NCT04305197

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 9, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

March 10, 2020

Last Update Submit

November 28, 2022

Conditions

Systemic Lupus Erythematosus

Keywords

Mild to Moderate

Outcome Measures

Primary Outcomes (6)

  • Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Up to 28 Days after the last dose of study drug

  • Number of Patients with Treatment-emergent Adverse Event(TEAEs) according to severity

    Up to 28 Days after the last dose of study drug

  • Number of participants with clinically significant physical examination abnormalities

    Up to 28 Days after the last dose of study drug

  • Number of participants with clinically significant vital signs abnormalities

    Up to 28 Days after the last dose of study drug

  • Number of participants with clinically significant ECG abnormalities

    Up to 28 Days after the last dose of study drug

  • Number of participants with clinically significant laboratory examination abnormalities

    Up to 28 Days after the last dose of study drug

Secondary Outcomes (17)

  • Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4)

    12 Weeks

  • Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6)

    12 Weeks

  • Occupancy rate of Bruton Tyrosine Kinase(BTK)

    14 Days

  • Serum Immunoglobulin (Ig) level

    12 Weeks

  • Changes from Baseline in Ig levels

    12 Weeks

  • +12 more secondary outcomes

Study Arms (4)

Lower Dose

EXPERIMENTAL
Drug: ICP-022

Medium Dose

EXPERIMENTAL
Drug: ICP-022

Higher Dose

EXPERIMENTAL
Drug: ICP-022

Placebo

PLACEBO COMPARATOR
Drug: Placebos

Interventions

ICP-022DRUG

Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period

Also known as: Orelabrutinib
Lower Dose
PlacebosDRUG

Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

Location

Peking University third hospital

Beijing, Beijing Municipality, 100000, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

University of Hong Kong Shenzhen Hospital

Shenzhen, Guangdong, China

Location

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Gulou Hospital Affiliated to Medical College of Nanjing University

Nanjing, Jiangsu, 210000, China

Location

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

orelabrutinib

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Zhanguo Li, MD/PhD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 12, 2020

Study Start

July 9, 2020

Primary Completion

April 28, 2022

Study Completion

April 28, 2022

Last Updated

November 30, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(11)