A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2015-004457-40-DE
• Date of registration: 22/06/2016
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SPRL
• Public title: A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.
• Scientific title: A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
• Date of first enrolment: 19/09/2016
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004457-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Chile, Colombia, Germany, Hungary, Mexico, Peru, Poland, Romania, Russian Federation, Spain, Ukraine, United States

Contacts

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB BIOSCIENCES GmbH

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB BIOSCIENCES GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
1.Clinical diagnosis of SLE confirmed by the SLICC Classification Criteria for SLE .
2.The subject has at least 1 of the following:
Anti-dsDNA antibodies confirmed by the central laboratory
OR Low complement (ie, either low C3, or low C4, or both) confirmed by the central laboratory
OR ANA titer of =1:80 confirmed by the central laboratory at in combination with at least 1 of the following:
?Historical positivity for anti-dsDNA or ?Positivity for anti-ENA confirmed by the central laboratory
3.The subject has moderate to severe SLE disease activity
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
1.Subject has a mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE.
2.Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments.
3.Subject has new or worsening Class III or IV lupus nephritis.
4.Subject has chronic kidney failure stage 3b.
5.Subject has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T cell deficiencies, or human T cell lymphotropic virus 1 infection at any time prior to or during the study.
6.Subject has clinically significant active or latent infection, for example, but not limited to, chronic viral hepatitis B or C.
7.Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection are excluded.
8.Subjects who have received live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug .
9.Subjects with a history of thromboembolic events within 12 months of Screening.
10.Subject has used protocol defined prohibited medications.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0 Level: LLT Classification code 10040967 Term: SLE System Organ Class: 100000004859

Therapeutic area: Body processes [G] - Immune system processes [G12]

Intervention(s)

Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Dapirolizumab pegol
Current Sponsor code: DZP
Other descriptive name: CDP7657
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solvent for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): •Percentage of subjects with BICLA response across 3 doses of
dapirolizumab pegol (DZP) and placebo (PBO) at Week 24.

Secondary Objective: •To assess the efficacy of the individual dose regimens of intravenous (iv) dapirolizumab pegol (DZP)
at Week 24
• To assess the safety and tolerability of intravenous (iv) dapirolizumab pegol (DZP)

Timepoint(s) of evaluation of this end point: Week 24

Main Objective: To assess the dose-response for the efficacy of intravenous (iv) dapirolizumab pegol (DZP; 3 dose groups) at Week 24 in adult subjects with moderately to severely active SLE receiving stable standard of care treatment.

Secondary Outcome(s)

Secondary end point(s): The percentage of subjects with BICLA response in the individual
dose groups at Week 24

Timepoint(s) of evaluation of this end point: Week 24

Secondary ID(s)

SL0023

Source(s) of Monetary Support

UCB Biopharma SPRL

Ethics review

Status: Approved
Approval date:
Contact: