NCT07012395
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis | NCT07012395 | Trialant Recruiting Interventional Phase 2 Updated Aug 25, 2026 A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis 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
ClinicalTrials.gov ID NCT07012395
Lead Sponsor Spyre Therapeutics, Inc. INDUSTRY
Overall Status Recruiting
Study Type Interventional
Phase Phase 2
Enrollment 645 Estimated
Last Update Posted Aug 25, 2026 Actual
Start Date May 27, 2025 Actual
Primary Completion Date Jun 2027 Estimated
Completion Date Mar 2028 Estimated 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
Brief 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.
Ulcerative Colitis Inflammatory Bowel Diseases Colitis Colitis, Ulcerative SPY001 SPY002 SPY003 Placebo
Ages Eligible for Study Adult (18-64) Older Adult (65+)
Sexes Eligible for Study All
Accepts Healthy Volunteers No Eligibility Criteria Inclusion Criteria:
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
Exclusion Criteria:
Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined
Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction
Failed 4 or more approved or investigational advanced therapy classes
Primary Purpose Treatment
Allocation Randomized
Interventional Model Parallel Assignment
Masking Quadruple SKYLINE-UC Trial Center Contact
info@skyline-uc.com 1-650-402-4238
Lead Sponsor Spyre Therapeutics, Inc. INDUSTRY
Enrolling by invitation Interventional Phase 2 Updated Sep 8, 2026 Completed Interventional Phase 2 Updated Apr 14, 2023 Completed Interventional Phase 2 Updated Oct 23, 2023 Unknown status Interventional Phase 3 Updated Sep 5, 2023 Completed Interventional Phase 2 Updated Jul 17, 2026 Withdrawn Interventional Phase 2 Updated Dec 17, 2020 Site 024 Recruiting
Canoga Park, California 91304, United States
SKYLINE-UC Trial Center Contact
Site 023 Recruiting
La Jolla, California 92037, United States
Site 012 Recruiting
Lancaster, California 93534, United States
Site 033 Recruiting
Colorado Springs, Colorado 91304, United States
Site 007 Recruiting
Kissimmee, Florida 34741, United States
029 Recruiting
Miami, Florida 33165, United States
Site 038 Recruiting
Chicago, Illinois 60637, United States
Site 006 Recruiting
Kansas City, Kansas 66160, United States
Site 030 Recruiting
Louisville, Kentucky 40202, United States
Site 035 Recruiting
Marrero, Louisiana 70072, United States
Site 011 Recruiting
Glen Burnie, Maryland 21061, United States
Site 003 Recruiting
Boston, Massachusetts 02114, United States
Site 028 Recruiting
Rochester, Minnesota 55905, United States
Site 037 Recruiting
New York, New York 10065, United States
040 Recruiting
Chapel Hill, North Carolina 27599, United States
Site 041 Recruiting
Durham, North Carolina 27710, United States
Site 016 Recruiting
Winston-Salem, North Carolina 27103, United States
Site 025 Recruiting
Providence, Rhode Island 02904, United States
Site 017 Recruiting
Kingsport, Tennessee 37663, United States
Site 013 Recruiting
Cedar Park, Texas 78613, United States
Site 005 Recruiting
Garland, Texas 75246, United States
Site 002 Recruiting
