Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis

MorphoSys

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Sclerosis

Treatments: Biological: MOR103; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01517282

2011-001064-22

Details and patient eligibility

About

Multiple sclerosis (MS) is a chronic inflammatory disease associated with central nervous system (CNS) demyelination and subsequent axonal degeneration. Multiple sclerosis exhibits an unpredictable and variable clinical course.

Multiple sclerosis plaques contain numerous types of cells and infiltrating macrophages have been identified to contribute significantly to demyelination in both clinical MS and animal models of MS. Granulocyte-macrophage colony-stimulating factor (GM CSF) stimulates proliferation and activation of macrophages, monocytes, neutrophils, eosinophils, dendritic cells and microglia with subsequent induction of proinflammatory biomolecules.

Therefore blocking GM CSF activity might be a therapeutic approach for the treatment of MS.

Full 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 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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 Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 4 patient groups, including a placebo group

MOR103 0.5 mg/kg

Experimental group

Description:

6 doses of MOR103 0.5 mg/kg administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6).

Treatment:

Biological: MOR103

MOR103 1.0 mg/kg

Experimental group

Description:

6 doses of MOR103 1.0 mg/kg administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6).

Treatment:

Biological: MOR103

MOR103 2.0 mg/kg

Experimental group

Description:

6 doses of MOR103 2.0 mg/kg administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6).

Treatment:

Biological: MOR103

Placebo

Placebo Comparator group

Description:

6 doses of placebo administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6).

Treatment:

Other: Placebo