Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07012395

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

Led by Spyre Therapeutics, Inc. · Updated on 2026-05-05

645

Participants Needed

191

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of ulcerative colitis for 3 months or longer confirmed by endoscopy and histology
  • Active ulcerative colitis with disease extent of 15 cm or more from the anal verge (up to 15% may 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
Not Eligible

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

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Trial Site Locations

Total: 191 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 035

Marrero, Louisiana, United States, 70072

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9

Site 011

Glen Burnie, Maryland, United States, 21061

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10

Site 003

Boston, Massachusetts, United States, 02114

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11

Site 028

Rochester, Minnesota, United States, 55905

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12

Site 037

New York, New York, United States, 10065

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13

040

Chapel Hill, North Carolina, United States, 27599

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14

Site 041

Durham, North Carolina, United States, 27710

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15

Site 016

Winston-Salem, North Carolina, United States, 27103

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16

Site 025

Providence, Rhode Island, United States, 02904

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17

Site 017

Kingsport, Tennessee, United States, 37663

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18

Site 013

Cedar Park, Texas, United States, 78613

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19

Site 005

Garland, Texas, United States, 75246

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20

Site 002

San Antonio, Texas, United States, 78229

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21

Site 008

Southlake, Texas, United States, 76092

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22

Site 009

Webster, Texas, United States, 77598

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23

Site 019

Tacoma, Washington, United States, 98405

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24

Site 208

Concord, Australia, 2139

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25

Site 202

Heidelberg, Australia, 3084

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26

Site 204

Liverpool, Australia, 2170

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27

Site 203

Melbourne, Australia, 3004

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28

Site 206

South Brisbane, Australia, 4101

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29

Site 207

Woolloongabba, Australia, 4102

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30

Site 463

Linz, Austria, 4021

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31

Site 475

Bruges, Belgium, 8310

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32

Site 471

Ghent, Belgium, 9000

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33

Site 472

Roeselare, Belgium, 9000

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34

Site 481

Banja Luka, Bosnia and Herzegovina, 78 000

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35

Site 484

Mostar, Bosnia and Herzegovina, 88000

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36

Site 483

Sarajevo, Bosnia and Herzegovina, 71000

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37

Site 494

Gorna Oryahovitsa, Bulgaria, 5100

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38

Site 498

Rousse, Bulgaria, 7002

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39

Site 492

Sofia, Bulgaria, 1343

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40

Site 495

Sofia, Bulgaria, 1463

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41

Site 083

London, Ontario, Canada, G8H 3P7

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42

Site 085

Greater Sudbury, Canada, P3C1X3

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43

Site 086

London, Canada, N6K 1M6

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44

Site 531

Brno, Czechia, 615 00

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45

Site 536

Klatovy, Czechia, 33901

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46

Site 534

Ostrava, Czechia, 702 00

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47

Site 538

Prague, Czechia, 150 00

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48

Site 551

Nantes, France, 44300

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49

Site 557

Nice, France, 06200

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50

Site 556

Pierre-Bénite, France, 69310

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51

Site 558

Saint-Etienne, France, 42270

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52

Site 584

Kutaisi, Georgia, 4600

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53

Site 589

Marneuli, Georgia, 3000

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54

Site 581

Tbilisi, Georgia, 0102

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55

Site 588

Tbilisi, Georgia, 0114

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56

Site 583

Tbilisi, Georgia, 01444

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57

Site 586

Tbilisi, Georgia, 0144

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58

Site 582

Tbilisi, Georgia, 0159

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59

Site 587

Tbilisi, Georgia, 0159

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60

Site 590

Tbilisi, Georgia, 0178

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61

Site 585

Tbilisi, Georgia, 0180

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62

Site 606

Berlin, Germany, 10117

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63

Site 604

Berlin, Germany, 14163

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64

Site 611

Brandenburg an der Havel, Germany, 14770

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65

Site 607

Dachau, Germany, 85221

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66

Site 609

Munich, Germany, 81377

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67

Site 603

Ulm, Germany, 89081

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68

Site 635

Athens, Attica, Greece, 11527

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69

Site 634

Athens, Greece, 10676

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70

Site 632

Athens, Greece, 115 27

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71

Site 631

Chaïdári, Greece, 124 62

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72

Site 654

Békéscsaba, Hungary, H-5600

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73

Site 655

Budapest, Hungary, H-1062

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74

Site 656

Budapest, Hungary, H-1083

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75

Site 651

Budapest, Hungary, H-1088

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76

Site 652

Székesfehérvár, Hungary, H-8000

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77

Site 270

Hyderabad, India, 500032

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78

Site 268

Jaipur, India, 302004

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79

Site 266

Kochi, India, 682040

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80

Site 265

Sūrat, India, 395002

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81

Site 445

Beer Yaaqov, Israel, 7033001

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82

Site 441

Beersheba, Israel, 8410101

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83

Site 443

Haifa, Israel, 31048

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84

Site 444

Jerusalem, Israel, 9103102

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85

Site 446

Jerusalem, Israel, 9112001

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86

Site 442

Nahariya, Israel, 2210001

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87

Site 682

Castellana Grotte, Bari, Italy, 70013

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88

Site 674

Rozzano, Milan, Italy, 20089

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89

Site 676

San Donato Milanese, Milan, Italy, 20097

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90

Site 671

Segrate, Milan, Italy, 20132

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91

Site 672

Negrar, Italy, 37024

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92

Site 677

Padova, Italy, 35128

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93

Site 681

Rome, Italy, 00168

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94

Site 675

Turin, Italy, 10128

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95

Site 291

Kobe, Japan, 650-0015

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96

Site 286

Saga, Japan, 849-8501

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97

Site 285

Sendai, Japan, 981-3213

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98

Site 293

Urayasu-shi, Japan, 279-0021

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99

Site 424

Amman, Jordan, 11196

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100

Site 421

Amman, Jordan, 11942

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101

Site 422

Irbid, Jordan, 21110

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102

Site 703

Vilnius, Lithuania, LT-08406

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103

Site 713

Chisinau, Moldova, MD2005

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104

Site 711

Chisinau, Moldova, MD2025

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105

Site 712

Chisinau, Moldova, MD2025

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106

Site 714

Chisinau, Moldova, MD2025

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107

Site 715

Chisinau, Moldova, MD2068

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108

Site 753

Bydgoszcz, Poland, 85-2299

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109

Site 732

Bydgoszcz, Poland, 85-794

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110

Site 749

Katowice, Poland, 40-600

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111

Site 735

Katowice, Poland, 40-748

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112

Site 748

Krakow, Poland, 31-501

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113

Site 743

Opole, Poland, 45-819

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114

Site 740

Poznan, Poland, 60-309

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115

Site 736

Rzeszów, Poland, 35-326

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116

Site 744

Sopot, Poland, 81-756

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117

Site 745

Staszów, Poland, 28-2200

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118

Site 737

Szczecin, Poland, 71-434

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119

Site 733

Szczecin, Poland, 71-685

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120

Site 752

Tychy, Poland, 43-100

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121

Site 739

Warsaw, Poland, 00--710

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122

Site 751

Warsaw, Poland, 00-189

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123

Site 754

Warsaw, Poland, 02-172

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124

Site 741

Warsaw, Poland, 02-786

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125

Site 731

Warsaw, Poland, 04-501

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126

Site 750

Warsaw, Poland, 57-300

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127

Site 738

Wroclaw, Poland, 52-416

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128

Site 734

Wroclaw, Poland, 53-149

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129

Site 747

Wroclaw, Poland, 53-611

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130

Site 742

Wroclaw, Poland, 54-239

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131

Site 783

Bucharest, Romania, 011273

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132

Site 784

Bucharest, Romania, 014142

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133

Site 781

Bucharest, Romania, 020125

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134

Site 786

Constanța, Romania, 900161

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135

Site 788

Timișoara, Romania, 300239

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136

Trial Site 804

Belgrade, Serbia, 11 000

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137

Site 802

Belgrade, Serbia, 11000

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138

Site 807

Belgrade, Serbia, 11000

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139

Site 803

Belgrade, Serbia, 11080

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140

Site 805

Niš, Serbia, 18 000

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141

Site 806

Užice, Serbia, 31000

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142

Site 801

Zrenjanin, Serbia, 23000

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143

Site 823

Bratislava, Slovakia, 811 09

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144

Site 822

Košice, Slovakia, 040 13

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145

Site 821

Prešov, Slovakia, 080 01

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146

Site 825

Zvolen, Slovakia, 960 01

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147

Site 357

Busan, South Korea, 48108

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148

Site 354

Daegu, South Korea, 40404

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149

Site 358

Daegu, South Korea, 42415

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150

Site 361

Daegu, South Korea, 42601

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151

Site 355

Daejeon, South Korea, 34943

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152

Site 356

Seoul, South Korea, 03312

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153

Site 351

Seoul, South Korea, 03722

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154

Site 352

Seoul, South Korea, 06591

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155

Site 360

Seoul, South Korea, 07985

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156

Site 362

Seoul, South Korea, 6351

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157

Site 359

Suwon, South Korea, 16247

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158

Site 353

Wŏnju, South Korea, 26426

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159

Site 832

Santiago de Compostela, A Coruna, Spain, 15702

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160

Site 835

Gijón, Spain, 33394

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161

Site 838

Lugo, Spain, 27003

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162

Site 834

Madrid, Spain, 28031

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163

Site 837

Madrid, Spain, 28222

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164

Site 836

Ourense, Spain, 32005

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165

Site 852

Basel, Switzerland, 4031

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166

Site 853

Bern, Switzerland, 3012

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167

Site 851

Sankt Gallen, Switzerland, 9007

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168

Site 394

Changhua, Taiwan, 500

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169

Site 392

Chiayi City, Taiwan, 600

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170

Site 396

Taichung, Taiwan, 404327

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171

Site 391

Taipei, Taiwan, 100225

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172

Site 397

Taipei, Taiwan, 104

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173

Site 393

Taoyuan City, Taiwan, 333

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174

Site 866

Kocaeli, Turkey (Türkiye), 41380

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175

Site 861

Mersin, Turkey (Türkiye), 33110

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176

Site 865

Sanliurfa, Turkey (Türkiye), 63290

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177

Site 862

Trabzon, Turkey (Türkiye), 61080

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178

Site 906

Ivano-Frankivsk, Ukraine, 76008

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179

Site 902

Kyiv, Ukraine, 02002

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180

Site 904

Kyiv, Ukraine, 02091

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181

Site 905

Kyiv, Ukraine, 03037

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182

Site 913

Kyiv, Ukraine, 04050

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183

Site 911

Kyiv, Ukraine, 04107

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184

Site 903

Kyiv, Ukraine, 04210

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185

Site 901

Lutsk, Ukraine, 43005

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186

Site 909

Lviv, Ukraine, 79010

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187

Site 912

Lviv, Ukraine, 79059

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188

Site 914

Poltava, Ukraine, 36011

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189

Site 908

Vinnytsia, Ukraine, 21009

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190

Site 910

Vinnytsia, Ukraine, 21028

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191

Site 907

Vinnytsia, Ukraine, 21029

Actively Recruiting

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Research Team

S

SKYLINE-UC Trial Center

CONTACT

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