Trial record 1 of 8 for:    MEDI551
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Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01585766
First received: April 9, 2012
Last updated: July 25, 2014
Last verified: July 2014

April 9, 2012
July 25, 2014
April 2012
February 2015   (final data collection date for primary outcome measure)
Safety and Tolerability [ Time Frame: Day 1 to Day 169 ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of ascending IV and SC doses of MEDI-551 in adult subjects with relapsing forms of MS through the assessment of treatment-emergent adverse events and serious adverse events
  • Safety and Tolerability (Phase 1) [ Time Frame: Day 1 to Day 169 ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of ascending doses of MEDI-551 in adult subjects with relapsing-remitting multiple sclerosis (RRMS) through the assessment of treatment-emergent adverse events and serious adverse events
  • Proportion of Relapse-Free Subjects (Phase 2) [ Time Frame: Day 337 ] [ Designated as safety issue: No ]
    To compare the effect of MEDI-551 versus Avonex on the proportion of relapse free subjects
Complete list of historical versions of study NCT01585766 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics of MEDI-551 [ Time Frame: Day 1 to Day 169 ] [ Designated as safety issue: No ]
    To evaluate the pharmacokinetics (PK) of MEDI-551 in the subject population (including but not limited to Cmax, Tmax, T1/2, AUC)
  • Pharmacodynamic Effect of MEDI-551 [ Time Frame: Day 1 to Day 169 ] [ Designated as safety issue: No ]
    To describe the pharmacodynamic (PD) effects of MEDI-551 as measured by the change in B cell count from baseline
  • Immunogenicity of MEDI-551 [ Time Frame: Day 1 to Day 169 ] [ Designated as safety issue: No ]
    To evaluate the immunogenicity (IM) of MEDI-551 in the subject population
  • Mean new cumulative gadolinium-enhancing lesion(s) (Phase 2) [ Time Frame: Day 169 and Day 337 ] [ Designated as safety issue: No ]
    To compare the effect of MEDI-551 versus Avonex on the mean new cumulative gadolinium-enhancing lesion(s)
  • Symbol Digit Modalities Test (Phase 1/Phase 2) [ Time Frame: Day 169 and Day 337 ] [ Designated as safety issue: No ]
    To evaluate the effect of MEDI-551 control on the Symbol Digit Modalities Test (SDMT)
  • Pharmacokinetics of MEDI-551 (Phase 1/Phase 2) [ Time Frame: Day 1 to Day 169 (Phase 1) and Day 1 to Day 337 (Phase 2) ] [ Designated as safety issue: No ]
    To evaluate the pharmacokinetics (PK) of MEDI-551 in the subject population (including but not limited to Cmax, Tmax, T1/2, AUC)
  • Pharmacodynamic Effect of MEDI-551 (Phase 1/Phase 2) [ Time Frame: Day 1 to Day 169 (Phase 1) and Day 1 to Day 337 (Phase 2) ] [ Designated as safety issue: No ]
    To describe the pharmacodynamic (PD) effects of MEDI-551 as measured by the change in the number of B cell count from baseline
  • Safety of MEDI-551 (Phase 2) [ Time Frame: Day 1 to Day 337 ] [ Designated as safety issue: Yes ]
    To evaluate the safety of MEDI-551 through the assessment of treatment-emergent adverse events and serious adverse events
  • Immunogenicity of MEDI-551 (Phase 1/Phase 2) [ Time Frame: Day 1 to Day 169 (Phase 1) and Day 1 to Day 337 (Phase 2) ] [ Designated as safety issue: No ]
    To evaluate the immunogenicity (IM) of MEDI-551 in the subject population
Not Provided
Not Provided
 
Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis

The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).

This is a Phase 1, multicenter, multinational, randomized, blinded, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of IV and SC doses of MEDI-551 in adult subjects with relapsing forms of MS.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing Forms
  • Biological: MEDI-551 IV
    Associated Dosage Level x 2 MEDI-551 IV
  • Biological: MEDI-551 SC
    Associated Dosage Level X 1 MEDI-551 SC
  • Drug: Placebo IV
    Placebo IV x 2
  • Drug: Placebo SC
    Placebo SC x 1
  • Experimental: MEDI-551 Dosage 1
    Dosage Level 1 x 2 MEDI-551 IV
    Intervention: Biological: MEDI-551 IV
  • Experimental: MEDI-551 Dosage 2
    Dosage Level 2 x 2 MEDI-551 IV
    Intervention: Biological: MEDI-551 IV
  • Experimental: MEDI-551 Dosage 3
    Dosage Level 3 x 1 MEDI-551 SC
    Intervention: Biological: MEDI-551 SC
  • Experimental: MEDI-551 Dosage 4
    Dosage Level 4 x 1 MEDI-551 SC
    Intervention: Biological: MEDI-551 SC
  • Experimental: MEDI-551 Dosage 5
    Dosage Level 5 x 2 MEDI-551 IV
    Intervention: Biological: MEDI-551 IV
  • Placebo Comparator: Placebo IV
    Placebo IV x 2
    Intervention: Drug: Placebo IV
  • Placebo Comparator: Placebo SC
    Placebo SC x 1
    Intervention: Drug: Placebo SC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
28
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed relapsing form of MS (ie, RRMS, SPMS, PRMS, or CIS) according to revised 2010 McDonald criteria and MRI brain lesions consistent with MS on screening
  • At least 1 documented relapse within the past 3 years prior to screening
  • EDSS between 0.0 and 6.5 at screening
  • Have no more than 20 Gd-enhancing T1 brain lesions detected by cranial MRI scan

Exclusion Criteria:

  • Subjects with impaired renal function
  • Major surgery within 8 weeks of the screening visit
  • Subjects who are unable to undergo cranial MRI scan
  • A history of hypersensitivity to Gd-containing MRI contrast agents
  • Has received within 1 year prior to screening: monoclonal antibodies, experimental B-cell depleting agents, or treatment with natalizumab (Tysabri) for greater than 3 months
  • Receiving monthly methylprednisone or equivalent glucocorticoid for disease modification of a relapsing form of MS
  • Known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, methylprednisolone or equivalent glucocorticoid, or to any component of the investigational drug
  • Diagnosis of PPMS, neuromyelitis optica, or other non-MS variant of neuro-inflammatory or demyelinating diseases
  • Any history of opportunistic infection or the presence of active infection within two months prior to screening or any herpes zoster infection that has not resolved within 12 weeks prior to screening
  • Any clinically significant findings during the screening phase, including physical, neurological, laboratory, or ECG examination as per protocol
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Poland,   Spain,   Ukraine,   United Kingdom
 
NCT01585766
CD-IA-MEDI-551-1102
Yes
MedImmune LLC
MedImmune LLC
PPD
Study Director: Medical Monitor MedImmune LLC
MedImmune LLC
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP