Generalized Myasthenia GravisPhase 3NCT03920293
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
A Phase 3 study testing Ravulizumab in people with Generalized Myasthenia Gravis, run by Alexion Pharmaceuticals, Inc. at 106 sites in 15 countries.
Trial summary
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Generalized Myasthenia Gravis
- What is being tested?
- Ravulizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 106 sitesin 15 countries
- Study dates
- 12 Mar 2019to 25 May 2023
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria.
- Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening.
- MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).
- Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis).
Who cannot join
- Medical Conditions
- Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening.
- History of thymectomy within the 12 months prior to screening.
- History of N meningitidis infection.
- Use of the following within the time period specified below:
- IV immunoglobulin within 4 weeks of randomization
Show all 9Show fewer
- Use of plasma exchange within 4 weeks of randomization
- Use of rituximab within 6 months of screening
- Participants who have received previous treatment with complement inhibitors (for example, eculizumab).
Trial locations and contacts
106 sites in 15 countries.
106 sites in 15 countries
United States49 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Aurora, Colorado, 80045
Research Site
Austin, Texas, 78756
Research Site
Baltimore, Maryland, 21287
Research Site
Boston, Massachusetts, 02116
Research Site
Burlington, Massachusetts, 01805
Research Site
Burlington, Vermont, 05401
Research Site
Chapel Hill, North Carolina, 27599
Research Site
Charleston, South Carolina, 29425
Research Site
Charlotte, North Carolina, 28207
Research Site
Chicago, Illinois, 60637
Research Site
Cincinnati, Ohio, 45219
Research Site
Cleveland, Ohio, 44195
Research Site
Colorado Springs, Colorado, 80907
Research Site
Columbia, Missouri, 65201
Research Site
Columbus, Ohio, 43221
Research Site
Dallas, Texas, 75206
Research Site
Durham, North Carolina, 27710
Research Site
East Lansing, Michigan, 48824
Research Site
Fairfield, Connecticut, 06824
Research Site
Fort Collins, Colorado, 80528
Research Site
Grand Rapids, Michigan, 49525
Research Site
Great Neck, New York, 11021
Research Site
Hershey, Pennsylvania, 17033
Research Site
Houston, Texas, 77030
Research Site
Indianapolis, Indiana, 46202
Research Site
Irvine, California, 92617
Research Site
Jacksonville, Florida, 32209
Research Site
Kansas City, Kansas, 66160
Research Site
Las Vegas, Nevada, 89104
Research Site
Las Vegas, Nevada, 89145
Research Site
Lexington, Kentucky, 40503
Research Site
Loma Linda, California, 92354
Research Site
Morgantown, West Virginia, 26506
Research Site
New York, New York, 10021
Research Site
North Charleston, South Carolina, 29406
Research Site
Palo Alto, California, 94304
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Phoenix, Arizona, 85013
Research Site
Phoenix, Arizona, 85018
Research Site
Phoenix, Arizona, 85028
Research Site
Pittsburgh, Pennsylvania, 15212
Research Site
Richmond, Virginia, 23298
Research Site
Rolling Meadows, Illinois, 60008
Research Site
Round Rock, Texas, 78681
Research Site
San Francisco, California, 94115
Research Site
Sylmar, California, 91342
Research Site
Tampa, Florida, 33612
Research Site
Washington D.C., District of Columbia, 20007
Japan14 sites
Research Site
Bunkyō City, 113-8655
Research Site
Chiba, 260-0877
Research Site
Fukuoka, 812-8582
Research Site
Hanamaki-shi, 025-0075
Research Site
Kawagoe-shi, 350-8550
Research Site
Moriguchi-shi, 570-8507
Research Site
Nagoya, 466-8560
Research Site
Niigata, 951-8585
Research Site
Osaka, 565-0871
Research Site
Sapporo, 060-8543
Research Site
Sapporo, 063-0005
Research Site
Sendai, 983-0045
Research Site
Shinjuku-ku, 160-8582
Research Site
Ube-shi, 755-8505
Germany6 sites
Research Site
Berlin, 10117
Research Site
Essen, 45147
Research Site
Hamburg, 20246
Research Site
Leipzig, 04103
Research Site
Münster, 48149
Research Site
Würzburg, 97070
Italy6 sites
Research Site
Bergamo, 24127
Research Site
Bologna, 40139
Research Site
Milan, 20133
Research Site
Naples, 80131
Research Site
Roma, 00168
Research Site
Rome, 00189
South Korea6 sites
Research Site
Daegu, 41404
Research Site
Seoul, 02841
Research Site
Seoul, 03722
Research Site
Seoul, 06351
Research Site
Seoul, 143-729
Research Site
Yangsan, 50612
Canada4 sites
Research Site
Edmonton, Alberta, T6G 2G3
Research Site
London, Ontario, N6A 5A5
Research Site
Montreal, Quebec, H3A 2B4
Research Site
Toronto, Ontario, M5G 2C4
France4 sites
Research Site
Garches, 92380
Research Site
Lille, 59037
Research Site
Marseille, 13005
Research Site
Nice, 6000
Spain4 sites
Research Site
Barcelona, 08025
Research Site
L'Hospitalet de Llobregat, 08907
Research Site
Madrid, 28040
Research Site
Murcia, 30120
Czechia3 sites
Research Site
Brno, 625 00
Research Site
Ostrava, 708 52
Research Site
Prague, 12800
Denmark3 sites
Research Site
Aalborg, 9100
Research Site
Arhus C, 8000
Research Site
Copenhagen, 2100
Netherlands2 sites
Research Site
Amsterdam, 1105 AZ
Research Site
Leiden, 2333 ZA
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).
- Conditions
- Generalized Myasthenia Gravis
- Being tested
- Ravulizumab, Placebo
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RavulizumabBiological
Also called ALXN1210, Ultomiris
Concentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
PlaceboDrug
Matching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
| Study group | Role | What they receive |
|---|---|---|
| Ravulizumab | Experimental | Participants will receive ravulizumab for the duration of the study. Receives: Biological: Ravulizumab |
| Placebo | Placebo comparator | Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26
The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Estimates were based on Mixed Effect Repeated Measures (MMRM) that included treatment group, stratification factor region, and MG-ADL total score at baseline, study visit, and study visit by treatment group interaction.
Measured: Baseline, Week 26
Secondary outcomes (5)
Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26
The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. The QMG scoring system was considered to be an objective evaluation of therapy for MG and was based on quantitative testing of sentinel muscle groups. A decrease in score indicated improvement. Estimates were based on MMRM that included treatment group, stratification factor region, and QMG total score at baseline, study visit, and study visit by treatment group interaction.
Measured: Baseline, Week 26
Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26
The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. A decrease in score indicated improvement. Percentage of participants with a ≥5-point reduction in the QMG total score are reported. Estimates were based on a generalized linear mixed model (GLMM) that included treatment group, stratification factor region and QMG total score at baseline, study visit and study visit by treatment group interaction.
Measured: Week 26
Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26
The revised Myasthenia Gravis Qualify of Life 15-item scale (MG-QOL15r) is a health-related QoL evaluative instrument specific to participants with MG. The MG-QOL15r was designed to provide information about participants' perception of impairment and disability, determine the degree to which disease manifestations are tolerated, and to be administered and interpreted easily. Each item was graded on a scale of 0 to 2, with 2 being the most severe. The range of MG-QOL15r score is 0 to 30. Higher scores indicated greater extent of and dissatisfaction with MG-related dysfunction. Estimates are based on MMRM that included treatment group, stratification factor region and MG-QOL15r score at baseline, study visit and study visit by treatment group interaction.
Measured: Baseline, Week 26
Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26
The Neuro-QOL Fatigue is a reliable and validated brief 19-item survey of fatigue, completed by the participant. Each items was rated on a scale of 1 to 5, with 5 being the most severe. The range of total score is 19 to 95. Higher scores indicated greater fatigue and greater impact of MG on activities. Estimates were based on MMRM that included treatment group, stratification factor region and Neuro-QoL Fatigue score at baseline, study visit, and study visit by treatment group interaction.
Measured: Baseline, Week 26
Percentage of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction of at Least 3 Points At Week 26
The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Percentage of participants with a ≥3-point reduction in the MG-ADL total score are reported. Estimates were based on a GLMM that included treatment group, stratification factor region and MG-ADL total score at baseline, study visit and study visit by treatment group interaction.
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start12 Mar 2019
- Primary completion11 May 2021
- Study completion25 May 2023
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 (4)Papers the sponsor has linked to this study.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920293
- Sponsor's protocol ID
- ALXN1210-MG-306
- Other IDs
- 2018-003243-39, 2018
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2019
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Vu T, Meisel A, Mantegazza R, Annane D, Katsuno M, Aguzzi R, Enayetallah A, Beasley KN, Rampal N, Howard JF. Terminal Complement Inhibitor Ravulizumab in Generalized Myasthenia Gravis. NEJM Evid. 2022 May;1(5):EVIDoa2100066. doi: 10.1056/EVIDoa2100066. Epub 2022 Apr 26.
PubMed 38319212Meisel A, Annane D, Vu T, Mantegazza R, Katsuno M, Aguzzi R, Frick G, Gault L, Howard JF Jr; CHAMPION MG Study Group. Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase 3 CHAMPION MG open-label extension. J Neurol. 2023 Aug;270(8):3862-3875. doi: 10.1007/s00415-023-11699-x. Epub 2023 Apr 27.
PubMed 37103755Vu T, Ortiz S, Katsuno M, Annane D, Mantegazza R, Beasley KN, Aguzzi R, Howard JF Jr. Ravulizumab pharmacokinetics and pharmacodynamics in patients with generalized myasthenia gravis. J Neurol. 2023 Jun;270(6):3129-3137. doi: 10.1007/s00415-023-11617-1. Epub 2023 Mar 9.
PubMed 36890354Vanoli F, Mantegazza R. Ravulizumab for the treatment of myasthenia gravis. Expert Opin Biol Ther. 2023 Mar;23(3):235-241. doi: 10.1080/14712598.2023.2185131. Epub 2023 Mar 8.
PubMed 36852670
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT03920293
- Acronym / sponsor ID
- ALXN1210-MG-306
- Conditions
- Generalized Myasthenia Gravis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Posted 26 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ravulizumab | Experimental | Biological: RavulizumabParticipants will receive ravulizumab for the duration of the study. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria.
- Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening.
- MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).
- Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis).
Key exclusion criteria (9 listed)
- Medical Conditions
- Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening.
- History of thymectomy within the 12 months prior to screening.
- History of N meningitidis infection.
- Use of the following within the time period specified below:
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 |
|---|---|---|
| RavulizumabAlso: ALXN1210, UltomirisConcentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight. | Biological | Ravulizumab |
| PlaceboMatching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight. | Drug | Placebo |
Primary outcome
Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26
Time frame: Baseline, Week 26
The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Estimates were based on Mixed Effect Repeated Measures (MMRM) that included treatment group, stratification factor region, and MG-ADL total score at baseline, study visit, and study visit by treatment group interaction.
5 secondary outcomes
Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26
Time frame: Baseline, Week 26
Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26
Time frame: Week 26
Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26
Time frame: Baseline, Week 26
Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26
Time frame: Baseline, Week 26
Percentage of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction of at Least 3 Points At Week 26
Time frame: Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38319212Vu T, Meisel A, Mantegazza R, Annane D, Katsuno M, Aguzzi R, Enayetallah A, Beasley KN, Rampal N, Howard JF. Terminal Complement Inhibitor Ravulizumab in Generalized Myasthenia Gravis. NEJM Evid. 2022 May;1(5):EVIDoa2100066. doi: 10.1056/EVIDoa2100066. Epub 2022 Apr 26.
- Derived from this study: PubMed 37103755Meisel A, Annane D, Vu T, Mantegazza R, Katsuno M, Aguzzi R, Frick G, Gault L, Howard JF Jr; CHAMPION MG Study Group. Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase 3 CHAMPION MG open-label extension. J Neurol. 2023 Aug;270(8):3862-3875. doi: 10.1007/s00415-023-11699-x. Epub 2023 Apr 27.
- Derived from this study: PubMed 36890354Vu T, Ortiz S, Katsuno M, Annane D, Mantegazza R, Beasley KN, Aguzzi R, Howard JF Jr. Ravulizumab pharmacokinetics and pharmacodynamics in patients with generalized myasthenia gravis. J Neurol. 2023 Jun;270(6):3129-3137. doi: 10.1007/s00415-023-11617-1. Epub 2023 Mar 9.
- Derived from this study: PubMed 36852670Vanoli F, Mantegazza R. Ravulizumab for the treatment of myasthenia gravis. Expert Opin Biol Ther. 2023 Mar;23(3):235-241. doi: 10.1080/14712598.2023.2185131. Epub 2023 Mar 8.
- Related InfoLink provided by the sponsor.
Related trials for Generalized Myasthenia Gravis
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized
RecruitingPhase 3
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Myasthenia Gravis
RecruitingPhase 2/3
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
Not yet recruitingEarly Phase 1
A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Refractory Generalized Myasthenia Gravis
Generalized Myasthenia Gravis (gMG)
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.
The record lists no contact. Use the official record to reach the sponsor.
106 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ravulizumab in people with Generalized Myasthenia Gravis, run by Alexion Pharmaceuticals, Inc. at 106 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. 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 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in United States, Japan, Germany, Italy, South Korea and 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 May 2022). 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?
Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26 (time frame: Baseline, Week 26). 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 NCT03920293, which also lists 4 linked publications.
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 28 May 2024.