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

June 4, 2026 updated by: Spyre Therapeutics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 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.

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

Study Type

Interventional

Enrollment (Estimated)

645

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: SKYLINE-UC Trial Center
Phone Number: 1-650-402-4238
Email: info@skyline-uc.com

Study Locations

Argentina
- Sant Fe
  - Rosario, Sant Fe, Argentina, 2000
    - Recruiting
    - Site 103
    - Contact:
      
      SKYLINE-UC Trial Center
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Recruiting
    - Site 104
    - Contact:
      
      SKYLINE-UC Trial Center
Australia
- - Concord, Australia, 2139
    - Recruiting
    - Site 208
    - Contact:
      
      SKYLINE-UC Trial Center
  - Heidelberg, Australia, 3084
    - Recruiting
    - Site 202
    - Contact:
      
      SKYLINE-UC Trial Center
  - Liverpool, Australia, 2170
    - Recruiting
    - Site 204
    - Contact:
      
      SKYLINE-UC Trial Center
  - Melbourne, Australia, 3004
    - Recruiting
    - Site 203
    - Contact:
      
      SKYLINE-UC Trial Center
  - South Brisbane, Australia, 4101
    - Recruiting
    - Site 206
    - Contact:
      
      SKYLINE-UC Trial Center
  - Woolloongabba, Australia, 4102
    - Recruiting
    - Site 207
    - Contact:
      
      SKYLINE--UC Trial Center
Austria
- - Linz, Austria, 4021
    - Recruiting
    - Site 463
    - Contact:
      
      SKYLINE-UC Trial Center
Belgium
- - Bruges, Belgium, 8310
    - Recruiting
    - Site 475
    - Contact:
      
      SKYLINE-UC Trial Center
  - Ghent, Belgium, 9000
    - Recruiting
    - Site 471
    - Contact:
      
      SKYLINE-UC Trial Center
  - Roeselare, Belgium, 9000
    - Recruiting
    - Site 472
    - Contact:
      
      SKYLINE-UC Trial Center
- Osst-Vlaanderen
  - Ghent, Osst-Vlaanderen, Belgium, 9000
    - Recruiting
    - Site 476
    - Contact:
      
      SKYLINE-UC Trial Center
  - Sint-Niklaas, Osst-Vlaanderen, Belgium, 9100
    - Recruiting
    - Site 474
    - Contact:
      
      SKYLINE-UC Trial Center
Bosnia and Herzegovina
- - Banja Luka, Bosnia and Herzegovina, 78 000
    - Recruiting
    - Site 481
    - Contact:
      
      SKYLINE-UC Trial Center
  - Mostar, Bosnia and Herzegovina, 88000
    - Recruiting
    - Site 484
    - Contact:
      
      SKYLINE-UC Trial Center
  - Sarajevo, Bosnia and Herzegovina, 71000
    - Recruiting
    - Site 483
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
Bulgaria
- - Gorna Oryahovitsa, Bulgaria, 5100
    - Recruiting
    - Site 494
    - Contact:
      
      SKYLINE-UC Trial Center
  - Rousse, Bulgaria, 7002
    - Recruiting
    - Site 498
    - Contact:
      
      SKYLINE-UC Trial Center
  - Sofia, Bulgaria, 1343
    - Recruiting
    - Site 492
    - Contact:
      
      SKYLINE-UC Trial Center
  - Sofia, Bulgaria, 1463
    - Recruiting
    - Site 495
    - Contact:
      
      SKYLINE-UC Trial Center
Canada
- - Greater Sudbury, Canada, P3C1X3
    - Recruiting
    - Site 085
    - Contact:
      
      SKYLINE-UC Trial Center
  - London, Canada, N6K 1M6
    - Recruiting
    - Site 086
    - Contact:
      
      SKYLINE-UC Trial Center
- Ontario
  - London, Ontario, Canada, G8H 3P7
    - Recruiting
    - Site 083
    - Contact:
      
      SKYLINE-UC Trial Center
Chile
- Los Lagos Region
  - Osorno, Los Lagos Region, Chile, 5290000
    - Recruiting
    - Site 153
    - Contact:
      
      SKYLINE-UC Trial Center
Croatia
- - Osijek, Croatia, 31000
    - Recruiting
    - Site 521
    - Contact:
      
      SKYLINE-UC Trial Center
Czechia
- - Brno, Czechia, 615 00
    - Recruiting
    - Site 531
    - Contact:
      
      SKYLINE-UC Trial Center
  - Klatovy, Czechia, 33901
    - Recruiting
    - Site 536
    - Contact:
      
