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A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Sponsor: Spyre Therapeutics, Inc.
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 - Any
Study Type
INTERVENTIONAL
Enrollment
645
Start Date
2025-05-27
Completion Date
2028-03
Last Updated
2026-05-19
Healthy Volunteers
No
Interventions
SPY001
Experimental
SPY002
Experimental
SPY003
Experimental
Placebo
Placebo
Locations (206)
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 004
Seattle, Washington, United States
Site 019
Tacoma, Washington, United States
Site 103
Rosario, Sant Fe, Argentina
Site 104
San Miguel de Tucumán, Tucumán Province, Argentina
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 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 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
Site 585
Tbilisi, Georgia
Site 606
Berlin, Germany
Site 604
Berlin, Germany
Site 611
Brandenburg an der Havel, Germany
Site 607
Dachau, Germany
Site 610
Frankfurt am Main, Germany
Site 602
Kiel, 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 654
Békéscsaba, Hungary
Site 655
Budapest, Hungary
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 682
Castellana Grotte, Bari, Italy
Site 679
Pavia, Lombardy, Italy
Site 674
Rozzano, Milan, Italy
Site 676
San Donato Milanese, Milan, Italy
Site 671
Segrate, Milan, Italy
Site 680
Turin, Piedmont, Italy
Site 672
Negrar, Italy
Site 677
Padova, Italy
Site 681
Rome, Italy
Site 675
Turin, Italy
Site 294
Chikushino-shi, Fukuoka, Japan
Site 291
Kobe, Japan
Site 286
Saga, Japan
Site 285
Sendai, Japan
Site 293
Urayasu-shi, Japan
Site 425
Amman, Jordan
Site 424
Amman, Jordan
Site 421
Amman, Jordan
Site 422
Irbid, Jordan
Site 704
Klaipėda, Lithuania
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 783
Bucharest, Romania
Site 784
Bucharest, Romania
Site 781
Bucharest, Romania
Site 782
Cluj-Napoca, 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 832
Santiago de Compostela, A Coruna, Spain
Site 835
Gijón, Spain
Site 838
Lugo, Spain
Site 834
Madrid, Spain
Site 837
Madrid, Spain
Site 836
Ourense, Spain
Site 831
Seville, Spain
Site 852
Basel, Switzerland
Site 853
Bern, Switzerland
Site 851
Sankt Gallen, Switzerland
Site 394
Changhua, Taiwan
Site 392
Chiayi City, Taiwan
Site 395
Kaohsiung City, Taiwan
Site 396
Taichung, Taiwan
Site 391
Taipei, Taiwan
Site 397
Taipei, Taiwan
Site 393
Taoyuan City, Taiwan
Site 866
Kocaeli, Turkey (Türkiye)
Site 861
Mersin, Turkey (Türkiye)
Site 865
Sanliurfa, Turkey (Türkiye)
Site 862
Trabzon, Turkey (Türkiye)
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