San Antonio, Texas 78229, United States
Site 008 Recruiting
Southlake, Texas 76092, United States
Site 009 Recruiting
Webster, Texas 77598, United States
Site 004 Recruiting
Seattle, Washington 98195, United States
Site 019 Recruiting
Tacoma, Washington 98405, United States
Site 105 Recruiting
La Plata, Buenos Aires 1900, Argentina
Site 102 Recruiting
Lujan de Cuyo, Mendoza Province 5505, Argentina
Site 103 Recruiting
Rosario, Sant Fe 2000, Argentina
Site 104 Recruiting
San Miguel de Tucumán, Tucumán Province 4000, Argentina
Site 208 Recruiting
Concord, 2139, Australia
Site 202 Recruiting
Heidelberg, 3084, Australia
Site 204 Recruiting
Liverpool, 2170, Australia
Site 203 Recruiting
Melbourne, 3004, Australia
Site 206 Recruiting
South Brisbane, 4101, Australia
Site 207 Recruiting
Woolloongabba, 4102, Australia
Site 463 Recruiting
Linz, 4021, Austria
Site 476 Recruiting
Ghent, Osst-Vlaanderen 9000, Belgium
Site 474 Recruiting
Sint-Niklaas, Osst-Vlaanderen 9100, Belgium
Site 475 Recruiting
Bruges, 8310, Belgium
Site 471 Recruiting
Ghent, 9000, Belgium
Site 472 Recruiting
Roeselare, 9000, Belgium
Site 481 Recruiting
Banja Luka, 78 000, Bosnia and Herzegovina
Site 484 Recruiting
Mostar, 88000, Bosnia and Herzegovina
Site 483 Recruiting
Sarajevo, 71000, Bosnia and Herzegovina
Site 123 Recruiting
Brasília, Federal District 70200-730, Brazil
Site 133 Recruiting
Goiânia, Goiás 74535-170, Brazil
Site 136 Recruiting
Juiz de Fora, Minas Gerais 36033-318, Brazil
Site 137 Recruiting
Teresina, Piauí 64.049-550, Brazil
Site 125 Recruiting
Caxias do Sul, Rio Grande do Sul 95070-560, Brazil
Site 134 Recruiting
Passo Fundo, Rio Grande do Sul 99010-120, Brazil
Site 126 Recruiting
Passo Fundo, Rio Grande do Sul 99010-260, Brazil
Site 122 Recruiting
Porto Alegre, Rio Grande do Sul 90035-903, Brazil
Site 121 Recruiting
Porto Alegre, Rio Grande do Sul 90160-093, Brazil
Site 135 Recruiting
Barretos, São Paulo 14.784-400, Brazil
Site 131 Recruiting
Campinas, São Paulo 13086045, Brazil
Site 129 Recruiting
Consolação, São Paulo 01307-002, Brazil
Site 138 Recruiting
Jaú, São Paulo 17201-130, Brazil
Site 128 Recruiting
Santo André, São Paulo 09080-110, Brazil
Site 127 Recruiting
Santos, São Paulo 11075-900, Brazil
Site 130 Recruiting
São José do Rio Preto, São Paulo 15015-110, Brazil
Site 132 Recruiting
São Paulo, 04077-020, Brazil
Site 494 Recruiting
Gorna Oryahovitsa, 5100, Bulgaria
Site 498 Recruiting
Rousse, 7002, Bulgaria
Site 492 Recruiting
Sofia, 1343, Bulgaria
Site 499 Recruiting
Sofia, 1407, Bulgaria
Site 495 Recruiting
Sofia, 1463, Bulgaria
Site 083 Recruiting
London, Ontario G8H 3P7, Canada
Site 084 Recruiting
Toronto, Ontario M5G1X5, Canada
Site 085 Recruiting
Greater Sudbury, P3C1X3, Canada
Site 086 Recruiting
London, N6K 1M6, Canada
Site 153 Recruiting
Osorno, Los Lagos Region 5290000, Chile
Site 152 Recruiting
Santiago, Santiago Metropolitan 8320000, Chile
Site 521 Recruiting
Osijek, 31000, Croatia
Site 524 Recruiting
Zagreb, 10000, Croatia
Site 531 Recruiting
Brno, 615 00, Czechia
Site 536 Recruiting
Klatovy, 33901, Czechia
Site 534 Recruiting
Ostrava, 702 00, Czechia
Site 537 Recruiting
Pardubice, 532 03, Czechia
