A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
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
Interventions
SPY001
SPY002
SPY003
Placebo
Conditions
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