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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: ICP-022
* Drug: ICP-022
* Drug: ICP-022
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lower Dose<br> | Drug: ICP-022<br>* Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period<br>* Other names: Orelabrutinib;|
| Experimental: Medium Dose<br> | Drug: ICP-022<br>* Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period<br>* Other names: Orelabrutinib;|
| Experimental: Higher Dose<br> | Drug: ICP-022<br>* Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period<br>* Other names: Orelabrutinib;|
| Placebo Comparator: Placebo<br> | Drug: Placebos<br>* Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Changes from Baseline in C3 |  | 12 Weeks | 
| Changes from Baseline in C4 |  | 12 Weeks | 
| Changes from Baseline in serum dsDNA |  | 12 Weeks | 
| Changes from Baseline in Anti-nuclear Antibodies |  | 12 Weeks | 
| Changes from Baseline in Interferon-α(INF-α) level | Changes from Baseline in cytokine levels | 12 Weeks | 
| Changes from Baseline in Interleukin-6(IL-6) level | Changes from Baseline in cytokine levels | 12 Weeks | 
| Changes from Baseline in total B cell counts |  | 12 Weeks | 
| Change from Baseline in Beffs count |  | 12 Weeks | 
| Changes from baseline in Bregs count |  | 12 Weeks | 
| Changes from Baseline in Bregs to Beffs ratio |  | 12 Weeks | 
| Changes from Baseline in Erythrocyte Sedimentation Rate(ESR) |  | 12 Weeks | 
| The plasma concentration-time curve |  | 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild to Moderate