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Lupus Erythematosus, SystemicPhase 4NCT05899907

Efficacy and Safety of Telitacicept in Early SLE

A Phase 4 study testing Telitacicept in people with Lupus Erythematosus, Systemic, run by Peking Union Medical College Hospital at 20 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with early stage of SLE . Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
Telitacicept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
20 sitesChina
Study dates
1 Sep 2022to 1 Sep 2025
Phase
Phase 4
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria
  • 18-65 years of age
  • body weight 45-90kg
  • antinuclear antibody titers ≥1:80, and/ or anti-double-stranded DNA antibodies
  • SLEDAI-2K score ≥8 scores
  • Disease duration less than 2 years (defined as the duration between the first appearance of any symptom/sign attributed to SLE and baseline)
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  • A stantard therapy for at least 30d for patients who are not treatment-naive
  • Negative pregnancy test for child-bearing women at screening and baseline
  • Provide written informed consent

Who cannot join

  • Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, and Immunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al
  • Active serious neuropsychiatric systemic lupus erythematosus or other severe situations of SLE who need pulse steroid treatment
  • severe lupus nephritis: 24hUP more than 6g, serum creatinine > 221umol/L
  • History of severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) requiring intervention within 60 days of baseline (Day 1)
  • Abnormal liver function (ALT or AST is 2 times higher than normal)
  • Baseline IgG below the lower limit of the normal range
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  • Pregnancy or breastfeeding women
  • Have a history of malignant tumors
  • Have any serious acute, chronic or recurrent infectious disease (such as pneumonia or active stage of pyelitis, recurrent pneumonia, chronic bronchiectasis and tuberculosis)
  • Chronic infections, such as Hepatitis B virus or hepatitis B and C and HIV
  • Cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolic pressure > 160mmHg or diastolic pressure > 100mmHg) or diabetics
  • Active hemorrhage or peptic ulcer
  • With other concommitant autoimmune disease;
  • Receipt of B-cell-targeted therapy (including belimumab) within 1 year before randomization
  • Receipt of IVIG within 28 days before randomization
  • Receipt of TNF inhibitor, IL-1R inhibitor or plasma exchange therapy within 90 days before randomization
  • Participated in other drugs clinical trials within 4 weeks.
  • Receipt of live vaccine within 4 weeks before randomization
  • Receipt of COVID-19 vaccine within 4 weeks before randomization
  • Subjects who in the opinion of the investigator are not suitable to participate

Trial locations and contacts

20 sites in 1 country.

Xiaomei Leng contact

+8613681057089

lpumch@126.com

20 sites in 1 country

China20 sites, 1 recruiting

  • Chinese Academy of Medical Sciences & Peking Union Medical College

    Beijing, Beijing Municipality, 100730

    Xiaomei Leng, +8613681057089, lpumch@126.com

    Xiaofeng Zeng

    Recruiting

  • Peking University Third Hospital

    Beijing

    Active, not recruiting

  • Fuyang People's Hospital

    Fuyang

    Active, not recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou

    Active, not recruiting

  • Nanfang Hospital, Southern Medical University

    Guanzhou

    Active, not recruiting

  • Qilu Hospital of Shandong University

    Jinan

    Active, not recruiting

  • the First People's Hospital of Yunnan Province

    Kunming

    Active, not recruiting

  • The Second Affiliated Hospital of Lanzhou University

    Lanzhou

    Active, not recruiting

  • The Affiliated Hospital of Nantong University

    Nantong

    Active, not recruiting

  • the Affiliated Hospital of Qingdao University

    Qingdao

    Active, not recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang

    Active, not recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou

    Active, not recruiting

  • Shanxi Baiqiuen Hospital

    Taiyuan

    Active, not recruiting

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

    Active, not recruiting

  • Weifang People's Hospital

    Weifang

    Active, not recruiting

  • Tongji Hospital, Tongji Medical College,

    Wuhan

    Active, not recruiting

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

    Wuhan

    Active, not recruiting

  • Wuxi Second People's Hospital

    Wuxi

    Active, not recruiting

  • the First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Active, not recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhenzhou

    Active, not recruiting

Other trials in China

About this study

Official title: A Study of Telitacicept in the Treatment of Early Stage Systemic Lupus Erythematosus

The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with early stage of SLE .

Read the detailed description

This is a phase 4, multicentre, randomised, double-blind, open-labeled study to evaluate the efficacy and safety of telitacicept in adult subjects with active early stage of SLE (disease duration less than 2 years).

Being tested
Telitacicept, Standard of Care
Keywords
Lupus Erythematosus, Systemic, Telitacicept
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.

  • TelitaciceptDrug

    Also called RC18

    160mg once a week for 48 weeks

  • Standard of CareDrug

    Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Study groups in NCT05899907
Study groupRoleWhat they receive
Treatment groupExperimentalStandard of care plus Telitacicept 160 mg sc per week; after week 12, the dose can be reduced to 80 mg per week due to safety considerations.
Receives: Drug: Telitacicept; Drug: Standard of Care
Control groupOtherStandard of care
Receives: Drug: Standard of Care

What is being measured

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

  1. Proportion of LLDAS in week 24

    Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials

    Measured: week 24

Secondary outcomes (6)

  1. Proportion of LLDAS in week 12

    Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials

    Measured: week 12

  2. Improvement in SLEDAI-2K

    Proportion of patients with SLEDAI-2K scores improvement ≥4 compared with baseline

    Measured: week 24 and 52

  3. Improvement in serological indices

    Improvement in anti-dsDNA antibody titers, C3, C4, T cell and B cell subsets and IgG, IgA, IgM compared with baseline

    Measured: week 24, 52

  4. Change in PGA

    PGA: physician global assesment(0-3)

    Measured: week 24, 52

  5. Number of participants with Adverse Events

    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose resulting in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant and which the investigator regards as serious based on appropriate medical judgment.

    Measured: up to week 52

  6. Disease flare

    Proportion of patients suffer from SLE flare

    Measured: up to week 52

Timeline

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

  1. First posted12 Jun 2023
  2. Study start1 Sep 2022
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Sep 2025 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05899907
Sponsor's protocol ID
PUMCH-HS3345D
Status last verified
Jun 2023
First submitted
26 Mar 2023
Last updated
12 Jun 2023
Results posted
No
Data monitoring committee
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 4 study testing Telitacicept in people with Lupus Erythematosus, Systemic, run by Peking Union Medical College Hospital at 20 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 9 inclusion and 20 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Xiaomei Leng (+8613681057089, lpumch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of LLDAS in week 24 (time frame: week 24). 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 NCT05899907.

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 12 Jun 2023.

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