We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01585766
First Posted: April 26, 2012
Last Update Posted: August 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MedImmune LLC
April 9, 2012
April 26, 2012
August 16, 2016
April 2012
January 2015   (Final data collection date for primary outcome measure)
Safety and Tolerability [ Time Frame: Day 1 to Day 169 ]
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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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) ]
    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) ]
    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 ]
    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) ]
    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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
 
Completed
56
June 2016
January 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Spain,   Ukraine,   United States
Czech Republic,   United Kingdom
 
NCT01585766
CD-IA-MEDI-551-1102
Yes
Not Provided
Not Provided
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: Armando Flor MedImmune LLC
MedImmune LLC
August 2016

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