Actively Recruiting
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
Led by Spyre Therapeutics, Inc. · Updated on 2026-06-08
645
Participants Needed
223
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of several investigational long-acting antibody treatments for adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter, proof-of-concept platform study aims to compare three monotherapy drugs and three combination therapies. The study is designed in two parts to explore these treatments in detail and to better understand their potential effects on UC. The study includes an initial open-label phase (Part A) where participants receive one of the three monotherapies to assess safety and early effectiveness. Following this, the randomized, placebo-controlled phase (Part B) will compare all six interventions—three monotherapies and three combinations—against a placebo. These treatments include intravenous induction followed by subcutaneous maintenance dosing, and new treatment arms may be added over time, completing at different schedules. Participants will undergo endoscopy and histology assessments, with outcomes measured primarily by changes in the Robarts Histopathology Index and rates of clinical remission at 12 weeks. Additional measures include clinical response, endoscopic improvement, and histologic improvements up to 48 weeks. Safety and efficacy will be carefully monitored throughout the study, which is expected to continue until March 2028.
CONDITIONS
Brief Title
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ulcerative colitis for at least 3 months confirmed by endoscopy and histology
- Active ulcerative colitis with disease extending at least 15 cm from the anal verge, with up to 15% allowed to have only proctitis
- Moderately to severely active disease defined by a modified Mayo score of 5 to 9, rectal bleeding subscore of 1 or more, and Mayo endoscopic subscore of 2 or more
You will not qualify if you...
- Current diagnosis of Crohn's disease or inflammatory bowel disease (IBD)-Undefined
- Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation, or other conditions likely requiring surgery during induction
- Failure of 4 or more approved or investigational advanced therapy classes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive investigational long-acting antibody treatments or placebo to assess safety and efficacy for moderately to severely active ulcerative colitis. Treatment includes monotherapies and combination therapies administered in two parts: an open-label phase and a randomized, placebo-controlled phase.
Regular visits during treatment period
Duration - Up to 36 weeks after treatment
Participants are monitored after treatment to assess longer-term outcomes and safety.
Periodic follow-up visits
Trial Site Locations
Total: 223 locations
1
Site 024
Canoga Park, California, United States, 91304
Actively Recruiting
2
Site 023
La Jolla, California, United States, 92037
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3
Site 012
Lancaster, California, United States, 93534
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4
Site 033
Colorado Springs, Colorado, United States, 91304
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5
Site 007
Kissimmee, Florida, United States, 34741
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6
029
Miami, Florida, United States, 33165
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7
Site 006
Kansas City, Kansas, United States, 66160
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8
Site 030
Louisville, Kentucky, United States, 40202
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9
Site 035
Marrero, Louisiana, United States, 70072
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10
Site 011
Glen Burnie, Maryland, United States, 21061
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11
Site 003
Boston, Massachusetts, United States, 02114
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12
Site 028
Rochester, Minnesota, United States, 55905
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13
Site 037
New York, New York, United States, 10065
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14
040
Chapel Hill, North Carolina, United States, 27599
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15
Site 041
Durham, North Carolina, United States, 27710
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16
Site 016
Winston-Salem, North Carolina, United States, 27103
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17
Site 025
Providence, Rhode Island, United States, 02904
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18
Site 017
Kingsport, Tennessee, United States, 37663
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19
Site 013
Cedar Park, Texas, United States, 78613
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20
Site 005
Garland, Texas, United States, 75246
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21
Site 002
San Antonio, Texas, United States, 78229
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22
Site 008
Southlake, Texas, United States, 76092
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23
Site 009
Webster, Texas, United States, 77598
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24
Site 004
Seattle, Washington, United States, 98195
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25
Site 019
Tacoma, Washington, United States, 98405
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26
Site 103
Rosario, Sant Fe, Argentina, 2000
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27
Site 104
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
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28
Site 208
Concord, Australia, 2139
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29
Site 202
Heidelberg, Australia, 3084
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30
Site 204
Liverpool, Australia, 2170
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31
Site 203
Melbourne, Australia, 3004
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32
Site 206
South Brisbane, Australia, 4101
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33
Site 207
Woolloongabba, Australia, 4102
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34
Site 463
Linz, Austria, 4021
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35
Site 476
Ghent, Osst-Vlaanderen, Belgium, 9000
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36
Site 474
Sint-Niklaas, Osst-Vlaanderen, Belgium, 9100
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37
Site 475
Bruges, Belgium, 8310
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38
Site 471
Ghent, Belgium, 9000
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39
Site 472
Roeselare, Belgium, 9000
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40
Site 481
Banja Luka, Bosnia and Herzegovina, 78 000
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41
Site 484
Mostar, Bosnia and Herzegovina, 88000
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42
Site 483
Sarajevo, Bosnia and Herzegovina, 71000
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43
Site 494
Gorna Oryahovitsa, Bulgaria, 5100
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44
Site 498
Rousse, Bulgaria, 7002
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45
Site 492
Sofia, Bulgaria, 1343
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46
Site 495
Sofia, Bulgaria, 1463
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47
Site 083
London, Ontario, Canada, G8H 3P7
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48
Site 085
Greater Sudbury, Canada, P3C1X3
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49
Site 086
London, Canada, N6K 1M6
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50
Site 153
Osorno, Los Lagos Region, Chile, 5290000
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51
Site 521
Osijek, Croatia, 31000
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52
Site 531
Brno, Czechia, 615 00
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53
Site 536
Klatovy, Czechia, 33901
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54
Site 534
Ostrava, Czechia, 702 00
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55
Site 537
Pardubice, Czechia, 532 03
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56
Site 538
Prague, Czechia, 150 00
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57
Site 555
Marseille, France, 13015
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58
Site 551
Nantes, France, 44300
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59
Site 557
Nice, France, 06200
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60
Site 556
Pierre-Bénite, France, 69310
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61
Site 558
Saint-Etienne, France, 42270
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62
Site 584
Kutaisi, Georgia, 4600
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63
Site 589
Marneuli, Georgia, 3000
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64
Site 581
Tbilisi, Georgia, 0102
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65
Site 588
Tbilisi, Georgia, 0114
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66
Site 583
Tbilisi, Georgia, 01444
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67
Site 586
Tbilisi, Georgia, 0144
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68
Site 582
Tbilisi, Georgia, 0159
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69
Site 587
Tbilisi, Georgia, 0159
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70
Site 590
Tbilisi, Georgia, 0178
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71
Site 585
Tbilisi, Georgia, 0180
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72
Site 606
Berlin, Germany, 10117
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73
Site 604
Berlin, Germany, 14163
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74
Site 611
Brandenburg an der Havel, Germany, 14770
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75
Site 607
Dachau, Germany, 85221
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76
Site 610
Frankfurt am Main, Germany, 60590
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77
Site 602
Kiel, Germany, 24105
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78
Site 608
Leipzig, Germany, 04103
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79
Site 609
Munich, Germany, 81377
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80
Site 603
Ulm, Germany, 89081
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81
Site 635
Athens, Attica, Greece, 11527
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82
Site 634
Athens, Greece, 10676
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83
Site 632
Athens, Greece, 115 27
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84
Site 631
Chaïdári, Greece, 124 62
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85
Site 654
Békéscsaba, Hungary, H-5600
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86
Site 655
Budapest, Hungary, H-1062
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87
Site 656
Budapest, Hungary, H-1083
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88
Site 651
Budapest, Hungary, H-1088
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89
Site 652
Székesfehérvár, Hungary, H-8000
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90
Site 270
Hyderabad, India, 500032
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91
Site 268
Jaipur, India, 302004
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92
Site 266
Kochi, India, 682040
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93
Site 265
Sūrat, India, 395002
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94
Site 445
Beer Yaaqov, Israel, 7033001
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95
Site 441
Beersheba, Israel, 8410101
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96
Site 443
Haifa, Israel, 31048
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97
Site 444
Jerusalem, Israel, 9103102
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98
Site 446
Jerusalem, Israel, 9112001
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99
Site 442
Nahariya, Israel, 2210001
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100
Site 682
Castellana Grotte, Bari, Italy, 70013
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101
Site 679
Pavia, Lombardy, Italy, 27100
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102
Site 673
Legnano, Milan, Italy, 20025
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103
Site 674
Rozzano, Milan, Italy, 20089
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104
Site 676
San Donato Milanese, Milan, Italy, 20097
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105
Site 671
Segrate, Milan, Italy, 20132
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106
Site 680
Turin, Piedmont, Italy, 10126
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107
Site 683
Bologna, Italy, 40138
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108
Site 672
Negrar, Italy, 37024
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109
Site 677
Padova, Italy, 35128
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110
Site 681
Rome, Italy, 00168
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111
Site 675
Turin, Italy, 10128
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112
Site 299
Kashiwa, Chiba, Japan, 277-0871
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113
Site 294
Chikushino-shi, Fukuoka, Japan, 818-8502
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114
Site 292
Shiwa-gun, Iwate, Japan, 028-3695
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115
Site 290
Ōita, Oita Prefecture, Japan, 870-0823
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116
Site 282
Chuo Ku, Osaka, Japan, 540-0006
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117
Site 291
Kobe, Japan, 650-0015
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118
Site 286
Saga, Japan, 849-8501
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119
Site 285
Sendai, Japan, 981-3213
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120
Site 293
Urayasu-shi, Japan, 279-0021
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121
Site 425
Amman, Jordan, 11194
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122
Site 424
Amman, Jordan, 11196
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123
Site 421
Amman, Jordan, 11942
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124
Site 422
Irbid, Jordan, 21110
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125
Site 423
Irbid, Jordan, 22110
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126
Site 426
Irbid, Jordan, 22110
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127
Site 704
Klaipėda, Lithuania, LT-92288
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128
Site 703
Vilnius, Lithuania, LT-08406
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129
Site 174
Saltillo, Coahuila, Mexico, 25050
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130
Site 175
Celaya, Guanajuato, Mexico, 38000
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131
Site 173
Tlajomulco de Zúñiga, Jalisco, Mexico, 45645
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132
Site 713
Chisinau, Moldova, MD2005
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133
Site 711
Chisinau, Moldova, MD2025
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134
Site 712
Chisinau, Moldova, MD2025
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135
Site 714
Chisinau, Moldova, MD2025
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136
Site 715
Chisinau, Moldova, MD2068
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137
Site 753
Bydgoszcz, Poland, 85-2299
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138
Site 732
Bydgoszcz, Poland, 85-794
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139
Site 749
Katowice, Poland, 40-600
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140
Site 735
Katowice, Poland, 40-748
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141
Site 748
Krakow, Poland, 31-501
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142
Site 743
Opole, Poland, 45-819
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143
Site 740
Poznan, Poland, 60-309
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144
Site 736
Rzeszów, Poland, 35-326
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145
Site 744
Sopot, Poland, 81-756
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146
Site 745
Staszów, Poland, 28-2200
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147
Site 737
Szczecin, Poland, 71-434
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148
Site 733
Szczecin, Poland, 71-685
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149
Site 752
Tychy, Poland, 43-100
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150
Site 739
Warsaw, Poland, 00--710
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151
Site 751
Warsaw, Poland, 00-189
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152
Site 754
Warsaw, Poland, 02-172
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153
Site 741
Warsaw, Poland, 02-786
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154
Site 731
Warsaw, Poland, 04-501
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155
Site 750
Warsaw, Poland, 57-300
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156
Site 738
Wroclaw, Poland, 52-416
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157
Site 734
Wroclaw, Poland, 53-149
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158
Site 747
Wroclaw, Poland, 53-611
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159
Site 742
Wroclaw, Poland, 54-239
