Ulcerative ColitisPhase 2SKYLINE-UCNCT07012395

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

A Phase 2 study testing SPY001, SPY002 and SPY003 in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Spyre Therapeutics, Inc. at 276 sites in 35 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis
What is being tested?: SPY001, SPY002 and SPY003
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 645 participants
Where: 276 sitesin 35 countries
Study dates: 27 May 2025to Mar 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

276 sites in 35 countries. Contact the study team or a site near you to ask about taking part.

SKYLINE-UC Trial Center contact

1-650-402-4238

info@skyline-uc.com

Country

City, postcode or hospital

Sites recruiting now only

276 sites in 35 countries

United States27 sites, 27 recruiting

Site 003
Boston, Massachusetts, 02114
SKYLINE-UC Trial Center
Recruiting
Site 024
Canoga Park, California, 91304
SKYLINE-UC Trial Center
Recruiting
Site 013
Cedar Park, Texas, 78613
SKYLINE-UC Trial Center
Recruiting
040
Chapel Hill, North Carolina, 27599
SKYLINE-UC Trial Center
Recruiting
Site 038
Chicago, Illinois, 60637
SKYLINE-UC Trial Center
Recruiting
Site 033
Colorado Springs, Colorado, 91304
SKYLINE-UC Trial Center
Recruiting
Site 041
Durham, North Carolina, 27710
SKYLINE-UC Trial Center
Recruiting
Site 005
Garland, Texas, 75246
SKYLINE-UC Trial Center
Recruiting
Site 011
Glen Burnie, Maryland, 21061
Skyline-UC Trial Center
Recruiting
Site 006
Kansas City, Kansas, 66160
SKYLINE-UC Trial Center
Recruiting
Site 017
Kingsport, Tennessee, 37663
SKYLINE-UC Trial Center
Recruiting
Site 007
Kissimmee, Florida, 34741
SKYLINE-UC Trial Center
Recruiting
Site 023
La Jolla, California, 92037
SKYLINE-UC Trial Center
Recruiting
Site 012
Lancaster, California, 93534
SKYLINE-UC Trial Center
Recruiting
Site 030
Louisville, Kentucky, 40202
SKYLINE-UC Trial Center
Recruiting
Site 035
Marrero, Louisiana, 70072
SKYLINE-UC Trial Center
Recruiting
029
Miami, Florida, 33165
SKYLINE-UC Trial Center
Recruiting
Site 037
New York, New York, 10065
SKYLINE-UC Trial Center
Recruiting
Site 025
Providence, Rhode Island, 02904
SKYLINE- UC Trial Center
Recruiting
Site 028
Rochester, Minnesota, 55905
SKYLINE-UC Trial Center
Recruiting
Site 002
San Antonio, Texas, 78229
SKYLINE-UC Trial Center
Recruiting
Site 004
Seattle, Washington, 98195
SKYLINE-UC Trial Center
Recruiting
Site 008
Southlake, Texas, 76092
SKYLINE-UC Trial Center
Recruiting
Site 039
St Louis, Missouri, 63110
SKYLINE-UC Trial Center
Recruiting
Site 019
Tacoma, Washington, 98405
SKYLINE-UC Trial Center
Recruiting
Site 009
Webster, Texas, 77598
SKYLINE-UC Trial Center
Recruiting
Site 016
Winston-Salem, North Carolina, 27103
SKYLINE-UC Trial Center
Recruiting

Other trials in United States

Poland23 sites, 23 recruiting

Site 753
Bydgoszcz, 85-2299
SKYLINE-UC Trial Center
Recruiting
Site 732
Bydgoszcz, 85-794
Skyline-UC Trial Center
Recruiting
Site 749
Katowice, 40-600
SKYLINE-UC Trial Center
Recruiting
Site 735
Katowice, 40-748
SKYLINE-UC Trial Center
Recruiting
Site 748
Krakow, 31-501
SKYLINE-UC Trial Center
Recruiting
Site 743
Opole, 45-819
SKYLINE-UC Trial Center
Recruiting
Site 740
Poznan, 60-309
SKYLINE-UC Trial Center
Recruiting
Site 736
Rzeszów, 35-326
SKYLINE-UC Trial Center
Recruiting
Site 744
Sopot, 81-756
SKYLINE-UC Trial Center
Recruiting
Site 745
Staszów, 28-2200
SKYLINE-UC Trial Center
Recruiting
Site 737
Szczecin, 71-434
SKYLINE-UC Trial Center
Recruiting
Site 733
Szczecin, 71-685
SKYLINE-UC Trial Center
Recruiting
Site 752
Tychy, 43-100
SKYLINE-UC Trial Center
Recruiting
Site 739
Warsaw, 00--710
SKYLINE-UC Trial Center
Recruiting
Site 751
Warsaw, 00-189
SKYLINE-UC Trial Center
Recruiting
Site 754
Warsaw, 02-172
SKYLINE-UC Trial Center
Recruiting
Site 741
Warsaw, 02-786
SKYLINE-UC Trial Center
Recruiting
Site 731
Warsaw, 04-501
SKYLINE-UC Trial Center
Recruiting
Site 750
Warsaw, 57-300
SKYLINE-UC Trial Center
Recruiting
Site 738
Wroclaw, 52-416
SKYLINE-UC Trial Center
Recruiting
Site 734
Wroclaw, 53-149
SKYLINE-UC Trial Center
Recruiting
Site 747
Wroclaw, 53-611
SKYLINE-UC Trial Center
Recruiting
Site 742
Wroclaw, 54-239
SKYLINE-UC Trial Center
Recruiting

Other trials in Poland

Japan22 sites, 22 recruiting

Site 295
Bunkyō-Ku, Tokyo, 113-8519
SKYLINE-UC Trial Center
Recruiting
Site 294
Chikushino-shi, Fukuoka, 818-8502
SKYLINE-UC Trial Center
Recruiting
Site 282
Chuo Ku, Osaka, 540-0006
SKYLINE-UC Trial Center
Recruiting
Site 299
Kashiwa, Chiba, 277-0871
SKYLINE-UC Trial Center
Recruiting
Site 291
Kobe, 650-0015
SKYLINE-UC Trial Center
Recruiting
Site 304
Maebashi, Gunma, 371-8511
SKYLINE-UC Trial Center
Recruiting
Site 296
Minato-Ku, Tokyo, 108-8642
SKYLINE-UC Trial Center
Recruiting
Site 303
Nara, 630-8581
SKYLINE-UC Trial Center
Recruiting
Site 290
Ōita, Oita Prefecture, 870-0823
SKYLINE-UC Trial Center
Recruiting
Site 284
Okayama, 703-851
SKYLINE-UC Trial Center
Recruiting
Site 288
Osaka, 545-8586
SKYLINE-UC Trial Center
Recruiting
Site 286
Saga, 849-8501
SKYLINE-UC Trial Center
Recruiting
Site 297
Sakura, Chiba, 285-8741
SKYLINE-UC Trial Center
Recruiting
Site 287
Sendai, Miyagi, 983-8520
SKYLINE-UC Trial Center
Recruiting
Site 285
Sendai, 981-3213
SKYLINE-UC Trial Center
Recruiting
Site 301
Shinjuku-Ku, Tokyo, 160-0023
SKYLINE-UC Trial Center
Recruiting
Site 281
Shinjuku-Ku, Tokyo, 169-0073
SKYLINE-UC Trial Center
Recruiting
Site 292
Shiwa-gun, Iwate, 028-3695
SKYLINE-UC Trial Center
Recruiting
Site 289
Takatsuki, Osaka, 569-8686
SKYLINE-UC Trial Center
Recruiting
Site 283
Tsu, Mie-ken, 514-8507
SKYLINE-UC Trial Center
Recruiting
Site 293
Urayasu-shi, 279-0021
SKYLINE-UC Trial Center
Recruiting
Site 300
Yokohama, Kanagawa, 232-0024
SKYLINE-UC Trial Center
Recruiting

Other trials in Japan

Brazil18 sites, 18 recruiting

Site 135
Barretos, São Paulo, 14.784-400
SKYLINE-UC Trial Center
Recruiting
Site 123
Brasília, Federal District, 70200-730
SKYLINE-UC Trial Center
Recruiting
Site 131
Campinas, São Paulo, 13086045
SKYLINE-UC Trial Center
Recruiting
Site 125
Caxias do Sul, Rio Grande do Sul, 95070-560
SKYLINE-UC Trial Center
Recruiting
Site 129
Consolação, São Paulo, 01307-002
SKYLINE-UC Trial Center
Recruiting
Site 133
Goiânia, Goiás, 74535-170
SKYLINE-UC Trial Center
Recruiting
Site 138
Jaú, São Paulo, 17201-130
SKYLINE-UC Trial Center
Recruiting
Site 136
Juiz de Fora, Minas Gerais, 36033-318
SKYLINE-UC Trial Center
Recruiting
Site 134
Passo Fundo, Rio Grande do Sul, 99010-120
SKYLINE-UC Trial Center
Recruiting
Site 126
Passo Fundo, Rio Grande do Sul, 99010-260
SKYLINE-UC Trial Center
Recruiting
Site 122
Porto Alegre, Rio Grande do Sul, 90035-903
SKYLINE-UC Trial Center
Recruiting
Site 121
Porto Alegre, Rio Grande do Sul, 90160-093
SKYLINE-UC Trial Center
Recruiting
Site 128
Santo André, São Paulo, 09080-110
SKYLINE-UC Trial Center
Recruiting
Site 127
Santos, São Paulo, 11075-900
SKYLINE-UC Trial Center
Recruiting
Site 130
São José do Rio Preto, São Paulo, 15015-110
SKYLINE-UC Trial Center
Recruiting
Site 132
São Paulo, 04077-020
SKYLINE-UC Trial Center
Recruiting
Site 124
São Paulo, 05652-900
SKYLINE-UC Trial Center
Recruiting
Site 137
Teresina, Piauí, 64.049-550
SKYLINE-UC Trial Center
Recruiting

