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RECRUITING
NCT07012395
PHASE2

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

Sponsor: Spyre Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

645

Start Date

2025-05-27

Completion Date

2028-03

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DRUG

SPY001

Experimental

DRUG

SPY002

Experimental

DRUG

SPY003

Experimental

OTHER

Placebo

Placebo

Locations (276)

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 038

Chicago, Illinois, United States

Site 006

Kansas City, Kansas, United States

Site 030

Louisville, Kentucky, 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 039

St Louis, Missouri, 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 004

Seattle, Washington, United States

Site 019

Tacoma, Washington, United States

Site 105

La Plata, Buenos Aires, Argentina

Site 102

Lujan de Cuyo, Mendoza Province, Argentina

Site 103

Rosario, Sant Fe, Argentina

Site 104

San Miguel de Tucumán, Tucumán Province, Argentina

Site 201

Murdoch, Western Australia, Australia

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 476

Ghent, Osst-Vlaanderen, Belgium

Site 474

Sint-Niklaas, Osst-Vlaanderen, Belgium

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 123

Brasília, Federal District, Brazil

Site 133

Goiânia, Goiás, Brazil

Site 136

Juiz de Fora, Minas Gerais, Brazil

Site 137

Teresina, Piauí, Brazil

Site 125

Caxias do Sul, Rio Grande do Sul, Brazil

Site 134

Passo Fundo, Rio Grande do Sul, Brazil

Site 126

Passo Fundo, Rio Grande do Sul, Brazil

Site 122

Porto Alegre, Rio Grande do Sul, Brazil

Site 121

Porto Alegre, Rio Grande do Sul, Brazil

Site 135

Barretos, São Paulo, Brazil

Site 131

Campinas, São Paulo, Brazil

Site 129

Consolação, São Paulo, Brazil

Site 138

Jaú, São Paulo, Brazil

Site 128

Santo André, São Paulo, Brazil

Site 127

Santos, São Paulo, Brazil

Site 130

São José do Rio Preto, São Paulo, Brazil

Site 132

São Paulo, Brazil

Site 124

São Paulo, Brazil

Site 494

Gorna Oryahovitsa, Bulgaria

Site 498

Rousse, Bulgaria

Site 492

Sofia, Bulgaria

Site 499

Sofia, Bulgaria

Site 495

Sofia, Bulgaria

Site 083

London, Ontario, Canada

Site 084

Toronto, Ontario, Canada

Site 082

Chicoutimi, Quebec, Canada

Site 087

Montreal, Quebec, Canada

Site 081

Montreal, Quebec, Canada

Site 085

Greater Sudbury, Canada

Site 086

London, Canada

Site 153

Osorno, Los Lagos Region, Chile

Site 152

Santiago, Santiago Metropolitan, Chile

Site 521

Osijek, Croatia

Site 524

Zagreb, Croatia

Site 531

Brno, Czechia

Site 536

Klatovy, Czechia

Site 534

Ostrava, Czechia

Site 537

Pardubice, Czechia

Site 538

Prague, Czechia

Site 555

Marseille, France

Site 551

Nantes, France

Site 557

Nice, France

Site 556

Pierre-Bénite, 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

And 176 more locations on ClinicalTrials.gov