Clinical trial NCT04305197: A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)
Official title: A Phase Ib/IIa Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerance, Pharmacokinetics/ Pharmacodynamics(PK/PD) of ICP-022 in Patients With Mild and Moderate Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Mild to Moderate
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

1. Male or female subjects aged 18 to 75
2. diagnosis of with SLE at least 6 months at screening visit
3. SLEDAE-2K≥5
4. Is receiving standard treatment for SLE and has been receiving treatment for at least 3 months.
5. At least one SLE activity manifestation (as assessed by SLEDAE-2K)

Exclusion Criteria:

1. Failure to comply with the requirements of the programme
2. A female or male partner who is pregnant or breastfeeding or who plans to become pregnant during the study period
3. Previously treated with a BTK inhibitor
4. Neuropsychiatric lupus (NPSLE)
5. Has other autoimmune diseases other than SLE

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 28 Days after the last dose of study drug
measure: Number of Patients with Treatment-emergent Adverse Event(TEAEs) according to severity
timeFrame: Up to 28 Days after the last dose of study drug
measure: Number of participants with clinically significant physical examination abnormalities
timeFrame: Up to 28 Days after the last dose of study drug
measure: Number of participants with clinically significant vital signs abnormalities
timeFrame: Up to 28 Days after the last dose of study drug
measure: Number of participants with clinically significant ECG abnormalities
timeFrame: Up to 28 Days after the last dose of study drug
measure: Number of participants with clinically significant laboratory examination abnormalities
timeFrame: Up to 28 Days after the last dose of study drug
Secondary outcomes:
measure: Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4)
timeFrame: 12 Weeks
measure: Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6)
timeFrame: 12 Weeks
measure: Occupancy rate of Bruton Tyrosine Kinase(BTK)
timeFrame: 14 Days
measure: Serum Immunoglobulin (Ig) level
timeFrame: 12 Weeks
measure: Changes from Baseline in Ig levels
timeFrame: 12 Weeks
measure: Changes from Baseline in C3
timeFrame: 12 Weeks
measure: Changes from Baseline in C4
timeFrame: 12 Weeks
measure: Changes from Baseline in serum dsDNA
timeFrame: 12 Weeks
measure: Changes from Baseline in Anti-nuclear Antibodies
timeFrame: 12 Weeks
measure: Changes from Baseline in Interferon-α(INF-α) level
timeFrame: 12 Weeks
measure: Changes from Baseline in Interleukin-6(IL-6) level
timeFrame: 12 Weeks
measure: Changes from Baseline in total B cell counts
timeFrame: 12 Weeks
measure: Change from Baseline in Beffs count
timeFrame: 12 Weeks
measure: Changes from baseline in Bregs count
timeFrame: 12 Weeks
measure: Changes from Baseline in Bregs to Beffs ratio
timeFrame: 12 Weeks
measure: Changes from Baseline in Erythrocyte Sedimentation Rate(ESR)
timeFrame: 12 Weeks
measure: The plasma concentration-time curve
timeFrame: 14 Days
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University third hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: University of Hong Kong Shenzhen Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Gulou Hospital Affiliated to Medical College of Nanjing University
state: Jiangsu
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: The First Affiliated Hospital of Shanxi Medical University
state: Shanxi
Study officials:
affiliation: Peking University People's Hospital
name: Zhanguo Li, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: