Current studies | UCB
UCB's Global Corporate Website


A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Brief summary

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.

Medical Condition

Systemic lupus erythematosus

Min. Age


Max. Age


Who Can Join?



Inclusion criteria
- Rescreening will be allowed once during the study in case there is new evidence for an inclusion criterion that was not fulfilled at the first screening or in case a study participant no longer meets an exclusion criterion or screening period exceeded the maximum duration due to delays in screening processes - Study participant must be ≥16 years of age, unless restricted by local regulation, at the time of signing the Informed Consent form (ICF) - Study participants who have moderate to severe disease activity due to either persisting active SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC) medication defined as: a. Diagnosed with SLE at least 24 weeks before the Screening Visit (Visit 1) study entry by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (in central laboratory at Screening) ii) Either complement C3 < lower limit of normal (LLN) OR complement C4
Exclusion criteria
- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study. This includes study participants with a life threatening condition - Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies - Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma - Study participant has an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder - Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection - Study participant had a reactivated latent infection (example, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2), or is currently receiving suppressive therapy for an opportunistic infection - Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion - Study participant has clinically significant active or latent infection - Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE - Study participant takes any protocol defined prohibited concomitant medication - Study participant has previously been randomized within this study or participant has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP - Study participant has participated in another study of an IMP within the previous 12 weeks or 5 half-lives of the investigational medicinal product (IMP) whatever is longer or is currently participating in another study of an IMP - Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate <30mL/min/1.73m^2, or serum creatinine >2.5 mg/dL, or participant has proteinuria >3 g/day, or protein: creatinine ratio >340 mg/mmol at the Screening Visit

Study Medication Description

Study Medication:

dapirolizumab pegol

Other Descriptive Name:

dapirolizumab pegol





Study Dates

August 2020

Actual Start Date of Enrollment

April 2024

Planned Study Completion Date

General Information

Study ID:
EudraCT Number:
2019-003406-27 Number:
Phase 3

Interested in enrolling in our study?

Just contact us

+43 (0) 1 291 80 08
0800-296176 (freephone)

+32 2 559 92 00
0800 38 008 (freephone)



+1 866 709 8444

Czech Republic
+420 221 773 442
800 144 395 (freephone)

+45 32462480
80 253827 (freephone)

+358 942733300
0800 9 13353 (freephone)

+33 1 47 29 45 55
0 805 222 949 (freephone)


+30 21 0997 4200
0080 012 9910 (freephone)

+36 1 472 5060
06 80 021 486 (freephone)

+353 1 463 2371
1800 93 00 75 (freephone)

+39 02 3007 9300
8009-86932 (freephone)

+32 2 559 92 12
8002 3204 (freephone)

+45 32462482
800-10101 (freephone)

+48 22 596 97 97
00 800 121 68 25 (freephone)

+351 213 025 300
800-8-56033 (freephone)


+4021 300 19 07

+421 2 592 020 23
0800 002 566 (freephone)

+34 915 70 06 49
8000-99684 (freephone)

+45 32462481
0200 898 671 (freephone)


+41 58 822 3180

The Netherlands
+31 76 573 1130
0800 3434335 (freephone)

+44 1753 777 100
0800 279 3177 (freephone)