Trial · NCT04346888
A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients
NCT04346888, Phase 2, Completed, Harbour BioMed (Guangzhou) Co. Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients. Trials, record NCT04346888. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04346888
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients
- NCT number
- NCT04346888
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Conditions
- Myasthenia Gravis
- Interventions
- HBM9161 Injection (680mg and 340 mg), Placebos, HBM9161 Injection (340 mg)
- First posted
- 2020-04-15
- Last updated
- 2023-03-08
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline to Day 43 | 43 days | The MG-ADL profile provides an assessment of MG symptom severity and measures 8 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the ADL score. The ADL score can range from 0 (least severe) to 24 (most severe) |
| Secondary | Change in the Myasthenia Gravis Composite (MGC) score from baseline to Day 43 | 43 days | The total QMG score is 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. |
| Secondary | Change in the Quantitative Myasthenia Gravis (QMG) score from baseline to Day 43 | 43 days | The QMG test is a standardized quantitative strength scoring system and measures 13 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the QMG score. The QMG score can range from 0 (least severe) to 39 (most severe). |
| Secondary | Change in the Myasthenia Gravis Quality of Life 15(MG-QoL15r) score from baseline to Day 43 | 43 days | The MG-QoL 15r scale is a patient-reported score that assesses the patient's perception of impairment and disability and the degree to which the patient tolerates disease manifestations. Each question was graded on a 3-point scale from 0=normal to 2=severe with a score of 0 to 30; the higher score indicates worse MG disease activity |
| Secondary | Proportion of participants with a decrease on the MG-ADL Score by ≥ 2 points from baseline to Day 43 | 43 days | |
| Secondary | Proportion of participants with an improvement and worse on the MGFA Post-intervention Status (MGFA-PIS) from baseline to Day 43. o Improvement: MGC Score reduce ≥ 3 points o Aggravation: MGC Score increase ≥ 3 points | 43 days | |
| Secondary | Change in the MG-ADL score from baseline to Day 120 | 120 days | |
| Secondary | Change in the MGC score from baseline to Day 120 | 120 days | |
| Secondary | Change in the QMG score from baseline to Day 120 | 120 days | |
| Secondary | Change in the MG-QoL15r score from baseline to Day 120 | 120 days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35412216 | DERIVED |
Source PubMed
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/NCT04346888
GET https://conductscience.org/api/trials/v1/NCT04346888/registered