MedTrace Logo

Atacicept Demonstrating Dose RESponSe

NCT01440231 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-08-21

No results posted yet for this study

Summary

Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells make proteins called antibodies, which in autoimmune disease can bind to one's own tissues and are thus referred to as autoantibodies. Atacicept blocks 2 factors in the body, called BLyS and APRIL, which are important for the maintenance of B-cells and plasma cells, and thus the production of antibodies. This study will assess whether treatment with atacicept can reduce SLE disease activity. Atacicept is still an experimental drug, meaning that it is not available outside of a clinical trial, and that its potential benefits and risks have not been fully determined.

A total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a 1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg, atacicept 115 mg or matching placebo, given subcutaneously once weekly for 24 weeks.

The primary objective of the trial is to evaluate the efficacy of atacicept compared to placebo in reducing SLE disease activity in subjects treated with standard of care (SoC) therapy and to investigate the dose-response relationship.

The secondary objectives of the trial are:

* To evaluate the effect of atacicept in reducing corticosteroid usage
* To evaluate the safety and tolerability profile of atacicept in subjects with SLE
* To confirm the PK and PD profiles of atacicept in SLE subjects
* To evaluate the changes in the Medical Outcomes Study Short Form General Health Survey \[SF-36\].

Conditions

Interventions

DRUG

Placebo

Matching placebo administered by subcutaneous injection, once weekly

DRUG

Atacicept

Atacicept 5 mg administered by subcutaneous injection, once weekly

DRUG

Atacicept

Atacicept 25 mg administered by subcutaneous injection, once weekly

DRUG

Atacicept

Atacicept 75 mg administered by subcutaneous injection, once weekly

DRUG

Atacicept

Atacicept 115 mg administered by subcutaneous injection, once weekly

Sponsors & Collaborators

Principal Investigators

  • Stephen Wax, MD, PhD · EMD Serono, Senior Medical Director, Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-08-31
Completion
2014-02-28

More Related Trials

Entities

Drugs
Diseases
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 NCT01440231 on ClinicalTrials.gov