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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ICP-022
ICP-022
ICP-022
Placebos
Sponsored by
Beijing InnoCare Pharma Tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Mild to Moderate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical College
  • Peking University People's Hospital
  • Peking University third hospital
  • Guangdong General Hospital
  • Shenzhen People's Hospital
  • University of Hong Kong Shenzhen Hospital
  • First Affiliated Hospital of Zhengzhou University
  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Gulou Hospital Affiliated to Medical College of Nanjing University
  • Huashan Hospital affiliated to Fudan University
  • The First Affiliated Hospital of Shanxi Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Lower Dose

Medium Dose

Higher Dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Patients with Treatment-emergent Adverse Event(TEAEs) according to severity
Number of participants with clinically significant physical examination abnormalities
Number of participants with clinically significant vital signs abnormalities
Number of participants with clinically significant ECG abnormalities
Number of participants with clinically significant laboratory examination abnormalities

Secondary Outcome Measures

Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4)
Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6)
Occupancy rate of Bruton Tyrosine Kinase(BTK)
Serum Immunoglobulin (Ig) level
Changes from Baseline in Ig levels
Changes from Baseline in C3
Changes from Baseline in C4
Changes from Baseline in serum dsDNA
Changes from Baseline in Anti-nuclear Antibodies
Changes from Baseline in Interferon-α(INF-α) level
Changes from Baseline in cytokine levels
Changes from Baseline in Interleukin-6(IL-6) level
Changes from Baseline in cytokine levels
Changes from Baseline in total B cell counts
Change from Baseline in Beffs count
Changes from baseline in Bregs count
Changes from Baseline in Bregs to Beffs ratio
Changes from Baseline in Erythrocyte Sedimentation Rate(ESR)
The plasma concentration-time curve

Full Information

First Posted
March 10, 2020
Last Updated
November 28, 2022
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04305197
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
April 28, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Mild to Moderate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower Dose
Arm Type
Experimental
Arm Title
Medium Dose
Arm Type
Experimental
Arm Title
Higher Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ICP-022
Other Intervention Name(s)
Orelabrutinib
Intervention Description
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Intervention Type
Drug
Intervention Name(s)
ICP-022
Other Intervention Name(s)
Orelabrutinib
Intervention Description
Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Intervention Type
Drug
Intervention Name(s)
ICP-022
Other Intervention Name(s)
Orelabrutinib
Intervention Description
Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Primary Outcome Measure Information:
Title
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Up to 28 Days after the last dose of study drug
Title
Number of Patients with Treatment-emergent Adverse Event(TEAEs) according to severity
Time Frame
Up to 28 Days after the last dose of study drug
Title
Number of participants with clinically significant physical examination abnormalities
Time Frame
Up to 28 Days after the last dose of study drug
Title
Number of participants with clinically significant vital signs abnormalities
Time Frame
Up to 28 Days after the last dose of study drug
Title
Number of participants with clinically significant ECG abnormalities
Time Frame
Up to 28 Days after the last dose of study drug
Title
Number of participants with clinically significant laboratory examination abnormalities
Time Frame
Up to 28 Days after the last dose of study drug
Secondary Outcome Measure Information:
Title
Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4)
Time Frame
12 Weeks
Title
Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6)
Time Frame
12 Weeks
Title
Occupancy rate of Bruton Tyrosine Kinase(BTK)
Time Frame
14 Days
Title
Serum Immunoglobulin (Ig) level
Time Frame
12 Weeks
Title
Changes from Baseline in Ig levels
Time Frame
12 Weeks
Title
Changes from Baseline in C3
Time Frame
12 Weeks
Title
Changes from Baseline in C4
Time Frame
12 Weeks
Title
Changes from Baseline in serum dsDNA
Time Frame
12 Weeks
Title
Changes from Baseline in Anti-nuclear Antibodies
Time Frame
12 Weeks
Title
Changes from Baseline in Interferon-α(INF-α) level
Description
Changes from Baseline in cytokine levels
Time Frame
12 Weeks
Title
Changes from Baseline in Interleukin-6(IL-6) level
Description
Changes from Baseline in cytokine levels
Time Frame
12 Weeks
Title
Changes from Baseline in total B cell counts
Time Frame
12 Weeks
Title
Change from Baseline in Beffs count
Time Frame
12 Weeks
Title
Changes from baseline in Bregs count
Time Frame
12 Weeks
Title
Changes from Baseline in Bregs to Beffs ratio
Time Frame
12 Weeks
Title
Changes from Baseline in Erythrocyte Sedimentation Rate(ESR)
Time Frame
12 Weeks
Title
The plasma concentration-time curve
Time Frame
14 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanguo Li, MD/PhD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Peking University third hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
University of Hong Kong Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Gulou Hospital Affiliated to Medical College of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Huashan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The First Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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