Trials / Active Not Recruiting
Active Not RecruitingNCT05796206
A Phase 2 Clinical Study of MIL62 in Systemic Lupus Erythematosus
A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Beijing Mabworks Biotech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MIL62 | MIL62 will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, and W55D1. |
| DRUG | placebo | Placebo will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, and W55D1. |
Timeline
- Start date
- 2023-05-26
- Primary completion
- 2026-02-01
- Completion
- 2026-07-01
- First posted
- 2023-04-03
- Last updated
- 2025-12-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05796206. Inclusion in this directory is not an endorsement.