A MULTI-CENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY FOLLOWED BY AN EXTENSION PERIOD EVALUATING THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Not Applicable

Recruiting

• Conditions: -M32 Systemic lupus erythematosus; Systemic lupus erythematosus; M32

• Registration Number: PER-044-16
• Lead Sponsor: CB Biopharma SPRL,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-13
• Study Completion: 2018-11-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written
Informed Consent form is signed and dated by the subject or legal representative prior to the
initiation of any study-specific assessment at Screening (Visit 1).
2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand
and complete diaries), visit schedule, and medication intake according to the judgment of the
Investigator.
3. Subject (male or female) is ≥18 years of age at Screening (Visit 1).
4. Subject has a bodyweight of ≥50kg and ≤160kg.
5. Adequate reading and writing abilities (in native language) such that the subject can
comprehend and answer the questions on the subject completed assessments.
6. The subject has SLE diagnosed by a physician, confirmed by the SLICC Classification
Criteria for SLE.
The subject has moderate to severe SLE disease activity as demonstrated by BILAG 2004

Exclusion Criteria

1. Subject has previously been randomized in this study or has previously participated in a DZP
clinical study.
2. Subject has any medical or psychiatric condition that, in the opinion of the Investigator,
could jeopardize or would compromise the subject’s ability to participate in this study.
3. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the
study or within 3 months following their final dose of study drug.
4. Subject has a history of malignancy, except the following treated cancers: cervical carcinoma
in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
5. Subject has a mixed connective tissue disease, scleroderma, and/or overlap syndromes of
SLE.
Subjects with SLE and secondary Sjögren’s syndrome are permitted provided they meet
the eligibility criteria. ETC

Study & Design

• Study Type: Interventional
• Study Design: Not specified