      SKYLINE-UC Trial Center
  - Ostrava, Czechia, 702 00
    - Recruiting
    - Site 534
    - Contact:
      
      SKYLINE-UC Trial Center
  - Pardubice, Czechia, 532 03
    - Recruiting
    - Site 537
    - Contact:
      
      SKYLINE-UC Trial Center
  - Prague, Czechia, 150 00
    - Recruiting
    - Site 538
    - Contact:
      
      SKYLINE-UC Trial Center
France
- - Marseille, France, 13015
    - Recruiting
    - Site 555
    - Contact:
      
      SKYLINE-UC Trial Center
  - Nantes, France, 44300
    - Recruiting
    - Site 551
    - Contact:
      
      SKYLINE-UC Trial Center
  - Nice, France, 06200
    - Recruiting
    - Site 557
    - Contact:
      
      SKYLINE-UC Trial Center
  - Pierre-Bénite, France, 69310
    - Recruiting
    - Site 556
    - Contact:
      
      SKYLINE-UC Trial Center
  - Saint-Etienne, France, 42270
    - Recruiting
    - Site 558
    - Contact:
      
      SKYLINE-UC Trial Center
Georgia
- - Kutaisi, Georgia, 4600
    - Recruiting
    - Site 584
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Marneuli, Georgia, 3000
    - Recruiting
    - Site 589
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Tbilisi, Georgia, 0159
    - Recruiting
    - Site 582
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Tbilisi, Georgia, 0178
    - Recruiting
    - Site 590
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Tbilisi, Georgia, 0180
    - Recruiting
    - Site 585
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Tbilisi, Georgia, 0102
    - Recruiting
    - Site 581
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Tbilisi, Georgia, 0114
    - Recruiting
    - Site 588
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Tbilisi, Georgia, 0144
    - Recruiting
    - Site 586
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Tbilisi, Georgia, 0159
    - Recruiting
    - Site 587
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Tbilisi, Georgia, 01444
    - Recruiting
    - Site 583
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
Germany
- - Berlin, Germany, 14163
    - Recruiting
    - Site 604
    - Contact:
      
      SKYLINE-UC Trial Center
  - Berlin, Germany, 10117
    - Recruiting
    - Site 606
    - Contact:
      
      SKYLINE-UC Trial Center
  - Brandenburg an der Havel, Germany, 14770
    - Recruiting
    - Site 611
    - Contact:
      
      SKYLINE-UC Trial Center
  - Dachau, Germany, 85221
    - Recruiting
    - Site 607
    - Contact:
      
      SKYLINE-UC Trial Center
  - Frankfurt am Main, Germany, 60590
    - Recruiting
    - Site 610
    - Contact:
      
      SKYLINE-UC Trial Center
  - Kiel, Germany, 24105
    - Recruiting
    - Site 602
    - Contact:
      
      SKYLINE-UC Trial Center
  - Leipzig, Germany, 04103
    - Recruiting
    - Site 608
    - Contact:
      
      SKYLINE-UC Trial Center
  - Munich, Germany, 81377
    - Recruiting
    - Site 609
    - Contact:
      
      SKYLINE-UC Trial Center
  - Ulm, Germany, 89081
    - Recruiting
    - Site 603
    - Contact:
      
      SKYLINE-UC Trial Center
Greece
- - Athens, Greece, 10676
    - Recruiting
    - Site 634
    - Contact:
      
      SKYLINE-UC Trial Center
  - Athens, Greece, 115 27
    - Recruiting
    - Site 632
    - Contact:
      
      SKYLINE-UC Trial Center
  - Chaïdári, Greece, 124 62
    - Recruiting
    - Site 631
    - Contact:
      
      SKYLINE-UC Trial Center
- Attica
  - Athens, Attica, Greece, 11527
    - Recruiting
    - Site 635
    - Contact:
      
      SKYLINE-UC Trial Center
Hungary
- - Budapest, Hungary, H-1083
    - Recruiting
    - Site 656
    - Contact:
      
      SKYLINE-UC Trial Center
  - Budapest, Hungary, H-1088
    - Recruiting
    - Site 651
    - Contact:
      
      SKYLINE-UC Trial Center
  - Budapest, Hungary, H-1062
    - Recruiting
    - Site 655
    - Contact:
      
      SKYLINE-UC Trial Center
  - Békéscsaba, Hungary, H-5600
    - Recruiting
    - Site 654
    - Contact:
      
