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NCT07012395PHASE2Recruiting

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

Spyre Therapeutics, Inc.

Start Date

5/27/2025

Completion Date

3/1/2028

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.

Detailed Description

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 A enrollment completed April 2026. 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. Part B enrollment commenced April 2026. Intervention arms will be added to the study over time and may complete at different times.

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

SPY001

DRUG

SPY002

DRUG

SPY003

OTHER

Placebo

Interested in This Trial?

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Conditions

Ulcerative ColitisInflammatory Bowel DiseasesColitisColitis, Ulcerative

Locations

Site 024

Canoga Park, California 91304

United States

Site 023

La Jolla, California 92037

United States

Site 012

Lancaster, California 93534

United States

Site 033

Colorado Springs, Colorado 91304

United States

Site 007

Kissimmee, Florida 34741

United States

029

Miami, Florida 33165

United States

Site 038

Chicago, Illinois 60637

United States

Site 006

Kansas City, Kansas 66160

United States

Site 030

Louisville, Kentucky 40202

United States

Site 035

Marrero, Louisiana 70072

United States

Site 011

Glen Burnie, Maryland 21061

United States

Site 003

Boston, Massachusetts 02114

United States

Site 028

Rochester, Minnesota 55905

United States

Site 037

New York, New York 10065

United States

040

Chapel Hill, North Carolina 27599

United States

Site 041

Durham, North Carolina 27710

United States

Site 016

Winston-Salem, North Carolina 27103

United States

Site 025

Providence, Rhode Island 02904

United States

Site 017

Kingsport, Tennessee 37663

United States

Site 013

Cedar Park, Texas 78613

United States

Site 005

Garland, Texas 75246

United States

Site 002

San Antonio, Texas 78229

United States

Site 008

Southlake, Texas 76092

United States

Site 009

Webster, Texas 77598

United States

Site 004

Seattle, Washington 98195

United States

Site 019

Tacoma, Washington 98405

United States

Site 105

La Plata, Buenos Aires 1900

Argentina

Site 102

Lujan de Cuyo, Mendoza Province 5505

Argentina

Site 103

Rosario, Sant Fe 2000

Argentina

Site 104

San Miguel de Tucumán, Tucumán Province 4000

Argentina

Site 208

Concord, 2139

Australia

Site 202

Heidelberg, 3084

Australia

Site 204

Liverpool, 2170

Australia

Site 203

Melbourne, 3004

Australia

Site 206

South Brisbane, 4101

Australia

Site 207

Woolloongabba, 4102

Australia

Site 463

Linz, 4021

Austria

Site 476

Ghent, Osst-Vlaanderen 9000

Belgium

Site 474

Sint-Niklaas, Osst-Vlaanderen 9100

Belgium

Site 475

Bruges, 8310

Belgium

Site 471

Ghent, 9000

Belgium

Site 472

Roeselare, 9000

Belgium

Site 481

Banja Luka, 78 000

Bosnia and Herzegovina

Site 484

Mostar, 88000

Bosnia and Herzegovina

Site 483

Sarajevo, 71000

Bosnia and Herzegovina

Site 123

Brasília, Federal District 70200-730

Brazil

Site 133

Goiânia, Goiás 74535-170

Brazil

Site 136

Juiz de Fora, Minas Gerais 36033-318

Brazil

Site 137

Teresina, Piauí 64.049-550

Brazil

Site 125

Caxias do Sul, Rio Grande do Sul 95070-560

Brazil

Site 134

Passo Fundo, Rio Grande do Sul 99010-120

Brazil

Site 126

Passo Fundo, Rio Grande do Sul 99010-260

Brazil

Site 122

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Site 121

Porto Alegre, Rio Grande do Sul 90160-093

Brazil

Site 131

Campinas, São Paulo 13086045

Brazil

Site 129

Consolação, São Paulo 01307-002

Brazil

Site 128

Santo André, São Paulo 09080-110

Brazil

Site 127

Santos, São Paulo 11075-900

Brazil

Site 130

São José do Rio Preto, São Paulo 15015-110

Brazil

Site 494

Gorna Oryahovitsa, 5100

Bulgaria

Site 498

Rousse, 7002

Bulgaria

Site 492

Sofia, 1343

Bulgaria

Site 499

Sofia, 1407

Bulgaria

Site 495

Sofia, 1463

Bulgaria

Site 083

London, Ontario G8H 3P7

Canada

Site 084

Toronto, Ontario M5G1X5

Canada

Site 085

Greater Sudbury, P3C1X3

Canada

Site 086

London, N6K 1M6

Canada

Site 153

Osorno, Los Lagos Region 5290000

Chile

Site 152

Santiago, Santiago Metropolitan 8320000

Chile

Site 521

Osijek, 31000

Croatia

Site 524

Zagreb, 10000

Croatia

Site 531

Brno, 615 00

Czechia

Site 536

Klatovy, 33901

Czechia

Site 534

Ostrava, 702 00

Czechia

Site 537

Pardubice, 532 03

Czechia

Site 538

Prague, 150 00

Czechia

Site 555

Marseille, 13015

France

Site 551

Nantes, 44300

France

Site 557

Nice, 06200

France

Site 556

Pierre-Bénite, 69310

France

Site 558

Saint-Etienne, 42270

France

Site 584

Kutaisi, 4600

Georgia

Site 589

Marneuli, 3000

Georgia

Site 581

Tbilisi, 0102

Georgia

Site 588

Tbilisi, 0114

Georgia

Site 583

Tbilisi, 01444

Georgia

Site 586

Tbilisi, 0144

Georgia

Site 582

Tbilisi, 0159

Georgia

Site 587

Tbilisi, 0159

Georgia

Site 590

Tbilisi, 0178

Georgia

Site 585

Tbilisi, 0180

Georgia

Site 606

Berlin, 10117

Germany

Site 604

Berlin, 14163

Germany

Site 611

Brandenburg an der Havel, 14770

Germany

Site 607

Dachau, 85221

Germany

Site 610

Frankfurt am Main, 60590

Germany

Site 602

Kiel, 24105

Germany

Site 608

Leipzig, 04103

Germany

Site 609

Munich, 81377

Germany

Site 603

Ulm, 89081

Germany

Site 635

Athens, Attica 11527

Greece

Site 634

Athens, 10676

Greece

Site 632

Athens, 115 27

Greece

Site 631

Chaïdári, 124 62

Greece

Site 654

Békéscsaba, H-5600

Hungary

Site 655

Budapest, H-1062

Hungary

Site 656

Budapest, H-1083

Hungary

Site 651

Budapest, H-1088

Hungary

Site 652

Székesfehérvár, H-8000

Hungary

Site 262

New Delhi, National Capital Territory of Delhi 110002

India

Site 270

Hyderabad, 500032

India

Site 268

Jaipur, 302004

India

Site 266

Kochi, 682040

India

Site 265

Sūrat, 395002

India

Site 445

Beer Yaaqov, 7033001

Israel

Site 441

Beersheba, 8410101

Israel

Site 443

Haifa, 31048

Israel

Site 444

Jerusalem, 9103102

Israel

Site 446

Jerusalem, 9112001

Israel

Site 442

Nahariya, 2210001

Israel

Site 682

Castellana Grotte, Bari 70013

Italy

Site 679

Pavia, Lombardy 27100

Italy

Site 673

Legnano, Milan 20025

Italy

Site 674

Rozzano, Milan 20089

Italy

Site 676

San Donato Milanese, Milan 20097

Italy

Site 671

Segrate, Milan 20132

Italy

Site 680

Turin, Piedmont 10126

Italy

Site 683

Bologna, 40138

Italy

Site 672

Negrar, 37024

Italy

Site 677

Padova, 35128

Italy

Site 681

Rome, 00168

Italy

Site 675

Turin, 10128

Italy

Site 299

Kashiwa, Chiba 277-0871

Japan

Site 297

Sakura, Chiba 285-8741

Japan

Site 294

Chikushino-shi, Fukuoka 818-8502

Japan

Site 304

Maebashi, Gunma 371-8511

Japan

Site 292

Shiwa-gun, Iwate 028-3695

Japan

Site 300

Yokohama, Kanagawa 232-0024

Japan

Site 283

Tsu, Mie-ken 514-8507

Japan

Site 287

Sendai, Miyagi 983-8520

Japan

Site 290

Ōita, Oita Prefecture 870-0823

Japan

Site 282

Chuo Ku, Osaka 540-0006

Japan

Site 295

Bunkyō-Ku, Tokyo 113-8519

Japan

Site 296

Minato-Ku, Tokyo 108-8642

Japan

Site 281

Shinjuku-Ku, Tokyo 169-0073

Japan

Site 291

Kobe, 650-0015

Japan

Site 303

Nara, 630-8581

Japan

Site 284

Okayama, 703-851

Japan

Site 288

Osaka, 545-8586

Japan

Site 286

Saga, 849-8501

Japan

Site 285

Sendai, 981-3213

Japan

Site 293

Urayasu-shi, 279-0021

Japan

Site 425

Amman, 11194

Jordan

Site 424

Amman, 11196

Jordan

Site 421

Amman, 11942

Jordan

Site 422

