Trial · NCT04524273
Myasthenia Gravis Inebilizumab Trial
NCT04524273, Phase 3, Active not recruiting, Amgen; results first posted 2026-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Myasthenia Gravis Inebilizumab Trial. Trials, record NCT04524273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04524273
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Myasthenia Gravis Inebilizumab Trial
- NCT number
- NCT04524273
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 238 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Myasthenia Gravis
- Interventions
- inebilizumab, IV Placebo
- First posted
- 2020-08-24
- Last updated
- 2026-05-15
- Results first posted
- 2026-03-10
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at Week 26 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the Overall Study Population | Baseline and Week 26 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses 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. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease Outcome measure is reported for the overall population. |
| Secondary | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score at Week 26 in the Overall Study Population | Baseline and Week 26 | The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease. Outcome measure is reported for the overall population. |
| Secondary | Change From Baseline at Week 26 in MG-ADL Score in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Baseline and Week 26 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses 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. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. |
| Secondary | Change From Baseline in QMG Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Baseline and Week 26 | The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. |
| Secondary | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in the Overall Study Population | Up to Week 26 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses 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. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. The protocol-allowed rescue therapy options included intravenous immunoglobulin (IVIg) and therapeutic plasma exchange (PLEX). Outcome measure is reported for the overall population. |
| Secondary | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Up to Week 26 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses 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. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. The protocol-allowed rescue therapy options included IVIg and PLEX. Outcome measure is reported in Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. |
| Secondary | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 52 and no Use of Rescue Therapy Between Day 28 and Week 52 in Anti-AChR-Ab+ Population | Up to Week 52 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses 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. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. The protocol-allowed rescue therapy options included IVIg and PLEX. Outcome measure is reported for the Anti-AChR-Ab+ population. |
| Secondary | Percentage of Participants With no Use of Rescue Therapy Between Day 28 and Week 52 in Anti-AChR-Ab+ Population | Up to Week 52 | The protocol-allowed rescue therapy options included corticosteroids, IVIg and PLEX. Outcome measure is reported for the Anti-AChR-Ab+ population. |
| Secondary | Change From Baseline in MG-ADL Score at Week 52 in the Anti-AChR-Ab+ Population | Baseline and Week 52 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses 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. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ population. |
| Secondary | Change From Baseline in QMG Score at Week 52 in the Anti-AChR-Ab+ Population | Baseline and Week 52 | The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ population. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score at Week 26 in the Overall Study Population | Baseline and Week 26 | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 26 in MG-ADL Score in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Baseline and Week 26 | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in QMG Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Baseline and Week 26 | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in the Overall Study Population | Up to Week 26 | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Up to Week 26 | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 52 and no Use of Rescue Therapy Between Day 28 and Week 52 in Anti-AChR-Ab+ Population | Up to Week 52 | |||
| SECONDARY | Percentage of Participants With no Use of Rescue Therapy Between Day 28 and Week 52 in Anti-AChR-Ab+ Population | Up to Week 52 | |||
| SECONDARY | Change From Baseline in MG-ADL Score at Week 52 in the Anti-AChR-Ab+ Population | Baseline and Week 52 | |||
| SECONDARY | Change From Baseline in QMG Score at Week 52 in the Anti-AChR-Ab+ Population | Baseline and Week 52 | |||
| SECONDARY | Change From Baseline in Myasthenia Gravis Composite (MGC) Score at Week 26 in the Overall Study Population | Baseline and Week 26 | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group127
