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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
CompletedPhase 1Relapsing and progressiveNCT01585766

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Placebo or sham

  • PLACEBO-IV-SC

Results by group

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

From study drug administration (Day 1) through the end of treatment period (Day 169)

GroupValueIntervalNumber analysed
PLACEBO-IV-SC6 Participants7
MEDI-551 30 Mg-IV5 Participants5
MEDI-551 60 Mg-SC3 Participants3
MEDI-551 100 Mg-IV3 Participants4
MEDI-551 300 Mg-SC3 Participants3
MEDI-551 600 Mg-IV6 Participants6

Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

From study drug administration (Day 1) through the long term follow up period (up to 18 months after early discontinuation visit or 24 week treatment period).

GroupValueIntervalNumber analysed
PLACEBO-IV-SC1 Participants7
MEDI-551 30 Mg-IV1 Participants5
MEDI-551 60 Mg-SC0 Participants3
MEDI-551 100 Mg-IV0 Participants4
MEDI-551 300 Mg-SC1 Participants3
MEDI-551 600 Mg-IV1 Participants6

Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs

From study drug administration (Day 1) through the end of treatment period (Day 169)

GroupValueIntervalNumber analysed
PLACEBO-IV-SC1 Participants7
MEDI-551 30 Mg-IV0 Participants5
MEDI-551 60 Mg-SC0 Participants3
MEDI-551 100 Mg-IV0 Participants4
MEDI-551 300 Mg-SC0 Participants3
MEDI-551 600 Mg-IV0 Participants6
PLACEBO-IV-SC0 Participants7
MEDI-551 30 Mg-IV0 Participants5
MEDI-551 60 Mg-SC0 Participants3
MEDI-551 100 Mg-IV1 Participants4
MEDI-551 300 Mg-SC0 Participants3
MEDI-551 600 Mg-IV0 Participants6
PLACEBO-IV-SC0 Participants7
MEDI-551 30 Mg-IV1 Participants5
MEDI-551 60 Mg-SC0 Participants3
MEDI-551 100 Mg-IV0 Participants4
MEDI-551 300 Mg-SC0 Participants3
MEDI-551 600 Mg-IV0 Participants6
PLACEBO-IV-SC0 Participants7
MEDI-551 30 Mg-IV0 Participants5
MEDI-551 60 Mg-SC0 Participants3
MEDI-551 100 Mg-IV0 Participants4
MEDI-551 300 Mg-SC0 Participants3
MEDI-551 600 Mg-IV1 Participants6

Number of Participants With Vital Sign Abnormalities Reported as TEAEs

From study drug administration (Day 1) through the end of treatment period (Day 169)

GroupValueIntervalNumber analysed
PLACEBO-IV-SC1 Participants7
MEDI-551 30 Mg-IV0 Participants5
MEDI-551 60 Mg-SC1 Participants3
MEDI-551 100 Mg-IV0 Participants4
MEDI-551 300 Mg-SC0 Participants3
MEDI-551 600 Mg-IV2 Participants6
PLACEBO-IV-SC0 Participants7
MEDI-551 30 Mg-IV0 Participants5
MEDI-551 60 Mg-SC1 Participants3
MEDI-551 100 Mg-IV0 Participants4
MEDI-551 300 Mg-SC0 Participants3
MEDI-551 600 Mg-IV0 Participants6
PLACEBO-IV-SC0 Participants7
MEDI-551 30 Mg-IV0 Participants5
MEDI-551 60 Mg-SC1 Participants3
MEDI-551 100 Mg-IV0 Participants4
MEDI-551 300 Mg-SC0 Participants3
MEDI-551 600 Mg-IV0 Participants6

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
PLACEBO-IV-SC71 (14.3%)
MEDI-551 60 Mg-SC30 (0.0%)
MEDI-551 100 Mg-IV40 (0.0%)
MEDI-551 300 Mg-SC31 (33.3%)
MEDI-551 30 Mg-IV51 (20.0%)
MEDI-551 600 Mg-IV61 (16.7%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    From study drug administration (Day 1) through the end of treatment period (Day 169)

    Safety

  • Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

    From study drug administration (Day 1) through the long term follow up period (up to 18 months after early discontinuation visit or 24 week treatment period).

    Safety

  • Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs

    From study drug administration (Day 1) through the end of treatment period (Day 169)

    Safety

  • Number of Participants With Vital Sign Abnormalities Reported as TEAEs

    From study drug administration (Day 1) through the end of treatment period (Day 169)

    Safety

Other measures (13)

  • Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-551

    Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169

    How the body handles the medicine

  • Maximum Observed Serum Concentration (Cmax) of MEDI-551

    Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169

    How the body handles the medicine

  • Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-last) of MEDI-551

    Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169

    How the body handles the medicine

  • Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity) of MEDI-551

    Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169

    How the body handles the medicine

  • Dose Normalized Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity/D) of MEDI-551

    Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169

    How the body handles the medicine

  • Clearance of MEDI-551

    Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169

    How the body handles the medicine

  • Terminal Elimination Half-life (t1/2) of MEDI-551

    Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169

    MRI lesionsHow the body handles the medicine

  • Absolute Subcutaneous Bioavailability (F%) of MEDI-551

    Predose (Day 1) and Days 4, 8, 15, 29, 57, 85, 113, 141, and 169

    How the body handles the medicine

  • Absolute CD20 B-cell Count at Baseline

    Baseline (Days -28 to -1)

    Immune response

  • Time to 90 Percent (%) CD20 B-cell Depletion

    Baseline (Days -28 to -1) to long-term follow-up (LTFU) (Up to 18 months after EDV or 24 Week treatment period)

    Walking and mobilityImmune response

Who could take part

Relapsing and progressive · 18 to 65

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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Related trials

History

    1. Started

      Apr 2012

    2. Main results due

      Jan 2015

    3. Finished

      Jun 2016

    4. Results posted

      Oct 2018

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