovakia
      • Bratislava, Slovakia, 811 09
        • Site 823
      • Prešov, Slovakia, 080 01
        • Site 824
  • South Korea
      • Busan, South Korea, 48108
        • Site 357
      • Daegu, South Korea, 42601
        • Site 361
      • Seoul, South Korea, 03312
        • Site 356
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
        • Site 353
  • Taiwan
      • Chiayi City, Taiwan, 600
        • Site 392
      • Taichung, Taiwan, 404327
        • Site 396
      • Taipei, Taiwan, 100225
        • Site 391
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76008
        • Site 906
      • Kyiv, Ukraine, 04050
        • Site 913
      • Kyiv, Ukraine, 04210
        • Site 903
      • Kyiv, Ukraine, 02091
        • Site 904
      • Kyiv, Ukraine, 02002
        • Site 902
      • Kyiv, Ukraine, 04106
        • Site 911
      • Lutsk, Ukraine, 43005
        • Site 901
      • Poltava, Ukraine, 36011
        • Site 914
  • United States
    • California
      • Lancaster, California, United States, 93534
        • Site 012
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Site 035
    • Texas
      • San Antonio, Texas, United States, 78229
        • Study Site 002
    • Washington
      • Tacoma, Washington, United States, 98405
        • Site 019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet 1 of the following criteria from Study SPY123-201:

  1. Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator
  2. Completed Part B
  3. Participated in Part B and met escape criteria per the SPY123-201 protocol (ie, did not achieve sufficient improvement after the induction treatment period [ITP] or experienced disease worsening during the maintenance treatment period [MTP]).

Exclusion Criteria:

  1. Met any treatment discontinuation criteria from Study SPY123-201.

  2. Is on any of the following prohibited medications:

    1. Immunosuppressants (eg, azathioprine, 6-mercaptopurine [6-MP], or methotrexate)
    2. Systemic tacrolimus, systemic cyclosporine, oral mycophenolate mofetil (MMF), immunoadsorption columns (such as Prosorba columns), penicillamine, leflunomide, thalidomide, or any other medications that may have immunosuppressive effects
    3. Any marketed advanced therapy (ie, biologic or small molecule)
    4. Any investigational therapy other than SPY123-201 study drug
    5. Total parenteral nutrition
  3. Development of any new, unstable, or uncontrolled metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological (including current and past neurological symptoms suggestive of demyelinating disease), respiratory, endocrine, or psychiatric disorder, acute or chronic infectious diseases, suspected or confirmed immunodeficiency, and suspected or confirmed malignancies, as determined by the Investigator that is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance.
  4. Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPY001 Dosing Regimen 1
Participants will receive SPY001
Drug: SPY001
Experimental
Other Names:
  • SPY001-001
Experimental: SPY002 Dosing Regimen 1
Participants will receive SPY002
Drug: SPY002
Experimental
Other Names:
  • SPY002-091
Experimental: SPY003 Dosing Regimen 1
Participants will receive SPY003
Drug: SPY003
Experimental
Other Names:
  • SPY003-207
Experimental: SPY001 Dosing Regimen 2
Participants will receive SPY001
Drug: SPY001
Experimental
Other Names:
  • SPY001-001
Experimental: SPY002 Dosing Regimen 2
Participants will receive SPY002
Drug: SPY002
Experimental
Other Names:
  • SPY002-091
Experimental: SPY003 Dosing Regimen 2
Participants will receive SPY003
Drug: SPY003
Experimental
Other Names:
  • SPY003-207
Experimental: SPY001 & SPY002
Participants will receive SPY001 and SPY002
Drug: SPY001
Experimental
Other Names:
  • SPY001-001
Drug: SPY002
Experimental
Other Names:
  • SPY002-091
Experimental: SPY001 & SPY003
Participants will receive SPY001 and SPY003
Drug: SPY001
Experimental
Other Names:
  • SPY001-001
Drug: SPY003
Experimental
Other Names:
  • SPY003-207
Experimental: SPY002 & SPY003
Participants will receive SPY002 and SPY003
Drug: SPY002
Experimental
Other Names:
  • SPY002-091
Drug: SPY003
Experimental
Other Names:
  • SPY003-207
Experimental: SPY002 Dosing Regimen 3
Participants will receive SPY002
Drug: SPY002
Experimental
Other Names:
  • SPY002-091

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who experienced an adverse event
Time Frame: Week 96
Incidence of treatment-emergent adverse events (TEAEs) as measured over time.
Week 96

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with endoscopic improvement
Time Frame: Week 48
Percentage of participants with endoscopic improvement at Week 48 will be assessed. Endoscopic improvement based on the Mayo endoscopic subscore (ranging from 0 to 3). Higher score indicates more severe disease.
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spyre Therapeutics, Inc.

Investigators

  • Study Director: SKYLINE Study Director, Spyre Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2026

Primary Completion (Estimated)

March 2, 2029

Study Completion (Estimated)

January 3, 2030

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPY123-202
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524640-35-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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