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Lupus NephritisPhase 2NCT04643470

Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

A Phase 2 study testing Zanubrutinib in people with Lupus Nephritis, run by BeiGene at 44 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lupus Nephritis
What is being tested?
Zanubrutinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
177 participants
Where
44 sitesChina
Study dates
22 Dec 2020to 26 Aug 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics 2012 criteria.
  • ISN/RPS 2003 Class III/IV lupus nephritis [Type III(A), III (A+C), IV (A), and IV (A+C)], with or without Class V, as confirmed by a renal biopsy.
  • Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening
  • Has 24-hour urine protein excretion > 1.0 g at screening.

Who cannot join

  • Exclusion criteria related to systemic lupus erythematous and other diseases:
  • Glomerulonephritis caused by reasons other than systemic lupus erythematous.
  • Sclerosis in >50% of glomeruli on renal biopsy.
  • Any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome.
  • Severe extrarenal SLE, including but not limited to severe pulmonary arterial hypertension, severe myocarditis, severe central nervous system lupus (such as neuropsychiatric SLE, seizures, psychosis, transverse myelitis, central nervous system vasculitis and optic neuritis), etc.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

China44 sites

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044

  • Peking University International Hospital

    Beijing, Beijing Municipality, 102206

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130022

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071

  • First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)

    Guangzhou, Guangdong, 510000

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong, 510080

  • The Third Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong, 510630

  • Guangdong Province Traditional Chinese Medical Hospitsal

    Guangzhou, Guangdong, 510655

  • Guizhou Provincial Peoples Hospital

    Guiyang, Guizhou, 550002

  • Hainan General Hospital

    Haikou, Hainan, 570206

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529030

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Liuzhou Workers Hospital

    Liuzhou, Guangxi, 545005

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu, 210002

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The Peoples Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • The Affiliated Hospital of Qingdao University Branch South

    Qingdao, Shandong, 266000

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • The Second Peoples Hospital of Shenzhen

    Shenzhen, Guangdong, 518037

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • The Second Affiliated Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300000

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu, 214023

  • The Second Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710004

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Zanubrutinib in Patients With Active Proliferative Lupus Nephritis

The primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis

Conditions
Lupus Nephritis
Being tested
Zanubrutinib, Placebo
Medical subject headings
Lupus Nephritis

What participants receive

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

  • ZanubrutinibDrug

    Also called BGB-3111, Brukinsa

    Administered as specified in the treatment arm

  • PlaceboDrug

    Placebo to match zanubrutinib

Study groups in NCT04643470
Study groupRoleWhat they receive
Zanubrutinib Low DoseExperimentalParticipants will receive zanubrutinib 40 mg twice daily (BID) for 72 weeks
Receives: Drug: Zanubrutinib
Zanubrutinib High DoseExperimentalParticipants will receive zanubrutinib 160 mg twice daily (BID) for 72 weeks
Receives: Drug: Zanubrutinib
Zanubrutinib Medium DoseExperimentalParticipants will receive zanubrutinib 160 mg once daily (QD) for 72 weeks
Receives: Drug: Zanubrutinib
PlaceboExperimentalParticipants will receive placebo to match zanubrutinib for 72 weeks
Receives: Drug: Placebo

What is being measured

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

  1. Proportion of participants with complete renal response

    Measured: Week 49 Day 1

Secondary outcomes (7)

  1. Proportion of participants achieving complete renal response

    Measured: Up to Week 73 Day 1

  2. Proportion of participants achieving partial renal response

    Measured: Up to Week 73 Day 1

  3. Proportion of participants achieving overall renal response

    Measured: Up to Week 73 Day 1

  4. Time to first complete renal response

    The time from the date of randomization to the date of the first complete renal response

    Measured: Up to Week 73 Day 1

  5. Time to first overall renal response

    The time from the date of randomization to the date of the first overall renal response

    Measured: Up to Week 73 Day 1

  6. Change in total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score

    SLEDAI-2K score is a systemic lupus erythematosus (SLE) activity index based on the presence of 24 features in 9 organ systems which ranges from 0 - 105, with higher scores indicating more severe features in participants in the past 30 days

    Measured: Baseline to Week 49 Day 1

  7. Area under plasma concentration time curve (AUC) of zanubrutinib

    Measured: Week 1 Day 1 and Week 5 Day 1

Timeline

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

  1. First posted25 Nov 2020
  2. Study start22 Dec 2020
  3. Primary completion26 Feb 2024
  4. Study completion26 Aug 2024

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
Double blind
Who is masked
Participant, Investigator
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04643470
Sponsor's protocol ID
BGB-3111-217
Other IDs
CTR20202662
Status last verified
Nov 2024
First submitted
18 Nov 2020
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zanubrutinib in people with Lupus Nephritis, run by BeiGene at 44 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with complete renal response (time frame: Week 49 Day 1). 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 NCT04643470.

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 29 Nov 2024.

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