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

Sponsor
UCB Biopharma S.P.R.L. (Industry)
Overall Status
Completed
CT.gov ID
NCT03052751
Collaborator
(none)
43
Enrollment
20
Locations
2
Arms
14.7
Actual Duration (Months)
2.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
This is an Investigator- and Subject-Blind study.
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
Actual Study Completion Date :
Aug 6, 2018

Arms and Interventions

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). 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 Names:
  • 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). 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 Names:
  • Rozanolixizumab

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

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score to Visit 9 [From Baseline to Visit 9 (up to Day 29)]

      The total QMG score was 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. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

    Secondary Outcome Measures

    1. Change From Baseline in Myasthenia Gravis-Composite Score to Visit 9 [From Baseline to Visit 9 (up to Day 29)]

      The total Myasthenia Gravis (MG)-composite score was 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. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

    2. Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) Score to Visit 9 [From Baseline to Visit 9 (up to Day 29)]

      The total MGDAL score was 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. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mg0002 712 Los Angeles California United States 90033
    2 Mg0002 701 Orange California United States 92868
    3 Mg0002 713 Miami Florida United States 33136
    4 Mg0002 708 Tampa Florida United States 33612
    5 Mg0002 707 Augusta Georgia United States 30912
    6 Mg0002 704 Columbus Ohio United States 43210
    7 Mg0002 102 Bruxelles Belgium
    8 Mg0002 103 Gent Belgium
    9 Mg0002 101 Leuven Belgium
    10 Mg0002 203 London Canada
    11 Mg0002 202 Montréal Canada
    12 Mg0002 201 Toronto Canada
    13 Mg0002 302 Ostrava-Poruba Czechia
    14 Mg0002 401 Aarhus Denmark
    15 Mg0002 402 Copenhagen Denmark
    16 Mg0002 505 Düsseldorf Germany
    17 Mg0002 502 Gummersbach Germany
    18 Mg0002 501 Jena Germany
    19 Mg0002 601 Barcelona Spain
    20 Mg0002 602 Barcelona Spain

    Sponsors and Collaborators

    • UCB Biopharma S.P.R.L.

    Investigators

    • Study Director: UCB Cares, +1 877 822 9493 (UCB)

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    UCB Biopharma S.P.R.L.
    ClinicalTrials.gov Identifier:
    NCT03052751
    Other Study ID Numbers:
    • MG0002
    • 2016-002698-36
    First Posted:
    Feb 14, 2017
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by UCB Biopharma S.P.R.L.
    UCB7665
    Myasthenia Gravis
    Additional relevant MeSH terms:
    Myasthenia Gravis
    Muscle Weakness
    Rozanolixizumab

    Study Results

    Participant Flow

    Recruitment Details The study started to enroll patients in May 2017 and concluded in August 2018.
    Pre-assignment Detail The Participant Flow refers to the Randomized Set (RS) which consisted of all participants randomized into the study at the first randomization visit.
    Arm/Group Title Placebo UCB7665 (7 mg/kg) Placebo - UCB7665 (7 mg/kg) Placebo - UCB7665 (4 mg/kg) UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg)
    Arm/Group Description Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2. Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2.
    Period Title: Dosing Period 1
    STARTED 22 21 0 0 0 0
    Completed Period 1 22 21 0 0 0 0
    Completed Period 1 and Started Period 2 22 20 0 0 0 0
    COMPLETED 22 20 0 0 0 0
    NOT COMPLETED 0 1 0 0 0 0
    Period Title: Dosing Period 1
    STARTED 0 0 11 11 10 10
    COMPLETED 0 0 8 11 10 10
    NOT COMPLETED 0 0 3 0 0 0
    Period Title: Dosing Period 1
    STARTED 22 21 11 11 10 10
    COMPLETED 22 21 11 11 9 10
    NOT COMPLETED 0 0 0 0 1 0

    Baseline Characteristics

    Arm/Group Title Placebo UCB7665 (7 mg/kg) Total Title
    Arm/Group Description Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg).
    Overall Participants 22 21 43
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    14
    63.6%
    18
    85.7%
    32
    74.4%
    >=65 years
    8
    36.4%
    3
    14.3%
    11
    25.6%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    53.3
    (15.7)
    50.5
    (14.7)
    51.9
    (15.1)
    Sex: Female, Male (Count of Participants)
    Female
    14
    63.6%
    13
    61.9%
    27
    62.8%
    Male
    8
    36.4%
    8
    38.1%
    16
    37.2%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    1
    4.5%
    0
    0%
    1
    2.3%
    Black
    1
    4.5%
    1
    4.8%
    2
    4.7%
    White
    19
    86.4%
    20
    95.2%
    39
    90.7%
    Other/mixed
    1
    4.5%
    0
    0%
    1
    2.3%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score to Visit 9
    Description The total QMG score was 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. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
    Time Frame From Baseline to Visit 9 (up to Day 29)

