Trials / Completed
CompletedNCT04515927
To Evaluate the Efficacy and Safety of JS002 in HoFH Patients
An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
- Sex
- All
- Age
- 12 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled. Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JS002 | Biological: JS002 Administered by subcutaneous injection |
Timeline
- Start date
- 2020-08-17
- Primary completion
- 2022-05-06
- Completion
- 2022-07-29
- First posted
- 2020-08-17
- Last updated
- 2024-07-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04515927. Inclusion in this directory is not an endorsement.