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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 : Completed
First Posted : February 14, 2017
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE February 10, 2017
First Posted Date  ICMJE February 14, 2017
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE May 15, 2017
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
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 Measures  ICMJE
 (submitted: February 10, 2017)
Change from Baseline in Quantitative Myasthenia Gravis (QMG) score to Visit 9 (Day 29) [ Time Frame: Baseline and Visit 9 (Day 29) ]
Change History Complete list of historical versions of study NCT03052751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • 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 Measures  ICMJE
 (submitted: February 10, 2017)
Change from Baseline in Myasthenia Gravis-Composite score to Visit 9 (Day 29) [ Time Frame: Baseline and Visit 9 (Day 29) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myasthenia Gravis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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).
    Intervention: Drug: UCB7665
  • 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).
    Interventions:
    • Drug: UCB7665
    • Other: Placebo
Publications * Smith B, Kiessling A, Lledo-Garcia R, Dixon KL, Christodoulou L, Catley MC, Atherfold P, D'Hooghe LE, Finney H, Greenslade K, Hailu H, Kevorkian L, Lightwood D, Meier C, Munro R, Qureshi O, Sarkar K, Shaw SP, Tewari R, Turner A, Tyson K, West S, Shaw S, Brennan FR. Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration. MAbs. 2018 Oct;10(7):1111-1130. doi: 10.1080/19420862.2018.1505464. Epub 2018 Sep 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2018)
43
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2017)
42
Actual Study Completion Date  ICMJE August 6, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   Denmark,   Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03052751
Other Study ID Numbers  ICMJE MG0002
2016-002698-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP