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
Status: Recruiting
Location: See all (218) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Site 024
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Canoga Park
Site 023
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La Jolla
Site 012
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Lancaster
Colorado
Site 033
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Colorado Springs
Florida
Site 007
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Kissimmee
029
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Miami
Kansas
Site 006
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Kansas City
Kentucky
Site 030
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Louisville
Louisiana
Site 035
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Marrero
Massachusetts
Site 003
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Boston
Maryland
Site 011
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Glen Burnie
Minnesota
Site 028
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Rochester
North Carolina
040
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Chapel Hill
Site 041
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Durham
Site 016
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Winston-salem
New York
Site 037
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New York
Rhode Island
Site 025
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Providence
Tennessee
Site 017
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Kingsport
Texas
Site 013
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Cedar Park
Site 005
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Garland
Site 002
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San Antonio
Site 008
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Southlake
Site 009
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Webster
Washington
Site 004
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Seattle
Site 019
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Tacoma
Other Locations
Argentina
Site 103
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Rosario
Site 104
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San Miguel De Tucumán
Australia
Site 208
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Concord
Site 202
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Heidelberg
Site 204
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Liverpool
Site 203
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Melbourne
Site 206
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South Brisbane
Site 207
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Woolloongabba
Austria
Site 463
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Linz
Belgium
Site 475
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Bruges
Site 471
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Ghent
Site 476
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Ghent
Site 472
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Roeselare
Site 474
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Sint-niklaas
Bosnia and Herzegovina
Site 481
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Banja Luka
Site 484
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Mostar
Site 483
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Sarajevo
Bulgaria
Site 494
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Gorna Oryahovitsa
Site 498
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Rousse
Site 492
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Sofia
Site 495
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Sofia
Canada
Site 085
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Greater Sudbury
Site 083
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London
Site 086
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London
Chile
Site 153
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Osorno
Croatia
Site 521
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Osijek
France
Site 555
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Marseille
Site 551
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Nantes
Site 557
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Nice
Site 556
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Pierre-bénite
Site 558
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Saint-etienne
Georgia
Site 584
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Kutaisi
Site 589
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Marneuli
Site 581
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Tbilisi
Site 582
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Tbilisi
Site 583
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Tbilisi
Site 585
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Tbilisi
Site 586
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Tbilisi
Site 587
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Tbilisi
Site 588
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Tbilisi
Site 590
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Tbilisi
Germany
Site 604
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Berlin
Site 606
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Berlin
Site 611
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Brandenburg An Der Havel
Site 607
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Dachau
Site 610
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Frankfurt Am Main
Site 602
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Kiel
Site 608
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Leipzig
Site 609
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Munich
Site 603
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Ulm
Greece
Site 632
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Athens
Site 634
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Athens
Site 635
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Athens
Site 631
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Chaïdári
Hungary
Site 654
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Békéscsaba
Site 651
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Budapest
Site 655
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Budapest
Site 656
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Budapest
Site 652
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Székesfehérvár
India
Site 270
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Hyderabad
Site 268
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Jaipur
Site 266
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Kochi
Site 265
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Sūrat
Israel
Site 445
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Beer Yaaqov
Site 441
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Beersheba
Site 443
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Haifa
Site 444
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Jerusalem
Site 446
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Jerusalem
Site 442
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Nahariya
Italy
Site 683
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Bologna
Site 682
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Castellana Grotte
Site 673
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Legnano
Site 672
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Negrar
Site 677
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Padova
Site 679
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Pavia
Site 681
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Rome
Site 674
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Rozzano
Site 676
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San Donato Milanese
Site 671
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Segrate
Site 675
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Turin
Site 680
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Turin
Japan
Site 294
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Chikushino-shi
Site 282
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Chuo Ku
Site 299
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Kashiwa
Site 291
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Kobe
Site 290
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Ōita
Site 286
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Saga
Site 285
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Sendai
Site 292
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Shiwa-gun
Site 293
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Urayasu-shi
Jordan
Site 421
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Amman
Site 424
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Amman
Site 425
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Amman
Site 422
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Irbid
Site 423
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Irbid
Site 426
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Irbid
Lithuania
Site 704
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Klaipėda
Site 703
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Vilnius
Mexico
Site 175
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Celaya
Site 174
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Saltillo
Site 173
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Tlajomulco De Zúñiga
Poland
Site 732
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Bydgoszcz
Site 753
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Bydgoszcz
Site 735
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Katowice
Site 749
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Katowice
Site 748
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Krakow
Site 743
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Opole
Site 740
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Poznan
Site 736
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Rzeszów
Site 744
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Sopot
Site 745
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Staszów
Site 733
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Szczecin
Site 737
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Szczecin
Site 752
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Tychy
Site 731
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Warsaw
Site 739
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Warsaw
Site 741
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Warsaw
Site 750
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Warsaw
Site 751
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Warsaw
Site 754
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Warsaw
Site 734
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Wroclaw
Site 738
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Wroclaw
Site 742
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Wroclaw
Site 747
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Wroclaw
Republic of Korea
Site 357
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Busan
Site 354
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Daegu
Site 358
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Daegu
Site 361
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Daegu
Site 355
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Daejeon
Site 351
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Seoul
Site 352
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Seoul
Site 356
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Seoul
Site 360
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Seoul
Site 362
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Seoul
Site 359
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Suwon
Site 353
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Wŏnju
Republic of Moldova
Site 711
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Chisinau
Site 712
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Chisinau
Site 713
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Chisinau
Site 714
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Chisinau
Site 715
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Chisinau
Romania
Site 781
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Bucharest
Site 783
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Bucharest
Site 784
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Bucharest
Site 782
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Cluj-napoca
Site 786
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Constanța
Site 788
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Timișoara
Serbia
Site 802
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Belgrade
Site 803
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Belgrade
Site 807
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Belgrade
Trial Site 804
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Belgrade
Site 805
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Niš
Site 806
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Užice
Site 801
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Zrenjanin
Slovakia
Site 823
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Bratislava
Site 822
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Košice
Site 821
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Prešov
Site 825
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Zvolen
Spain
Site 835
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Gijón
Site 838
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Lugo
Site 834
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Madrid
Site 837
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Madrid
Site 836
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Ourense
Site 832
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Santiago De Compostela
Site 831
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Seville
Switzerland
Site 852
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Basel
Site 853
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Bern
Site 851
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Sankt Gallen
Taiwan
Site 394
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Changhua
Site 392
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Chiayi City
Site 395
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Kaohsiung City
Site 396
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Taichung
Site 391
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Taipei
Site 397
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Taipei
Site 393
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Taoyuan City
Turkey
Site 866
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Kocaeli
Site 861
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Mersin
Site 865
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Sanliurfa
Site 862
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Trabzon
Ukraine
Site 906
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Ivano-frankivsk
Site 902
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Kyiv
Site 903
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Kyiv
Site 904
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Kyiv
Site 905
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Kyiv
Site 911
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Kyiv
Site 913
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Kyiv
Site 901
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Lutsk
Site 909
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Lviv
Site 912
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Lviv
Site 914
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Poltava
Site 907
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Vinnytsia
Site 908
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Vinnytsia
Site 910
RECRUITING
Vinnytsia
Contact Information
Primary
SKYLINE-UC Trial Center
info@skyline-uc.com
1-650-402-4238
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2028-03
Participants
Target number of participants: 645
Treatments
Experimental: Intervention Specific Appendix - SPY001: Part A
Participants will receive open-label dose of SPY001
Experimental: Intervention Specific Appendix - SPY002: Part A
Participants will receive open-label dose of SPY002
Experimental: Intervention Specific Appendix - SPY003: Part A
Participants will receive open-label dose of SPY003
Experimental: Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B
Participants will receive double-blind dosing regimen 1 of SPY001
Experimental: Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B
Participants will receive double-blind dosing regimen 2 of SPY001
Experimental: Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B
Participants will receive double-blind dosing regimen 1 of SPY002
Experimental: Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B
Participants will receive double-blind dosing regimen 2 of SPY002
Experimental: Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B
Participants will receive double-blind dosing regimen 1 of SPY003
Experimental: Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B
Participants will receive double-blind dosing regimen 2 of SPY003
Experimental: Intervention Specific Appendix - SPY120: Part B
Participants will receive double-blind dose of SPY001 and SPY002
Experimental: Intervention Specific Appendix - SPY130: Part B
Participants will receive double-blind dose of SPY001 and SPY003
Experimental: Intervention Specific Appendix - SPY230: Part B
Participants will receive double-blind dose of SPY002 and SPY003
Placebo_comparator: Placebo: Part B
Participants will receive matching placebo
Related Therapeutic Areas
Sponsors
Leads: Spyre Therapeutics, Inc.