Other trials in Brazil

Ukraine14 sites, 14 recruiting

Site 906
Ivano-Frankivsk, 76008
SKYLINE-UC, Trial Center
Recruiting
Site 902
Kyiv, 02002
SKYLINE-UC, Trial Center
Recruiting
Site 904
Kyiv, 02091
SKYLINE-UC, Trial Center
Recruiting
Site 905
Kyiv, 03037
SKYLINE-UC, Trial Center
Recruiting
Site 913
Kyiv, 04050
SKYLINE-UC, Trial Center
Recruiting
Site 911
Kyiv, 04107
SKYLINE-UC, Trial Center
Recruiting
Site 903
Kyiv, 04210
SKYLINE-UC, Trial Center
Recruiting
Site 901
Lutsk, 43005
SKYLINE-UC, Trial Center
Recruiting
Site 909
Lviv, 79010
SKYLINE-UC, Trial Center
Recruiting
Site 912
Lviv, 79059
SKYLINE-UC Trial Center
Recruiting
Site 914
Poltava, 36011
SKYLINE-UC, Trial Center
Recruiting
Site 908
Vinnytsia, 21009
SKYLINE-UC, Trial Center
Recruiting
Site 910
Vinnytsia, 21028
SKYLINE-UC Trial Center
Recruiting
Site 907
Vinnytsia, 21029
SKYLINE-UC, Trial Center
Recruiting

Other trials in Ukraine

Italy12 sites, 12 recruiting

Site 683
Bologna, 40138
SKYLINE-UC Trial Center
Recruiting
Site 682
Castellana Grotte, Bari, 70013
SKYLINE-UC Trial Center
Recruiting
Site 673
Legnano, Milan, 20025
SKYLINE-UC Trial Center
Recruiting
Site 672
Negrar, 37024
SKYLINE-UC Trial Center
Recruiting
Site 677
Padova, 35128
SKYLINE-UC Trial Center
Recruiting
Site 679
Pavia, Lombardy, 27100
SKYLINE-UC Trial Center
Recruiting
Site 681
Rome, 00168
SKYLINE-UC Trial Center
Recruiting
Site 674
Rozzano, Milan, 20089
Recruiting
Site 676
San Donato Milanese, Milan, 20097
SKYLINE-UC Trial Center
Recruiting
Site 671
Segrate, Milan, 20132
SKYLINE-UC Trial Center
Recruiting
Site 680
Turin, Piedmont, 10126
SKYLINE-UC Trial Center
Recruiting
Site 675
Turin, 10128
SKYLINE-UC Trial Center
Recruiting

Other trials in Italy

South Korea12 sites, 12 recruiting

Site 357
Busan, 48108
SKYLINE-UC Trial Center
Recruiting
Site 354
Daegu, 40404
SKYLINE-UC Trial Center
Recruiting
Site 358
Daegu, 42415
SKYLINE-UC Trial Center
Recruiting
Site 361
Daegu, 42601
SKYLINE-UC Trial Center
Recruiting
Site 355
Daejeon, 34943
SKYLINE-UC, Trial Center
Recruiting
Site 356
Seoul, 03312
SKYLINE-UC Trial Center
Recruiting
Site 351
Seoul, 03722
SKYLINE-UC Trial Center
Recruiting
Site 352
Seoul, 06591
SKYLINE-UC Trial Center
Recruiting
Site 360
Seoul, 07985
SKYLINE-UC Trial Center
Recruiting
Site 362
Seoul, 6351
SKYLINE-UC, Trial Center
Recruiting
Site 359
Suwon, 16247
SKYLINE-UC Trial Center
Recruiting
Site 353
Wŏnju, 26426
SKYLINE-UC Trial Center
Recruiting

Other trials in South Korea

Germany11 sites, 11 recruiting

Site 606
Berlin, 10117
SKYLINE-UC Trial Center
Recruiting
Site 605
Berlin, 12559
SKYLINE-UC Trial Center
Recruiting
Site 613
Berlin, 14050
SKYLINE-UC Trial Center
Recruiting
Site 604
Berlin, 14163
SKYLINE-UC Trial Center
Recruiting
Site 611
Brandenburg an der Havel, 14770
SKYLINE-UC Trial Center
Recruiting
Site 607
Dachau, 85221
SKYLINE-UC Trial Center
Recruiting
Site 610
Frankfurt am Main, 60590
SKYLINE-UC Trial Center
Recruiting
Site 602
Kiel, 24105
SKYLINE-UC Trial Center
Recruiting
Site 608
Leipzig, 04103
SKYLINE-UC Trial Center
Recruiting
Site 609
Munich, 81377
SKYLINE-UC Trial Center
Recruiting
Site 603
Ulm, 89081
SKYLINE-UC Trial Center
Recruiting

