Status:
COMPLETED
Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis
Lead Sponsor:
MorphoSys AG
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Multiple sclerosis (MS) is a chronic inflammatory disease associated with central nervous system (CNS) demyelination and subsequent axonal degeneration. Multiple sclerosis exhibits an unpredictable an...
Detailed Description
Recent clinical studies demonstrated a possible dysregulation of the balance of pro and anti inflammatory lymphocytes, which may contribute to the pathogenesis of MS. It was shown in animal models of...
Eligibility Criteria
Inclusion
- Key
- Outpatients with a diagnosis of RRMS or SPMS, who are currently not being treated and who have at least 1 of the following:
- At least 1 documented relapse within 1 year before Screening, or
- Two documented relapses within the past 2 years before Screening, or
- A new gadolinium (Gd)-enhancing lesion on magnetic resonance imaging (MRI) T1-weighted imaging within 1 year before Screening, or
- A new T2 lesion on MRI within 1 year before Screening. The patient must have 10 or less, Gd-enhancing lesions per T1-weighted MRI at Screening as assessed by a central reader.
- The patient must be able and willing to ambulate, with an Expanded Disability Status Scale (EDSS) score of ≥ 2.0 and ≤ 6.5 at both the Screening Visit and the Baseline Visit
- Key
Exclusion
- A patient with primary progressive MS (PPMS)
- A patient who has previously received at any time any of the following
- B-cell or T-cell depleting therapies
- Cytotoxic agents, any immunosuppressive/immunomodulating agents
- A patient who has not stabilized, in the opinion of the investigator
- A patient with any medical condition or uncontrolled disease states other than MS requiring or likely to require systemic treatment with corticosteroids or other immune compromising agents
- A patient with current or a history of major chronic inflammatory autoimmune diseases other than MS
- A patient with any type of infection
- Patients on chronic prophylactic or suppressive antibiotic, antifungal,or antiviral agents
- A patient with a history of tuberculosis.
- A patient with any signs of excretory hepatic or kidney dysfunction
- A patient with a positive test for Hepatitis B or Hepatitis C
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01517282
Start Date
January 1 2012
End Date
February 1 2014
Last Update
November 21 2014
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Morphosys Investigative Site
Berlin, Germany
2
Morphosys Investigative Site
Gdansk, Poland
3
Morphosys Investigative Site
Poznan, Poland
4
Morhosys Investigative Site
Manchester, United Kingdom