NCT06015230Active, not recruitingPhase 1/2
Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE
A Phase Ⅰb/Ⅱ, Randomized, Double-blind, Placebo-controlled Study to Investigate the Tolerability, Safety,Pharmacokinetics and Efficacy of an Intravenous Treatment Regimen of GR1603 in Subjects with Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 25 Sept 2024
Brief summary (registry, in English)
A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody targeting IFNAR1, which can block IFNAR binding to type I interferons such as IFNα and be used to treat systemic lupus erythematosus.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 1 Jun 2023
- Start date
- 8 Mar 2022
- Primary completion date
- 10 Jun 2028
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Diseases
- Lupus (SLE)
- NCT number
- NCT06015230
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 136
- From 8 Mar 2022 to the primary completion date, 10 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clinically significant active infection
Lab values
- Clinically significant laboratory test
Other
- Active severe or unstable neuropsychiatric SLE
Who the study is looking for
- Diagnosis of SLE according to the ACR 1997 ≥24 weeks
- Active moderate to severe SLE
- At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking union Medical Hosipital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.