Clinical Trial: Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Moderate to Sever

Brief Summary: The purpose of the study is to evaluate the clinical efficacy of UCB7665 as an chronic-intermittent treatment in subjects with generalized myasthenia gravis (MG) who are classified as moderate to severe.

Detailed Summary:
Sponsor: UCB Biopharma S.P.R.L.

Current Primary Outcome: Change from Baseline in Quantitative Myasthenia Gravis (QMG) score to Visit 9 [ Time Frame: Baseline and Visit 9 (Day 29) ]

The total QMG score is obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity.


Original Primary Outcome: Change from Baseline in Quantitative Myasthenia Gravis (QMG) score to Visit 9 (Day 29) [ Time Frame: Baseline and Visit 9 (Day 29) ]

Current Secondary Outcome:

  • Change from Baseline in Myasthenia Gravis-Composite score to Visit 9 [ Time Frame: Baseline and Visit 9 (Day 29) ]
    The total Myasthenia Gravis(MG)-composite score is obtained by summing the responses to each individual item (10 items; Grade:0-9 depending on item). The score ranges from 0 to 50, with lower scores indicating lower disease activity.
  • Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) score to Visit 9 [ Time Frame: Baseline and Visit 9 (Day 29) ]
    The total MGDAL score is obtained by summing the responses to each individual item (8 items; Grades: 0,1,2,3). The score ranges from 0 to 24, with lower scores indicating lower disease activity.


Original Secondary Outcome: Change from Baseline in Myasthenia Gravis-Composite score to Visit 9 (Day 29) [ Time Frame: Baseline and Visit 9 (Day 29) ]

Information By: UCB Pharma

Dates:
Date Received: February 10, 2017
Date Started: April 28, 2017
Date Completion: September 14, 2018
Last Updated: April 26, 2017
Last Verified: April 2017