Actively Recruiting

Phase 3
Age: 16Years +
All Genders
NCT06617325

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

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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