Site 538 Recruiting
Prague, 150 00, Czechia
Site 555 Recruiting
Marseille, 13015, France
Site 551 Recruiting
Nantes, 44300, France
Site 557 Recruiting
Nice, 06200, France
Site 556 Recruiting
Pierre-Bénite, 69310, France
Site 558 Recruiting
Saint-Etienne, 42270, France
Site 584 Recruiting
Kutaisi, 4600, Georgia
Site 589 Recruiting
Marneuli, 3000, Georgia
Site 581 Recruiting
Tbilisi, 0102, Georgia
Site 588 Recruiting
Tbilisi, 0114, Georgia
Site 583 Recruiting
Tbilisi, 01444, Georgia
Site 586 Recruiting
Tbilisi, 0144, Georgia
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Tbilisi, 0159, Georgia
Site 587 Recruiting
Tbilisi, 0159, Georgia
Site 590 Recruiting
Tbilisi, 0178, Georgia
Site 585 Recruiting
Tbilisi, 0180, Georgia
Site 606 Recruiting
Berlin, 10117, Germany
Site 613 Recruiting
Berlin, 14050, Germany
Site 604 Recruiting
Berlin, 14163, Germany
Site 611 Recruiting
Brandenburg an der Havel, 14770, Germany
Site 607 Recruiting
Dachau, 85221, Germany
Site 610 Recruiting
Frankfurt am Main, 60590, Germany
Site 602 Recruiting
Kiel, 24105, Germany
Site 608 Recruiting
Leipzig, 04103, Germany
Site 609 Recruiting
Munich, 81377, Germany
Site 603 Recruiting
Ulm, 89081, Germany
Site 635 Recruiting
Athens, Attica 11527, Greece
Site 634 Recruiting
Athens, 10676, Greece
Site 632 Recruiting
Athens, 115 27, Greece
Site 631 Recruiting
Chaïdári, 124 62, Greece
Site 654 Recruiting
Békéscsaba, H-5600, Hungary
Site 655 Recruiting
Budapest, H-1062, Hungary
Site 656 Recruiting
Budapest, H-1083, Hungary
Site 651 Recruiting
Budapest, H-1088, Hungary
Site 652 Recruiting
Székesfehérvár, H-8000, Hungary
Site 262 Recruiting
New Delhi, National Capital Territory of Delhi 110002, India
Site 263 Recruiting
New Delhi, National Capital Territory of Delhi 110029, India
Site 270 Recruiting
Hyderabad, 500032, India
Site 268 Recruiting
Jaipur, 302004, India
Site 266 Recruiting
Kochi, 682040, India
Site 265 Recruiting
Sūrat, 395002, India
Site 445 Recruiting
Beer Yaaqov, 7033001, Israel
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Beersheba, 8410101, Israel
Site 443 Recruiting
Haifa, 31048, Israel
Site 444 Recruiting
Jerusalem, 9103102, Israel
Site 446 Recruiting
Jerusalem, 9112001, Israel
Site 442 Recruiting
Nahariya, 2210001, Israel
Site 682 Recruiting
Castellana Grotte, Bari 70013, Italy
Site 679 Recruiting
Pavia, Lombardy 27100, Italy
Site 673 Recruiting
Legnano, Milan 20025, Italy
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Rozzano, Milan 20089, Italy
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San Donato Milanese, Milan 20097, Italy
Site 671 Recruiting
Segrate, Milan 20132, Italy
Site 680 Recruiting
Turin, Piedmont 10126, Italy
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Bologna, 40138, Italy
Site 672 Recruiting
Negrar, 37024, Italy
Site 677 Recruiting
Padova, 35128, Italy
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Rome, 00168, Italy
Site 675 Recruiting
Turin, 10128, Italy
Site 299 Recruiting
Kashiwa, Chiba 277-0871, Japan
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Sakura, Chiba 285-8741, Japan
Site 294 Recruiting
Chikushino-shi, Fukuoka 818-8502, Japan
Site 304 Recruiting
Maebashi, Gunma 371-8511, Japan
Site 292 Recruiting
Shiwa-gun, Iwate 028-3695, Japan
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Yokohama, Kanagawa 232-0024, Japan
Site 283 Recruiting
Tsu, Mie-ken 514-8507, Japan
Site 287 Recruiting
Sendai, Miyagi 983-8520, Japan
Site 290 Recruiting
Ōita, Oita Prefecture 870-0823, Japan
Site 282 Recruiting
Chuo Ku, Osaka 540-0006, Japan
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Site 289 Recruiting
Takatsuki, Osaka 569-8686, Japan
Site 295 Recruiting
Bunkyō-Ku, Tokyo 113-8519, Japan
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Site 296 Recruiting
Minato-Ku, Tokyo 108-8642, Japan
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Site 281 Recruiting
Shinjuku-Ku, Tokyo 169-0073, Japan
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Site 291 Recruiting
Kobe, 650-0015, Japan
Site 303 Recruiting
Nara, 630-8581, Japan
Site 284 Recruiting
Okayama, 703-851, Japan
Site 288 Recruiting
Osaka, 545-8586, Japan
Site 286 Recruiting
Saga, 849-8501, Japan
Site 285 Recruiting
Sendai, 981-3213, Japan
Site 293 Recruiting
Urayasu-shi, 279-0021, Japan
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Site 425 Recruiting
Amman, 11194, Jordan
Site 424 Recruiting
Amman, 11196, Jordan
Site 421 Recruiting
Amman, 11942, Jordan
Site 422 Recruiting
Irbid, 21110, Jordan
Site 423 Recruiting
Irbid, 22110, Jordan
Site 426 Recruiting
Irbid, 22110, Jordan
Site 704 Recruiting
Klaipėda, LT-92288, Lithuania
Site 703 Recruiting
Vilnius, LT-08406, Lithuania
Site 174 Recruiting
Saltillo, Coahuila 25050, Mexico
Site 175 Recruiting
Celaya, Guanajuato 38000, Mexico
Site 173 Recruiting
Tlajomulco de Zúñiga, Jalisco 45645, Mexico
Site 172 Recruiting
Coyoacán, Mexico City 04100, Mexico
Site 171 Recruiting
Querétaro, 76000, Mexico
Site 713 Recruiting
Chisinau, MD2005, Moldova
Site 711 Recruiting
Chisinau, MD2025, Moldova
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Chisinau, MD2025, Moldova
Site 714 Recruiting
Chisinau, MD2025, Moldova
Site 715 Recruiting
Chisinau, MD2068, Moldova
Site 753 Recruiting
Bydgoszcz, 85-2299, Poland
Site 732 Recruiting
Bydgoszcz, 85-794, Poland
Site 749 Recruiting
Katowice, 40-600, Poland
Site 735 Recruiting
Katowice, 40-748, Poland
Site 748 Recruiting
Krakow, 31-501, Poland
Site 743 Recruiting
Opole, 45-819, Poland
Site 740 Recruiting
Poznan, 60-309, Poland
Site 736 Recruiting
Rzeszów, 35-326, Poland
Site 744 Recruiting
Sopot, 81-756, Poland
Site 745 Recruiting
Staszów, 28-2200, Poland
Site 737 Recruiting
Szczecin, 71-434, Poland
Site 733 Recruiting
Szczecin, 71-685, Poland
Site 752 Recruiting
Tychy, 43-100, Poland
Site 739 Recruiting
Warsaw, 00--710, Poland
Site 751 Recruiting
Warsaw, 00-189, Poland
Site 754 Recruiting
Warsaw, 02-172, Poland
Site 741 Recruiting
Warsaw, 02-786, Poland
Site 731 Recruiting
Warsaw, 04-501, Poland
Site 750 Recruiting
Warsaw, 57-300, Poland
Site 738 Recruiting
Wroclaw, 52-416, Poland
Site 734 Recruiting
Wroclaw, 53-149, Poland
Site 747 Recruiting
Wroclaw, 53-611, Poland
Site 742 Recruiting
Wroclaw, 54-239, Poland
Site 783 Recruiting
Bucharest, 011273, Romania
Site 784 Recruiting
