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ENROLLING BY INVITATION
NCT07652294
PHASE2

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

Sponsor: Spyre Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

645

Start Date

2026-06-08

Completion Date

2030-01-03

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

SPY001

Experimental

DRUG

SPY002

Experimental

DRUG

SPY003

Experimental

Locations (98)

Site 023

La Jolla, California, United States

Site 012

Lancaster, California, United States

Site 007

Kissimmee, Florida, United States

Site 035

Marrero, Louisiana, United States

Site 028

Rochester, Minnesota, United States

Site 025

Providence, Rhode Island, United States

Study Site 002

San Antonio, Texas, United States

Site 008

Southlake, Texas, United States

Site 019

Tacoma, Washington, United States

Site 102

Lujan de Cuyo, Mendoza Province, Argentina

Site 103

Rosario, Santa Fe Province, Argentina

Site 208

Concord, New South Wales, Australia

Site 206

South Brisbane, Queensland, Australia

Site 463

Linz, Upper Austria, Austria

Site 461

Salzburg, Austria

Site 473

Leuven, Flemish Brabant, Belgium

Site 471

Ghent, Oost-Vlaanderen, Belgium

Site 126

Passo Fundo, Rio Grande Sul, Brazil

Site 128

Santo André, São Paulo, Brazil

Site 153

Osorno, Los Lagos Region, Chile

Site 152

Santiago, Santiago Metropolitan, Chile

Site 531

Brno, Czechia

Site 584

Kutaisi, Georgia

Site 589

Marneuli, Georgia

Site 581

Tbilisi, Georgia

Site 588

Tbilisi, Georgia

Site 583

Tbilisi, Georgia

Site 586

Tbilisi, Georgia

Site 582

Tbilisi, Georgia

Site 587

Tbilisi, Georgia

Site 603

Ulm, Germany

Site 634

Athens, Greece

Site 654

Békéscsaba, Hungary

Site 651

Budapest, Hungary

Site 652

Székesfehérvár, Hungary

Site 673

Legnano, Milan, Italy

Site 672

Negrar, Verona, Italy

Site 424

Amman, Jordan

Site 421

Amman, Jordan

Site 422

Irbid, Jordan

Site 423

Irbid, Jordan

Site 174

Saltillo, Coahuila, Mexico

Site 175

Celaya, Guanajuato, Mexico

Site 173

Tlajomulco de Zúñiga, Jalisco, Mexico

Site 711

Chisinau, Moldova

Site 715

Chisinau, Moldova

Site 712

Chisinau, Moldova

Site 753

Bydgoszcz, Poland

Site 732

Bydgoszcz, Poland

Site 748

Krakow, Poland

Site 750

Kłodzko, Poland

Site 746

Lodz, Poland

Site 743

Opole, Poland

Site 740

Poznan, Poland

Site 736

Rzeszów, Poland

Site 744

Sopot, Poland

Site 737

Szczecin, Poland

Site 733

Szczecin, Poland

Site 752

Tychy, Poland

Site 754

Warsaw, Poland

Site 731

Warsaw, Poland

Site 738

Wroclaw, Poland

Site 734

Wroclaw, Poland

Site 747

Wroclaw, Poland

Site 742

Wroclaw, Poland

Site 781

Bucharest, Romania

Site 788

Timișoara, Romania

Site 802

Belgrade, Serbia

Site 803

Belgrade, Serbia

Site 807

Belgrade, Serbia

Site 801

Zrenjanin, Serbia

Site 823

Bratislava, Slovakia

Site 822

Košice, Slovakia

Site 824

Prešov, Slovakia

Site 353

Wŏnju, Gangwon-do, South Korea

Site 357

Busan, South Korea

Site 354

Daegu, South Korea

Site 361

Daegu, South Korea

Site 355

Daejeon, South Korea

Site 356

Seoul, South Korea

Site 362

Seoul, South Korea

Site 360

Seoul, South Korea

Site 394

Changhua, Taiwan

Site 392

Chiayi City, Taiwan

Site 395

Kaohsiung City, Taiwan

Site 396

Taichung, Taiwan

Site 391

Taipei, Taiwan

Site 906

Ivano-Frankivsk, Ukraine

Site 902

Kyiv, Ukraine

Site 904

Kyiv, Ukraine

Site 913

Kyiv, Ukraine

Site 911

Kyiv, Ukraine

Site 903

Kyiv, Ukraine

Site 901

Lutsk, Ukraine

Site 909

Lviv, Ukraine

Site 914

Poltava, Ukraine

Site 908

Vinnytsia, Ukraine

Site 907

Vinnytsia, Ukraine