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Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CDP323
placebo
CDP323
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring CDP323, Relapsing Multiple Sclerosis, Magnetic Resonance Imaging, Oral Compound, MS

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • relapsing form of MS
  • screening EDSS score 0 - 5.5, inclusive
  • at least one clinical relapse in the 12 months before screening
  • active disease, defined by set of MRI activity criteria
  • failed prior treatment with beta-interferons or glatiramer acetate

Exclusion Criteria:

  • signs of silent infections, including positive tests for HIV1, HIV2 or Hepatitis B or Hepatitis C or tuberculosis
  • known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation
  • pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening within certain time frames

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CDP323 1000 mg/day

CDP323 500 mg/day

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28).
The following lesions are considered newly active: new gadolinium enhancement on T1-weighted images; new lesions on T2-weighted images, but non-enhancing on T1-weighted images; new enlargement on T2-weighted images, but non-enhancing on T1-weighted images.

Secondary Outcome Measures

Occurrence of any treatment emergent adverse event.

Full Information

First Posted
June 8, 2007
Last Updated
September 2, 2011
Sponsor
UCB Pharma
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00484536
Brief Title
Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323
Official Title
Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
The study was discontinued due to unfavorable interim analysis
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
Collaborators
Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
CDP323, Relapsing Multiple Sclerosis, Magnetic Resonance Imaging, Oral Compound, MS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDP323 1000 mg/day
Arm Type
Experimental
Arm Title
CDP323 500 mg/day
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CDP323
Intervention Description
250 mg capsules, 500 mg bid (1000 mg/day)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
capsules, once daily
Intervention Type
Drug
Intervention Name(s)
CDP323
Intervention Description
250 mg Capsules, 500 mg, once daily
Primary Outcome Measure Information:
Title
The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28).
Description
The following lesions are considered newly active: new gadolinium enhancement on T1-weighted images; new lesions on T2-weighted images, but non-enhancing on T1-weighted images; new enlargement on T2-weighted images, but non-enhancing on T1-weighted images.
Time Frame
Cumulative number of newly active lesions from baseline to Week 28.
Secondary Outcome Measure Information:
Title
Occurrence of any treatment emergent adverse event.
Time Frame
During up to 24 weeks of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: relapsing form of MS screening EDSS score 0 - 5.5, inclusive at least one clinical relapse in the 12 months before screening active disease, defined by set of MRI activity criteria failed prior treatment with beta-interferons or glatiramer acetate Exclusion Criteria: signs of silent infections, including positive tests for HIV1, HIV2 or Hepatitis B or Hepatitis C or tuberculosis known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening within certain time frames
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Cullman
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Springs
State/Province
Colorado
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Maitland
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Northbrook
State/Province
Illinois
Country
United States
City
Fort Wayne
State/Province
Indiana
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Lenexa
State/Province
Kansas
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Farmington Hills
State/Province
Michigan
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Providence
State/Province
Rhode Island
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Kirkland
State/Province
Washington
Country
United States
City
Charleston
State/Province
West Virginia
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Diepenbeek
Country
Belgium
City
Gent
Country
Belgium
City
Melsbroek
Country
Belgium
City
Overpelt
Country
Belgium
City
Sijsele
Country
Belgium
City
Sint-Truiden
Country
Belgium
City
London
State/Province
Ontario
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Gatineau
State/Province
Quebec
Country
Canada
City
Greenfield Park
State/Province
Quebec
Country
Canada
City
Sherbrooke
State/Province
Quebec
Country
Canada
City
Oulu
Country
Finland
City
Tampere
Country
Finland
City
Turku
Country
Finland
City
Besancon
Country
France
City
Clermont-Ferrand
Country
France
City
Lyon Cedex 03
Country
France
City
Rennes
Country
France
City
Strasbourg
Country
France
City
Bayreuth
Country
Germany
City
Berlin
Country
Germany
City
Giessen
Country
Germany
City
Hamburg
Country
Germany
City
Marburg
Country
Germany
City
Rostock
Country
Germany
City
Ulm
Country
Germany
City
Wiesbaden
Country
Germany
City
Budapest
Country
Hungary
City
Gyor
Country
Hungary
City
Nyiregyhaza
Country
Hungary
City
Pecs
Country
Hungary
City
Amsterdam
Country
Netherlands
City
Breda
Country
Netherlands
City
Nieuwegein
Country
Netherlands
City
Nijmegen
Country
Netherlands
City
Barcelona
Country
Spain
City
Bilbao
Country
Spain
City
Girona
Country
Spain
City
Madrid
Country
Spain
City
Malaga
Country
Spain
City
Oviedo
Country
Spain
City
Santa Cruz de Tenerife
Country
Spain
City
Sevilla
Country
Spain
City
Goteborg
Country
Sweden
City
Umea
Country
Sweden
City
Hartshill
Country
United Kingdom
City
Newcastle
Country
United Kingdom
City
Nottingham
Country
United Kingdom
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323

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