Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MorphoSys AG
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 EAE that during the disease effect or phase GM CSF sustained neuroinflammation via myeloid cells that infiltrate the CNS proving an essential role of GM CSF in encephalitogenicity.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
1. A patient with primary progressive MS (PPMS)
2. 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
3. A patient who has not stabilized, in the opinion of the investigator
4. 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
5. A patient with current or a history of major chronic inflammatory autoimmune diseases other than MS
6. A patient with any type of infection
7. Patients on chronic prophylactic or suppressive antibiotic, antifungal,or antiviral agents
8. A patient with a history of tuberculosis.
9. A patient with any signs of excretory hepatic or kidney dysfunction
10. A patient with a positive test for Hepatitis B or Hepatitis C
Clareo Health | Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis
