Clinical Trial: MSC2364447C Phase 1b in Systemic Lupus Erythematosus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase Ib Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biological Effect of MSC2364447C in Systemic Lupus

Brief Summary: The primary purpose of this Phase 1b double-blind, randomized, placebo-controlled trial is to evaluate the safety, tolerability, pharmacokinetic (PK), and biological effect of MSC2364447C administered for 4 weeks in systemic lupus erythematosus subjects (SLE).

Detailed Summary:
Sponsor: EMD Serono Research & Development Institute, Inc.

Current Primary Outcome:

  • Number of subjects with treatment emergent adverse events (TEAEs) [ Time Frame: From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration ]
    TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration up to 4 weeks after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
  • Number of subjects with TEAEs according to severity [ Time Frame: From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration ]
    The severity of TEAEs will be graded using National cancer institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v 4.03) definitions of Grade 1 through Grade 5 following his/her best medical judgment. The severity of the AEs will be classified as follows: Grade 1 or mild, Grade 2 or moderate, Grade 3 or severe, Grade 4 or life-threatening and Grade 5 or death.
  • Number of subjects with clinically significant laboratory abnormalities [ Time Frame: screening up to Day 56 ]
    Clinical laboratory parameters being monitored for safety will be summarized using descriptive statistics, by postdose shifts relative to Baseline for relevant parameters using relevant cut-offs. Clinical significance will be determined by investigator.
  • Number of subjects with clinically significant abnormal vital signs: blood pressure, pulse rate, respiratory rate [ Time Frame: screening up to Day 56 ]
    Observed valu

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Area under the plasma concentration-time curve from time zero to 6 hours after administration (AUC0-6) [ Time Frame: Predose, 0.25, 0.5, 1.0, 2.0, 4.0, and 6.0 hours post-dose on Day 1 and Day 28 ]
    • Maximum observed plasma concentration (Cmax) [ Time Frame: Predose, 0.25, 0.5, 1.0, 2.0, 4.0, and 6.0 hours post-dose on Day 1 and Day 28 ]
    • Time to reach maximum plasma concentration (tmax) [ Time Frame: Predose, 0.25, 0.5, 1.0, 2.0, 4.0, and 6.0 hours post-dose on Day 1 and Day 28 ]
    • Concentration observed immediately before next dosing (Cpre) (Day 28) [ Time Frame: Predose (within 30 minutes prior to dosing) on Day 28 ]
    • Dose-normalized AUC0-6h (AUC0-6h/dose) [ Time Frame: Predose, 0.25, 0.5, 1.0, 2.0, 4.0, and 6.0 hours post-dose on Day 1 and Day 28 ]
    • Dose-normalized Cmax (Cmax/dose) [ Time Frame: Predose, 0.25, 0.5, 1.0, 2.0, 4.0, and 6.0 hours post-dose on Day 1 and Day 28 ]
    • Accumulation ratio for AUC0-6 (Racc(AUC0-6)) [ Time Frame: Predose, 0.25, 0.5, 1.0, 2.0, 4.0, and 6.0 hours post-dose on Day 1 and Day 28 ]
      Accumulation ratio for AUC will be calculated as AUC0-6, Day28 divided by AUC0-6, Day1
    • Accumulation ratio for Cmax (Racc(Cmax)) [ Time Frame: Predose, 0.25, 0.5, 1.0, 2.0, 4.0, and 6.0 hours post-dose on Day 1 and Day 28 ]
      Accumulation ratio for Cmax, calculated as Cmax, Day28 divided by Cmax, Day1


    Original Secondary Outcome: Same as current

    Information By: EMD Serono

    Dates:
    Date Received: August 28, 2015
    Date Started: November 2015
    Date Completion:
    Last Updated: November 28, 2016
    Last Verified: November 2016