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Systemic Lupus ErythematosusPhase 3NCT04082416

Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

A Phase 3 study testing RC18 160 mg plus standard therapy in people with Systemic Lupus Erythematosus, run by RemeGen Co., Ltd. at 1 site 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 purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
RC18 160 mg plus standard therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
335 participants
Where
1 siteChina
Study dates
16 Oct 2019to 30 Jun 2022
Phase
Phase 3
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

  • Active SLE disease#and at least according with 4 of the 11 items of the American College of Rheumatology (ACR) criteria 1997.
  • Age \& Gender: Male or female between 18 and 65 years of age inclusive#and the sex ratio is not limited
  • Signed informed consent form#willing or able to participate in all required study evaluations and procedures.
  • SELENA-SLEDAI(Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index) score ≥ 8 during the screening period.and if there is Hypo-complement or the Anti-dsDNA score, SELENA-SLEDAI disease activity score should be at least 6 at screening .
  • Autoantibody-positive
  • on a stable SLE treatment regimen for at least 30 days prior to Day 1, which consisted of any of the following (alone or in combination): cortical hormone,anti-malarials,non-steroidal anti inflammatory drugs (NSAIDs),or any immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate

Who cannot join

  • kidney disease ：Severe lupus nephritis 8 weeks prior to randomization (designed as:Urine protein>6g/24h or serum creatinine ( SCr>2.5mg/dL or 221umol/L ) or needing for hemodialysis or receipting high dose cortical hormone ≥14 days( metacortandracin>100mg/d or equivalent)
  • Central nervous system disease caused by SLE or non SLE 8 weeks prior to randomization (including epilepsy、 mental disease、organic encephalopathy syndrome、cerebrovascular accident, encephalitis, central nervous system vasculitis;
  • there are serious heart, liver, kidney and other important organs and blood, endocrine system diseases and medical history;
  • Evaluation criteria for severity :
  • Alanine aminotransferase#ALT#or aspartate aminotransferase (AST) ≥2 upper limit of normal (ULN);
  • Creatinine Clearance (Ccr)<30ml/min;
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  • White Blood Cell Count(WBCs)<2.5x 10(9)/L;
  • hemoglobin<85g/L;
  • Platelets<50x 10(9)/L.
  • Have a historically active hepatitis or active hepatitis or medical history,hepatitis B :Patients with positive HBsAg are excluded.;Hepatitis C: Patients with hepatitis C antibody positive are excluded;
  • Immune deficiency, uncontrolled severe infection and patients with active or recurrent peptic ulcer;
  • Pregnant , lactating women and men or women who have birth plans in the past 12 months ;
  • Have a history of allergic reaction to human biological medicines.
  • Receipt of live vaccine within 1 month;
  • Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking the time for the elderly).
  • Have received treatment with B cell targeted therapy such as Rituximab or Epratuzumab etc.
  • Receipt of anti-tumor necrosis factor#interleukin receptor antagonist#
  • Receipt of IV immunoglobulin(IVIG),prednisone>100mg/d more than 14 days or plasma exchange;
  • There are active infections (such as herpes zoster, human immunodeficiency virus (HIV) virus infection, active tuberculosis, etc.) during the screening period;
  • Patients have depression or the significant suicide ideation;
  • Interleukin(IL)-2, thalidomide, Tripterygium wilfordii and traditional Chinese medicine preparation containing Tripterygium Wilfordii were used within 28 days before randomization
  • Investigator considers candidates not appropriating for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Remegen，ltd.

    Yantai, Shandong

Other trials in China

About this study

Official title: A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).

The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE.

Being tested
Placebo plus standard therapy, RC18 160 mg plus standard therapy
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.

  • Placebo plus standard therapyBiological

    Also called Standard therapy

    Standard therapy comprises any of the following (alone or in combination):

    corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )

  • RC18 160 mg plus standard therapyBiological

    Also called Standard therapy

    Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )

Study groups in NCT04082416
Study groupRoleWhat they receive
RC18 160mgExperimentalPatients received the test group RC18 160mg weekly administered subcutaneously for 52 times.
Receives: Biological: RC18 160 mg plus standard therapy
PlaceboPlacebo comparatorPatients received the test group Placebo weekly administered subcutaneously for 52 times.
Receives: Biological: Placebo plus standard therapy

What is being measured

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

  1. SLE Responder Index (SRI) Response Rate

    At Week 52 the percent of subjects with ≥ 4 point reduction from baseline in SELENA-SLEDAI score and increasing no more than 0.3 points in PGA and no new BILAG A organ domain score or 1 new BILAG B organ domain scores compared with baseline at the time of assessment

    Measured: Week 52

Secondary outcomes (5)

  1. Percent of subjects with ≥ 4 point reduction from baseline in SELENA-SLEDAI score

    Measured: Week 52

  2. Mean Change From Baseline in Physician's global assessment(PGA)

    Physician's global assessment, PGA.The measurement tool is Visual Analogue Scale/Score（VAS）.The doctor assesses participant's disease activity on a VAS of 0-100 mm on the questionnaire form.The higher values represent a worse outcome.There are not combined subscales.

    Measured: Week 52

  3. Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline or ≤ 7.5 mg/Day，During Weeks 44 Through 52.

    Measured: Week 44 through 52

  4. Mean Change From Baseline in Serological Examination Index

    Measured: week 52

  5. The flare time after randomization

    Measured: 52 weeks

Timeline

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

  1. First posted9 Sep 2019
  2. Study start16 Oct 2019
  3. Primary completion24 Apr 2022
  4. Study completion30 Jun 2022

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04082416
Sponsor's protocol ID
18C010
Status last verified
May 2023
First submitted
1 Sep 2019
Last updated
11 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van Vollenhoven RF, Wang L, Merrill JT, Liu Y, Bao C, Li F, Hu J, Huang C, Zhao J, Huang C, Mo H, Wei W, Lu F, Li J, Zhao D, Wang W, Li L, Zuraw Q, Wang X, Wang X, Fang J, Zhang F; 18C010 Trial Investigators. A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus. N Engl J Med. 2025 Oct 16;393(15):1475-1485. doi: 10.1056/NEJMoa2414719.

    PubMed 41092329

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RC18 160 mg plus standard therapy in people with Systemic Lupus Erythematosus, run by RemeGen Co., Ltd. at 1 site 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 6 inclusion and 22 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

SLE Responder Index (SRI) Response Rate (time frame: Week 52). 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 NCT04082416, which also lists 1 linked publication.

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 11 May 2023.

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