CompletedPhase 3

Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis

China111 participantsStarted 2022-06-30

Plain-language summary

The primary study objective is to evaluate medium- and long-term safety of HBM9161 in combination with background treatment for gMG patients through the observation on adverse events and laboratory abnormalities during study period.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Completed the HBM9161.3 Phase 3 study
✓. Signed written informed consent.
✓. Suitable for continued treatment with HBM9161 as judged by the investigator.
✓. Female patients of childbearing potential and male patients with female partners of childbearing potential can participate in this study, but reliable contraceptive measures must be taken (such as physical barrier contraception (patients and their partners), contraceptive pills or patches, spermicide and barrier or intrauterine device). Up to 60 days after the last dose.
✓. A negative urine pregnancy at baseline must be observed for women of childbearing age.

Exclusion criteria

✕. Had received any other clinical study drug since the administration of the study drug in the 9161.3 Phase 3 study.
✕. Females who are pregnant or lactating or planning to become pregnant during the study period, or females of childbearing potential who are not using an effective method of contraception.

What they're measuring

Incidence of AEs during the study

Timeframe: during the study，up to 24 weeks

Trial details

NCT IDNCT05332210

SponsorHarbour BioMed (Guangzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-26

View on ClinicalTrials.gov More Myasthenia Gravis trials