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 (145) 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
RECRUITING
Canoga Park
Site 023
RECRUITING
La Jolla
Site 012
RECRUITING
Lancaster
Colorado
Site 033
RECRUITING
Colorado Springs
Florida
Site 007
RECRUITING
Kissimmee
029
RECRUITING
Miami
Kansas
Site 006
RECRUITING
Kansas City
Louisiana
Site 035
RECRUITING
Marrero
Massachusetts
Site 003
RECRUITING
Boston
Maryland
Site 011
RECRUITING
Glen Burnie
Minnesota
Site 028
RECRUITING
Rochester
North Carolina
040
RECRUITING
Chapel Hill
Site 016
RECRUITING
Winston-salem
Rhode Island
Site 025
RECRUITING
Providence
Tennessee
Site 017
RECRUITING
Kingsport
Texas
Site 013
RECRUITING
Cedar Park
Site 005
RECRUITING
Garland
Site 002
RECRUITING
San Antonio
Site 008
RECRUITING
Southlake
Site 009
RECRUITING
Webster
Washington
Site 019
RECRUITING
Tacoma
Other Locations
Australia
Site 208
RECRUITING
Concord
Site 202
RECRUITING
Heidelberg
Site 204
RECRUITING
Liverpool
Site 206
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South Brisbane
Site 207
RECRUITING
Woolloongabba
Austria
Site 463
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Linz
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
RECRUITING
Gorna Oryahovitsa
Site 498
RECRUITING
Rousse
Site 492
RECRUITING
Sofia
Site 495
RECRUITING
Sofia
Canada
Site 085
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Greater Sudbury
Site 083
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London
Site 086
RECRUITING
London
Georgia
Site 584
RECRUITING
Kutaisi
Site 589
RECRUITING
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
Greece
Site 632
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Athens
Site 634
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Athens
Site 631
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Chaïdári
Hungary
Site 651
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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
RECRUITING
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
RECRUITING
Nahariya
Italy
Site 672
RECRUITING
Negrar
Site 675
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Turin
Jordan
Site 422
RECRUITING
Irbid
Poland
Site 732
RECRUITING
Bydgoszcz
Site 753
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Bydgoszcz
Site 735
RECRUITING
Katowice
Site 749
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Katowice
Site 748
RECRUITING
Krakow
Site 743
RECRUITING
Opole
Site 740
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Poznan
Site 736
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Rzeszów
Site 744
RECRUITING
Sopot
Site 745
RECRUITING
Staszów
Site 733
RECRUITING
Szczecin
Site 737
RECRUITING
Szczecin
Site 752
RECRUITING
Tychy
Site 731
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Warsaw
Site 739
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Warsaw
Site 741
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Warsaw
Site 750
RECRUITING
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
RECRUITING
Wroclaw
Republic of Korea
Site 357
RECRUITING
Busan
Site 354
RECRUITING
Daegu
Site 358
RECRUITING
Daegu
Site 361
RECRUITING
Daegu
Site 355
RECRUITING
Daejeon
Site 351
RECRUITING
Seoul
Site 352
RECRUITING
Seoul
Site 356
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Seoul
Site 360
RECRUITING
Seoul
Site 362
RECRUITING
Seoul
Site 359
RECRUITING
Suwon
Site 353
RECRUITING
Wŏnju
Republic of Moldova
Site 711
RECRUITING
Chisinau
Site 712
RECRUITING
Chisinau
Site 713
RECRUITING
Chisinau
Site 714
RECRUITING
Chisinau
Site 715
RECRUITING
Chisinau
Romania
Site 786
RECRUITING
Constanța
Serbia
Site 802
RECRUITING
Belgrade
Site 803
RECRUITING
Belgrade
Site 807
RECRUITING
Belgrade
Trial Site 804
RECRUITING
Belgrade
Site 805
RECRUITING
Niš
Site 806
RECRUITING
Užice
Site 801
RECRUITING
Zrenjanin
Slovakia
Site 823
RECRUITING
Bratislava
Site 822
RECRUITING
Košice
Site 821
RECRUITING
Prešov
Site 825
RECRUITING
Zvolen
Spain
Site 834
RECRUITING
Madrid
Site 837
RECRUITING
Madrid
Site 836
RECRUITING
Ourense
Switzerland
Site 852
RECRUITING
Basel
Site 853
RECRUITING
Bern
Site 851
RECRUITING
Sankt Gallen
Taiwan
Site 394
RECRUITING
Changhua
Site 392
RECRUITING
Chiayi City
Site 396
RECRUITING
Taichung
Site 391
RECRUITING
Taipei
Site 397
RECRUITING
Taipei
Site 393
RECRUITING
Taoyuan
Ukraine
Site 906
RECRUITING
Ivano-frankivsk
Site 902
RECRUITING
Kyiv
Site 903
RECRUITING
Kyiv
Site 904
RECRUITING
Kyiv
Site 905
RECRUITING
Kyiv
Site 911
RECRUITING
Kyiv
Site 913
RECRUITING
Kyiv
Site 901
RECRUITING
Lutsk
Site 909
RECRUITING
Lviv
Site 912
RECRUITING
Lviv
Site 914
RECRUITING
Poltava
Site 907
RECRUITING
Vinnytsia
Site 908
RECRUITING
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.