Status:
COMPLETED
A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE)
Eligibility Criteria
Inclusion
- Male or female subjects aged 18 to 75
- diagnosis of with SLE at least 6 months at screening visit
- SLEDAE-2K≥5
- Is receiving standard treatment for SLE and has been receiving treatment for at least 3 months.
- At least one SLE activity manifestation (as assessed by SLEDAE-2K)
Exclusion
- Failure to comply with the requirements of the programme
- A female or male partner who is pregnant or breastfeeding or who plans to become pregnant during the study period
- Previously treated with a BTK inhibitor
- Neuropsychiatric lupus (NPSLE)
- Has other autoimmune diseases other than SLE
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04305197
Start Date
July 9 2020
End Date
April 28 2022
Last Update
November 30 2022
Active Locations (11)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100000
3
Peking University third hospital
Beijing, Beijing Municipality, China, 100000
4
Guangdong General Hospital
Guangzhou, Guangdong, China