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Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

NCT01972568 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2018-01-02

Study results available
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Summary

This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

Atacicept 75 milligram (mg)

Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.

DRUG

Atacicept 150 mg

Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.

DRUG

Placebo

Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Responsible · EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-04-30
Completion
2016-09-30

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Chile
  • Czechia
  • Germany
  • Italy
  • Japan
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01972568 on ClinicalTrials.gov