CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 289 enrolled
Drug / intervention
CC-220 +1 moredrug
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.

Search/NCT03161483
NCT03161483Phase 2Completed

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Celgene·interventional·Posted May 19, 2017·Updated Jun 15, 2023

In Brief

A Phase 2 clinical trial evaluating CC-220 and Placebo for Lupus Erythematosus, Systemic. Completed, enrolled 289 participants across 184 sites in 15 countries.

Detailed Summary

The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus. Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belgium, Brazil, Canada, Colombia, France, Germany, Hungary, Italy, Mexico, Poland, Russia, Serbia, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 19, 2017
Enrollment StartAug 31, 2017
Primary CompletionAug 3, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 9.1 years ago

Interventions

CC-220drug

CC-220

Placeboother

Placebo QD PO