Generalized Myasthenia GravisPhase 2NCT03772587
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
A Phase 2 study testing M281 in people with Generalized Myasthenia Gravis, run by Momenta Pharmaceuticals, Inc. at 61 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing standard of care therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Myasthenia Gravis
- What is being tested?
- M281
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 61 sitesin 8 countries
- Study dates
- 10 Apr 2019to 25 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Participants must be ≥18 years of age with a documented history of Generalized Myasthenia Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, and no history of any neurologic disorder other than MG that might interfere with the accuracy of study assessments.
Additional, more specific criteria are defined in the protocol.
Trial locations and contacts
61 sites in 8 countries.
61 sites in 8 countries
United States31 sites
Momenta Investigational Site
Augusta, Georgia, 30912
Momenta Investigational Site
Aurora, Colorado, 80045
Momenta Investigational Site
Austin, Texas, 78756
Momenta Investigational Site
Boca Raton, Florida, 33487
Momenta Investigational Site
Boston, Massachusetts, 02114
Momenta Investigational Site
Boston, Massachusetts, 02115
Momenta Investigational Site
Boston, Massachusetts, 02215
Momenta Investigational Site
Charlotte, North Carolina, 28207
Momenta Investigational Site
Cincinnati, Ohio, 45267
Momenta Investigational Site
Columbia, Missouri, 65212
Momenta Investigational Site
Columbus, Ohio, 43210
Momenta Investigational Site
Cordova, Tennessee, 38106
Momenta Investigational Site
Detroit, Michigan, 48202
Momenta Investigational Site
Durham, North Carolina, 27710
Momenta Investigational Site
East Lansing, Michigan, 48824
Momenta Investigational Site
Fairway, Kansas, 66205
Momenta Investigational Site
Lake Barrington, Illinois, 60010
Momenta Investigational Site
Los Angeles, California, 90048
Momenta Investigational Site
Maitland, Florida, 32751
Momenta Investigational Site
Meridian, Idaho, 83642
Momenta Investigational Site
New Brunswick, New Jersey, 08550
Momenta Investigational Site
New Haven, Connecticut, 06511
Momenta Investigational Site
New York, New York, 10021
Momenta Investigational Site
Orange, California, 92868
Momenta Investigational Site
Phoenix, Arizona, 85013
Momenta Investigational Site
Port Charlotte, Florida, 33952
Momenta Investigational Site
Raleigh, North Carolina, 27607
Momenta Investigational Site
Round Rock, Texas, 78681
Momenta Investigational Site
St. Petersburg, Florida, 33713
Momenta Investigational Site
Stanford, California, 94305
Momenta Investigational Site
Tucson, Arizona, 85724
Spain9 sites
Momenta Investigational Site
Badalona, Catalonia, 08036
Momenta Investigational Site
Barcelona, Catalan, 08035
Momenta Investigational Site
Barcelona, Catalan, 08041
Momenta Investigational Site
Donostia / San Sebastian, Gipuzkoa, 20014
Momenta Investigational Site
L'Hospitalet de Llobregat, Catalonia, 08907
Momenta Investigational Site
Madrid, 28007
Momenta Investigational Site
Madrid, 28040
Momenta Investigational Site
Seville, 41013
Momenta Investigational Site
Valencia, 46026
Canada4 sites
Momenta Investigational Site
Edmonton, Alberta, T6G 2G3
Momenta Investigational Site
London, Ontario, N6A 5A5
Momenta Investigational Site
Québec, Quebec, G1J 1Z4
Momenta Investigational Site
Toronto, Ontario, M5G 2C4
Germany4 sites
Momenta Investigational Site
Düsseldorf, 40225
Momenta Investigational Site
Göttingen, Lower Saxony, 37075
Momenta Investigational Site
Gummersbach, 51643
Momenta Investigational Site
Münster, 48149
Poland4 sites
Momenta Investigational Site
Krakow, 31-505
Momenta Investigational Site
Lodz, 90-324
Momenta Investigational Site
Warsaw, 01-684
Momenta Investigational Site
Warsaw, 01-868
Belgium3 sites
Momenta Investigational Site
Antwerp, 2650
Momenta Investigational Site
Brussels, 1070
Momenta Investigational Site
Leuven, Vlaams Brabant, 3000
Italy3 sites
Momenta Investigational Site
Cefalù, 90015
Momenta Investigational Site
Messina, 98125
Momenta Investigational Site
Milan, 20133
United Kingdom3 sites
Momenta Investigational Site
Birmingham, B15 2TH
Momenta Investigational Site
Sheffield, S11 9NE
Momenta Investigational Site
Southampton, SO16 6YD
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing standard of care therapy.