Other trials in Germany

Georgia10 sites, 10 recruiting

Site 584
Kutaisi, 4600
SKYLINE-UC, Trial Center
Recruiting
Site 589
Marneuli, 3000
SKYLINE-UC, Trial Center
Recruiting
Site 581
Tbilisi, 0102
SKYLINE-UC, Trial Center
Recruiting
Site 588
Tbilisi, 0114
SKYLINE-UC, Trial Center
Recruiting
Site 583
Tbilisi, 01444
SKYLINE-UC, Trial Center
Recruiting
Site 586
Tbilisi, 0144
SKYLINE-UC, Trial Center
Recruiting
Site 582
Tbilisi, 0159
SKYLINE-UC, Trial Center
Recruiting
Site 587
Tbilisi, 0159
SKYLINE-UC, Trial Center
Recruiting
Site 590
Tbilisi, 0178
SKYLINE-UC, Trial Center
Recruiting
Site 585
Tbilisi, 0180
SKYLINE-UC, Trial Center
Recruiting

Other trials in Georgia

Australia7 sites, 7 recruiting

Site 208
Concord, 2139
SKYLINE-UC Trial Center
Recruiting
Site 202
Heidelberg, 3084
SKYLINE-UC Trial Center
Recruiting
Site 204
Liverpool, 2170
SKYLINE-UC Trial Center
Recruiting
Site 203
Melbourne, 3004
SKYLINE-UC Trial Center
Recruiting
Site 201
Murdoch, Western Australia, 6150
SKYLINE-UC Trial Center
Recruiting
Site 206
South Brisbane, 4101
SKYLINE-UC Trial Center
Recruiting
Site 207
Woolloongabba, 4102
Skyline--UC Trial Center
Recruiting

Other trials in Australia

Canada7 sites, 7 recruiting

Site 082
Chicoutimi, Quebec, G7H 5H6
SKYLINE-UC Trial Center
Recruiting
Site 085
Greater Sudbury, P3C1X3
SKYLINE-UC Trial Center
Recruiting
Site 083
London, Ontario, G8H 3P7
SKYLINE-UC Trial Center
Recruiting
Site 086
London, N6K 1M6
SKYLINE-UC Trial Center
Recruiting
Site 087
Montreal, Quebec, H3G 1A4
SKYLINE-UC Trial Center
Recruiting
Site 081
Montreal, Quebec, H4J 1C5
SKYLINE-UC Trial Center
Recruiting
Site 084
Toronto, Ontario, M5G1X5
SKYLINE-UC Trial Center
Recruiting

Other trials in Canada

Serbia7 sites, 7 recruiting

Trial Site 804
Belgrade, 11 000
SKYLINE-UC Trial Center
Recruiting
Site 802
Belgrade, 11000
SKYLINE-UC, Trial Center
Recruiting
Site 807
Belgrade, 11000
SKYLINE-UC, Trial Center
Recruiting
Site 803
Belgrade, 11080
SKYLINE-UC, Trial Center
Recruiting
Site 805
Niš, 18 000
SKYLINE-UC Trial Center
Recruiting
Site 806
Užice, 31000
SKYLINE-UC, Trial Center
Recruiting
Site 801
Zrenjanin, 23000
SKYLINE-UC, Trial Center
Recruiting

Other trials in Serbia

Spain7 sites, 7 recruiting

Site 835
Gijón, 33394
SKYLINE-UC Trial Center
Recruiting
Site 838
Lugo, 27003
SKYLINE-UC Trial Center
Recruiting
Site 834
Madrid, 28031
SKYLINE-UC Trial Center
Recruiting
Site 837
Madrid, 28222
SKYLINE-UC Trial Center
Recruiting
Site 836
Ourense, 32005
SKYLINE-UC Trial Center
Recruiting
Site 832
Santiago de Compostela, A Coruna, 15702
SKYLINE-UC Trial Center
Recruiting
Site 831
Seville, 41013
SKYLINE-UC Trial Center
Recruiting

Other trials in Spain

Taiwan7 sites, 7 recruiting

Site 394
Changhua, 500
SKYLINE-UC Trial Center
Recruiting
Site 392
Chiayi City, 600
SKYLINE-UC Trial Center
Recruiting
Site 395
Kaohsiung City, 833401
SKYLINE-UC Trial Center
Recruiting
Site 396
Taichung, 404327
SKYLINE-UC Trial Center
Recruiting
Site 391
Taipei, 100225
SKYLINE-UC Trial Center
Recruiting
Site 397
Taipei, 104
SKYLINE-UC Trial Center
Recruiting
Site 393
Taoyuan City, 333
SKYLINE-UC Trial Center
Recruiting

