A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305197
• Other study ID #: ICP-CL-00109
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 9, 2020
• Est. completion date: April 28, 2022

Study information

• Verified date: November 2022
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• ICP-022
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
• ICP-022
Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
• ICP-022
Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
• Placebos
Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University third hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Gulou Hospital Affiliated to Medical College of Nanjing University	Nanjing	Jiangsu
China	Huashan Hospital affiliated to Fudan University	Shanghai	Shanghai
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	University of Hong Kong Shenzhen Hospital	Shenzhen	Guangdong
China	The First Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to 28 Days after the last dose of study drug
Primary	Number of Patients with Treatment-emergent Adverse Event(TEAEs) according to severity		Up to 28 Days after the last dose of study drug
Primary	Number of participants with clinically significant physical examination abnormalities		Up to 28 Days after the last dose of study drug
Primary	Number of participants with clinically significant vital signs abnormalities		Up to 28 Days after the last dose of study drug
Primary	Number of participants with clinically significant ECG abnormalities		Up to 28 Days after the last dose of study drug
Primary	Number of participants with clinically significant laboratory examination abnormalities		Up to 28 Days after the last dose of study drug
Secondary	Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4)		12 Weeks
Secondary	Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6)		12 Weeks
Secondary	Occupancy rate of Bruton Tyrosine Kinase(BTK)		14 Days
Secondary	Serum Immunoglobulin (Ig) level		12 Weeks
Secondary	Changes from Baseline in Ig levels		12 Weeks
Secondary	Changes from Baseline in C3		12 Weeks
Secondary	Changes from Baseline in C4		12 Weeks
Secondary	Changes from Baseline in serum dsDNA		12 Weeks
Secondary	Changes from Baseline in Anti-nuclear Antibodies		12 Weeks
Secondary	Changes from Baseline in Interferon-a(INF-a) level	Changes from Baseline in cytokine levels	12 Weeks
Secondary	Changes from Baseline in Interleukin-6(IL-6) level	Changes from Baseline in cytokine levels	12 Weeks
Secondary	Changes from Baseline in total B cell counts		12 Weeks
Secondary	Change from Baseline in Beffs count		12 Weeks
Secondary	Changes from baseline in Bregs count		12 Weeks
Secondary	Changes from Baseline in Bregs to Beffs ratio		12 Weeks
Secondary	Changes from Baseline in Erythrocyte Sedimentation Rate(ESR)		12 Weeks
Secondary	The plasma concentration-time curve		14 Days