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score at Week 26 in the Overall Study Population | Overall: Placebo | -2.3 | 95% Confidence Interval -3.4 to -1.3 | Score on a scale | |
| Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score at Week 26 in the Overall Study Population | Overall: Inebilizumab 300 mg | -4.8 | 95% Confidence Interval -5.8 to -3.8 | Score on a scale | |
| Change From Baseline at Week 26 in MG-ADL Score in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Anti-AChR-Ab+: Placebo | -2.4 | 95% Confidence Interval -3.2 to -1.6 | Score on a scale | |
| Change From Baseline at Week 26 in MG-ADL Score in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Anti-AChR-Ab+: Inebilizumab 300 mg | -4.2 | 95% Confidence Interval -5.0 to -3.4 | Score on a scale | |
| Change From Baseline at Week 26 in MG-ADL Score in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Anti-MuSK-Ab+: Placebo | -1.7 | 95% Confidence Interval -3.1 to -0.2 | Score on a scale | |
| Change From Baseline at Week 26 in MG-ADL Score in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Anti-MuSK-Ab+: Inebilizumab 300 mg | -3.9 | 95% Confidence Interval -5.3 to -2.4 | Score on a scale | |
| Change From Baseline in QMG Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Anti-AChR-Ab+: Placebo | -2.0 | 95% Confidence Interval -3.1 to -0.9 | Score on a scale | |
| Change From Baseline in QMG Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Anti-AChR-Ab+: Inebilizumab 300 mg | -4.4 | 95% Confidence Interval -5.5 to -3.3 | Score on a scale | |
| Change From Baseline in QMG Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Anti-MuSK-Ab+: Placebo | -3.0 | 95% Confidence Interval -5.2 to -0.7 | Score on a scale | |
| Change From Baseline in QMG Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Anti-MuSK-Ab+: Inebilizumab 300 mg | -5.2 | 95% Confidence Interval -7.4 to -3.0 | Score on a scale |
1 to 10 of 127Source ClinicalTrials.gov
See all 127 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| RCP | STARTED | Anti-AChR-Ab+: Placebo | 95 | |
| RCP | STARTED | Anti-AChR-Ab+: Inebilizumab 300 mg | 95 | |
| RCP | STARTED | Anti-MuSK-Ab+: Placebo | 24 | |
| RCP | STARTED | Anti-MuSK-Ab+: Inebilizumab 300 mg | 24 | |
| RCP | COMPLETED | Anti-AChR-Ab+: Placebo | 68 | |
| RCP | COMPLETED | Anti-AChR-Ab+: Inebilizumab 300 mg | 75 | |
| RCP | COMPLETED | Anti-MuSK-Ab+: Placebo | 23 | |
| RCP | COMPLETED | Anti-MuSK-Ab+: Inebilizumab 300 mg | 24 | |
| RCP | NOT COMPLETED | Anti-AChR-Ab+: Placebo | 27 | |
| RCP | NOT COMPLETED | Anti-AChR-Ab+: Inebilizumab 300 mg | 20 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events168
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | RCP: Placebo | 8 | 119 | |
| other | Diarrhoea | Gastrointestinal disorders | RCP: Inebilizumab 300 mg | 4 | 119 | |
| other | Diarrhoea | Gastrointestinal disorders | Optional OLP: Inebilizumab 300 mg | 1 | 178 | |
| other | COVID-19 | Infections and infestations | RCP: Placebo | 9 | 119 | |
| other | COVID-19 | Infections and infestations | RCP: Inebilizumab 300 mg | 12 | 119 | |
| other | COVID-19 | Infections and infestations | Optional OLP: Inebilizumab 300 mg | 10 | 178 | |
| other | Nasopharyngitis | Infections and infestations | RCP: Placebo | 3 | 119 | |
| other | Nasopharyngitis | Infections and infestations | RCP: Inebilizumab 300 mg | 8 | 119 | |
| other | Nasopharyngitis | Infections and infestations | Optional OLP: Inebilizumab 300 mg | 8 | 178 | |
| other | Upper respiratory tract infection | Infections and infestations | RCP: Placebo | 7 | 119 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RCP: Placebo | 2 | 119 |
| Total, all-cause mortality | RCP: Inebilizumab 300 mg | 1 | 119 |
| Total, all-cause mortality | Optional OLP: Inebilizumab 300 mg | 1 | 178 |
| Total, other adverse events | RCP: Placebo | 47 | 119 |
| Total, other adverse events | RCP: Inebilizumab 300 mg | 53 | 119 |
| Total, other adverse events | Optional OLP: Inebilizumab 300 mg | 40 | 178 |
| Total, serious adverse events | RCP: Placebo | 16 | 119 |
| Total, serious adverse events | RCP: Inebilizumab 300 mg | 10 | 119 |
| Total, serious adverse events | Optional OLP: Inebilizumab 300 mg | 14 | 178 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Overall: Inebilizumab 300 mg vs Overall: Placebo: Percentage of Participants Experiencing Exacerbation by Week 26 in the Overall Study Population | Trial comparisons |
| Overall: Inebilizumab 300 mg vs Overall: Placebo: Percentage of Participants With Anti-drug Antibodies (ADA) by Week 26 in the Overall Study Population | Trial comparisons |
| Overall: Inebilizumab 300 mg vs Overall: Placebo: Percentage of Participants With Steroid Tapered to ≤ 5 mg/Day Steroid at Week 26 in the Overall Study Population | Trial comparisons |
| Overall: Inebilizumab 300 mg vs Overall: Placebo: Percentage of Participants Who Achieved ≥ 50% Steroid Reduction at Week 26 in the Overall Study Population | Trial comparisons |
Overall: Inebilizumab 300 mg vs Overall: Placebo: Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in the Overall Study Population | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04524273
GET https://conductscience.org/api/trials/v1/NCT04524273/registered?page=2