Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Led by UCB Biopharma SRL · Updated on 2026-05-01
450
Participants Needed
225
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Study participant must be 16 years of age or older (18 years for China) at the time of signing the Informed Consent form
- Participants must have moderate to severe disease activity due to persistent active SLE or frequent relapsing-remitting SLE despite stable standard of care medication
- Diagnosed with SLE at least 24 weeks before Screening Visit by a qualified physician
- Classified by 2019 SLE EULAR/ACR classification criteria for SLE
- Serological evidence for SLE at Screening, including at least one of the following: anti-dsDNA antibodies, low complement C3 or C4, or antinuclear antibodies with specific autoantibodies
- Moderately to severely active disease defined by BILAG 2004 Grade B in 2 or more organ systems and/or Grade A in 1 or more organ systems at Screening and Baseline, and SLEDAI-2K scores meeting specified thresholds
- Receiving stable doses of antimalarial treatment combined with glucocorticoids and/or immunosuppressants or glucocorticoids and/or immunosuppressants alone if antimalarials are inappropriate
You will not qualify if you...
- Medical or psychiatric conditions that could compromise participation, including life-threatening conditions
- History of anaphylactic reaction to parenteral contrast agents, human or murine proteins, or monoclonal antibodies, including latex allergy
- History of malignancy except treated cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
- Mixed connective tissue disease, scleroderma, or overlap syndrome with SLE
- Evidence of HIV infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection
- Clinically significant active or latent infection
- Reactivated latent infection or opportunistic infection within 12 weeks prior to first study medication infusion or current suppressive therapy for opportunistic infection
- Receipt of live or live attenuated vaccines within 6 weeks prior to first study medication infusion
- Use of prohibited medications within specified washout periods
- Previous randomization in this study or prior assignment to dapirolizumab pegol treatment in a DZP study
- Participation in another investigational medicinal product study within the previous 12 weeks or 5 half-lives of the IMP
- Chronic kidney failure stage 4, with eGFR less than 30 mL/min/1.73m2, serum creatinine over 2.5 mg/dL, proteinuria over 3g/day, or protein:creatinine ratio over 340 mg/mmol at Screening Visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 225 locations
1
Sl0044 50058
Avondale, Arizona, United States, 85392
Actively Recruiting
2
Sl0044 50550
Chandler, Arizona, United States, 85225
Actively Recruiting
3
Sl0044 50713
Gilbert, Arizona, United States, 85297
Actively Recruiting
4
Sl0044 50662
Glendale, Arizona, United States, 85306
Actively Recruiting
5
Sl0044 50052
Phoenix, Arizona, United States, 85032
Actively Recruiting
6
Sl0044 50677
Scottsdale, Arizona, United States, 85258
Actively Recruiting
7
Sl0044 50670
Searcy, Arkansas, United States, 72143
Actively Recruiting
8
Sl0044 50737
Beverly Hills, California, United States, 90210
Actively Recruiting
9
Sl0044 50775
Beverly Hills, California, United States, 90211
Actively Recruiting
10
Sl0044 50257
La Jolla, California, United States, 92037
Actively Recruiting
11
Sl0044 50275
La Palma, California, United States, 90623-1730
Actively Recruiting
12
Sl0044 50755
Los Alamitos, California, United States, 90720
Actively Recruiting
13
Sl0044 50258
Los Angeles, California, United States, 90022
Actively Recruiting
14
Sl0044 50725
Menifee, California, United States, 92586
Actively Recruiting
15
Sl0044 50340
Orange, California, United States, 92868
Actively Recruiting
16
Sl0044 50316
San Leandro, California, United States, 94578
Actively Recruiting
17
Sl0044 50719
Aurora, Colorado, United States, 80045
Actively Recruiting
18
Sl0044 50239
Brandon, Florida, United States, 33511
Actively Recruiting
19
Sl0044 50630
Clearwater, Florida, United States, 33765
Actively Recruiting
20
Sl0044 50747
Coral Gables, Florida, United States, 33134
Actively Recruiting
21
Sl0044 50751
Coral Gables, Florida, United States, 33134
Actively Recruiting
22
Sl0044 50362
Gainesville, Florida, United States, 32610
Actively Recruiting
23
Sl0044 50763
Margate, Florida, United States, 33063
Actively Recruiting
24
Sl0044 50735
Miami, Florida, United States, 33155
Actively Recruiting
25
Sl0044 50681
Miami, Florida, United States, 33172
Actively Recruiting
26
Sl0044 50324
Plantation, Florida, United States, 33324
Actively Recruiting
27
Sl0044 50698
Tampa, Florida, United States, 33614
Actively Recruiting
28
Sl0044 50585
Winter Park, Florida, United States, 32789
Actively Recruiting
29
Sl0044 50566
Gainesville, Georgia, United States, 30501-2418
Actively Recruiting
30
Sl0044 50659
Marietta, Georgia, United States, 30152
Actively Recruiting
31
Sl0044 50699
Chicago, Illinois, United States, 60616
Actively Recruiting
32
Sl0044 50717
Willowbrook, Illinois, United States, 60527
Actively Recruiting
33
Sl0044 50748
New Albany, Indiana, United States, 47150
Actively Recruiting
34
Sl0044 50319
Iowa City, Iowa, United States, 52242.
Actively Recruiting
35
Sl0044 50074
Kansas City, Kansas, United States, 66160
Actively Recruiting
36
Sl0044 50586
Louisville, Kentucky, United States, 40202-5700
Actively Recruiting
37
Sl0044 50023
Baton Rouge, Louisiana, United States, 70836
Actively Recruiting
38
Sl0044 50285
Lake Charles, Louisiana, United States, 70605
Actively Recruiting
39
Sl0044 50660
New Orleans, Louisiana, United States, 70112
Actively Recruiting
40
Sl0044 50730
Rockville, Maryland, United States, 20850
Actively Recruiting
41
Sl0044 50219
Detroit, Michigan, United States, 48201
Actively Recruiting
42
Sl0044 50682
Kansas City, Missouri, United States, 64151
Actively Recruiting
43
Sl0044 50010
Brooklyn, New York, United States, 11201
Actively Recruiting
44
Sl0044 50264
Manhasset, New York, United States, 11030
Actively Recruiting
45
Sl0044 50077
New York, New York, United States, 10021
Actively Recruiting
46
Sl0044 50241
Syracuse, New York, United States, 13210
Actively Recruiting
47
Sl0044 50238
Charlotte, North Carolina, United States, 28211
Actively Recruiting
48
Sl0044 50365
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
49
Sl0044 50001
Jackson, Tennessee, United States, 38305
Actively Recruiting
50
Sl0044 50693
Murfreesboro, Tennessee, United States, 37128
