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Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05688696
Collaborator
(none)
186
Enrollment
39
Locations
3
Arms
28
Anticipated Duration (Months)
4.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are receiving standard of care (SOC) therapy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Orelabrutinib (Low Dose)
  • Drug: Orelabrutinib (High Dose)
  • Drug: Orelabrutinib Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
186 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
May 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Orelabrutinib Lower Dose

Drug: Orelabrutinib (Low Dose)
Subjects will be administered with lower dose of Orelabrutinib orally once daily in combination with SOC therapy
Experimental: Orelabrutinib Higher Dose

Drug: Orelabrutinib (High Dose)
Subjects will be administered with higher dose of Orelabrutinib orally once daily in combination with SOC therapy
Placebo Comparator: Placebo

Drug: Orelabrutinib Placebo
Subjects will be administered with Orelabrutinib Placebo orally once daily in combination with SOC therapy

Outcome Measures

Primary Outcome Measures

  1. SLE Responder Index (SRI) - 4 response rate [Week 48]

    SRI-4 response is defined as: 1)≥4 point reduction from baseline in SLE disease activity index-2000 (SLEDAI-2K) score; 2) no worsening (increase of <0.3 points from baseline) in Physician's Global Assessment (PGA); 3) no new A organ domain score or no more than 1 new B organ domain scores compared with baseline in British Isles Lupus Assessment Group (BILAG)-2004.

Secondary Outcome Measures

  1. SLE Responder Index (SRI) - 6 response rate [Week 48]

    SRI-6 response is defined as: 1)≥6 point reduction from baseline in SLE disease activity index-2000 (SLEDAI-2K) score; 2) no worsening (increase of <0.3 points from baseline) in Physician's Global Assessment (PGA); 3) no new A organ domain score or no more than 1 new B organ domain scores compared with baseline in British Isles Lupus Assessment Group (BILAG)-2004.

  2. British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rate [Week 48]

    BICLA response is defined as: 1) In BILAG-2004, reduction of all baseline A to B/C/D and baseline B to C/D, and no worsening in other organ systems (as defined by no new A organ domain score or no more than 1 new B organ domain scores); 2) No worsening from baseline in SLEDAI-2K, where worsening is defined as an increase from baseline of >0 points in SLEDAI-2K; 3) No worsening (increase of <0.3 points from baseline) in PGA.

  3. Time to 1st flare [Week 48]

  4. The proportion of subjects whose average prednisone dose has been reduced by≥25% from baseline to ≤7.5 mg/day [Week 48]

  5. Changes from baseline in the levels of complement C3, complement C4, and anti-dsDNA antibody [Week 48]

    Adopt the unified unit standard of central laboratory testing

  6. Treatment Emergent Adverse Events, Treatment Related Adverse Events, Treatment Emergent Serious Adverse Events, Treatment Related Serious Adverse Events. [Up to Week 52]

  7. Mean change from baseline in the 36-Item Short Form Health Survey (SF-36) scores (The SF-36 consists of eight domains. Each domain score ranges from 0-100. The higher the score, the better the health. ) [Week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. have had a detailed understanding of the nature, significance, potential benefits, potential risks, and procedures of the study, and voluntarily signed a written Informed Consent Form (ICF).

  2. Males or females aged≥18 and ≤75 years.

  3. Have a clinical diagnosis of SLE 6 months prior to signing the ICF, meeting at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.

  4. SLEDAI-2K≥8 at screening.

  5. Are on a stable SLE SOC therapy consisting of any of the following medications for a period of at least 30 days prior to the first dose: glucocorticoid, and/or anti-malarials, and/or immunosuppressive agents.

  6. Have a positive test for anti-dsDNA antibody (> normal range) and/or anti-nuclear antibody (ANA) and/or anti-Smith antibody at screening.

  7. Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational agent. In this trial.

Exclusion Criteria:
Medical conditions:

  1. Pregnant or lactating women, and men or women who have birth plans in the past 12 months.

  2. Have neuropsychiatric systemic lupus erythematosus (NPSLE) within 6 months prior to the first dose, including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cranial neuropathy, cerebritis, cerebral vasculitis or lupus headache.

  3. Have severe lupus nephritis, or have required hemodialysis or high-dose glucocorticoid within 90 days prior to the first dose.

  4. Have autoimmune diseases other than SLE (excluding secondary Sjogren's syndrome).

  5. Have a history of any non-SLE disease that has required treatment with oral or intravenous or intramuscular or subcutaneous injection glucocorticoids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.

  6. Have a history of or current diagnosis of Central Nervous System (CNS) diseases.

  7. Have clinically documented cardiovascular diseases that are obviously unstable or not effectively treated.

  8. Have significant active lung diseases (e.g., interstitial lung disease, obstructive pulmonary disease).

  9. Have severe hepatobiliary diseases.

  10. Have a history of malignant neoplasm.

  11. Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.

  12. Have known allergies to any component of the investigational agent as described in the Protocol.

Concomitant medication and surgery:

  1. Have received rituximab, epratuzumab, or any other B cell-depleting therapy within 12 months prior to randomization.

  2. Have received cyclophosphamide and chlorambucil within 6 months prior to randomization.

  3. Have received belimumab, tumor necrosis factor (TNF) blockers, interleukin receptor blockers or other biological agents within 3 months prior to randomization (or 5 half-lives, whichever is longer).

Lab tests:

  1. Have a positive test for human immunodeficiency virus (HIV) antibody.

  2. Have a positive test for Hepatitis B Surface Antigen (HBsAg) or hepatitis C antibody, or have a positive test for hepatitis B virus (HBV) DNA by Polymerase Chain Reaction (PCR) if positive for Hepatitis B Core Antibody (HBcAb).

  3. Have abnormal tissue or organ function, meeting any of the following at screening:

  • Absolute neutrophil count (ANC) < 1.5 × 109/L; hemoglobin < 90 g/L; lymphocyte count < 0.8 × 109 /L.

  • Calculated estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation < 45 mL/min/1.73 m2.

Others:
  1. Have other conditions that are not appropriate for participation in the trial as considered by the investigator.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The first affiliated hospital of bengbu medical college Bengbu Anhui China 233099
2 The First Affiliated Hospital of Anhui Medical University Hefei Anhui China 230022
3 Peking University People's Hospital Beijing Beijing China 100000
4 China-Japan Friendship Hospital Beijing Beijing China 100029
5 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China 100050
6 The First Affiliated Hospital of XiaMen University Xiamen Fujian China 361009
7 The First Affiliated Hospital,Sun Yat-sen University Guangzhou Guangdong China 510080
8 The Seventh Affiliated Hospital, Sun Yat-sen University Shenzhen Guangdong China 518107
9 Affiliated Hospital of Guilin Medical University Guilin Guangxi Zhuang Autonomous Region China 541001
10 Affiliated Hospital of HeBei University Baoding Hebei China 071030
11 Hebei People's Hospital Shijiazhuang Hebei China 050051
12 Daqing Oilfield General Hospital Daqing Heilongjiang China Contact: Junsong Li
13 The first hospital of Qiqihar Qiqihar Heilongjiang China 161005
14 The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan China 471003
15 First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
16 Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430022
17 The Second XIANGYA Hospital Of Central South University Changsha Hunan China 410000
18 Yiyang Central Hospital Yiyang Hunan China 413000
19 Zhuzhou Central Hospital Zhuzhou Hunan China 412000
20 Xuzhou Central Hospital Xuzhou Jiangsu China 221000
21 Jiujiang NO.1 People's Hospital Jiujiang Jiangxi China 332000
22 The First Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
23 Jilin Provincial People's Hospital Changchun Jilin China 130021
24 Shengjing Hospital of china medical university Shenyang Liaoning China 110004
25 Affiliated Hospital of Inner Mongolia Medical University Hohhot Nei Monggol Autonomous Region China 010000
26 Affiliated Hospital of Binzhou Medical College Binzhou Shandong China 256699
27 Jining First People's Hospital Jining Shandong China 272002
28 Linyi People's Hospital Linyi Shandong China 276034
29 Changhai Hospital of Shanghai Shanghai Shanghai China 200000
30 Renji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200000
31 The First Hospital of Shanxi Medical University Taiyuan Shanxi China 030001
32 The Second Hospital of Shanxi Medical University Taiyuan Shanxi China 030001
33 The First Affiliated Hospital of Xi 'an Jiaotong University Xi'an Shanxi China 710061
34 Tianjin Medical University General Hospital Tianjin Tianjin China 300000
35 Xinjiang Uygur Autonomous Region People's Hospital Ürümqi Xinjiang China 830000
36 The Third People's Hospital of Huzhou Huzhou Zhejiang China 313002
37 The First Hospital of Ningbo Ningbo Zhejiang China 315010
38 The First People's Hospital of Wenling Wenling Zhejiang China 317500
39 Wenzhou People's Hospital Wenzhou Zhejiang China 325099

Sponsors and Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05688696
Other Study ID Numbers:
  • ICP-CL-00124
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Jan 19, 2023