RecruitingPhase 2NCT07012395

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

Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis


Sponsor

Spyre Therapeutics, Inc.

Enrollment

645 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing several new long-acting antibody-based treatments — used alone or in combination — for people with moderately to severely active ulcerative colitis (UC), a chronic inflammatory disease of the large bowel that causes diarrhea, bleeding, and abdominal pain. **You may be eligible if...** - You have been diagnosed with ulcerative colitis for at least 3 months, confirmed by colonoscopy and biopsy - You have moderate-to-severe active disease (based on endoscopy scores and symptoms) - You have tried standard treatments that have not worked well enough **You may NOT be eligible if...** - You have Crohn's disease, or it is unclear whether you have Crohn's or UC - You have had a prior colon surgery or a stoma - You have active infections (such as C. difficile or CMV in the colon) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSPY001

Experimental

DRUGSPY002

Experimental

DRUGSPY003

Experimental

OTHERPlacebo

Placebo


Locations(175)

Site 024

Canoga Park, California, United States

Site 023

La Jolla, California, United States

Site 012

Lancaster, California, United States

Site 033

Colorado Springs, Colorado, United States

Site 007

Kissimmee, Florida, United States

029

Miami, Florida, United States

Site 006

Kansas City, Kansas, United States

Site 035

Marrero, Louisiana, United States

Site 011

Glen Burnie, Maryland, United States

Site 003

Boston, Massachusetts, United States

Site 028

Rochester, Minnesota, United States

Site 037

New York, New York, United States

040

Chapel Hill, North Carolina, United States

Site 041

Durham, North Carolina, United States

Site 016

Winston-Salem, North Carolina, United States

Site 025

Providence, Rhode Island, United States

Site 017

Kingsport, Tennessee, United States

Site 013

Cedar Park, Texas, United States

Site 005

Garland, Texas, United States

Site 002

San Antonio, Texas, United States

Site 008

Southlake, Texas, United States

Site 009

Webster, Texas, United States

Site 019

Tacoma, Washington, United States

Site 208

Concord, Australia

Site 202

Heidelberg, Australia

Site 204

Liverpool, Australia

Site 203

Melbourne, Australia

Site 206

South Brisbane, Australia

Site 207

Woolloongabba, Australia

Site 463

Linz, Austria

Site 475

Bruges, Belgium

Site 471

Ghent, Belgium

Site 472

Roeselare, Belgium

Site 481

Banja Luka, Bosnia and Herzegovina

Site 484

Mostar, Bosnia and Herzegovina

Site 483

Sarajevo, Bosnia and Herzegovina

Site 494

Gorna Oryahovitsa, Bulgaria

Site 498

Rousse, Bulgaria

Site 492

Sofia, Bulgaria

Site 495

Sofia, Bulgaria

Site 083

London, Ontario, Canada

Site 085

Greater Sudbury, Canada

Site 086

London, Canada

Site 531

Brno, Czechia

Site 536

Klatovy, Czechia

Site 534

Ostrava, Czechia

Site 538

Prague, Czechia

Site 551

Nantes, France

Site 558

Saint-Etienne, France

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 590

Tbilisi, Georgia

Site 585

Tbilisi, Georgia

Site 606

Berlin, Germany

Site 604

Berlin, Germany

Site 611

Brandenburg an der Havel, Germany

Site 607