Actively Recruiting
51
Sl0044 50562
Allen, Texas, United States, 75013
Actively Recruiting
52
Sl0044 50738
Bellaire, Texas, United States, 77401
Actively Recruiting
53
Sl0044 50673
Fort Worth, Texas, United States, 76109
Actively Recruiting
54
Sl0044 50723
Houston, Texas, United States, 77002
Actively Recruiting
55
Sl0044 50688
Houston, Texas, United States, 77054
Actively Recruiting
56
Sl0044 50696
Houston, Texas, United States, 77090
Actively Recruiting
57
Sl0044 50773
Irving, Texas, United States, 75061
Actively Recruiting
58
Sl0044 50718
Mansfield, Texas, United States, 76063
Actively Recruiting
59
Sl0044 50036
Mesquite, Texas, United States, 75150
Actively Recruiting
60
Sl0044 50061
Spokane Valley, Washington, United States, 99216
Actively Recruiting
61
Sl0044 60004
C.a.b.a, Argentina
Actively Recruiting
62
Sl0044 60002
Capital Federal, Argentina
Actively Recruiting
63
Sl0044 60024
Córdoba, Argentina
Actively Recruiting
64
Sl0044 60029
Mendoza, Argentina
Actively Recruiting
65
Sl0044 60003
Quilmes, Argentina
Actively Recruiting
66
Sl0044 60011
San Juan, Argentina
Actively Recruiting
67
Sl0044 60014
San Miguel de Tucumán, Argentina
Actively Recruiting
68
Sl0044 40002
Leuven, Belgium
Actively Recruiting
69
Sl0044 40060
Liège, Belgium
Actively Recruiting
70
Sl0044 50259
Rimouski, Canada
Actively Recruiting
71
Sl0044 50045
Toronto, Canada
Actively Recruiting
72
Sl0044 60018
Santiago, Chile
Actively Recruiting
73
Sl0044 20293
Baotou, China
Actively Recruiting
74
Sl0044 20128
Beijing, China
Actively Recruiting
75
Sl0044 20157
Beijing, China
Actively Recruiting
76
Sl0044 20173
Beijing, China
Actively Recruiting
77
Sl0044 20201
Bengbu, China
Actively Recruiting
78
Sl0044 20291
Changchun, China
Actively Recruiting
79
Sl0044 20342
Changchun, China
Actively Recruiting
80
Sl0044 20295
Changsha, China
Actively Recruiting
81
Sl0044 20186
Changzhou, China
Actively Recruiting
82
Sl0044 20137
Chengdu, China
Actively Recruiting
83
Sl0044 20019
Guangzhou, China
Actively Recruiting
84
Sl0044 20360
Guangzhou, China
Actively Recruiting
85
Sl0044 20290
Guilin, China
Actively Recruiting
86
Sl0044 20271
Haikou, China
Actively Recruiting
87
Sl0044 20296
Hangzhou, China
Actively Recruiting
88
Sl0044 20185
Jinan, China
Actively Recruiting
89
Sl0044 20364
Jiujiang, China
Actively Recruiting
90
Sl0044 20192
Nanchang, China
Actively Recruiting
91
Sl0044 20024
Nanjing, China
Actively Recruiting
92
Sl0044 20331
Nanning, China
Actively Recruiting
93
Sl0044 20272
Pingxiang, China
Actively Recruiting
94
Sl0044 20020
Shanghai, China
Actively Recruiting
95
Sl0044 20172
Shanghai, China
Actively Recruiting
96
Sl0044 20346
Shantou, China
Actively Recruiting
97
Sl0044 20363
Shijiazhuang, China
Actively Recruiting
98
Sl0044 20204
Suzhou, China
Actively Recruiting
99
Sl0044 20136
Tianjin, China
Actively Recruiting
100
Sl0044 20275
Urumuqi, China
Actively Recruiting
101
Sl0044 20025
Wenzhou, China
Actively Recruiting
102
Sl0044 20180
Wuhan, China
Actively Recruiting
103
Sl0044 20270
Wuhan, China
Actively Recruiting
104
Sl0044 20274
Xi'an, China
Actively Recruiting
105
Sl0044 20341
Xiamen, China
Actively Recruiting
106
Sl0044 20273
Yangzhou, China
Actively Recruiting
107
Sl0044 20132
Zhengzhou, China
Active, Not Recruiting
108
Sl0044 20361
Zhuzhou, China
Actively Recruiting
109
Sl0044 40903
Aalborg, Denmark
Actively Recruiting
110
Sl0044 40513
Copenhagen, Denmark
Actively Recruiting
111
Sl0044 40489
Odense, Denmark
Actively Recruiting
112
Sl0044 40896
Bordeaux, France
Actively Recruiting
113
Sl0044 40848
Le Mans, France
Actively Recruiting
114
Sl0044 40506
Montpellier, France
Actively Recruiting
115
Sl0044 40480
Berlin, Germany
Actively Recruiting
116
Sl0044 40386
Cologne, Germany
Actively Recruiting
117
Sl0044 40716
Cologne, Germany
Actively Recruiting
118
Sl0044 40322
Dessau, Germany
Withdrawn
119
Sl0044 40356
Dresden, Germany
Actively Recruiting
120
Sl0044 40072
Freiburg im Breisgau, Germany
Actively Recruiting
121
Sl0044 40717
Greifswald, Germany
Actively Recruiting
122
Sl0044 40027
Herne, Germany
Actively Recruiting
123
Sl0044 40139
Jena, Germany
Actively Recruiting
124
Sl0044 40078
Leipzig, Germany
Actively Recruiting
125
Sl0044 40854
Mainz, Germany
Actively Recruiting
126
Sl0044 40815
München, Germany
Actively Recruiting
127
Sl0044 40402
Tübingen, Germany
Actively Recruiting
128
Sl0044 40715
Vogelsang-gommern, Germany
Actively Recruiting
129
Sl0044 40376
Athens, Greece
Actively Recruiting
130
Sl0044 40501
Athens, Greece
Actively Recruiting
131
Sl0044 40377
Heraklion, Greece
Actively Recruiting
132
Sl0044 40507
Larissa, Greece
Actively Recruiting
133
Sl0044 40816
Brescia, Italy
Actively Recruiting
134
Sl0044 40514
Genova, Italy
Actively Recruiting
135
Sl0044 40291
Milan, Italy
Actively Recruiting
136
Sl0044 40471
Milan, Italy
Actively Recruiting
137
Sl0044 40509
Padova, Italy
Actively Recruiting
138
Sl0044 40176
Pisa, Italy
Actively Recruiting
139
Sl0044 40148
Roma, Italy
Actively Recruiting
140
Sl0044 40675
Roma, Italy
Actively Recruiting
141
Sl0044 40860
Roma, Italy
Actively Recruiting
142
Sl0044 40897
Roma, Italy
Actively Recruiting
143
Sl0044 40830
Rozzano, Italy
Actively Recruiting
144
Sl0044 20035
Bunkyō City, Japan
Actively Recruiting
145
Sl0044 20196
Bunkyō City, Japan
Actively Recruiting
146
Sl0044 20279
Bunkyō City, Japan
Actively Recruiting
147
Sl0044 20030
Chūōku, Japan
Actively Recruiting
148
Sl0044 20281
Fukuoka, Japan
Actively Recruiting
149
Sl0044 20039
Kawagoe, Japan
Actively Recruiting
150
Sl0044 20045
Kita-gun, Japan
Actively Recruiting
151
Sl0044 20065
Kitakyushu, Japan
Actively Recruiting
152
Sl0044 20301
Kurashiki, Japan
Actively Recruiting
153
Sl0044 20069
Meguro-ku, Japan
Actively Recruiting
154
Sl0044 20071
Nagasaki, Japan
Actively Recruiting
155
Sl0044 20287
Nagoya, Japan
Actively Recruiting
156
Sl0044 20084
Saga, Japan
Actively Recruiting
157
Sl0044 20283
Sagamihara, Japan
Actively Recruiting
158
Sl0044 20031
Sapporo, Japan
Actively Recruiting
159
Sl0044 20042
Sasebo, Japan
Actively Recruiting
160
Sl0044 20171
Sendai, Japan
Actively Recruiting
161
Sl0044 20070
Shinjuku-ku, Japan
Actively Recruiting
162
Sl0044 20076
Shinjuku-ku, Japan
Actively Recruiting
163
Sl0044 20285
Shinjuku-ku, Japan
Actively Recruiting
164
Sl0044 20288
Shinjuku-ku, Japan
Actively Recruiting
165
Sl0044 20277
Suita, Japan
Actively Recruiting
166
Sl0044 20032
Suita-shi, Japan
Actively Recruiting
167
Sl0044 20278
Tsu, Japan
Actively Recruiting
168
Sl0044 20358
Wakayama, Japan
Actively Recruiting
169
Sl0044 20276
Yoshida-gun, Japan
Actively Recruiting
170
Sl0044 50250
Cuernavaca, Mexico
Actively Recruiting
171
Sl0044 40838
Amsterdam, Netherlands
Actively Recruiting
172
Sl0044 40292
Groningen, Netherlands
Actively Recruiting
173
Sl0044 40565
Maastricht, Netherlands
Actively Recruiting
174
Sl0044 60026
Arequipa, Peru
Actively Recruiting
175
Sl0044 60009
Surco, Peru
Actively Recruiting
176
Sl0044 40398
Katowice, Poland
Actively Recruiting
177
Sl0044 40795
Katowice, Poland
Actively Recruiting
178
Sl0044 40502
Krakow, Poland
Actively Recruiting
179
Sl0044 40037
Lublin, Poland
Actively Recruiting
180
Sl0044 40044
Poznan, Poland
Actively Recruiting
181
Sl0044 40484
Poznan, Poland
Actively Recruiting
182
Sl0044 40821
Poznan, Poland
Actively Recruiting
183
Sl0044 40097
Warsaw, Poland
Actively Recruiting
184
Sl0044 40098
Warsaw, Poland
Actively Recruiting
185
Sl0044 40397
Wroclaw, Poland
Actively Recruiting
186
Sl0044 40481
Wroclaw, Poland
Actively Recruiting
187
Sl0044 50671
Caguas, Puerto Rico
Actively Recruiting
188
Sl0044 50683
San Juan, Puerto Rico
Actively Recruiting
189
Sl0044 40730
Belgrade, Serbia
Actively Recruiting
190
Sl0044 40466
Kragujevac, Serbia
Actively Recruiting
191
Sl0044 40861
Niška Banja, Serbia
Actively Recruiting
192
Sl0044 40392
Novi Sad, Serbia
Actively Recruiting
193
Sl0044 20141
Busan, South Korea
Actively Recruiting
194
Sl0044 20108
Incheon, South Korea
Actively Recruiting
195
Sl0044 20104
Seoul, South Korea
Actively Recruiting
196
Sl0044 20351
Seoul, South Korea
Actively Recruiting
197
Sl0044 20092
Suwon, South Korea
Actively Recruiting
198
Sl0044 40045
A Coruña, Spain
Actively Recruiting
199
Sl0044 40826
Badajoz, Spain
Actively Recruiting
200
Sl0044 40159
Barcelona, Spain
Actively Recruiting
201
Sl0044 40160
Barcelona, Spain
Actively Recruiting
202
Sl0044 40839
Castellon, Spain
Actively Recruiting
203
Sl0044 40857
Madrid, Spain
Actively Recruiting
204
Sl0044 40341
Málaga, Spain
Actively Recruiting
205
Sl0044 40521
Mérida, Spain
Actively Recruiting
206
Sl0044 40101
Sabadell, Spain
Actively Recruiting
207
Sl0044 40853
Santiago de Compostela, Spain
Actively Recruiting
208
Sl0044 40049
Seville, Spain
Actively Recruiting
209
Sl0044 40103
Seville, Spain
Actively Recruiting
210
Sl0044 40106
Seville, Spain
Actively Recruiting
211
Sl0044 40863
Vitoria-Gasteiz, Spain
Actively Recruiting
212
Sl0044 20330
New Taipei City, Taiwan
Actively Recruiting
213
Sl0044 20080
Taichung, Taiwan
Actively Recruiting
214
Sl0044 20113
Taichung, Taiwan
Actively Recruiting
215
Sl0044 20142
Taichung, Taiwan
Actively Recruiting
216
Sl0044 20086
Taipei, Taiwan
Actively Recruiting
217
Sl0044 20099
Taipei, Taiwan
Actively Recruiting
218
Sl0044 20362
Taipei, Taiwan
Actively Recruiting
219
Sl0044 20082
Taoyuan City, Taiwan
Actively Recruiting
220
Sl0044 40847
Bath, United Kingdom
Actively Recruiting
221
Sl0044 40858
Belfast, United Kingdom
Actively Recruiting
222
Sl0044 40281
Leeds, United Kingdom
Actively Recruiting
223
Sl0044 40864
Newcastle upon Tyne, United Kingdom
Actively Recruiting
224
Sl0044 40701
Sheffield, United Kingdom
Actively Recruiting
225
Sl0044 40725
West Bromwich, United Kingdom
Actively Recruiting
Research Team
U
UCB Cares
CONTACT
U
UCB Cares
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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