- Conditions
- Generalized Myasthenia Gravis
- Being tested
- M281, Placebo
- Keywords
- M281, Generalized Myasthenia Gravis
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M281Drug
M281 administered as IV infusion
PlaceboOther
Placebo administered as intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Not described Receives: Other: Placebo |
| Group 2 | Experimental | Not described Receives: Drug: M281 |
| Group 3 | Experimental | Not described Receives: Drug: M281 |
| Group 4 | Experimental | Not described Receives: Drug: M281 |
| Group 5 | Experimental | Not described Receives: Drug: M281 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE are defined as any AE occurring during or after the initiation of the first infusion of study drug.
Measured: Up to Day 113
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Measured: Up to Day 113
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. For this study, any common terminology criteria for adverse events (CTCAE) Grade 3 or higher event of severe infection or hypoalbuminemia was considered as AESI.
Measured: Up to Day 113
Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score
The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Measured: Baseline to Day 57
Secondary outcomes (16)
Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57
Estimate of additional change from baseline in MG-ADL total score for every 10 percent (%) additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57. The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Measured: Baseline and Day 57
Change From Baseline in Total MG-ADL Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57
Estimate of additional change from baseline in MG-ADL total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The MG-ADL was used to assess participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). Total score is sum of eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Measured: Baseline and Day 57
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57
Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Measured: Baseline and Day 57
Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57
Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Measured: Baseline and Day 57
Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or Greater Than or Equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57
The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Measured: Day 57
Change From Baseline in Total QMG Score at Day 57
The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Measured: Baseline and Day 57
Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57
The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Measured: Day 57
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57
The MG-QoL15r was used to assess the participant's limitations related to living with MG. Each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation.
Measured: Baseline and Day 57
Change From Baseline in Total Serum IgG at Day 57
Change from baseline in total serum IgG was reported. Blood samples were collected for analysis of total serum IgG.
Measured: Baseline and Day 57
Change From Baseline in Total MG-ADL Score at Day 85 and Day 113
The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Measured: Baseline, Day 85 and Day 113
Change From Baseline in Total QMG Score at Day 85 and Day 113
The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Measured: Baseline, Day 85 and Day 113
Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113
The MG-QoL15r was used to assess the participant's limitations related to living with MG. Each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation.
Measured: Baseline, Day 85 and Day 113
Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57
The MGFA was used to assess the participant's MG severity. MGFA classification identifies the subgroup participants with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both. In the MGFA classification, lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III).
Measured: Baseline and Day 57
Number of Participants With Shift From Baseline in MGFA Classification to Day 113
The MGFA was used to assess the participant's MG severity. MGFA classification identifies the subgroup participants with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both. In the MGFA classification, lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III).
Measured: Baseline to Day 113
Change From Baseline in Total Serum IgG at Day 85 and Day 113
Change from baseline in total serum IgG at Day 85 and Day 113 was analyzed. Blood samples were collected for analysis of total serum IgG.
Measured: Baseline, Day 85 and Day 113
Serum Concentrations of Nipocalimab
Serum concentrations of nipocalimab were reported. Concentrations below the lowest quantifiable concentration (< LLOQ) that is <0.15 microgram/milliliter (mcg/mL) was treated as zero in calculating the summary statistics.
