A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS) (ATAMS)

April 15, 2016 updated by: EMD Serono

A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course

To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Box Hill, Australia
        • Research Site
      • Fitzroy, Australia
        • Research Site
      • New Lambton, Australia
        • Research Site
      • Woodville, Australia
        • Research Site
  • Austria
      • Innsbruck, Austria
        • Research Site
  • Belgium
      • Diepenbeek, Belgium
        • Research Site
      • Sijsele, Belgium
        • Research Site
  • Canada
      • Ontario, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
  • France
      • Caen, France
        • Research Site
      • Saint-Herblain, France
        • Research Site
  • Germany
      • Bochum, Germany
        • Research Site
      • Dusseldorf, Germany
        • Research Site
  • Lebanon
      • Beirut, Lebanon
        • Research Site
      • Beyrouth, Lebanon
        • Research Site
  • Lithuania
      • Kaunas, Lithuania
        • Research Site
  • Netherlands
      • Breda, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
  • Russian Federation
      • Dnipropetrovsk, Russian Federation
        • Research Site
      • Ekaterinburg, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
      • Samara, Russian Federation
        • Research Site
      • Vladimir, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
  • Sweden
      • Stockholm, Sweden
        • Research Site
  • Switzerland
      • Basel, Switzerland
        • Research Site
  • Ukraine
      • Kharkiv, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Odessa, Ukraine
        • Research Site
      • Uzhgorod, Ukraine
        • Research Site
  • United Kingdom
      • London, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Stoke on Trent, United Kingdom
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Illinois
      • Northbrook, Illinois, United States
        • Research Site
    • Michigan
      • East Lansing, Michigan, United States
        • Research Site
    • New Hampshire
      • Dartmouth, New Hampshire, United States
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

  • Have primary progressive multiple sclerosis (MS)
  • Have secondary progressive MS without superimposed relapses
  • Relevant cardiac, hepatic and renal diseases as specified in the protocol
  • Pretreatment with immunosuppressants and immunomodulating drugs as specified in the protocol
  • Clinical significant abnormalities in blood cell counts and immunoglobulin levels as specified in the protocol
  • Clinical significant acute or chronic infections as specified in the protocol Other protocol-defined exclusion criteria could apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo matched to atacicept
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
Experimental: Atacicept 75 mg
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Experimental: Atacicept 150 mg
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Experimental: Atacicept 25 mg
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
Time Frame: Weeks 12 to 36
Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).
Weeks 12 to 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of New T1 Gd-enhancing Lesions Per Participant
Time Frame: Weeks 12, 24, 36
Analysis of new T1 Gd-enhancing lesions was done using MRI scans.
Weeks 12, 24, 36
Percentage of Participants Free From Relapses
Time Frame: Baseline up to Week 36
A relapse was defined as the fulfillment of all the following criteria: a) neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours; b) absence of fever or known infection (fever with temperature [axillary, orally, or intrauriculary] greater than (>) 37.5 degrees Celsius or 99.5 degrees Fahrenheit); and c) objective neurological impairment, correlating with the participant's reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. Percentage of participants free from relapses during 36-week treatment period was reported.
Baseline up to Week 36
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time Frame: From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug up to 12 weeks after the last dose of the study drug that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAEs included subjects with both non serious and serious TEAEs.
From the first dose of study drug administration up to 12 weeks after the last dose of the study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Investigators

  • Study Director: Medical Responsible, EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 21, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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