      SKYLINE-UC Trial Center
  - Székesfehérvár, Hungary, H-8000
    - Recruiting
    - Site 652
    - Contact:
      
      SKYLINE-UC Trial Center
India
- - Hyderabad, India, 500032
    - Recruiting
    - Site 270
    - Contact:
      
      SKYLINE-UC Trial Center
  - Jaipur, India, 302004
    - Recruiting
    - Site 268
    - Contact:
      
      SKYLINE-UC Trial Center
  - Kochi, India, 682040
    - Recruiting
    - Site 266
    - Contact:
      
      SKYLINE-UC Trial Center
  - Sūrat, India, 395002
    - Recruiting
    - Site 265
    - Contact:
      
      SKYLINE-UC Trial Center
Israel
- - Beer Yaaqov, Israel, 7033001
    - Recruiting
    - Site 445
    - Contact:
      
      SKYLINE-UC Trial Center
  - Beersheba, Israel, 8410101
    - Recruiting
    - Site 441
    - Contact:
      
      SKYLINE-UC Trial Center
  - Haifa, Israel, 31048
    - Recruiting
    - Site 443
    - Contact:
      
      SKYLINE-UC Trial Center
  - Jerusalem, Israel, 9103102
    - Recruiting
    - Site 444
    - Contact:
      
      SKYLINE-UC Trial Center
  - Jerusalem, Israel, 9112001
    - Recruiting
    - Site 446
    - Contact:
      
      SKYLINE-UC Trial Center
  - Nahariya, Israel, 2210001
    - Recruiting
    - Site 442
    - Contact:
      
      SKYLINE-UC Trial Center
Italy
- - Bologna, Italy, 40138
    - Recruiting
    - Site 683
    - Contact:
      
      SKYLINE-UC Trial Center
  - Negrar, Italy, 37024
    - Recruiting
    - Site 672
    - Contact:
      
      SKYLINE-UC Trial Center
  - Padova, Italy, 35128
    - Recruiting
    - Site 677
    - Contact:
      
      SKYLINE-UC Trial Center
  - Rome, Italy, 00168
    - Recruiting
    - Site 681
    - Contact:
      
      SKYLINE-UC Trial Center
  - Turin, Italy, 10128
    - Recruiting
    - Site 675
    - Contact:
      
      SKYLINE-UC Trial Center
- Bari
  - Castellana Grotte, Bari, Italy, 70013
    - Recruiting
    - Site 682
    - Contact:
      
      SKYLINE-UC Trial Center
- Lombardy
  - Pavia, Lombardy, Italy, 27100
    - Recruiting
    - Site 679
    - Contact:
      
      SKYLINE-UC Trial Center
- Milan
  - Legnano, Milan, Italy, 20025
    - Recruiting
    - Site 673
    - Contact:
      
      SKYLINE-UC Trial Center
  - Rozzano, Milan, Italy, 20089
    - Recruiting
    - Site 674
  - San Donato Milanese, Milan, Italy, 20097
    - Recruiting
    - Site 676
    - Contact:
      
      SKYLINE-UC Trial Center
  - Segrate, Milan, Italy, 20132
    - Recruiting
    - Site 671
    - Contact:
      
      SKYLINE-UC Trial Center
- Piedmont
  - Turin, Piedmont, Italy, 10126
    - Recruiting
    - Site 680
    - Contact:
      
      SKYLINE-UC Trial Center
Japan
- - Kobe, Japan, 650-0015
    - Recruiting
    - Site 291
    - Contact:
      
      SKYLINE-UC Trial Center
  - Saga, Japan, 849-8501
    - Recruiting
    - Site 286
    - Contact:
      
      SKYLINE-UC Trial Center
  - Sendai, Japan, 981-3213
    - Recruiting
    - Site 285
    - Contact:
      
      SKYLINE-UC Trial Center
  - Urayasu-shi, Japan, 279-0021
    - Recruiting
    - Site 293
    - Contact:
      
      SKYLINE-UC Trial Center
- Chiba
  - Kashiwa, Chiba, Japan, 277-0871
    - Recruiting
    - Site 299
    - Contact:
      
      SKYLINE-UC Trial Center
- Fukuoka
  - Chikushino-shi, Fukuoka, Japan, 818-8502
    - Recruiting
    - Site 294
    - Contact:
      
      SKYLINE-UC Trial Center
- Iwate
  - Shiwa-gun, Iwate, Japan, 028-3695
    - Recruiting
    - Site 292
    - Contact:
      
      SKYLINE-UC Trial Center
- Oita Prefecture
  - Ōita, Oita Prefecture, Japan, 870-0823
    - Recruiting
    - Site 290
    - Contact:
      
      SKYLINE-UC Trial Center
- Osaka
  - Chuo Ku, Osaka, Japan, 540-0006
    - Recruiting
    - Site 282
    - Contact:
      
      SKYLINE-UC Trial Center
Jordan
- - Amman, Jordan, 11196
    - Recruiting
    - Site 424
    - Contact:
      
      SKYLINE-UC Trial Center
  - Amman, Jordan, 11942
    - Recruiting
    - Site 421
    - Contact:
      
      SKYLINE-UC Trial Center
  - Amman, Jordan, 11194
    - Recruiting
    - Site 425
    - Contact:
      
      SKYLINE-UC Trial Center
  - Irbid, Jordan, 21110
    - Recruiting
    - Site 422
    - Contact:
      
      SKYLINE-UC Trial Center
  - Irbid, Jordan, 22110
    - Recruiting
    - Site 423
    - Contact:
      
      SKYLINE-UC Trial Center
  - Irbid, Jordan, 22110
    - Recruiting
    - Site 426
    - Contact:
      
      SKYLINE-UC Trial Center
Lithuania
- - Klaipėda, Lithuania, LT-92288
    - Recruiting
    - Site 704
    - Contact:
      
      SKYLINE-UC Trial Center
  - Vilnius, Lithuania, LT-08406
    - Recruiting
    - Site 703
    - Contact:
      
      SKYLINE-UC Trial Center
Mexico
- Coahuila
  - Saltillo, Coahuila, Mexico, 25050
    - Recruiting
    - Site 174
    - Contact:
      
      SKYLINE-UC Trial Center
- Guanajuato
  - Celaya, Guanajuato, Mexico, 38000
    - Recruiting
    - Site 175
    - Contact:
      
      SKYLINE-UC Trial Center
- Jalisco
  - Tlajomulco de Zúñiga, Jalisco, Mexico, 45645
    - Recruiting
    - Site 173
    - Contact:
      
      SKYLINE-UC Trial Center
Moldova
- - Chisinau, Moldova, MD2025
    - Recruiting
    - Site 711
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Chisinau, Moldova, MD2025
    - Recruiting
    - Site 712
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Chisinau, Moldova, MD2068
    - Recruiting
    - Site 715
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Chisinau, Moldova, MD2005
    - Recruiting
    - Site 713
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Chisinau, Moldova, MD2025
    - Recruiting
    - Site 714
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
Poland
- - Bydgoszcz, Poland, 85-794
    - Recruiting
    - Site 732
    - Contact:
      
      SKYLINE-UC Trial Center
  - Bydgoszcz, Poland, 85-2299
    - Recruiting
    - Site 753
    - Contact:
      
      SKYLINE-UC Trial Center
  - Katowice, Poland, 40-748
    - Recruiting
    - Site 735
    - Contact:
      
      SKYLINE-UC Trial Center
  - Katowice, Poland, 40-600
    - Recruiting
    - Site 749
    - Contact:
      
      SKYLINE-UC Trial Center
  - Krakow, Poland, 31-501
    - Recruiting
    - Site 748
    - Contact:
      
      SKYLINE-UC Trial Center
  - Opole, Poland, 45-819
    - Recruiting
    - Site 743
    - Contact:
      
      SKYLINE-UC Trial Center
  - Poznan, Poland, 60-309
    - Recruiting
    - Site 740
    - Contact:
      
      SKYLINE-UC Trial Center
  - Rzeszów, Poland, 35-326
    - Recruiting
    - Site 736
    - Contact:
      
      SKYLINE-UC Trial Center
  - Sopot, Poland, 81-756
    - Recruiting
    - Site 744
    - Contact:
      
      SKYLINE-UC Trial Center
  - Staszów, Poland, 28-2200
    - Recruiting
    - Site 745
    - Contact:
      
      SKYLINE-UC Trial Center
  - Szczecin, Poland, 71-685
    - Recruiting
    - Site 733
    - Contact:
      
      SKYLINE-UC Trial Center
  - Szczecin, Poland, 71-434
    - Recruiting
    - Site 737
    - Contact:
      
      SKYLINE-UC Trial Center
  - Tychy, Poland, 43-100
    - Recruiting
    - Site 752
    - Contact:
      
      SKYLINE-UC Trial Center
  - Warsaw, Poland, 57-300
    - Recruiting
    - Site 750
    - Contact:
      
      SKYLINE-UC Trial Center
  - Warsaw, Poland, 00--710
    - Recruiting
    - Site 739
    - Contact:
      
      SKYLINE-UC Trial Center
  - Warsaw, Poland, 04-501
    - Recruiting
    - Site 731
    - Contact:
      
      SKYLINE-UC Trial Center
  - Warsaw, Poland, 02-786
    - Recruiting
    - Site 741
    - Contact:
      
      SKYLINE-UC Trial Center
  - Warsaw, Poland, 00-189
    - Recruiting
    - Site 751
    - Contact:
      
      SKYLINE-UC Trial Center
  - Warsaw, Poland, 02-172
    - Recruiting
    - Site 754
    - Contact:
      
      SKYLINE-UC Trial Center
  - Wroclaw, Poland, 53-149
    - Recruiting
    - Site 734
    - Contact:
      
      SKYLINE-UC Trial Center
  - Wroclaw, Poland, 53-611
    - Recruiting
    - Site 747
    - Contact:
      
      SKYLINE-UC Trial Center
  - Wroclaw, Poland, 52-416
    - Recruiting
    - Site 738
    - Contact:
      
      SKYLINE-UC Trial Center
  - Wroclaw, Poland, 54-239
    - Recruiting
    - Site 742
    - Contact:
      
      SKYLINE-UC Trial Center
Romania
- - Bucharest, Romania, 014142
    - Recruiting
    - Site 784
    - Contact:
      
      SKYLINE-UC Trial Center
  - Bucharest, Romania, 020125
    - Recruiting
    - Site 781
    - Contact:
      
      SKYLINE--UC Trial Center
  - Bucharest, Romania, 011273
    - Recruiting
    - Site 783
    - Contact:
      
      SKYLINE-UC Trial Center
  - Cluj-Napoca, Romania, 400061
    - Recruiting
    - Site 782
    - Contact:
      
      SKYLINE-UC Trial Center
  - Constanța, Romania, 900161
    - Recruiting
    - Site 786
    - Contact:
      
      SKYLINE-UC Trial Center
  - Timișoara, Romania, 300239
    - Recruiting
    - Site 788
    - Contact:
      
      SKYLINE-UC Trial Center
Serbia
- - Belgrade, Serbia, 11000
    - Recruiting
    - Site 802
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Belgrade, Serbia, 11000
    - Recruiting
    - Site 807
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Belgrade, Serbia, 11080
    - Recruiting
    - Site 803
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Belgrade, Serbia, 11 000
    - Recruiting
    - Trial Site 804
    - Contact:
      
      SKYLINE-UC Trial Center
  - Niš, Serbia, 18 000
    - Recruiting
    - Site 805
    - Contact:
      
      SKYLINE-UC Trial Center
  - Užice, Serbia, 31000
    - Recruiting
    - Site 806
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Zrenjanin, Serbia, 23000
    - Recruiting
    - Site 801
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
Slovakia
- - Bratislava, Slovakia, 811 09
    - Recruiting
    - Site 823
    - Contact:
      
      SKYLINE-UC Trial Center
  - Košice, Slovakia, 040 13
    - Recruiting
    - Site 822
    - Contact:
      
      SKYLINE-UC Trial Center
  - Prešov, Slovakia, 080 01
    - Recruiting
    - Site 821
    - Contact:
      
      SKYLINE-UC Trial Center
  - Zvolen, Slovakia, 960 01
    - Recruiting
    - Site 825
    - Contact:
      
      SKYLINE-UC Trial Center
South Korea
- - Busan, South Korea, 48108
    - Recruiting
    - Site 357
    - Contact:
      
      SKYLINE-UC Trial Center
  - Daegu, South Korea, 42601
    - Recruiting
    - Site 361
    - Contact:
      
      SKYLINE-UC Trial Center
  - Daegu, South Korea, 40404
    - Recruiting
    - Site 354
    - Contact:
      
      SKYLINE-UC Trial Center
  - Daegu, South Korea, 42415
    - Recruiting
    - Site 358
    - Contact:
      
      SKYLINE-UC Trial Center
  - Daejeon, South Korea, 34943
    - Recruiting
    - Site 355
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Seoul, South Korea, 6351
    - Recruiting
    - Site 362
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Seoul, South Korea, 03722
    - Recruiting
    - Site 351
    - Contact:
      
      SKYLINE-UC Trial Center
  - Seoul, South Korea, 03312
    - Recruiting
    - Site 356
    - Contact:
      
      SKYLINE-UC Trial Center
  - Seoul, South Korea, 07985
    - Recruiting
    - Site 360
    - Contact:
      
