Systemic Lupus ErythematosusPhase 2NCT02885610
Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
A Phase 2 study testing RC18 80 mg plus standard therapy, RC18 160 mg plus standard therapy and RC18 240 mg plus standard therapy in people with Systemic Lupus Erythematosus, run by RemeGen Co., Ltd. at 1 site in China.
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, Besides ,to provide dose basis for follow-up clinical trials. 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 80 mg plus standard therapy, RC18 160 mg plus standard therapy and RC18 240 mg plus standard therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to 9 Jul 2019
- 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 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 hypocomlement 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 ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin ).
Who cannot join
- Severe lupus nephritis within two months(designed as:Urine protein>6g/24h or serum creatinine ( SCr）>2.5mg/dL or 221umol/L ) or needing for hemodialysis or recepting high dose cortical hormone ≥14 days( metacortandracin>100mg/d or equivalent)
- Central nervous system disease caused by SLE or non SLE within two months (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;
Show all 21Show fewer
- 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;
- Investigator considers candidates not appropriating for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating 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, Besides ,to provide dose basis for follow-up clinical trials.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Placebo plus standard therapy, RC18 80 mg plus standard therapy, RC18 160 mg plus standard therapy, RC18 240 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,leflunomide, Tacrolimus ,ciclosporin )
RC18 80 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,leflunomide, 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,leflunomide, Tacrolimus ,ciclosporin )
RC18 240 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 therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin )
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Placebo SC plus standard therapy; placebo once weekly ,and total of 48 doses Receives: Biological: Placebo plus standard therapy |
| RC18 80 mg plus standard therapy | Experimental | RC18 80 mg/kg SC plus standard therapy RC18 80 mg SC once weekly X 48 doses Receives: Biological: RC18 80 mg plus standard therapy |
| RC18 160 mg plus standard therapy | Experimental | RC18 160 mg/kg SC plus standard therapy RC18 160 mg SC once weekly X 48 doses Receives: Biological: RC18 160 mg plus standard therapy |
| RC18 240 mg plus standard therapy | Experimental | RC18 240 mg/kg SC plus standard therapy RC18 240 mg SC once weekly X 48 doses Receives: Biological: RC18 240 mg plus standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLE Responder Index (SRI) Response Rate
At Week 48, 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 48
Secondary outcomes (1)
Percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startDec 2015
- Primary completion11 Jun 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fengchun Zhang, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885610
- Sponsor's protocol ID
- C005 SLECLLI
- Status last verified
- Mar 2020
- First submitted
- 26 Aug 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Wu D, Li J, Xu D, Merrill JT, van Vollenhoven RF, Liu Y, Hu J, Li Y, Li F, Huang C, Wang G, Li X, Zhao J, Zhao D, Huang C, Liu H, Wei W, Shi G, Lu F, Zuo X, Bi L, Li Z, Wang X, Zhang M, Tie N, Li J, Mo H, Fang J, Bao C, Zhang F. Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2024 Mar 12;83(4):475-487. doi: 10.1136/ard-2023-224854.
PubMed 38129117
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).
- ClinicalTrials.gov ID
- NCT02885610
- Acronym / sponsor ID
- C005 SLECLLI
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, Besides ,to provide dose basis for follow-up clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Biological: Placebo plus standard therapyPlacebo SC plus standard therapy; placebo once weekly ,and total of 48 doses |
| RC18 80 mg plus standard therapy | Experimental | Biological: RC18 80 mg plus standard therapyRC18 80 mg/kg SC plus standard therapy RC18 80 mg SC once weekly X 48 doses |
| RC18 160 mg plus standard therapy | Experimental | Biological: RC18 160 mg plus standard therapyRC18 160 mg/kg SC plus standard therapy RC18 160 mg SC once weekly X 48 doses |
| RC18 240 mg plus standard therapy | Experimental | Biological: RC18 240 mg plus standard therapyRC18 240 mg/kg SC plus standard therapy RC18 240 mg SC once weekly X 48 doses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 hypocomlement or the Anti-dsDNA score, SELENA-SLEDAI disease activity score should be at least 6 at screening .
- Autoantibody-positive
Key exclusion criteria (21 listed)
- Severe lupus nephritis within two months(designed as:Urine protein>6g/24h or serum creatinine ( SCr）>2.5mg/dL or 221umol/L ) or needing for hemodialysis or recepting high dose cortical hormone ≥14 days( metacortandracin>100mg/d or equivalent)
- Central nervous system disease caused by SLE or non SLE within two months (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;
- Alanine aminotransferase（ALT）or aspartate aminotransferase (AST) ≥2 upper limit of normal (ULN);
- Creatinine Clearance (Ccr)<30ml/min;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo plus standard therapyAlso: Standard therapyStandard 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,leflunomide, Tacrolimus ,ciclosporin ) | Biological | Placebo Comparator |
| RC18 80 mg plus standard therapyAlso: Standard therapyStandard 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,leflunomide, Tacrolimus ,ciclosporin ) | Biological | RC18 80 mg plus standard therapy |
| RC18 160 mg plus standard therapyAlso: Standard therapyStandard 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,leflunomide, Tacrolimus ,ciclosporin ) | Biological | RC18 160 mg plus standard therapy |
| RC18 240 mg plus standard therapyAlso: Standard therapyStandard 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,leflunomide, Tacrolimus ,ciclosporin ) | Biological | RC18 240 mg plus standard therapy |
Primary outcome
SLE Responder Index (SRI) Response Rate
Time frame: Week 48
At Week 48, 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.
1 secondary outcome
Percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score
Time frame: Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 38129117Wu D, Li J, Xu D, Merrill JT, van Vollenhoven RF, Liu Y, Hu J, Li Y, Li F, Huang C, Wang G, Li X, Zhao J, Zhao D, Huang C, Liu H, Wei W, Shi G, Lu F, Zuo X, Bi L, Li Z, Wang X, Zhang M, Tie N, Li J, Mo H, Fang J, Bao C, Zhang F. Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2024 Mar 12;83(4):475-487. doi: 10.1136/ard-2023-224854.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengchun Zhang principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RC18 80 mg plus standard therapy, RC18 160 mg plus standard therapy and RC18 240 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 21 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 4 Mar 2020. 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 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?
SLE Responder Index (SRI) 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 NCT02885610, 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 4 Mar 2020.