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

November 28, 2022 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China
        • the First Affiliated Hospital of Bengbu Medical College
    • Beijing
      • Beijing, Beijing, China, 100000
        • Peking University Third Hospital
      • Beijing, Beijing, China, 100000
        • Peking University People's Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong General Hospital
      • Shenzhen, Guangdong, China
        • Shenzhen People's Hospital
      • Shenzhen, Guangdong, China
        • University of Hong Kong Shenzhen Hospital
    • Henan
      • Zhengzhou, Henan, China
        • First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China
        • Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Gulou Hospital Affiliated to Medical College of Nanjing University
    • Shanghai
      • Shanghai, Shanghai, China
        • Huashan Hospital Affiliated to Fudan University
    • Shanxi
      • Taiyuan, Shanxi, China
        • The First Affiliated Hospital of Shanxi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebos
Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Experimental: Medium Dose
Drug: ICP-022
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
  • Orelabrutinib
Drug: ICP-022
Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
  • Orelabrutinib
Drug: ICP-022
Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
  • Orelabrutinib
Experimental: Lower Dose
Drug: ICP-022
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
  • Orelabrutinib
Drug: ICP-022
Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
  • Orelabrutinib
Drug: ICP-022
Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
  • Orelabrutinib
Experimental: Higher Dose
Drug: ICP-022
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
  • Orelabrutinib
Drug: ICP-022
Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
  • Orelabrutinib
Drug: ICP-022
Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
  • Orelabrutinib

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Up to 28 Days after the last dose of study drug
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
Up to 28 Days after the last dose of study drug
Number of participants with clinically significant physical examination abnormalities
Time Frame: Up to 28 Days after the last dose of study drug
Up to 28 Days after the last dose of study drug
Number of participants with clinically significant vital signs abnormalities
Time Frame: Up to 28 Days after the last dose of study drug
Up to 28 Days after the last dose of study drug
Number of participants with clinically significant ECG abnormalities
Time Frame: Up to 28 Days after the last dose of study drug
Up to 28 Days after the last dose of study drug
Number of participants with clinically significant laboratory examination abnormalities
Time Frame: Up to 28 Days after the last dose of study drug
Up to 28 Days after the last dose of study drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4)
Time Frame: 12 Weeks
12 Weeks
Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6)
Time Frame: 12 Weeks
12 Weeks
Occupancy rate of Bruton Tyrosine Kinase(BTK)
Time Frame: 14 Days
14 Days
Serum Immunoglobulin (Ig) level
Time Frame: 12 Weeks
12 Weeks
Changes from Baseline in Ig levels
Time Frame: 12 Weeks
12 Weeks
Changes from Baseline in C3
Time Frame: 12 Weeks
12 Weeks
Changes from Baseline in C4
Time Frame: 12 Weeks
12 Weeks
Changes from Baseline in serum dsDNA
Time Frame: 12 Weeks
12 Weeks
Changes from Baseline in Anti-nuclear Antibodies
Time Frame: 12 Weeks
12 Weeks
Changes from Baseline in Interferon-α(INF-α) level
Time Frame: 12 Weeks
Changes from Baseline in cytokine levels
12 Weeks
Changes from Baseline in Interleukin-6(IL-6) level
Time Frame: 12 Weeks
Changes from Baseline in cytokine levels
12 Weeks
Changes from Baseline in total B cell counts
Time Frame: 12 Weeks
12 Weeks
Change from Baseline in Beffs count
Time Frame: 12 Weeks
12 Weeks
Changes from baseline in Bregs count
Time Frame: 12 Weeks
12 Weeks
Changes from Baseline in Bregs to Beffs ratio
Time Frame: 12 Weeks
12 Weeks
Changes from Baseline in Erythrocyte Sedimentation Rate(ESR)
Time Frame: 12 Weeks
12 Weeks
The plasma concentration-time curve
Time Frame: 14 Days
14 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhanguo Li, MD/PhD, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICP-CL-00109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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