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Trial record 2 of 20 for:    Recruiting Studies | myasthenia gravis

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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by UCB Pharma ( UCB Biopharma S.P.R.L. )
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier:
NCT03052751
First received: February 10, 2017
Last updated: August 31, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Myasthenia Gravis Drug: UCB7665 Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Severe Myasthenia Gravis

Resource links provided by NLM:


Further study details as provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 42
Actual Study Start Date: May 15, 2017
Estimated Study Completion Date: September 14, 2018
Estimated Primary Completion Date: July 6, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosage Regimen 1
Subjects randomized in dosage regimen 1 will receive 3 doses of UCB7655 (dose 1) in dosing period 1 and will then be re-randomized into dosing period 2 to receive 3 doses of UCB7665 (dose 1 or dose 2).
Drug: UCB7665
UCB7665 will be administered in 2 different dosages (dose 1 and dose 2) in dosage regimen 1 and 2.
Experimental: Dosage Regimen 2
Subjects randomized in dosage regimen 2 will receive 3 doses of placebo in dosing period 1 and will then be re-randomized into dosing period 2 to receive 3 doses of UCB7665 (dose 1 or dose 2).
Drug: UCB7665
UCB7665 will be administered in 2 different dosages (dose 1 and dose 2) in dosage regimen 1 and 2.
Other: Placebo
Placebo will be administered in period 1 of dosage regimen 2.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a well-documented diagnosis of myasthenia gravis (MG) at Visit 1 (Screening), based on subject history and supported by previous evaluations
  • Subject would currently be considered for treatment with immunological therapy such as intravenous immunoglobulin/plasma exchange (IVIG/PLEX) by the investigator
  • Subject has documented evidence in his/her medical history or at Screening of detectable autoantibodies (anti-acetylcholine receptor+ve (Anti-AChR+ve) or anti-muscle specific kinase+ve (Anti-MuSK+ve)
  • Female subjects must either be: postmenopausal, permanently sterilized or if childbearing potential applicable will use a highly effective method of birth control
  • Male subjects must be willing to use a method of contraception

Exclusion Criteria:

  • Subject has previously received treatment in this study or subject has previously been exposed to UCB7665
  • Subject has participated in another study of an investigational medicinal product (IMP;or a medical device) within the previous 30 days of Screening or is currently participating in another study of an investigational medicinal product (IMP; or a medical device)
  • Subject has a known hypersensitivity to any components of the IMP
  • Subject has a history of hyperprolinemia, since L-proline is a constituent of the UCB7665 IMP
  • Subjects with MG only affecting the ocular muscles
  • Subjects with severe weakness affecting oropharyngeal or respiratory muscles, or who have myasthenic crisis at Screening or impending crisis
  • Subject has quantitative myasthenia gravis (QMG) score of <11 at Baseline
  • Subject has a serum total immunoglobulin G (IgG) level <= 6g/L at Screening
  • Absolute neutrophil count <1500 cells/mm^3
  • Subject has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
  • Subject has any laboratory abnormality that, in the opinion of the investigator, is clinically significant, has not resolved at randomization, and could jeopardize or would compromise the subject's ability to participate in this study
  • Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
  • Subject has received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline (whichever is longer)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03052751

Contacts
Contact: UCB Cares +1 844 599 ext 2273 UCBCares@ucb.com

Locations
United States, California
Mg0002 712 Recruiting
Los Angeles, California, United States, 90033
United States, District of Columbia
Mg0002 705 Recruiting
Washington, D.C., District of Columbia, United States, 20037
United States, Florida
Mg0002 713 Recruiting
Miami, Florida, United States, 33136
Mg0002 708 Recruiting
Tampa, Florida, United States, 33612
United States, North Carolina
Mg0002 703 Recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Mg0002 704 Recruiting
Columbus, Ohio, United States, 43210
Belgium
Mg0002 102 Recruiting
Bruxelles, Belgium
Mg0002 103 Recruiting
Gent, Belgium
Mg0002 101 Recruiting
Leuven, Belgium
Czechia
Mg0002 301 Recruiting
Brno, Czechia
Mg0002 302 Recruiting
Ostrava-Poruba, Czechia
Denmark
Mg0002 402 Recruiting
Copenhagen, Denmark
Germany
Mg0002 505 Recruiting
Düsseldorf, Germany
Mg0002 502 Recruiting
Gummersbach, Germany
Mg0002 501 Recruiting
Jena, Germany
Mg0002 503 Recruiting
Marburg, Germany
Mg0002 504 Recruiting
Wermsdorf, Germany
Spain
Mg0002 601 Recruiting
Barcelona, Spain
Mg0002 602 Recruiting
Barcelona, Spain
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares +1 844 599 2273 (UCB)
  More Information

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03052751     History of Changes
Other Study ID Numbers: MG0002
2016-002698-36 ( EudraCT Number )
Study First Received: February 10, 2017
Last Updated: August 31, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
UCB7665
Myasthenia Gravis

Additional relevant MeSH terms:
Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 21, 2017