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 (43) 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 012
RECRUITING
Lancaster
Colorado
Site 033
RECRUITING
Colorado Springs
Florida
Site 007
RECRUITING
Kissimmee
029
RECRUITING
Miami
Louisiana
Site 035
RECRUITING
Marrero
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
Georgia
Site 584
RECRUITING
Kutaisi
Site 589
RECRUITING
Marneuli
Site 581
RECRUITING
Tbilisi
Site 582
RECRUITING
Tbilisi
Site 585
RECRUITING
Tbilisi
Site 586
RECRUITING
Tbilisi
Site 587
RECRUITING
Tbilisi
Site 588
RECRUITING
Tbilisi
Site 590
RECRUITING
Tbilisi
Republic of Moldova
Site 711
RECRUITING
Chisinau
Site 712
RECRUITING
Chisinau
Site 713
RECRUITING
Chisinau
Site 714
RECRUITING
Chisinau
Site 715
RECRUITING
Chisinau
Serbia
Site 802
RECRUITING
Belgrade
Site 803
RECRUITING
Belgrade
Site 807
RECRUITING
Belgrade
Site 806
RECRUITING
Užice
Site 801
RECRUITING
Zrenjanin
Ukraine
Site 906
RECRUITING
Ivano-frankivsk
Site 903
RECRUITING
Kyiv
Site 904
RECRUITING
Kyiv
Site 911
RECRUITING
Kyiv
Site 913
RECRUITING
Kyiv
Site 901
RECRUITING
Lutsk
Site 909
RECRUITING
Lviv
Site 914
RECRUITING
Poltava
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
Hemorrhagic Proctocolitis
Colitis
Ulcerative Colitis
Viral Gastroenteritis
Sponsors
Leads: Spyre Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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