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Clinical Trials/EUCTR2015-004457-40-HU
EUCTR2015-004457-40-HUActive, not recruitingPhase 1

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

CB Biopharma SPR0 sites182 target enrollmentStarted: July 13, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
182
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility 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.

Investigators

Sponsor
CB Biopharma SPR

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