Other trials in Taiwan

Turkey (Türkiye)7 sites, 7 recruiting

Site 867
Istanbul, 34093
SKYLINE-UC Trial Center
Recruiting
Site 864
Izmir, 35575
SKYLINE-UC Trial Center
Recruiting
Site 866
İzmit, 41380
SKYLINE-UC Trial Center
Recruiting
Site 861
Mersin, 33110
SKYLINE-UC Trial Center
Recruiting
Site 863
Sakarya, 54290
SKYLINE-UC Trial Center
Recruiting
Site 865
Sanliurfa, 63300
SKYLINE-UC Trial Center
Recruiting
Site 862
Trabzon, 61080
SKYLINE-UC Trial Center
Recruiting

Other trials in Turkey (Türkiye)

India6 sites, 6 recruiting

Site 270
Hyderabad, 500032
SKYLINE-UC Trial Center
Recruiting
Site 268
Jaipur, 302004
SKYLINE-UC Trial Center
Recruiting
Site 266
Kochi, 682040
SKYLINE-UC Trial Center
Recruiting
Site 262
New Delhi, National Capital Territory of Delhi, 110002
SKYLINE-UC Trial Center
Recruiting
Site 263
New Delhi, National Capital Territory of Delhi, 110029
SKYLINE-UC Trial Center
Recruiting
Site 265
Sūrat, 395002
SKYLINE-UC Trial Center
Recruiting

Other trials in India

Israel6 sites, 6 recruiting

Site 445
Beer Yaaqov, 7033001
SKYLINE-UC Trial Center
Recruiting
Site 441
Beersheba, 8410101
SKYLINE-UC Trial Center
Recruiting
Site 443
Haifa, 31048
SKYLINE-UC Trial Center
Recruiting
Site 444
Jerusalem, 9103102
SKYLINE-UC Trial Center
Recruiting
Site 446
Jerusalem, 9112001
SKYLINE-UC Trial Center
Recruiting
Site 442
Nahariya, 2210001
SKYLINE-UC Trial Center
Recruiting

Other trials in Israel

Jordan6 sites, 6 recruiting

Site 425
Amman, 11194
SKYLINE-UC Trial Center
Recruiting
Site 424
Amman, 11196
SKYLINE-UC Trial Center
Recruiting
Site 421
Amman, 11942
SKYLINE-UC Trial Center
Recruiting
Site 422
Irbid, 21110
SKYLINE-UC Trial Center
Recruiting
Site 423
Irbid, 22110
SKYLINE-UC Trial Center
Recruiting
Site 426
Irbid, 22110
SKYLINE-UC Trial Center
Recruiting

Other trials in Jordan

Romania6 sites, 6 recruiting

Site 783
Bucharest, 011273
SKYLINE-UC Trial Center
Recruiting
Site 784
Bucharest, 014142
SKYLINE-UC Trial Center
Recruiting
Site 781
Bucharest, 020125
SKYLINE--UC Trial Center
Recruiting
Site 782
Cluj-Napoca, 400061
SKYLINE-UC Trial Center
Recruiting
Site 786
Constanța, 900161
SKYLINE-UC Trial Center
Recruiting
Site 788
Timișoara, 300239
SKYLINE-UC Trial Center
Recruiting

Other trials in Romania

Belgium5 sites, 5 recruiting

Site 475
Bruges, 8310
SKYLINE-UC Trial Center
Recruiting
Site 476
Ghent, Osst-Vlaanderen, 9000
SKYLINE-UC Trial Center
Recruiting
Site 471
Ghent, 9000
SKYLINE-UC Trial Center
Recruiting
Site 472
Roeselare, 9000
SKYLINE-UC Trial Center
Recruiting
Site 474
Sint-Niklaas, Osst-Vlaanderen, 9100
SKYLINE-UC Trial Center
Recruiting

Other trials in Belgium

Bulgaria5 sites, 5 recruiting

Site 494
Gorna Oryahovitsa, 5100
SKYLINE-UC Trial Center
Recruiting
Site 498
Rousse, 7002
SKYLINE-UC Trial Center
Recruiting
Site 492
Sofia, 1343
SKYLINE-UC Trial Center
Recruiting
Site 499
Sofia, 1407
SKYLINE-UC Trial Center
Recruiting
Site 495
Sofia, 1463
SKYLINE-UC Trial Center
Recruiting

Other trials in Bulgaria

Czechia5 sites, 5 recruiting

Site 531
Brno, 615 00
SKYLINE-UC Trial Center
Recruiting
Site 536
Klatovy, 33901
SKYLINE-UC Trial Center
Recruiting
Site 534
Ostrava, 702 00
SKYLINE-UC Trial Center
Recruiting
Site 537
Pardubice, 532 03
SKYLINE-UC Trial Center
Recruiting
Site 538
Prague, 150 00
SKYLINE-UC Trial Center
Recruiting

Other trials in Czechia

France5 sites, 5 recruiting

Site 555
Marseille, 13015
SKYLINE-UC Trial Center
Recruiting
Site 551
Nantes, 44300
SKYLINE-UC Trial Center
Recruiting
Site 557
Nice, 06200
SKYLINE-UC Trial Center
Recruiting
Site 556
Pierre-Bénite, 69310
SKYLINE-UC Trial Center
Recruiting
Site 558
Saint-Etienne, 42270
SKYLINE-UC Trial Center
Recruiting

Other trials in France

Hungary5 sites, 5 recruiting

Site 654
Békéscsaba, H-5600
SKYLINE-UC Trial Center
Recruiting
Site 655
Budapest, H-1062
SKYLINE-UC Trial Center
Recruiting
Site 656
Budapest, H-1083
SKYLINE-UC Trial Center
Recruiting
Site 651
Budapest, H-1088
SKYLINE-UC Trial Center
Recruiting
Site 652
Székesfehérvár, H-8000
SKYLINE-UC Trial Center
Recruiting

Other trials in Hungary

Mexico5 sites, 5 recruiting

Site 175
Celaya, Guanajuato, 38000
SKYLINE-UC Trial Center
Recruiting
Site 172
Coyoacán, Mexico City, 04100
SKYLINE-UC Trial Center
Recruiting
Site 171
Querétaro, 76000
SKYLINE-UC Trial Center
Recruiting
Site 174
Saltillo, Coahuila, 25050
SKYLINE-UC Trial Center
Recruiting
Site 173
Tlajomulco de Zúñiga, Jalisco, 45645
SKYLINE-UC Trial Center
Recruiting

Other trials in Mexico

Moldova5 sites, 5 recruiting

Site 713
Chisinau, MD2005
SKYLINE-UC, Trial Center
Recruiting
Site 711
Chisinau, MD2025
SKYLINE-UC, Trial Center
Recruiting
Site 712
Chisinau, MD2025
SKYLINE-UC, Trial Center
Recruiting
Site 714
Chisinau, MD2025
SKYLINE-UC, Trial Center
Recruiting
Site 715
Chisinau, MD2068
SKYLINE-UC, Trial Center
Recruiting

Other trials in Moldova

Argentina4 sites, 4 recruiting

Site 105
La Plata, Buenos Aires, 1900
SKYLINE-UC Trial Center
Recruiting
Site 102
Lujan de Cuyo, Mendoza Province, 5505
SKYLINE-UC Trial Center
Recruiting
Site 103
Rosario, Sant Fe, 2000
SKYLINE-UC Trial Center
Recruiting
Site 104
San Miguel de Tucumán, Tucumán Province, 4000
SKYLINE-UC Trial Center
Recruiting

Other trials in Argentina

Greece4 sites, 4 recruiting

Site 635
Athens, Attica, 11527
SKYLINE-UC Trial Center
Recruiting
Site 634
Athens, 10676
SKYLINE-UC Trial Center
Recruiting
Site 632
Athens, 115 27
SKYLINE-UC Trial Center
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Site 631
Chaïdári, 124 62
SKYLINE-UC Trial Center
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Other trials in Greece

Slovakia4 sites, 4 recruiting

Site 823
Bratislava, 811 09
SKYLINE-UC Trial Center
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Site 822
Košice, 040 13
SKYLINE-UC Trial Center
Recruiting
Site 821
Prešov, 080 01
SKYLINE-UC Trial Center
Recruiting
Site 825
Zvolen, 960 01
SKYLINE-UC Trial Center
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Other trials in Slovakia

Bosnia and Herzegovina3 sites, 3 recruiting

Site 481
Banja Luka, 78 000
SKYLINE-UC Trial Center
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Site 484
Mostar, 88000
SKYLINE-UC Trial Center
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Site 483
Sarajevo, 71000
SKYLINE-UC, Trial Center
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Lithuania3 sites, 3 recruiting

Site 704
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SKYLINE-UC Trial Center
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Site 702
Vilnius, LT-08406
SKYLINE-UC Trial Center
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Site 703
Vilnius, LT-08406
SKYLINE-UC Trial Center
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Switzerland3 sites, 3 recruiting

Site 852
Basel, 4031
SKYLINE-UC Trial Center
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Site 853
Bern, 3012
SKYLINE-UC Trial Center
Recruiting
Site 851
Sankt Gallen, 9007
SKYLINE-UC Trial Center
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Chile2 sites, 2 recruiting

Site 153
Osorno, Los Lagos Region, 5290000
SKYLINE-UC Trial Center
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Site 152
Santiago, Santiago Metropolitan, 8320000
SKYLINE-UC Trial Center
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Croatia2 sites, 2 recruiting

Site 521
Osijek, 31000
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Site 524
Zagreb, 10000
SKYLINE-UC Trial Center
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Austria1 site, 1 recruiting

Site 463
Linz, 4021
SKYLINE-UC Trial Center
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About this study

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

Read the 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.

Conditions: Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
Being tested: SPY001, SPY002, SPY003, Placebo
Medical subject headings: Colitis, Ulcerative, Inflammatory Bowel Diseases, Colitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPY001Drug
Also called SPY001-001
Experimental
SPY002Drug
Also called SPY002-091
Experimental
SPY003Drug
Also called SPY003-207
Experimental
PlaceboOther
Placebo

Study groups in NCT07012395
Study group	Role	What they receive
Intervention Specific Appendix - SPY001: Part A	Experimental	Participants will receive open-label dose of SPY001 Receives: Drug: SPY001
Intervention Specific Appendix - SPY002: Part A	Experimental	Participants will receive open-label dose of SPY002 Receives: Drug: SPY002
Intervention Specific Appendix - SPY003: Part A	Experimental	Participants will receive open-label dose of SPY003 Receives: Drug: SPY003
Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B	Experimental	Participants will receive double-blind dosing regimen 1 of SPY001 Receives: Drug: SPY001
Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B	Experimental	Participants will receive double-blind dosing regimen 2 of SPY001 Receives: Drug: SPY001
Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B	Experimental	Participants will receive double-blind dosing regimen 1 of SPY002 Receives: Drug: SPY002
Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B	Experimental	Participants will receive double-blind dosing regimen 2 of SPY002 Receives: Drug: SPY002
Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B	Experimental	Participants will receive double-blind dosing regimen 1 of SPY003 Receives: Drug: SPY003
Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B	Experimental	Participants will receive double-blind dosing regimen 2 of SPY003 Receives: Drug: SPY003
Intervention Specific Appendix - SPY120: Part B	Experimental	Participants will receive double-blind dose of SPY001 and SPY002 Receives: Drug: SPY001; Drug: SPY002
Intervention Specific Appendix - SPY130: Part B	Experimental	Participants will receive double-blind dose of SPY001 and SPY003 Receives: Drug: SPY001; Drug: SPY003
Intervention Specific Appendix - SPY230: Part B	Experimental	Participants will receive double-blind dose of SPY002 and SPY003 Receives: Drug: SPY002; Drug: SPY003
Placebo: Part B	Placebo comparator	Participants will receive matching placebo Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A: Change in Robarts Histopathology Index (RHI)
Change in Robarts Histopathology Index (RHI) from baseline at Week 12 will be assessed. The RHI is used to quantify and assess histological activity of UC, comprising of scores for inflammatory infiltrates, neutrophils, erosions or ulceration. Scores are assigned to each of these features, with a total ranging from 0 (no disease activity) to 33 (most severe disease activity). Higher score indicates more severe disease.
Measured: Week 12
Part B: Percentage of participants with clinical remission
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.
Measured: Week 12

Secondary outcomes (7)

Part A: Percentage of participants with clinical remission
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.
Measured: Week 12
Part A: Percentage of participants with endoscopic improvement
Percentage of participants with endoscopic improvement at Week 12 will be assessed. Endoscopic improvement based on the Mayo endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher score indicates more severe disease.
Measured: Week 12
Part B: Percentage of participants with endoscopic improvement
Percentage of participants with endoscopic improvement at Week 12 will be assessed. Endoscopic improvement based on the Mayo endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher score indicates more severe disease.
Measured: Week 12
Part B: Percentage of participants with clinical response
Percentage of participants with clinical response at Week 12 will be assessed. Clinical response is based on the modified Mayo Score, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.
Measured: Week 12
Part B: Percentage of participants with histologic improvement
Percentage of participants with histologic improvement at Week 12 will be assessed. Histologic improvement is based on the Geboes score. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. Higher score indicates more severe disease.
Measured: Week 12
Part B: Percentage of participants achieving histologic endoscopic mucosal improvement (HEMI).
Percentage of participants with HEMI at Week 12 will be assessed. Mucosal improvement is based on the Mayo endoscopic subscore and the Geboes score. The Mayo endoscopic subscore ranges from 0 to 3, as assessed by central reading. Higher score indicates more severe disease. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. Higher score indicates more severe disease
Measured: Week 12
Part B: Percentage of participants with clinical remission
Percentage of participants with clinical remission at Week 48 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.
Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 2025Mar 2028

First posted10 Jun 2025
Study start27 May 2025
Primary completionJun 2027 (estimated)
Study completionMar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 645 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07012395
Sponsor's protocol ID: SPY123-201
Acronym: SKYLINE-UC
Status last verified: Oct 2026
First submitted: 27 May 2025
Last updated: 27 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

SKYLINE-UC Trial Center

1-650-402-4238

info@skyline-uc.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07012395
Acronym / sponsor ID: SKYLINE-UC / SPY123-201
Conditions: Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 645 participants (estimated)
Lead sponsor: Spyre Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 27 May 2025 (actual)
Primary completion: Jun 2027 (estimated)
Study completion: Mar 2028 (estimated)
First posted: 10 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Part A is the open-label portion of the study assessing safety and preliminary efficacy of monotherapies. Part A enrollment completed April 2026.

