Status:
NOT_YET_RECRUITING
A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
Lead Sponsor:
ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of active SLE.
Detailed Description
This is a phase Ib/II study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg and 1.6mg/kg dose level, Phase II study is a multi-center, randomized, doub...
Eligibility Criteria
Inclusion
- Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.
- SLEDAI total score ≥ 6 at screening
- BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
- Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
- Other protocol defined inclusion criteria may apply.
Exclusion
- Active or unstable neuropsychiatric SLE or lupus nephritis
- Autoimmune or rheumatic disease other than SLE
- Significant, uncontrolled medical conditions not related to SLE
- Active and/or severe viral, bacterial or fungal infection
- History of malignancy within 5 years
- Other protocol defined exclusion criteria may apply.
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2026
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT06535412
Start Date
October 10 2024
End Date
June 10 2026
Last Update
August 2 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.