      SKYLINE-UC Trial Center
  - Seoul, South Korea, 06591
    - Recruiting
    - Site 352
    - Contact:
      
      SKYLINE-UC Trial Center
  - Suwon, South Korea, 16247
    - Recruiting
    - Site 359
    - Contact:
      
      SKYLINE-UC Trial Center
  - Wŏnju, South Korea, 26426
    - Recruiting
    - Site 353
    - Contact:
      
      SKYLINE-UC Trial Center
Spain
- - Gijón, Spain, 33394
    - Recruiting
    - Site 835
    - Contact:
      
      SKYLINE-UC Trial Center
  - Lugo, Spain, 27003
    - Recruiting
    - Site 838
    - Contact:
      
      SKYLINE-UC Trial Center
  - Madrid, Spain, 28031
    - Recruiting
    - Site 834
    - Contact:
      
      SKYLINE-UC Trial Center
  - Madrid, Spain, 28222
    - Recruiting
    - Site 837
    - Contact:
      
      SKYLINE-UC Trial Center
  - Ourense, Spain, 32005
    - Recruiting
    - Site 836
    - Contact:
      
      SKYLINE-UC Trial Center
  - Seville, Spain, 41013
    - Recruiting
    - Site 831
    - Contact:
      
      SKYLINE-UC Trial Center
- A Coruna
  - Santiago de Compostela, A Coruna, Spain, 15702
    - Recruiting
    - Site 832
    - Contact:
      
      SKYLINE-UC Trial Center
Switzerland
- - Basel, Switzerland, 4031
    - Recruiting
    - Site 852
    - Contact:
      
      SKYLINE-UC Trial Center
  - Bern, Switzerland, 3012
    - Recruiting
    - Site 853
    - Contact:
      
      SKYLINE-UC Trial Center
  - Sankt Gallen, Switzerland, 9007
    - Recruiting
    - Site 851
    - Contact:
      
      SKYLINE-UC Trial Center
Taiwan
- - Changhua, Taiwan, 500
    - Recruiting
    - Site 394
    - Contact:
      
      SKYLINE-UC Trial Center
  - Chiayi City, Taiwan, 600
    - Recruiting
    - Site 392
    - Contact:
      
      SKYLINE-UC Trial Center
  - Kaohsiung City, Taiwan, 833401
    - Recruiting
    - Site 395
    - Contact:
      
      SKYLINE-UC Trial Center
  - Taichung, Taiwan, 404327
    - Recruiting
    - Site 396
    - Contact:
      
      SKYLINE-UC Trial Center
  - Taipei, Taiwan, 100225
    - Recruiting
    - Site 391
    - Contact:
      
      SKYLINE-UC Trial Center
  - Taipei, Taiwan, 104
    - Recruiting
    - Site 397
    - Contact:
      
      SKYLINE-UC Trial Center
  - Taoyuan City, Taiwan, 333
    - Recruiting
    - Site 393
    - Contact:
      
      SKYLINE-UC Trial Center
Turkey (Türkiye)
- - Kocaeli, Turkey (Türkiye), 41380
    - Recruiting
    - Site 866
    - Contact:
      
      SKYLINE-UC Trial Center
  - Mersin, Turkey (Türkiye), 33110
    - Recruiting
    - Site 861
    - Contact:
      
      SKYLINE-UC Trial Center
  - Sanliurfa, Turkey (Türkiye), 63290
    - Recruiting
    - Site 865
    - Contact:
      
      SKYLINE-UC Trial Center
  - Trabzon, Turkey (Türkiye), 61080
    - Recruiting
    - Site 862
    - Contact:
      
      SKYLINE-UC Trial Center
Ukraine
- - Ivano-Frankivsk, Ukraine, 76008
    - Recruiting
    - Site 906
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Kyiv, Ukraine, 04050
    - Recruiting
    - Site 913
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Kyiv, Ukraine, 02091
    - Recruiting
    - Site 904
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Kyiv, Ukraine, 04210
    - Recruiting
    - Site 903
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Kyiv, Ukraine, 04107
    - Recruiting
    - Site 911
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Kyiv, Ukraine, 02002
    - Recruiting
    - Site 902
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Kyiv, Ukraine, 03037
    - Recruiting
    - Site 905
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Lutsk, Ukraine, 43005
    - Recruiting
    - Site 901
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Lviv, Ukraine, 79010
    - Recruiting
    - Site 909
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Lviv, Ukraine, 79059
    - Recruiting
    - Site 912
    - Contact:
      