Intervention arms will be added to the study over time and may complete at different times.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 13

Arm	Type	Receives
Intervention Specific Appendix - SPY001: Part A	Experimental	Drug: SPY001Participants will receive open-label dose of SPY001
Intervention Specific Appendix - SPY002: Part A	Experimental	Drug: SPY002Participants will receive open-label dose of SPY002
Intervention Specific Appendix - SPY003: Part A	Experimental	Drug: SPY003Participants will receive open-label dose of SPY003
Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B	Experimental	Drug: SPY001Participants will receive double-blind dosing regimen 1 of SPY001
Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B	Experimental	Drug: SPY001Participants will receive double-blind dosing regimen 2 of SPY001
Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B	Experimental	Drug: SPY002Participants will receive double-blind dosing regimen 1 of SPY002
Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B	Experimental	Drug: SPY002Participants will receive double-blind dosing regimen 2 of SPY002
Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B	Experimental	Drug: SPY003Participants will receive double-blind dosing regimen 1 of SPY003
Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B	Experimental	Drug: SPY003Participants will receive double-blind dosing regimen 2 of SPY003
Intervention Specific Appendix - SPY120: Part B	Experimental	Drug: SPY001, Drug: SPY002Participants will receive double-blind dose of SPY001 and SPY002
Intervention Specific Appendix - SPY130: Part B	Experimental	Drug: SPY001, Drug: SPY003Participants will receive double-blind dose of SPY001 and SPY003
Intervention Specific Appendix - SPY230: Part B	Experimental	Drug: SPY002, Drug: SPY003Participants will receive double-blind dose of SPY002 and SPY003
Placebo: Part B	Placebo comparator	Other: PlaceboParticipants will receive matching placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SPY001Also: SPY001-001Experimental	Drug	Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B, Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B, Intervention Specific Appendix - SPY001: Part A, Intervention Specific Appendix - SPY120: Part B, Intervention Specific Appendix - SPY130: Part B
SPY002Also: SPY002-091Experimental	Drug	Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B, Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B, Intervention Specific Appendix - SPY002: Part A, Intervention Specific Appendix - SPY120: Part B, Intervention Specific Appendix - SPY230: Part B
SPY003Also: SPY003-207Experimental	Drug	Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B, Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B, Intervention Specific Appendix - SPY003: Part A, Intervention Specific Appendix - SPY130: Part B, Intervention Specific Appendix - SPY230: Part B
PlaceboPlacebo	Other	Placebo: Part B

Primary outcome

Part A: Change in Robarts Histopathology Index (RHI)
Time frame: Week 12
Change in Robarts Histopathology Index (RHI) from baseline at Week 12 will be assessed. The RHI is used to quantify and assess histological activity of UC, comprising of scores for inflammatory infiltrates, neutrophils, erosions or ulceration. Scores are assigned to each of these features, with a total ranging from 0 (no disease activity) to 33 (most severe disease activity). Higher score indicates more severe disease.
Part B: Percentage of participants with clinical remission
Time frame: Week 12
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.

7 secondary outcomes

Part A: Percentage of participants with clinical remission
Time frame: Week 12
Part A: Percentage of participants with endoscopic improvement
Time frame: Week 12
Part B: Percentage of participants with endoscopic improvement
Time frame: Week 12
Part B: Percentage of participants with clinical response
Time frame: Week 12
Part B: Percentage of participants with histologic improvement
Time frame: Week 12
Part B: Percentage of participants achieving histologic endoscopic mucosal improvement (HEMI).
Time frame: Week 12
Part B: Percentage of participants with clinical remission
Time frame: Week 48

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Ulcerative Colitis

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
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Enrolling by invitationPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

SKYLINE-UC Trial Center contact

1-650-402-4238

info@skyline-uc.com

SKYLINE-UC Study Director study director

Spyre Therapeutics

276 sites in 35 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SPY001, SPY002 and SPY003 in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Spyre Therapeutics, Inc. at 276 sites in 35 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 276 sites in United States, Poland, Japan, Brazil, Ukraine and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SKYLINE-UC Trial Center (1-650-402-4238, info@skyline-uc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Change in Robarts Histopathology Index (RHI) (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07012395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.