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Systemic Lupus Erythematosus, SLEPhase 2NCT05688696

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

A Phase 2 study testing Orelabrutinib (Low Dose) and Orelabrutinib (High Dose) in people with Systemic Lupus Erythematosus, SLE, run by Beijing InnoCare Pharma Tech Co., Ltd. at 41 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Lupus Erythematosus, SLE
What is being tested?
Orelabrutinib (Low Dose) and Orelabrutinib (High Dose)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
186 participants
Where
41 sitesChina
Study dates
29 Apr 2023to 30 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • Males or females aged≥18 and ≤75 years.
  • 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.
  • SLEDAI-2K≥8 at screening.
  • 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.
  • Have a positive test for anti-dsDNA antibody (> normal range) and/or anti-nuclear antibody (ANA) and/or anti-Smith antibody at screening.
  • 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.

Who cannot join

  • Medical conditions:
  • Pregnant or lactating women, and men or women who have birth plans in the past 12 months.
  • 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.
  • Have severe lupus nephritis, or have required hemodialysis or high-dose glucocorticoid within 90 days prior to the first dose.
  • Have autoimmune diseases other than SLE (excluding secondary Sjogren's syndrome).
  • 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.
Show all 25Show fewer
  • Have a history of or current diagnosis of Central Nervous System (CNS) diseases.
  • Have clinically documented cardiovascular diseases that are obviously unstable or not effectively treated.
  • Have significant active lung diseases (e.g., interstitial lung disease, obstructive pulmonary disease).
  • Have severe hepatobiliary diseases.
  • Have a history of malignant neoplasm.
  • Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.
  • Have known allergies to any component of the investigational agent as described in the Protocol.
  • Concomitant medication and surgery:
  • Have received rituximab, epratuzumab, or any other B cell-depleting therapy within 12 months prior to randomization.
  • Have received cyclophosphamide and chlorambucil within 6 months prior to randomization.
  • 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:
  • Have a positive test for human immunodeficiency virus (HIV) antibody.
  • 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).
  • Have abnormal tissue or organ function, meeting any of the following at screening:
  • Absolute neutrophil count (ANC) < 1.5 × 10^9/L; hemoglobin < 90 g/L; lymphocyte count < 0.8 × 10^9 /L.
  • Calculated estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation < 45 mL/min/1.73 m2.
  • Others:
  • Have other conditions that are not appropriate for participation in the trial as considered by the investigator.

Trial locations and contacts

41 sites in 1 country.

Zhanguo Li, PhD contact

010-88324172

Zgli@yahoo.cn

41 sites in 1 country

China41 sites, 41 recruiting

  • Affiliated Hospital of HeBei University

    Baoding, Hebei, 071030

    Minghua Xu

    Recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100000

    Zhanguo Li

    Recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

    GuoChun Wang

    Not yet recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Yanying Liu

    Recruiting

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui, 233099

    Changhao Xie

    Recruiting

  • Affiliated Hospital of Binzhou Medical College

    Binzhou, Shandong, 256699

    Xuebin Wang

    Recruiting

  • Jilin Provincial People's Hospital

    Changchun, Jilin, 130021

    Guoping Jiang

    Recruiting

  • The Second XIANGYA Hospital Of Central South University

    Changsha, Hunan, 410000

    Jing Tian

    Not yet recruiting

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, Contact: Junsong Li

    Junsong Li

    Recruiting

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Niansheng Yang

    Recruiting

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541001

    Baozhen Li

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Zongwen Shuai

    Recruiting

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Nei Monggol Autonomous Region, 010000

