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Atacicept Demonstrating Dose RESponSe

NCT ID: NCT01440231

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-02-28

Brief Summary

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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 \[SF-36\].

Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Keywords

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Rheumatology Double-Blind Placebo-Controlled Multidose Dose-Response Phase II Systemic Lupus Erythematosus SLE Atacicept

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo administered by subcutaneous injection, once weekly

Arm 2

Group Type EXPERIMENTAL

Atacicept

Intervention Type DRUG

Atacicept 5 mg administered by subcutaneous injection, once weekly

Arm 3

Group Type EXPERIMENTAL

Atacicept

Intervention Type DRUG

Atacicept 25 mg administered by subcutaneous injection, once weekly

Arm 4

Group Type EXPERIMENTAL

Atacicept

Intervention Type DRUG

Atacicept 75 mg administered by subcutaneous injection, once weekly

Arm 5

Group Type EXPERIMENTAL

Atacicept

Intervention Type DRUG

Atacicept 115 mg administered by subcutaneous injection, once weekly

Interventions

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Placebo

Matching placebo administered by subcutaneous injection, once weekly

Intervention Type DRUG

Atacicept

Atacicept 5 mg administered by subcutaneous injection, once weekly

Intervention Type DRUG

Atacicept

Atacicept 25 mg administered by subcutaneous injection, once weekly

Intervention Type DRUG

Atacicept

Atacicept 75 mg administered by subcutaneous injection, once weekly

Intervention Type DRUG

Atacicept

Atacicept 115 mg administered by subcutaneous injection, once weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female of ≥18 years of age
* Written informed consent
* Diagnosis of SLE satisfying at least 4 out of the 11 ACR criteria during the course of their illness
* Disease duration of at least 6 months
* SLEDAI-2K score ≥ 6 at screening
* Positive test results for antinuclear antibody (ANA) (HEp-2 ANA ≥1:80) and/or anti-double-stranded deoxyribonucleic acid (dsDNA) (≥30 IU/mL) at screening
* Negative serum pregnancy test and highly effective method of contraception for woman of childbearing potential.

Exclusion Criteria

* Increase in dosing of corticosteroids within 2 weeks prior to screening
* Introduction of MMF within 3 months prior to TD1 or increase in dosing within 1 month before screening
* Change in dosing of immunosuppressants or corticosteroids during the screening period
* Serum IgG \< 6g/L
* Estimated Glomerular Filtration Rate (GFR) \<50 mL/min/1.73m²
* Urinary protein:creatinine ratio \>2 mg/mg
* History of demyelinating disease
* Breastfeeding or pregnancy
* Legal or limited legal capacity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMD Serono

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Wax, MD, PhD

Role: STUDY_DIRECTOR

EMD Serono, Senior Medical Director, Rheumatology

Countries

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United States

Other Identifiers

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BB-IND 11,584

Identifier Type: OTHER

Identifier Source: secondary_id

EMR 700461-018

Identifier Type: -

Identifier Source: org_study_id