Trial · NCT04227470
A Study of HBM9161 in NMOSD Patients
NCT04227470, Phase 1, Completed, Harbour BioMed (Guangzhou) Co. Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of HBM9161 in NMOSD Patients. Trials, record NCT04227470. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04227470
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of HBM9161 in NMOSD Patients
- NCT number
- NCT04227470
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Conditions
- NMO Spectrum Disorder
- Interventions
- HBM9161 Injection
- First posted
- 2020-01-13
- Last updated
- 2022-01-25
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of treatment related adverse events (AEs) | 189 days | Number of treatment related adverse events (AEs) |
| Secondary | Immunoglobins changes from baseline to week 27 | 189 days | Change of concentration of immunoglobins in mg/ml overtime after administration of HBM9161 from baseline to week 27 |
| Secondary | Neurological Disability changes from baseline to week 27 | 189 days | Neurological Disability changes from baseline to week 27 as measured by Expanded Disability Scale Score (EDSS, Score 0-10, higher means a worse outcome) |
| Secondary | Low Contrast Visual Acuity (LCVA) changes from baseline to week 27 | 189 days | Low Contrast Visual Acuity (LCVA) changes from baseline to week 27 as measured by Sloan Low Contrast Letter Scale (SLCLS Letter, Score 0-70, higher means a better outcome) |
| Secondary | Patient reported improvement changes from baseline to week 27 | 189 days | Patient reported improvement changes from baseline to week 27 as measured by Patient Global Impression-Improvement (PGI-I, Score 1-7, higher means a worse outcome) |
| Secondary | Percentage of patients who received rescue therapy | 189 days | Percentage of patients who received rescue therapy |
| Secondary | Percentage of patients who have relapse | 189 days | Percentage of patients who have relapse |
| Secondary | Walking ability changes from baseline to week 27 | 189 days | Walking ability changes from baseline to week 27 as measured by time used for 25-foot Walk (applicable for patients who are able to walk) |
| Secondary | The seropositive rate of anti-HBM9161 antibody after treatment | 189 days | Evaluation of the seropositive rate of anti-HBM9161 antibody after treatment |
| Other | Maximum change from baseline to week 27 in total serum AQP4-IgG concentrations | 189 days | Maximum change from baseline in total serum AQP4-IgG concentrations |
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 |
|---|---|
| 40489809 | 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/NCT04227470
GET https://conductscience.org/api/trials/v1/NCT04227470/registered