Actively Recruiting
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Led by Bicara Therapeutics · Updated on 2026-05-14
650
Participants Needed
161
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
CONDITIONS
Official Title
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Confirmed diagnosis of recurrent or metastatic Head and Neck Squamous Cell Carcinoma in the oral cavity, hypopharynx, larynx, or oropharynx (HPV-negative if oropharynx)
- No prior systemic therapy for recurrent or metastatic disease; completed prior systemic therapy over 6 months ago if given for locally advanced disease
- Available archival tumor tissue or willingness to undergo biopsy at screening
- PD-L1 combined positive score (CPS) of 1 or higher
- Measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as defined by the study protocol
You will not qualify if you...
- Disease suitable for local therapy with curative intent
- Prior treatment with anti-TGF-beta therapy
- Prior treatment with anti-EGFR antibodies except certain cases for locally advanced disease
- History of grade 2 or higher intolerance or hypersensitivity to anti-EGFR therapy or murine proteins
- Prior immune checkpoint inhibitor therapy within 6 months before study treatment
- Disease progression within 6 months after curative intent systemic therapy for locally advanced disease
- Life expectancy less than 3 months
- Active central nervous system metastases or related neurological conditions
- Active major bleeding or recent major bleeding within 4 weeks
- Participation in another clinical study or treatment with investigational drug within required washout period
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active chronic hepatitis B or untreated hepatitis C infection
- Known HIV infection
- History of organ transplantation requiring immunosuppression
- Other malignancies treated within 2 years except specific low-risk cancers
- Recent systemic corticosteroid or immunosuppressive medication use within 7 days before first dose
- Use of live vaccines within 4 weeks prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 161 locations
1
Site # 0137
Birmingham, Alabama, United States, 35233
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2
Site #0147
Phoenix, Arizona, United States, 85054
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3
Site #0107
La Jolla, California, United States, 92093
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4
Site #0106
Los Angeles, California, United States, 90095
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5
Site#0144
Sacramento, California, United States, 95817
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6
Site #0130
San Francisco, California, United States, 94143
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7
Site #0150
Stanford, California, United States, 94305
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8
Site #0122
Aurora, Colorado, United States, 80012
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9
Site #0124
Aurora, Colorado, United States, 80045
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10
Site#0121
Aurora, Colorado, United States, 80045
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11
Site#0127
Newark, Delaware, United States, 19713
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12
Site #0148
Jacksonville, Florida, United States, 32224
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13
Site #0136
Palm Bay, Florida, United States, 32901
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14
Site #0105
Tampa, Florida, United States, 33612
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15
Site #0133
Chicago, Illinois, United States, 60064
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16
Site#0140
Iowa City, Iowa, United States, 52242
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17
Site #0149
Westwood, Kansas, United States, 66205
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18
Site#0109
Lexington, Kentucky, United States, 40536
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19
Site#0111
Louisville, Kentucky, United States, 40202
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20
Site#0115
Louisville, Kentucky, United States, 40202
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21
Site #0112
Baltimore, Maryland, United States, 21201
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22
Site #0131
Boston, Massachusetts, United States, 02114
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23
Site#0101
Boston, Massachusetts, United States, 02136
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24
Site #0156
Maplewood, Minnesota, United States, 55109
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25
Site #0146
Rochester, Minnesota, United States, 55905
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26
Site #0114
St Louis, Missouri, United States, 63110
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27
Site #0119
Hackensack, New Jersey, United States, 07601
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28
Site #0145
Newark, New Jersey, United States, 07103
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29
Site #0155
New York, New York, United States, 10003
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30
Site#0142
New York, New York, United States, 10021
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31
Site#0118
Durham, North Carolina, United States, 27703
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32
Site#0154
Canton, Ohio, United States, 44708
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33
Site#0117
Cincinnati, Ohio, United States, 45221
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34
Site #0151
Cleveland, Ohio, United States, 44106
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35
Site #0108
Cleveland, Ohio, United States, 44195
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36
Site #0113
Portland, Oregon, United States, 97213
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37
Site #0103
Pittsburgh, Pennsylvania, United States, 15206
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38
Site #0123
Pittsburgh, Pennsylvania, United States, 15240
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39
Site #0132
Providence, Rhode Island, United States, 02903
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40
Site#0104
Charleston, South Carolina, United States, 29425
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41
Site#0126
Nashville, Tennessee, United States, 37203
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42
Site #0116
Nashville, Tennessee, United States, 37232
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43
Site#0102
Houston, Texas, United States, 77005
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44
Site #0152
Waco, Texas, United States, 676712
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45
Site#0134
Charlottesville, Virginia, United States, 22904
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46
Site #0129
Richmond, Virginia, United States, 23219
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47
Site #0138
Richmond, Virginia, United States, 23249
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48
Site # 0160
Edmonds, Washington, United States, 98026
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49
Site # 0159
Seattle, Washington, United States, 98104
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50
Site #0125
Seattle, Washington, United States, 98109
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51
Site#0120
Vancouver, Washington, United States, 98684
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52
Site #0141
Madison, Wisconsin, United States, 53705
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53
Site #0157
Madison, Wisconsin, United States, 53792
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54
Site # 2301
Buenos Aires, Argentina, C1190
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55
Site # 2306
Buenos Aires, Argentina, C1425
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56
Site # 2305
Rosario, Argentina, CP2000
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57
Site#0302
Camperdown, New South Wales, Australia, 2050
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58
Site #0306
Kingswood, New South Wales, Australia, 2747
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59
Site#0304
Waratah, New South Wales, Australia, 2298
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60
Site #0305
Southport, Queensland, Australia, 4215
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61
Site#0307
Tugun, Queensland, Australia, 4224
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62
Site #0303
Heidelberg, Victoria, Australia, 3084
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63
Site#0301
North Melbourne, Victoria, Australia, 3051
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64
Site#0308
Murdoch, Western Australia, Australia, 6150
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65
Site #1602
Salzburg, Austria, 5020
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66
Site #1601
Vienna, Austria, 1090
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67
Site #1007
Bruges, Belgium, 8000
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68
Site #1005
Mons, Belgium, 7000
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69
Site #1002
Namur, Belgium, 5000
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70
Site #1003
Namur, Belgium, 5530
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71
Site #1001
Sint-Niklaas, Belgium, 9100
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72
Site #1006
Wilrijk, Belgium, 2610
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73
Site #0202
Vancouver, British Columbia, Canada, V5Z 4E6
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74
Site #0203
Montreal, Quebec, Canada, H2X 0C1
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75
Site # 2101
Hradec Králové, Czechia, 500 03
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76
Site #2102
Prague, Czechia, 15006
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77
Site #0809
Amiens, France, 80480
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78
Site # 0812
Bordeaux, France, 33075
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79
Site #0810
Lyon, France, 69004
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80
Site # 0813
Paris, France, 75005
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81
Site #0805
Rennes, France, 35042
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82
Site #0807
Saint-Grégoire, France, 35760
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83
Site #0808
Strasbourg, France, 67200
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84
Site # 0811
Toulouse, France, 31059
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85
Site #0806
Vandœuvre-lès-Nancy, France, 54519
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86
Site #0801
Villejuif, France, 94805
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87
Site #0710
Aachen, Germany, 52074
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88
Site # 0701
Berlin, Germany, 12200
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89
Site # 0714
Berlin, Germany, 12351
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90
Site # 0705
Chemnitz, Germany, 09116
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91
Site #0707
Dresden, Germany, 01067
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92
Site #0706
Düsseldorf, Germany, 40225
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93
Site # 0718
Hanover, Germany, 30625
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94
Site #0717
Karlsruhe, Germany, 76137
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95
Site # 0715
München, Germany, 81675
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96
Site # 0703
Stuttgart, Germany, 70174
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97
Site # 1701
Athens, Greece, 12461
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98
Site # 0603
Cork, Ireland, T12 DC4A
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99
Site #0602
Dublin, Ireland, D08 NHY1
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100
Site #0601
Dublin, Ireland, D09 V2N0
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101
Site #0904
Bologna, Italy, 40138
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102
Site #0911
Florence, Italy, 50134
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103
Site #0907
Milan, Italy, 20132
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104
Site #0901
Milan, Italy, 20133
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105
Site #0905
Milan, Italy, 20142
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106
Site # 0912
Milan, Italy, 20162
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107
Site #0915
Naples, Italy, 80131
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108
Site #0908
Palermo, Italy, 90127
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109
Site # 0903
Pavia, Italy, 27100
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110
Site # 0909
Pisa, Italy, 56126
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111
Site #0917
Rome, Italy, 00161
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112
Site #0918
Rome, Italy, 00168
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113
Site #0906
Rome, Italy, 00186
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114
Site # 0919
Rozzano, Italy, 20089
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115
Site # 0902
Siena, Italy, 53100
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116
Site # 2802
George Town, Malaysia, 11200
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117
Site #0401
Christchurch, New Zealand, 8011
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118
Site#0402
Rotorua, New Zealand, 3010
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119
Site #1401
Gdansk, Poland, 80-214
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120
Site # 1405
Gliwice, Poland, 44-102
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121
Site #1403
Katowice, Poland, 40-519
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122
Site #1407
Konin, Poland, 62-500
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123
Site #1404
Krakow, Poland, 31-826
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124
Site #1402
Siedlce, Poland, 08-110
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125
Site #1406
Warsaw, Poland, 02-781
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126
Site #1506
Braga, Portugal, 4710-243
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127
Site #1503
Coimbra, Portugal
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128
Site #1508
Lisbon, Portugal, 1099-023
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129
Site #1501
Portimão, Portugal, 8500-338
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130
Site #1505
Porto, Portugal, 4200-072
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131
Site #1507
Porto, Portugal, 4200-319
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132
Site #1502
Senhora da Hora, Portugal, 4464-509
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133
Site # 1504
Vila Nova de Gaia, Portugal, 4434-502
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134
Site # 2901
Singapore, Singapore, 168583
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135
Site # 2705
Hwasun, South Korea, 58128
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136
Site # 2706
Seongnam, South Korea, 13620
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137
Site # 2701
Seoul, South Korea, 3080
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138
Site #1301
Barcelona, Spain, 08035
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139
Site #1305
Barcelona, Spain, 08036
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140
Site #1304
Barcelona, Spain, 08041
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141
Site # 1302
Barcelona, Spain, 08908
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142
Site #1310
Madrid, Spain, 28027
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143
Site #1303
Madrid, Spain, 28041
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144
Site #1306
Pamplona, Spain, 31008
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145
Site #1309
Santander, Spain, 39008
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146
Site #1307
Valencia, Spain, 46010
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147
Site #1308
Valencia, Spain, 46014
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148
Site #0504
Aberdeen, United Kingdom, AB25 2ZN
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149
Site #0512
Birmingham, United Kingdom, B15 2TH
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150
Site #0513
Cambridge, United Kingdom, CB2 0QQ
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151
Site # 0510
Glasgow, United Kingdom, G12 0YN
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152
Site #0511
Leeds, United Kingdom, LS9 7TF
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153
Site #0507
Liverpool, United Kingdom, L7 8YA
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154
Site #0505
London, United Kingdom, SW3 6JJ
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155
Site #0502
London, United Kingdom, WC1E 6AG
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156
Site #0508
Manchester, United Kingdom, M20 4BX
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157
Site #0506
Middlesex, United Kingdom, HA6 2RN
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158
Site #0503
Nottingham, United Kingdom, NG5 1PB
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159
Site #0515
Oxford, United Kingdom, OX3 7LE
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160
Site # 0514
Portsmouth, United Kingdom, PO6 3LY
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161
Site # 0501
Sutton, United Kingdom, SM2 5PT
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Research Team
M
Medical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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