Measured: Baseline (Pre Infusion and Post Infusion), Day 15 (Pre Infusion), Day 29 (Pre Infusion), Day 43 (Pre Infusion), Day 57 (Pre Infusion and Post Infusion) and Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start10 Apr 2019
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momenta Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Momenta General Queries, Study director, Momenta Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772587
- Sponsor's protocol ID
- MOM-M281-004
- Other IDs
- 2018-002247-28, 2018
- Status last verified
- May 2023
- First submitted
- 10 Dec 2018
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antozzi C, Guptill J, Bril V, Gamez J, Meuth SG, Nowak RJ, Quan D, Sevilla T, Jouvin MH, Jin J, Karcher K, Ramchandren S, Sun H, Ling L, Zhu Y, Arroyo S; Vivacity-MG Phase 2 Study Group. Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis: Results From the Randomized Phase 2 Vivacity-MG Study. Neurology. 2024 Jan 23;102(2):e207937. doi: 10.1212/WNL.0000000000207937. Epub 2023 Dec 21.
PubMed 38165333
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT03772587
- Acronym / sponsor ID
- MOM-M281-004
- Conditions
- Generalized Myasthenia Gravis
- Keywords
- M281, Generalized Myasthenia Gravis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Momenta Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Posted 27 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing standard of care therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Other: Placebo |
| Group 2 | Experimental | Drug: M281 |
| Group 3 | Experimental | Drug: M281 |
| Group 4 | Experimental | Drug: M281 |
| Group 5 | Experimental | Drug: M281 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M281M281 administered as IV infusion | Drug | Group 2, Group 3, Group 4, Group 5 |
| PlaceboPlacebo administered as intravenous (IV) infusion | Other | Group 1 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
Time frame: Up to Day 113
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE are defined as any AE occurring during or after the initiation of the first infusion of study drug.
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Time frame: Up to Day 113
An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
Time frame: Up to Day 113
An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. For this study, any common terminology criteria for adverse events (CTCAE) Grade 3 or higher event of severe infection or hypoalbuminemia was considered as AESI.
Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score
Time frame: Baseline to Day 57
The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
16 secondary outcomes
Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57
Time frame: Baseline and Day 57
Change From Baseline in Total MG-ADL Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57
Time frame: Baseline and Day 57
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57
Time frame: Baseline and Day 57
Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57
Time frame: Baseline and Day 57
Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or Greater Than or Equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57
Time frame: Day 57
Change From Baseline in Total QMG Score at Day 57
Time frame: Baseline and Day 57
Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57
Time frame: Day 57
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57
Time frame: Baseline and Day 57
Change From Baseline in Total Serum IgG at Day 57
Time frame: Baseline and Day 57
Change From Baseline in Total MG-ADL Score at Day 85 and Day 113
Time frame: Baseline, Day 85 and Day 113
Change From Baseline in Total QMG Score at Day 85 and Day 113
Time frame: Baseline, Day 85 and Day 113
Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113
Time frame: Baseline, Day 85 and Day 113
Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57
Time frame: Baseline and Day 57
Number of Participants With Shift From Baseline in MGFA Classification to Day 113
Time frame: Baseline to Day 113
Change From Baseline in Total Serum IgG at Day 85 and Day 113
Time frame: Baseline, Day 85 and Day 113
Serum Concentrations of Nipocalimab
Time frame: Baseline (Pre Infusion and Post Infusion), Day 15 (Pre Infusion), Day 29 (Pre Infusion), Day 43 (Pre Infusion), Day 57 (Pre Infusion and Post Infusion) and Day 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38165333Antozzi C, Guptill J, Bril V, Gamez J, Meuth SG, Nowak RJ, Quan D, Sevilla T, Jouvin MH, Jin J, Karcher K, Ramchandren S, Sun H, Ling L, Zhu Y, Arroyo S; Vivacity-MG Phase 2 Study Group. Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis: Results From the Randomized Phase 2 Vivacity-MG Study. Neurology. 2024 Jan 23;102(2):e207937. doi: 10.1212/WNL.0000000000207937. Epub 2023 Dec 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Momenta General Queries study director
Momenta Pharmaceuticals, Inc.
61 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing M281 in people with Generalized Myasthenia Gravis, run by Momenta Pharmaceuticals, Inc. at 61 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Spain, Canada, Germany, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability (time frame: Up to Day 113). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03772587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.