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160
Site 783
Bucharest, Romania, 011273
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161
Site 784
Bucharest, Romania, 014142
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162
Site 781
Bucharest, Romania, 020125
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163
Site 782
Cluj-Napoca, Romania, 400061
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164
Site 786
Constanța, Romania, 900161
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165
Site 788
Timișoara, Romania, 300239
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166
Trial Site 804
Belgrade, Serbia, 11 000
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167
Site 802
Belgrade, Serbia, 11000
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168
Site 807
Belgrade, Serbia, 11000
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169
Site 803
Belgrade, Serbia, 11080
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170
Site 805
Niš, Serbia, 18 000
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171
Site 806
Užice, Serbia, 31000
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172
Site 801
Zrenjanin, Serbia, 23000
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173
Site 823
Bratislava, Slovakia, 811 09
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174
Site 822
Košice, Slovakia, 040 13
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175
Site 821
Prešov, Slovakia, 080 01
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176
Site 825
Zvolen, Slovakia, 960 01
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177
Site 357
Busan, South Korea, 48108
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178
Site 354
Daegu, South Korea, 40404
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179
Site 358
Daegu, South Korea, 42415
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180
Site 361
Daegu, South Korea, 42601
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181
Site 355
Daejeon, South Korea, 34943
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182
Site 356
Seoul, South Korea, 03312
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183
Site 351
Seoul, South Korea, 03722
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184
Site 352
Seoul, South Korea, 06591
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185
Site 360
Seoul, South Korea, 07985
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186
Site 362
Seoul, South Korea, 6351
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187
Site 359
Suwon, South Korea, 16247
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188
Site 353
Wŏnju, South Korea, 26426
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189
Site 832
Santiago de Compostela, A Coruna, Spain, 15702
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190
Site 835
Gijón, Spain, 33394
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191
Site 838
Lugo, Spain, 27003
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192
Site 834
Madrid, Spain, 28031
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193
Site 837
Madrid, Spain, 28222
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194
Site 836
Ourense, Spain, 32005
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195
Site 831
Seville, Spain, 41013
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196
Site 852
Basel, Switzerland, 4031
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197
Site 853
Bern, Switzerland, 3012
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198
Site 851
Sankt Gallen, Switzerland, 9007
Actively Recruiting
199
Site 394
Changhua, Taiwan, 500
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200
Site 392
Chiayi City, Taiwan, 600
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201
Site 395
Kaohsiung City, Taiwan, 833401
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202
Site 396
Taichung, Taiwan, 404327
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203
Site 391
Taipei, Taiwan, 100225
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204
Site 397
Taipei, Taiwan, 104
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205
Site 393
Taoyuan City, Taiwan, 333
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206
Site 866
Kocaeli, Turkey (Türkiye), 41380
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207
Site 861
Mersin, Turkey (Türkiye), 33110
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208
Site 865
Sanliurfa, Turkey (Türkiye), 63290
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209
Site 862
Trabzon, Turkey (Türkiye), 61080
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210
Site 906
Ivano-Frankivsk, Ukraine, 76008
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211
Site 902
Kyiv, Ukraine, 02002
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212
Site 904
Kyiv, Ukraine, 02091
Actively Recruiting
213
Site 905
Kyiv, Ukraine, 03037
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214
Site 913
Kyiv, Ukraine, 04050
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215
Site 911
Kyiv, Ukraine, 04107
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216
Site 903
Kyiv, Ukraine, 04210
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217
Site 901
Lutsk, Ukraine, 43005
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218
Site 909
Lviv, Ukraine, 79010
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219
Site 912
Lviv, Ukraine, 79059
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220
Site 914
Poltava, Ukraine, 36011
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221
Site 908
Vinnytsia, Ukraine, 21009
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222
Site 910
Vinnytsia, Ukraine, 21028
Actively Recruiting
223
Site 907
Vinnytsia, Ukraine, 21029
Actively Recruiting
Research Team
S
SKYLINE-UC Trial Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
13
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