    Hongbin Li

    Not yet recruiting

  • The Third People's Hospital of Huzhou

    Huzhou, Zhejiang, 313002

    Xiaobing Yang

    Recruiting

  • Jining First People's Hospital

    Jining, Shandong, 272002

    Jianhong Zhao

    Recruiting

  • Jiujiang NO.1 People's Hospital

    Jiujiang, Jiangxi, 332000

    Ju Liu

    Recruiting

  • Linyi People's Hospital

    Linyi, Shandong, 276034

    Zunzhong Li

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

    Xiaofei Shi

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Rui Wu

    Recruiting

  • The First Hospital of Ningbo

    Ningbo, Zhejiang, 315010

    Wen Qin

    Recruiting

  • The first hospital of Qiqihar

    Qiqihar, Heilongjiang, 161005

    Wei Zhong

    Recruiting

  • Changhai Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200000

    Jie Gao

    Recruiting

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

    Sheng Chen

    Recruiting

  • The first affiliated hospital of shantou university medical college

    Shantou, Guangdong, 515041

    Zhiduo Hou

    Recruiting

  • Shengjing Hospital of china medical university

    Shenyang, Liaoning, 110004

    Xiaofei Wang

    Recruiting

  • The Seventh Affiliated Hospital, Sun Yat-sen University

    Shenzhen, Guangdong, 518107

    Ruojie Gu

    Recruiting

  • Hebei People's Hospital

    Shijiazhuang, Hebei, 050051

    Fang Li

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

    Zhichun Liu

    Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Zili Fu

    Recruiting

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Xiaoxia Wang

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300000

    Wei Wei

    Not yet recruiting

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang, 830000

    Lijun Wu

    Recruiting

  • The First People's Hospital of Wenling

    Wenling, Zhejiang, 317500

    Yongjun Cheng

    Recruiting

  • Wenzhou People's Hospital

    Wenzhou, Zhejiang, 325099

    Suxian Lin

    Recruiting

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Anbin Huang

    Recruiting

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi’an, Shanxi, 710061

    Lan He

    Recruiting

  • The First Affiliated Hospital of XiaMen University

    Xiamen, Fujian, 361009

    Guixiu Shi

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000

    Lin Liu

    Recruiting

  • Yiyang Central Hospital

    Yiyang, Hunan, 413000

    Jian Shi

    Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Shengyun Liu

    Recruiting

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 412000

    Zhenhua Wen

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Orelabrutinib (Low Dose), Orelabrutinib (High Dose), Orelabrutinib Placebo
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orelabrutinib (Low Dose)Drug

    Subjects will be administered with lower dose of Orelabrutinib orally once daily in combination with SOC therapy

  • Orelabrutinib (High Dose)Drug

    Subjects will be administered with higher dose of Orelabrutinib orally once daily in combination with SOC therapy

  • Orelabrutinib PlaceboDrug

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

Study groups in NCT05688696
Study groupRoleWhat they receive
Orelabrutinib Lower DoseExperimentalNot described
Receives: Drug: Orelabrutinib (Low Dose)
Orelabrutinib Higher DoseExperimentalNot described
Receives: Drug: Orelabrutinib (High Dose)
PlaceboPlacebo comparatorNot described
Receives: Drug: Orelabrutinib Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SLE Responder Index (SRI) - 4 response rate

    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.

    Measured: Week 48

Secondary outcomes (7)

  1. SLE Responder Index (SRI) - 6 response rate

    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.

    Measured: Week 48

  2. British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rate

    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.

    Measured: Week 48

  3. Time to 1st flare

    Measured: Week 48

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

    Measured: Week 48

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

    Adopt the unified unit standard of central laboratory testing

    Measured: Week 48

  6. Treatment Emergent Adverse Events, Treatment Related Adverse Events, Treatment Emergent Serious Adverse Events, Treatment Related Serious Adverse Events.

    Measured: 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. )

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start29 Apr 2023
  3. Primary completion25 Aug 2025 (estimated)
  4. Study completion30 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05688696
Sponsor's protocol ID
ICP-CL-00124
Status last verified
Aug 2024
First submitted
10 Jan 2023
Last updated
16 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orelabrutinib (Low Dose) and Orelabrutinib (High Dose) in people with Systemic Lupus Erythematosus, SLE, run by Beijing InnoCare Pharma Tech Co., Ltd. at 41 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhanguo Li, PhD (010-88324172, Zgli@yahoo.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SLE Responder Index (SRI) - 4 response rate (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05688696.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.

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