    Outcome Measure Data

    Analysis Population Description
    The FAS consisted of all participants in the SS who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
    Arm/Group Title Placebo (FAS) UCB7665 (7 mg/kg) (FAS)
    Arm/Group Description Participants received 3 doses of placebo in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29). Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
    Measure Participants 22 21
    Least Squares Mean (Standard Error) [scores on a scale]
    -1.2
    (0.6)
    -1.8
    (0.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (FAS), UCB7665 (7 mg/kg) (FAS)
    Comments Mixed Model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline QMG score, and random effect for participant. The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value =0.221
    Comments One-sided p-value was presented for difference.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
    Estimated Value -0.7
    Confidence Interval (1-Sided) 95%
    to 0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimate included treatment and treatment by visit interaction effects.
    2. Secondary Outcome
    Title Change From Baseline in Myasthenia Gravis-Composite Score to Visit 9
    Description The total Myasthenia Gravis (MG)-composite score was 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. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
    Time Frame From Baseline to Visit 9 (up to Day 29)

    Outcome Measure Data

    Analysis Population Description
    The FAS consisted of all participants in the SS who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
    Arm/Group Title Placebo (FAS) UCB7665 (7 mg/kg) (FAS)
    Arm/Group Description Participants received 3 doses of placebo in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29). Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
    Measure Participants 22 21
    Least Squares Mean (Standard Error) [scores on a scale]
    -1.2
    (0.9)
    -3.1
    (0.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (FAS), UCB7665 (7 mg/kg) (FAS)
    Comments MMRM ANCOVA model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline MG-composite score, and random effect for participant. The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value =0.089
    Comments One-sided p-value was presented for difference.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
    Estimated Value -1.8
    Confidence Interval (1-Sided) 95%
    to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimate included treatment and treatment by visit interaction effects.
    3. Secondary Outcome
    Title Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) Score to Visit 9
    Description The total MGDAL score was 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. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
    Time Frame From Baseline to Visit 9 (up to Day 29)

    Outcome Measure Data

    Analysis Population Description
    The FAS consisted of all participants in the SS who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
    Arm/Group Title Placebo (FAS) UCB7665 (7 mg/kg) (FAS)
    Arm/Group Description Participants received 3 doses of placebo in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29). Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1. Participants formed the Full Analysis Set (FAS) which consisted of all participants in the Safety Set (SS) who had a Baseline and at least 1 post-Baseline QMG measurement during Dosing Period 1 (up to and including Visit 9, ie, Day 29).
    Measure Participants 22 21
    Least Squares Mean (Standard Error) [scores on a scale]
    -0.4
    (0.5)
    -1.8
    (0.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (FAS), UCB7665 (7 mg/kg) (FAS)
    Comments ANCOVA model included fixed terms for treatment group, covariate of Baseline MGADL score.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value =0.036
    Comments One-sided p-value was presented for difference.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference vs Placebo
    Estimated Value -1.4
    Confidence Interval (1-Sided) 95%
    to -0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimate included treatment effect.

    Adverse Events

    Time Frame From the start of Treatment Period at Baseline and up to Observation Period at 8 weeks after the final dose of IMP.
    Adverse Event Reporting Description
    Arm/Group Title Placebo (SS) UCB7665 (7 mg/kg) (SS) Placebo - UCB7665 (7 mg/kg) (SS) Placebo - UCB7665 (4 mg/kg) (SS) UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) (SS) UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) (SS)
    Arm/Group Description Participants received 3 doses of placebo in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants formed the Safety Set (SS) which consisted of all participants in the Randomized Set (RS) who had received at least 1 dose of investigational product (IMP). Participants received 3 doses of UCB7665 (7 mg/kg) in Dosing Period 1 and then were re-randomized into Dosing Period 2 to receive 3 doses of UCB7665 (7 mg/kg or 4 mg/kg). Participants formed the Safety Set (SS) which consisted of all participants in the Randomized Set (RS) who had received at least 1 dose of investigational product (IMP). Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS). Participants randomized to receive 3 doses of placebo at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS). Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS). Participants randomized to receive 3 doses of UCB7665 (7 mg/kg) at weekly intervals in Dosing Period 1 were then re-randomized to receive 3 doses of UCB7665 (4 mg/kg) at weekly intervals in Dosing Period 2. Participants formed the Safety Set (SS).
    All Cause Mortality
    Placebo (SS) UCB7665 (7 mg/kg) (SS) Placebo - UCB7665 (7 mg/kg) (SS) Placebo - UCB7665 (4 mg/kg) (SS) UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) (SS) UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) (SS)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/22 (0%) 0/21 (0%) 0/11 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%)
    Serious Adverse Events
    Placebo (SS) UCB7665 (7 mg/kg) (SS) Placebo - UCB7665 (7 mg/kg) (SS) Placebo - UCB7665 (4 mg/kg) (SS) UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) (SS) UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) (SS)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/22 (9.1%) 0/21 (0%) 3/11 (27.3%) 1/11 (9.1%) 1/10 (10%) 0/10 (0%)
    Injury, poisoning and procedural complications
    Ulna fracture 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Nervous system disorders
    Headache 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Presyncope 1/22 (4.5%) 1 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Myasthenia gravis 1/22 (4.5%) 1 0/21 (0%) 0 1/11 (9.1%) 1 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Myasthenia gravis crisis 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/10 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo (SS) UCB7665 (7 mg/kg) (SS) Placebo - UCB7665 (7 mg/kg) (SS) Placebo - UCB7665 (4 mg/kg) (SS) UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) (SS) UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) (SS)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/22 (31.8%) 13/21 (61.9%) 7/11 (63.6%) 9/11 (81.8%) 8/10 (80%) 9/10 (90%)
    Blood and lymphatic system disorders
    Anaemia 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Thrombocytopenia 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/10 (0%) 0
    Cardiac disorders
    Bundle branch block left 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Ear and labyrinth disorders
    Tinnitus 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Eye disorders
    Diplopia 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Eyelid ptosis 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Keratitis 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 1
    Vision blurred 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Gastrointestinal disorders
    Diarrhoea 2/22 (9.1%) 2 3/21 (14.3%) 3 1/11 (9.1%) 1 4/11 (36.4%) 4 1/10 (10%) 1 2/10 (20%) 2
    Nausea 0/22 (0%) 0 2/21 (9.5%) 3 0/11 (0%) 0 0/11 (0%) 0 1/10 (10%) 2 2/10 (20%) 2
    Vomiting 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 2/10 (20%) 2 0/10 (0%) 0
    Abdominal pain 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Cheilitis 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 1
    General disorders
    Fatigue 3/22 (13.6%) 4 0/21 (0%) 0 1/11 (9.1%) 1 1/11 (9.1%) 3 0/10 (0%) 0 0/10 (0%) 0
    Gait disturbance 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 3 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Infusion site pruritus 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/10 (10%) 3 0/10 (0%) 0
    Infusion site swelling 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 2
    Pyrexia 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Asthenia 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Inflammatory pain 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Infusion site reaction 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Infections and infestations
    Upper respiratory tract infection 0/22 (0%) 0 2/21 (9.5%) 2 1/11 (9.1%) 1 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Cystitis 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 2 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Bronchitis 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Nasopharyngitis 3/22 (13.6%) 3 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/10 (0%) 0
    Respiratory tract infection 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 1
    Rhinitis 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 1
    Urinary tract infection 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Injury, poisoning and procedural complications
    Injury corneal 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 1
    Investigations
    Lymphocyte count decreased 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/10 (0%) 0
    Metabolism and nutrition disorders
    Fluid retention 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 1
    Hypophosphataemia 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness 0/22 (0%) 0 0/21 (0%) 0 2/11 (18.2%) 2 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 1
    Back pain 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 1/10 (10%) 1 0/10 (0%) 0
    Limb discomfort 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/10 (10%) 2 0/10 (0%) 0
    Musculoskeletal pain 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 1/10 (10%) 1
    Pain in extremity 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 2 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Arthralgia 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Groin pain 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Muscle spasms 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 1
    Musculoskeletal stiffness 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 1
    Nervous system disorders
    Headache 3/22 (13.6%) 5 12/21 (57.1%) 22 3/11 (27.3%) 4 2/11 (18.2%) 2 4/10 (40%) 5 4/10 (40%) 6
    Dizziness 3/22 (13.6%) 3 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 2/10 (20%) 2 1/10 (10%) 1
    Myasthenic syndrome 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 2/10 (20%) 2 1/10 (10%) 1
    Dysarthria 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Hypoaesthesia 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Paraesthesia 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 1
    Psychiatric disorders
    Insomnia 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/10 (0%) 0
    Stress 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/10 (10%) 1
    Renal and urinary disorders
    Haematuria 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/10 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 2/11 (18.2%) 3 1/10 (10%) 1 0/10 (0%) 0
    Oropharyngeal pain 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 2 1/10 (10%) 1 0/10 (0%) 0
    Dysphonia 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/10 (0%) 0
    Laryngeal inflammation 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Orthopnoea 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Paranasal sinus discomfort 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0
    Skin and subcutaneous tissue disorders
    Rash 0/22 (0%) 0 0/21 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/10 (0%) 0
    Vascular disorders
    Haematoma 0/22 (0%) 0 0/21 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/10 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title UCB
    Organization Cares
    Phone +1844 599 ext 2273
    Email UCBCares@ucb.com
    Responsible Party:
    UCB Biopharma S.P.R.L.
    ClinicalTrials.gov Identifier:
    NCT03052751
    Other Study ID Numbers:
    • MG0002
    • 2016-002698-36
    First Posted:
    Feb 14, 2017
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Jul 1, 2021