Trial · NCT03052751
Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
NCT03052751, Phase 2, Completed, UCB Biopharma S.P.R.L.; results first posted 2021-08-03
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis. Trials, record NCT03052751. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03052751
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
- NCT number
- NCT03052751
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Conditions
- Myasthenia Gravis
- Interventions
- UCB7665, Placebo
- First posted
- 2017-02-14
- Last updated
- 2021-08-03
- Other registries' IDs
- eudract:2016-002698-36
- Results first posted
- 2021-08-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score to Visit 9 | From Baseline to Visit 9 (up to Day 29) | 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). | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Myasthenia Gravis-Composite Score to Visit 9 | From Baseline to Visit 9 (up to Day 29) | 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). | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 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). | scores on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
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 to Visit 9 | Placebo (FAS) | -1.2 | Standard Error 0.6 | scores on a scale | |
| Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score to Visit 9 | UCB7665 (7 mg/kg) (FAS) | -1.8 | Standard Error 0.6 | scores on a scale | |
| Change From Baseline in Myasthenia Gravis-Composite Score to Visit 9 | Placebo (FAS) | -1.2 | Standard Error 0.9 | scores on a scale | |
| Change From Baseline in Myasthenia Gravis-Composite Score to Visit 9 | UCB7665 (7 mg/kg) (FAS) | -3.1 | Standard Error 0.9 | scores on a scale | |
| Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) Score to Visit 9 | Placebo (FAS) | -0.4 | Standard Error 0.5 | scores on a scale | |
| Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) Score to Visit 9 | UCB7665 (7 mg/kg) (FAS) | -1.8 | Standard Error 0.5 | scores on a scale |
Source ClinicalTrials.gov
Participant flow66
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dosing Period 1 | STARTED | Placebo | 22 | |
| Dosing Period 1 | STARTED | UCB7665 (7 mg/kg) | 21 | |
| Dosing Period 1 | STARTED | Placebo - UCB7665 (7 mg/kg) | 0 | |
| Dosing Period 1 | STARTED | Placebo - UCB7665 (4 mg/kg) | 0 | |
| Dosing Period 1 | STARTED | UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) | 0 | |
| Dosing Period 1 | STARTED | UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) | 0 | |
| Dosing Period 1 | Completed Period 1 | Placebo | 22 | |
| Dosing Period 1 | Completed Period 1 | UCB7665 (7 mg/kg) | 21 | |
| Dosing Period 1 | Completed Period 1 | Placebo - UCB7665 (7 mg/kg) | 0 | |
| Dosing Period 1 | Completed Period 1 | Placebo - UCB7665 (4 mg/kg) | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 participant flowAdverse events378
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 | Anaemia | Blood and lymphatic system disorders | Placebo (SS) | 0 | 22 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | UCB7665 (7 mg/kg) (SS) | 0 | 21 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo - UCB7665 (7 mg/kg) (SS) | 0 | 11 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo - UCB7665 (4 mg/kg) (SS) | 1 | 11 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) (SS) | 0 | 10 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) (SS) | 0 | 10 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo (SS) | 0 | 22 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | UCB7665 (7 mg/kg) (SS) | 0 | 21 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo - UCB7665 (7 mg/kg) (SS) | 0 | 11 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo - UCB7665 (4 mg/kg) (SS) | 0 | 11 | 0 |
1 to 10 of 378Source ClinicalTrials.gov
See all 378 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (SS) | 0 | 22 |
| Total, all-cause mortality | UCB7665 (7 mg/kg) (SS) | 0 | 21 |
| Total, all-cause mortality | Placebo - UCB7665 (7 mg/kg) (SS) | 0 | 11 |
| Total, all-cause mortality | Placebo - UCB7665 (4 mg/kg) (SS) | 0 | 11 |
| Total, all-cause mortality | UCB7665 (7 mg/kg) - UCB7665 (7 mg/kg) (SS) | 0 | 10 |
| Total, all-cause mortality | UCB7665 (7 mg/kg) - UCB7665 (4 mg/kg) (SS) | 0 | 10 |
| Total, other adverse events | Placebo (SS) | 7 | 22 |
| Total, other adverse events | UCB7665 (7 mg/kg) (SS) | 13 | 21 |
| Total, other adverse events | Placebo - UCB7665 (7 mg/kg) (SS) | 7 | 11 |
| Total, other adverse events | Placebo - UCB7665 (4 mg/kg) (SS) | 9 | 11 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers4
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03052751
GET https://conductscience.org/api/trials/v1/NCT03052751/flow?page=2