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Completed

NCT Number: NCT04305197

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

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)

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICP-022

Drug

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

Other names: Orelabrutinib

Placebos

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. Number of participants with clinically significant physical examination abnormalities

    Time frame: Up to 28 Days after the last dose of study drug

  4. Number of participants with clinically significant vital signs abnormalities

    Time frame: Up to 28 Days after the last dose of study drug

  5. Number of participants with clinically significant ECG abnormalities

    Time frame: Up to 28 Days after the last dose of study drug

  6. Number of participants with clinically significant laboratory examination abnormalities

    Time frame: Up to 28 Days after the last dose of study drug

Secondary outcomes

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

    Time frame: 12 Weeks

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

    Time frame: 12 Weeks

  3. Occupancy rate of Bruton Tyrosine Kinase(BTK)

    Time frame: 14 Days

  4. Serum Immunoglobulin (Ig) level

    Time frame: 12 Weeks

  5. Changes from Baseline in Ig levels

    Time frame: 12 Weeks

  6. Changes from Baseline in C3

    Time frame: 12 Weeks

  7. Changes from Baseline in C4

    Time frame: 12 Weeks

  8. Changes from Baseline in serum dsDNA

    Time frame: 12 Weeks

  9. Changes from Baseline in Anti-nuclear Antibodies

    Time frame: 12 Weeks

  10. Changes from Baseline in Interferon-α(INF-α) level

    Time frame: 12 Weeks

    Changes from Baseline in cytokine levels

  11. Changes from Baseline in Interleukin-6(IL-6) level

    Time frame: 12 Weeks

    Changes from Baseline in cytokine levels

  12. Changes from Baseline in total B cell counts

    Time frame: 12 Weeks

  13. Change from Baseline in Beffs count

    Time frame: 12 Weeks

  14. Changes from baseline in Bregs count

    Time frame: 12 Weeks

  15. Changes from Baseline in Bregs to Beffs ratio

    Time frame: 12 Weeks

  16. Changes from Baseline in Erythrocyte Sedimentation Rate(ESR)

    Time frame: 12 Weeks

  17. The plasma concentration-time curve

    Time frame: 14 Days

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 12, 2020
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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