      SKYLINE-UC Trial Center
  - Poltava, Ukraine, 36011
    - Recruiting
    - Site 914
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Vinnytsia, Ukraine, 21009
    - Recruiting
    - Site 908
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Vinnytsia, Ukraine, 21029
    - Recruiting
    - Site 907
    - Contact:
      
      SKYLINE-UC
      
      Phone Number: Trial Center
  - Vinnytsia, Ukraine, 21028
    - Recruiting
    - Site 910
    - Contact:
      
      SKYLINE-UC Trial Center
United States
- California
  - Canoga Park, California, United States, 91304
    - Recruiting
    - Site 024
    - Contact:
      
      SKYLINE-UC Trial Center
  - La Jolla, California, United States, 92037
    - Recruiting
    - Site 023
    - Contact:
      
      SKYLINE-UC Trial Center
  - Lancaster, California, United States, 93534
    - Recruiting
    - Site 012
    - Contact:
      
      SKYLINE-UC Trial Center
- Colorado
  - Colorado Springs, Colorado, United States, 91304
    - Recruiting
    - Site 033
    - Contact:
      
      SKYLINE-UC Trial Center
- Florida
  - Kissimmee, Florida, United States, 34741
    - Recruiting
    - Site 007
    - Contact:
      
      SKYLINE-UC Trial Center
  - Miami, Florida, United States, 33165
    - Recruiting
    - 029
    - Contact:
      
      SKYLINE-UC Trial Center
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - Site 006
    - Contact:
      
      SKYLINE-UC Trial Center
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - Site 030
    - Contact:
      
      SKYLINE-UC Trial Center
- Louisiana
  - Marrero, Louisiana, United States, 70072
    - Recruiting
    - Site 035
    - Contact:
      
      SKYLINE-UC Trial Center
- Maryland
  - Glen Burnie, Maryland, United States, 21061
    - Recruiting
    - Site 011
    - Contact:
      
      SKYLINE-UC Trial Center
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Site 003
    - Contact:
      
      SKYLINE-UC Trial Center
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Site 028
    - Contact:
      
      SKYLINE-UC Trial Center
- New York
  - New York, New York, United States, 10065
    - Recruiting
    - Site 037
    - Contact:
      
      SKYLINE-UC Trial Center
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - Recruiting
    - 040
    - Contact:
      
      SKYLINE-UC Trial Center
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Site 041
    - Contact:
      
      SKYLINE-UC Trial Center
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - Site 016
    - Contact:
      
      SKYLINE-UC Trial Center
- Rhode Island
  - Providence, Rhode Island, United States, 02904
    - Recruiting
    - Site 025
    - Contact:
      
      SKYLINE- UC Trial Center
- Tennessee
  - Kingsport, Tennessee, United States, 37663
    - Recruiting
    - Site 017
    - Contact:
      
      SKYLINE-UC Trial Center
- Texas
  - Cedar Park, Texas, United States, 78613
    - Recruiting
    - Site 013
    - Contact:
      
      SKYLINE-UC Trial Center
  - Garland, Texas, United States, 75246
    - Recruiting
    - Site 005
    - Contact:
      
      SKYLINE-UC Trial Center
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Site 002
    - Contact:
      
      SKYLINE-UC Trial Center
  - Southlake, Texas, United States, 76092
    - Recruiting
    - Site 008
    - Contact:
      
      SKYLINE-UC Trial Center
  - Webster, Texas, United States, 77598
    - Recruiting
    - Site 009
    - Contact:
      
      SKYLINE-UC Trial Center
- Washington
  - Seattle, Washington, United States, 98195
    - Recruiting
    - Site 004
    - Contact:
      
      SKYLINE-UC Trial Center
  - Tacoma, Washington, United States, 98405
    - Recruiting
    - Site 019
    - Contact:
      
      SKYLINE-UC Trial Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Specific Appendix - SPY001: Part A Participants will receive open-label dose of SPY001	Drug: SPY001 Experimental Other Names: SPY001-001
Experimental: Intervention Specific Appendix - SPY002: Part A Participants will receive open-label dose of SPY002	Drug: SPY002 Experimental Other Names: SPY002-091
Experimental: Intervention Specific Appendix - SPY003: Part A Participants will receive open-label dose of SPY003	Drug: SPY003 Experimental Other Names: SPY003-207
Experimental: Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B Participants will receive double-blind dosing regimen 1 of SPY001	Drug: SPY001 Experimental Other Names: SPY001-001
Experimental: Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B Participants will receive double-blind dosing regimen 2 of SPY001	Drug: SPY001 Experimental Other Names: SPY001-001
Experimental: Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B Participants will receive double-blind dosing regimen 1 of SPY002	Drug: SPY002 Experimental Other Names: SPY002-091
Experimental: Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B Participants will receive double-blind dosing regimen 2 of SPY002	Drug: SPY002 Experimental Other Names: SPY002-091
Experimental: Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B Participants will receive double-blind dosing regimen 1 of SPY003	Drug: SPY003 Experimental Other Names: SPY003-207
Experimental: Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B Participants will receive double-blind dosing regimen 2 of SPY003	Drug: SPY003 Experimental Other Names: SPY003-207
Experimental: Intervention Specific Appendix - SPY120: Part B Participants will receive double-blind dose of SPY001 and SPY002	Drug: SPY001 Experimental Other Names: SPY001-001 Drug: SPY002 Experimental Other Names: SPY002-091
Experimental: Intervention Specific Appendix - SPY130: Part B Participants will receive double-blind dose of SPY001 and SPY003	Drug: SPY001 Experimental Other Names: SPY001-001 Drug: SPY003 Experimental Other Names: SPY003-207
Experimental: Intervention Specific Appendix - SPY230: Part B Participants will receive double-blind dose of SPY002 and SPY003	Drug: SPY002 Experimental Other Names: SPY002-091 Drug: SPY003 Experimental Other Names: SPY003-207
Placebo Comparator: Placebo: Part B Participants will receive matching placebo	Other: Placebo Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 12
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.	Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spyre Therapeutics, Inc.

Investigators

Study Director: SKYLINE-UC Study Director, Spyre Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

May 27, 2025

First Submitted That Met QC Criteria

June 4, 2025

First Posted (Actual)

June 10, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

SPY123-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammatory Bowel Diseases

Cook Children's Health Care System

Not yet recruiting

Ex-vivo Confocal Imaging and Proteomic Profiling to Determine Treatment Response in Children With IBD

IBD | IBD - Inflammatory Bowel Disease | IBD (Inflammatory Bowel Disease)

United States
Ningbo Medical Center Lihuili Hospital

Recruiting

Efficacy of Individualized Aerobic Exercise Training in Patients With Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD)

China
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Recruiting

Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna

IBD - Inflammatory Bowel Disease

Italy
Chang Kyun Lee
Chonnam National University Hospital; Kyungpook National University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine and other collaborators

Recruiting

Omics-driven Research on the Gut-Oral Microbiome, Metabolome, Lifestyle, and Clinical Integration in Korean Inflammatory Bowel Disease (ORIGIN)

Inflammatory Bowel Disease (IBD)

Korea, Republic of
Xijing Hospital

Not yet recruiting

Evaluating the Effectiveness of 68Ga-grazytracer PET/CT in Inflammatory Bowel Disease

Inflammatory Bowel Diseases (IBD)

China
Assiut University

Not yet recruiting

Comparing the Accuracy of Different Ultrasound-based Scores to Assess Disease Severity in Patients with Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD)
University of British Columbia

Completed

Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease

Inflammatory Bowel Disease 11

Canada
University of Chicago

Terminated

Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD)

United States
University of Texas Southwestern Medical Center

Enrolling by invitation

Automated Clinical Pathway for Inflammatory Bowel Disease Care

Inflammatory Bowel Disease | Inflammatory Bowel Disease (IBD)

United States
University Hospital, Grenoble
Institute for Advanced Biosciences (IAB), Grenoble

Not yet recruiting

Metabolic Reprogramming of Monocytes in Inflammatory Flares of Inflammatory Bowel Diseases (REPRO-MICI)

Inflammatory Bowel Disease (IBD)

France

Clinical Trials on Placebo

Galderma R&D

Completed

Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea

Germany
SamA Pharmaceutical Co., Ltd

Unknown

Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis | Acute Upper Respiratory Tract Infection

Korea, Republic of
National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Completed

Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

Male Subjects With Type II Diabetes (T2DM)

Germany
Akeso

Not yet recruiting

A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

Atopic Dermatitis

China
Heptares Therapeutics Limited

Completed

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

Pharmacokinetics | Safety Issues

United Kingdom
GlaxoSmithKline

Completed

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

United Kingdom, Netherlands
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Xuanwu Hospital, Beijing

Completed

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

Parkinson Disease

China
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

Infections, Bacterial

United States
Chong Kun Dang Pharmaceutical

Unknown

Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet

Hypertension | Dyslipidemias

Korea, Republic of

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

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Inflammatory Bowel Diseases

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations