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.
- Conditions
- SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUSMedDRA version: 19.0 Level: LLT Classification code 10040967 Term: SLE System Organ Class: 100000004859Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2015-004457-40-HU
- Lead Sponsor
- CB Biopharma SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 182
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;<br> Secondary Objective: •To assess the efficacy of the individual dose regimens of intravenous (iv) dapirolizumab pegol (DZP)<br> at Week 24<br> • To assess the safety and tolerability of intravenous (iv) dapirolizumab pegol (DZP)<br> ;<br> Primary end point(s): •Percentage of subjects with BICLA response across 3 doses of<br> dapirolizumab pegol (DZP) and placebo (PBO) at Week 24.<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): The percentage of subjects with BICLA response in the individual<br> dose groups at Week 24<br> ;Timepoint(s) of evaluation of this end point: Week 24