At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 36 enrolled
Drug / intervention
BT063 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated Dose, Multicentre Phase IIa Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
In Brief
A Phase 2 clinical trial evaluating BT063 and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 36 participants across 14 sites in 4 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesBelarus, Georgia, Poland, Serbia
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartSep 2015
Primary CompletionOct 2017
TodayJul 2026
First PostedSep 18, 2015
Enrollment StartSep 28, 2015
Primary CompletionOct 25, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.8 years ago
Interventions
BT063biological
Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)
Placebobiological
Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)