Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD

NCT07652294 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 3 other identifiers: SPY123-2022025-524640-35-002025
• Study Type: interventional
• Target: 645
• Locations: 18 countries
• Sites: 59

Brief Summary

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

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative

Keywords

Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who experienced an adverse event

  Incidence of treatment-emergent adverse events (TEAEs) as measured over time.

  Week 96

Secondary Outcomes (1)

• Percentage of participants with endoscopic improvement

  Week 48

Study Arms (10)

SPY001 Dosing Regimen 1

EXPERIMENTAL

Participants will receive SPY001

Drug: SPY001

SPY002 Dosing Regimen 1

EXPERIMENTAL

Participants will receive SPY002

Drug: SPY002

SPY003 Dosing Regimen 1

EXPERIMENTAL

Participants will receive SPY003

Drug: SPY003

SPY001 Dosing Regimen 2

EXPERIMENTAL

Participants will receive SPY001

Drug: SPY001

SPY002 Dosing Regimen 2

EXPERIMENTAL

Participants will receive SPY002

Drug: SPY002

SPY003 Dosing Regimen 2

EXPERIMENTAL

Participants will receive SPY003

Drug: SPY003

SPY001 & SPY002

EXPERIMENTAL

Participants will receive SPY001 and SPY002

Drug: SPY001; Drug: SPY002

SPY001 & SPY003

EXPERIMENTAL

Participants will receive SPY001 and SPY003

Drug: SPY001; Drug: SPY003

SPY002 & SPY003

EXPERIMENTAL

Participants will receive SPY002 and SPY003

Drug: SPY002; Drug: SPY003

SPY002 Dosing Regimen 3

EXPERIMENTAL

Participants will receive SPY002

Drug: SPY002

Interventions

SPY001 DRUG

Experimental

Also known as: SPY001-001

SPY001 & SPY002; SPY001 & SPY003; SPY001 Dosing Regimen 1; SPY001 Dosing Regimen 2

SPY002 DRUG

Experimental

Also known as: SPY002-091

SPY001 & SPY002; SPY002 & SPY003; SPY002 Dosing Regimen 1; SPY002 Dosing Regimen 2; SPY002 Dosing Regimen 3

SPY003 DRUG

Experimental

Also known as: SPY003-207

SPY001 & SPY003; SPY002 & SPY003; SPY003 Dosing Regimen 1; SPY003 Dosing Regimen 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet 1 of the following criteria from Study SPY123-201:
• Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator
• Completed Part B
• 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 \[MTP\]).

You may not qualify if:

• Met any treatment discontinuation criteria from Study SPY123-201.
• Is on any of the following prohibited medications:
• Immunosuppressants (eg, azathioprine, 6-mercaptopurine \[6-MP\], or methotrexate)
• 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
• Any marketed advanced therapy (ie, biologic or small molecule)
• Any investigational therapy other than SPY123-201 study drug
• Total parenteral nutrition
• 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.
• Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.

Sponsors & Collaborators

• Spyre Therapeutics, Inc.: lead

Study Sites (59)

Site 012

Lancaster, California, 93534, United States

Location

Site 007

Kissimmee, Florida, 34741, United States

Location

Site 035

Marrero, Louisiana, 70072, United States

Location

Site 025

Providence, Rhode Island, 02904, United States

Location

Study Site 002

San Antonio, Texas, 78229, United States

Location

Site 019

Tacoma, Washington, 98405, United States

Location

Site 103

Rosario, Santa Fe Province, 2000, Argentina

Location

Site 206

South Brisbane, Queensland, 4101, Australia

Location

Site 471

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Site 531

Brno, 615 00, Czechia

Location

Site 584

Kutaisi, 4600, Georgia

Location

Site 589

Marneuli, 3000, Georgia

Location

Site 581

Tbilisi, 0102, Georgia

Location

Site 588

Tbilisi, 0114, Georgia

Location

Site 583

Tbilisi, 0144, Georgia

Location

Site 586

Tbilisi, 0144, Georgia

Location

Site 582

Tbilisi, 0159, Georgia

Location

Site 634

Athens, 106 76, Greece

Location

Site 651

Budapest, H-1088, Hungary

Location

Site 672

Negrar, Verona, 37024, Italy

Location

Site 424

Amman, 11196, Jordan

Location

Site 422

Irbid, 21110, Jordan

Location

Site 711

Chisinau, MD-2025, Moldova

Location

Site 753

Bydgoszcz, 85-229, Poland

Location

Site 732

Bydgoszcz, 85-794, Poland

Location

Site 750

Kłodzko, 57-300, Poland

Location

Site 743

Opole, 45-819, Poland

Location

Site 740

Poznan, 60-309, Poland

Location

Site 736

Rzeszów, 35-326, Poland

Location

Site 744

Sopot, 81-756, Poland

Location

Site 737

Szczecin, 71-434, Poland

Location

Site 752

Tychy, 43-100, Poland

Location

Site 754

Warsaw, 02-172, Poland

Location

Site 731

Warsaw, 04-501, Poland

Location

Site 738

Wroclaw, 52-416, Poland

Location

Site 734

Wroclaw, 53-149, Poland

Location

Site 747

Wroclaw, 53-611, Poland

Location

Site 742

Wroclaw, 54-239, Poland

Location

Site 788

Timișoara, 300239, Romania

Location

Site 802

Belgrade, 11000, Serbia

Location

Site 801

Zrenjanin, 23000, Serbia

Location

Site 823

Bratislava, 811 09, Slovakia

Location

Site 824

Prešov, 080 01, Slovakia

Location

Site 353

Wŏnju, Gangwon-do, 26426, South Korea

Location

Site 357

Busan, 48108, South Korea

Location

Site 361

Daegu, 42601, South Korea

Location

Site 355

Daejeon, 34943, South Korea

Location

Site 356

Seoul, 03312, South Korea

Location

Site 392

Chiayi City, 600, Taiwan

Location

Site 396

Taichung, 404327, Taiwan

Location

Site 391

Taipei, 100225, Taiwan

Location

Site 906

Ivano-Frankivsk, 76008, Ukraine

Location

Site 902

Kyiv, 02002, Ukraine

Location

Site 904

Kyiv, 02091, Ukraine

Location

Site 913

Kyiv, 04050, Ukraine

Location

Site 911

Kyiv, 04106, Ukraine

Location

Site 903

Kyiv, 04210, Ukraine

Location

Site 901

Lutsk, 43005, Ukraine

Location

Site 914

Poltava, 36011, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• SKYLINE Study Director

  Spyre Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): March 2, 2029
• Study Completion (Estimated): January 3, 2030
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1); US (6); AR (1); GR (1); JO (2); RO (1); PL (15); GE (7); KR (5); SE (2); UA (8); TW (3); CZ (1); HU (1); IT (1); AU (1); SL (2); BE (1)