Irbid, 21110

Jordan

Site 423

Irbid, 22110

Jordan

Site 426

Irbid, 22110

Jordan

Site 704

Klaipėda, LT-92288

Lithuania

Site 703

Vilnius, LT-08406

Lithuania

Site 174

Saltillo, Coahuila 25050

Mexico

Site 175

Celaya, Guanajuato 38000

Mexico

Site 173

Tlajomulco de Zúñiga, Jalisco 45645

Mexico

Site 713

Chisinau, MD2005

Moldova

Site 711

Chisinau, MD2025

Moldova

Site 712

Chisinau, MD2025

Moldova

Site 714

Chisinau, MD2025

Moldova

Site 715

Chisinau, MD2068

Moldova

Site 753

Bydgoszcz, 85-2299

Poland

Site 732

Bydgoszcz, 85-794

Poland

Site 749

Katowice, 40-600

Poland

Site 735

Katowice, 40-748

Poland

Site 748

Krakow, 31-501

Poland

Site 743

Opole, 45-819

Poland

Site 740

Poznan, 60-309

Poland

Site 736

Rzeszów, 35-326

Poland

Site 744

Sopot, 81-756

Poland

Site 745

Staszów, 28-2200

Poland

Site 737

Szczecin, 71-434

Poland

Site 733

Szczecin, 71-685

Poland

Site 752

Tychy, 43-100

Poland

Site 739

Warsaw, 00--710

Poland

Site 751

Warsaw, 00-189

Poland

Site 754

Warsaw, 02-172

Poland

Site 741

Warsaw, 02-786

Poland

Site 731

Warsaw, 04-501

Poland

Site 750

Warsaw, 57-300

Poland

Site 738

Wroclaw, 52-416

Poland

Site 734

Wroclaw, 53-149

Poland

Site 747

Wroclaw, 53-611

Poland

Site 742

Wroclaw, 54-239

Poland

Site 783

Bucharest, 011273

Romania

Site 784

Bucharest, 014142

Romania

Site 781

Bucharest, 020125

Romania

Site 782

Cluj-Napoca, 400061

Romania

Site 786

Constanța, 900161

Romania

Site 788

Timișoara, 300239

Romania

Trial Site 804

Belgrade, 11 000

Serbia

Site 802

Belgrade, 11000

Serbia

Site 807

Belgrade, 11000

Serbia

Site 803

Belgrade, 11080

Serbia

Site 805

Niš, 18 000

Serbia

Site 806

Užice, 31000

Serbia

Site 801

Zrenjanin, 23000

Serbia

Site 823

Bratislava, 811 09

Slovakia

Site 822

Košice, 040 13

Slovakia

Site 821

Prešov, 080 01

Slovakia

Site 825

Zvolen, 960 01

Slovakia

Site 357

Busan, 48108

South Korea

Site 354

Daegu, 40404

South Korea

Site 358

Daegu, 42415

South Korea

Site 361

Daegu, 42601

South Korea

Site 355

Daejeon, 34943

South Korea

Site 356

Seoul, 03312

South Korea

Site 351

Seoul, 03722

South Korea

Site 352

Seoul, 06591

South Korea

Site 360

Seoul, 07985

South Korea

Site 362

Seoul, 6351

South Korea

Site 359

Suwon, 16247

South Korea

Site 353

Wŏnju, 26426

South Korea

Site 832

Santiago de Compostela, A Coruna 15702

Spain

Site 835

Gijón, 33394

Spain

Site 838

Lugo, 27003

Spain

Site 834

Madrid, 28031

Spain

Site 837

Madrid, 28222

Spain

Site 836

Ourense, 32005

Spain

Site 831

Seville, 41013

Spain

Site 852

Basel, 4031

Switzerland

Site 853

Bern, 3012

Switzerland

Site 851

Sankt Gallen, 9007

Switzerland

Site 394

Changhua, 500

Taiwan

Site 392

Chiayi City, 600

Taiwan

Site 395

Kaohsiung City, 833401

Taiwan

Site 396

Taichung, 404327

Taiwan

Site 391

Taipei, 100225

Taiwan

Site 397

Taipei, 104

Taiwan

Site 393

Taoyuan City, 333

Taiwan

Site 867

Istanbul, 34093

Turkey (Türkiye)

Site 864

Izmir, 35575

Turkey (Türkiye)

Site 866

İzmit, 41380

Turkey (Türkiye)

Site 861

Mersin, 33110

Turkey (Türkiye)

Site 863

Sakarya, 54290

Turkey (Türkiye)

Site 865

Sanliurfa, 63300

Turkey (Türkiye)

Site 862

Trabzon, 61080

Turkey (Türkiye)

Site 906

Ivano-Frankivsk, 76008

Ukraine

Site 902

Kyiv, 02002

Ukraine

Site 904

Kyiv, 02091

Ukraine

Site 905

Kyiv, 03037

Ukraine

Site 913

Kyiv, 04050

Ukraine

Site 911

Kyiv, 04107

Ukraine

Site 903

Kyiv, 04210

Ukraine

Site 901

Lutsk, 43005

Ukraine

Site 909

Lviv, 79010

Ukraine

Site 912

Lviv, 79059

Ukraine

Site 914

Poltava, 36011

Ukraine

Site 908

Vinnytsia, 21009

Ukraine

Site 910

Vinnytsia, 21028

Ukraine

Site 907

Vinnytsia, 21029

Ukraine