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

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ClinicalTrials.gov Identifier: NCT03052751
Recruitment Status : Active, not recruiting
First Posted : February 14, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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

Condition or disease Intervention/treatment Phase
Myasthenia Gravis Drug: UCB7665 Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
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
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : May 31, 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

UCB7665 (INN: Rozanolixizumab) is a humanized monoclonal antibody that is being developed for treatment of IgG autoantibody-mediated conditions such as myasthenia gravis (MG)

Other Name: Rozanolixizumab

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.

UCB7665 (INN: Rozanolixizumab) is a humanized monoclonal antibody that is being developed for treatment of IgG autoantibody-mediated conditions such as myasthenia gravis (MG)

Other Name: Rozanolixizumab

Other: Placebo
Placebo will be administered in period 1 of dosage regimen 2.




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 (immunoglobulin/plasma exchange (IVIG/PLEX)) by the investigator
  • Subject has a well-documented record of autoantibodies against anti-acetylcholine receptor (Anti-AChR) or anti-muscle specific kinase (Anti-MuSK) prior to Screening
  • 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 Myasthenia Gravis (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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052751


Locations
United States, California
Mg0002 712
Los Angeles, California, United States, 90033
Mg0002 701
Orange, California, United States, 92868
United States, Florida
Mg0002 713
Miami, Florida, United States, 33136
Mg0002 708
Tampa, Florida, United States, 33612
United States, Georgia
Mg0002 707
Augusta, Georgia, United States, 30912
United States, Ohio
Mg0002 704
Columbus, Ohio, United States, 43210
Belgium
Mg0002 102
Bruxelles, Belgium
Mg0002 103
Gent, Belgium
Mg0002 101
Leuven, Belgium
Canada
Mg0002 203
London, Canada
Mg0002 202
Montréal, Canada
Mg0002 201
Toronto, Canada
Czechia
Mg0002 302
Ostrava-Poruba, Czechia
Denmark
Mg0002 401
Aarhus, Denmark
Mg0002 402
Copenhagen, Denmark
Germany
Mg0002 505
Düsseldorf, Germany
Mg0002 502
Gummersbach, Germany
Mg0002 501
Jena, Germany
Spain
Mg0002 601
Barcelona, Spain
Mg0002 602
Barcelona, Spain
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares +1 877 822 9493 (UCB)

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 )
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: June 2018

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:
Muscle Weakness
Myasthenia Gravis
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