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A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus

NCT03161483 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2023-06-15

Study results available
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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.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

CC-220

CC-220

OTHER

Placebo

Placebo QD PO

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Nataliya Agafonova, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2021-08-03
Completion
2021-08-03
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Russia
  • Serbia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161483 on ClinicalTrials.gov