Bucharest, 014142, Romania
Site 781 Recruiting
Bucharest, 020125, Romania
Site 782 Recruiting
Cluj-Napoca, 400061, Romania
Site 786 Recruiting
Constanța, 900161, Romania
Site 788 Recruiting
Timișoara, 300239, Romania
Trial Site 804 Recruiting
Belgrade, 11 000, Serbia
Site 802 Recruiting
Belgrade, 11000, Serbia
Site 807 Recruiting
Belgrade, 11000, Serbia
Site 803 Recruiting
Belgrade, 11080, Serbia
Site 805 Recruiting
Niš, 18 000, Serbia
Site 806 Recruiting
Užice, 31000, Serbia
Site 801 Recruiting
Zrenjanin, 23000, Serbia
Site 823 Recruiting
Bratislava, 811 09, Slovakia
Site 822 Recruiting
Košice, 040 13, Slovakia
Site 821 Recruiting
Prešov, 080 01, Slovakia
Site 825 Recruiting
Zvolen, 960 01, Slovakia
Site 357 Recruiting
Busan, 48108, South Korea
Site 354 Recruiting
Daegu, 40404, South Korea
Site 358 Recruiting
Daegu, 42415, South Korea
Site 361 Recruiting
Daegu, 42601, South Korea
Site 355 Recruiting
Daejeon, 34943, South Korea
Site 356 Recruiting
Seoul, 03312, South Korea
Site 351 Recruiting
Seoul, 03722, South Korea
Site 352 Recruiting
Seoul, 06591, South Korea
Site 360 Recruiting
Seoul, 07985, South Korea
Site 362 Recruiting
Seoul, 6351, South Korea
Site 359 Recruiting
Suwon, 16247, South Korea
Site 353 Recruiting
Wŏnju, 26426, South Korea
Site 832 Recruiting
Santiago de Compostela, A Coruna 15702, Spain
Site 835 Recruiting
Gijón, 33394, Spain
Site 838 Recruiting
Lugo, 27003, Spain
Site 834 Recruiting
Madrid, 28031, Spain
Site 837 Recruiting
Madrid, 28222, Spain
Site 836 Recruiting
Ourense, 32005, Spain
Site 831 Recruiting
Seville, 41013, Spain
Site 852 Recruiting
Basel, 4031, Switzerland
Site 853 Recruiting
Bern, 3012, Switzerland
Site 851 Recruiting
Sankt Gallen, 9007, Switzerland
Site 394 Recruiting
Changhua, 500, Taiwan
Site 392 Recruiting
Chiayi City, 600, Taiwan
Site 395 Recruiting
Kaohsiung City, 833401, Taiwan
Site 396 Recruiting
Taichung, 404327, Taiwan
Site 391 Recruiting
Taipei, 100225, Taiwan
Site 397 Recruiting
Taipei, 104, Taiwan
Site 393 Recruiting
Taoyuan City, 333, Taiwan
Site 867 Recruiting
Istanbul, 34093, Turkey (Türkiye)
Site 864 Recruiting
Izmir, 35575, Turkey (Türkiye)
Site 866 Recruiting
İzmit, 41380, Turkey (Türkiye)
Site 861 Recruiting
Mersin, 33110, Turkey (Türkiye)
Site 863 Recruiting
Sakarya, 54290, Turkey (Türkiye)
Site 865 Recruiting
Sanliurfa, 63300, Turkey (Türkiye)
Site 862 Recruiting
Trabzon, 61080, Turkey (Türkiye)
Site 906 Recruiting
Ivano-Frankivsk, 76008, Ukraine
Site 902 Recruiting
Kyiv, 02002, Ukraine
Site 904 Recruiting
Kyiv, 02091, Ukraine
Site 905 Recruiting
Kyiv, 03037, Ukraine
Site 913 Recruiting
Kyiv, 04050, Ukraine
Site 911 Recruiting
Kyiv, 04107, Ukraine
Site 903 Recruiting
Kyiv, 04210, Ukraine
Site 901 Recruiting
Lutsk, 43005, Ukraine
Site 909 Recruiting
Lviv, 79010, Ukraine
Site 912 Recruiting
Lviv, 79059, Ukraine
Site 914 Recruiting
Poltava, 36011, Ukraine
Site 908 Recruiting
Vinnytsia, 21009, Ukraine
Site 910 Recruiting
Vinnytsia, 21028, Ukraine
Site 907 Recruiting
Vinnytsia, 21029, Ukraine
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SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact
SKYLINE-UC Trial Center Contact