Dachau, Germany

Site 609

Munich, Germany

Site 603

Ulm, Germany

Site 635

Athens, Attica, Greece

Site 634

Athens, Greece

Site 632

Athens, Greece

Site 631

Chaïdári, Greece

Site 656

Budapest, Hungary

Site 651

Budapest, Hungary

Site 652

Székesfehérvár, Hungary

Site 270

Hyderabad, India

Site 268

Jaipur, India

Site 266

Kochi, India

Site 265

Sūrat, India

Site 445

Beer Yaaqov, Israel

Site 441

Beersheba, Israel

Site 443

Haifa, Israel

Site 444

Jerusalem, Israel

Site 446

Jerusalem, Israel

Site 442

Nahariya, Israel

Site 676

San Donato Milanese, Milan, Italy

Site 671

Segrate, Milan, Italy

Site 672

Negrar, Italy

Site 681

Rome, Italy

Site 675

Turin, Italy

Site 293

Urayasu-shi, Japan

Site 424

Amman, Jordan

Site 421

Amman, Jordan

Site 422

Irbid, Jordan

Site 703

Vilnius, Lithuania

Site 713

Chisinau, Moldova

Site 711

Chisinau, Moldova

Site 712

Chisinau, Moldova

Site 714

Chisinau, Moldova

Site 715

Chisinau, Moldova

Site 753

Bydgoszcz, Poland

Site 732

Bydgoszcz, Poland

Site 749

Katowice, Poland

Site 735

Katowice, Poland

Site 748

Krakow, Poland

Site 743

Opole, Poland

Site 740

Poznan, Poland

Site 736

Rzeszów, Poland

Site 744

Sopot, Poland

Site 745

Staszów, Poland

Site 737

Szczecin, Poland

Site 733

Szczecin, Poland

Site 752

Tychy, Poland

Site 739

Warsaw, Poland

Site 751

Warsaw, Poland

Site 754

Warsaw, Poland

Site 741

Warsaw, Poland

Site 731

Warsaw, Poland

Site 750

Warsaw, Poland

Site 738

Wroclaw, Poland

Site 734

Wroclaw, Poland

Site 747

Wroclaw, Poland

Site 742

Wroclaw, Poland

Site 784

Bucharest, Romania

Site 781

Bucharest, Romania

Site 786

Constanța, Romania

Site 788

Timișoara, Romania

Trial Site 804

Belgrade, Serbia

Site 802

Belgrade, Serbia

Site 807

Belgrade, Serbia

Site 803

Belgrade, Serbia

Site 805

Niš, Serbia

Site 806

Užice, Serbia

Site 801

Zrenjanin, Serbia

Site 823

Bratislava, Slovakia

Site 822

Košice, Slovakia

Site 821

Prešov, Slovakia

Site 825

Zvolen, Slovakia

Site 357

Busan, South Korea

Site 354

Daegu, South Korea

Site 358

Daegu, South Korea

Site 361

Daegu, South Korea

Site 355

Daejeon, South Korea

Site 356

Seoul, South Korea

Site 351

Seoul, South Korea

Site 352

Seoul, South Korea

Site 360

Seoul, South Korea

Site 362

Seoul, South Korea

Site 359

Suwon, South Korea

Site 353

Wŏnju, South Korea

Site 835

Gijón, Spain

Site 838

Lugo, Spain

Site 834

Madrid, Spain

Site 837

Madrid, Spain

Site 836

Ourense, Spain

Site 852

Basel, Switzerland

Site 853

Bern, Switzerland

Site 851

Sankt Gallen, Switzerland

Site 394

Changhua, Taiwan

Site 392

Chiayi City, Taiwan

Site 396

Taichung, Taiwan

Site 391

Taipei, Taiwan

Site 397

Taipei, Taiwan

Site 393

Taoyuan City, Taiwan

Site 906

Ivano-Frankivsk, Ukraine

Site 902

Kyiv, Ukraine

Site 904

Kyiv, Ukraine

Site 905

Kyiv, Ukraine

Site 913

Kyiv, Ukraine

Site 911

Kyiv, Ukraine

Site 903

Kyiv, Ukraine

Site 901

Lutsk, Ukraine

Site 909

Lviv, Ukraine

Site 912

Lviv, Ukraine

Site 914

Poltava, Ukraine

Site 908

Vinnytsia, Ukraine

Site 910

Vinnytsia, Ukraine

Site 907

Vinnytsia, Ukraine

View Full Details on ClinicalTrials.gov

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NCT07012395


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