Primary Sjögren's SyndromePhase 2NCT04078386
A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome
A Phase 2 study testing RC18 240 mg and RC18 160 mg in people with Primary Sjögren's Syndrome, run by RemeGen Co., Ltd. at 14 sites in China.
Trial summary
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- RC18 240 mg and RC18 160 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 14 sitesChina
- Study dates
- 21 Nov 2019to 26 Oct 2021
- 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
- Voluntarily signed informed consent ;
- Patient with primary Sjögren's syndrome according to the European - American consensus group criteria.
- Seropositive at screening for anti-Ro/Sjögren's syndrome type A(SSA) antibodies
- ESSDAI score ≥ 5.
Who cannot join
- Diagnosis of secondary Sjogren's syndrome, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis and other autoimmune diseases;
- Abnormal laboratory parameters need to be excluded, including but not limited to:
- Immunosuppressive agents were used within 4 weeks prior to randomization.;
- The use of hydroxychloroquine was allowed during the trial, and the pre-randomized drug regimen was stable for less than 12 weeks;
- Use of biological agents for targeted therapy in the first 6 months of randomization;
- Treatment of primary Sjogren's syndrome with traditional Chinese medicine and proprietary Chinese medicine within 4 weeks before randomization;
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- The use of saliva-stimulating drugs within 7 days prior to randomization;
- Sodium hyaluronate eye drops, artificial tears can be used, and the stability time of the randomized pre-medication scheme is less than 4 weeks;
- Intravenous immunoglobulin therapy or plasma exchange therapy within 6 months before randomization;
- Infection with herpes zoster or HIV and hepatitis C virus(HCV) antibody positive;
- Currently suffering from active hepatitis or severe liver lesions and history;
- Malignant tumor patients ;
- Combined with involvement of important organs or neuropathy;
- 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 shorter).
- Pregnant , lactating women and men or women who have birth plans during the research;
- Investigator considers candidates not appropriating for the study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Beijing Hospital
Beijing
Peking Union Medical College Hospital
Beijing
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
The Second Xiangya Hospital of Central South University
Changsha, Hunan
West China School of Medicine，West China Hospital of Sichuan University
Chengdu
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
The First Affiliated Hospital of USTC，Anhui Provincial Hospital
Hefei, Anhui
Huzhou Third Municipal Hospital
Huzhou, Zhejiang
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Pingxiang People's Hospital
Pingxiang, Jiangxi
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Tianjin Medical University General Hospital
Tianjin
The First Affiliated Hospital of Xiamen University
Xiamen
About this study
Official title: A Phase II Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Primary Sjögren's Syndrome
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- Placebo, RC18 240 mg, RC18 160 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Patients received the test group Placebo weekly administered subcutaneously for 24 times.
RC18 240 mgBiological
Arm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
RC18 160 mgBiological
Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
| Study group | Role | What they receive |
|---|---|---|
| RC18 240mg | Experimental | Not described Receives: Biological: RC18 240 mg |
| RC18 160 mg | Experimental | Not described Receives: Biological: RC18 160 mg |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of change of European League Against Rheumatism Sjögren's syndrome disease activity(ESSDAI) score compared to the baseline at week 24.
ESSDAI= European League Against Rheumatism Sjögren's syndrome disease activity index score.The ESSDAI includes It includes 12 domains (ie, organ systems: cutaneous,respiratory, renal, articular, muscular，peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular,constitutional,lymphadenopathic,biological).. Each domain is divided into 3-4 levels of activity.The higher the score, the more serious the symptoms ,that is,the worse the results.Subscales are combined by summed.
Measured: week 24
Secondary outcomes (6)
The amount of change of ESSDAI score compared to the baseline at week 12.
ESSDAI= European League Against Rheumatism Sjögren's syndrome disease activity index score.The ESSDAI includes It includes 12 domains (ie, organ systems: cutaneous,respiratory, renal, articular, muscular，peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular,constitutional,lymphadenopathic,biological).. Each domain is divided into 3-4 levels of activity.The higher the score, the more serious the symptoms ,that is,the worse the results.Subscales are combined by summed.
Measured: week 12
The amount of change of European League Against Rheumatism Sjögren'sSyndrome Patient Reported Index(ESSPRI) score compared to the baseline at week 12 and week 24
European League Against Rheumatism Sjögren's Syndrome Patient Reported Index.Dryness, pain, somatic and mental fatigue were identified as the main symptoms of patients with primary SS. It was suspected that a single 0-10 numerical scale for each domain was sufficient to assess these symptoms.The higher values represent a worse outcome.Subscales are combined by averaged.
Measured: week 12，24
Doctors assess overall changes in disease activity relative to baseline at week 12 and week 24
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.
Measured: week 12,24
Overall patient assessment of disease activity compared to baseline at week 12 and week 24
The measurement tool is Visual Analogue Scale/Score（VAS）. The participant assesses his/her own disease activity on a VAS of 0 - 100 mm on the questionnaire form.
Measured: week 12,24
Changes in short form(SF)-36 relative to baseline at week 12 and week 24
SF-36=36-item short form. As a concise health questionnaire, SF-36 summarized the quality of life of the subjects from eight aspects: physiological function, physical pain, general health condition, energy, social function, emotional function and mental health.The SF-361 is a self-report, 36 item survey measuring health-related quality-of-life. Thirty-five items are used to construct 8 scales. An additional item measures health transition.The higher values represent a better outcome.Subscales are combined by averaged.
Measured: week 12,24
Statistical Analysis of the variation of multidimensional fatigue inventory relative to baseline at week 12 and week 24
Multidimensional Fatigue Inventory.The MFI is a 20-item scale designed to evaluate fi ve dimensions of fatigue: general fatigue, physical fatigue, reduced motivation,reduced activity, and mental fatigue.The higher values represent a worse outcome,Subscales are combined by summed.
Measured: week 12,24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start21 Nov 2019
- Primary completion23 Jun 2021
- Study completion26 Oct 2021
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 Primary Sjögren's SyndromeStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078386
- Sponsor's protocol ID
- 18C012
- Status last verified
- May 2026
- First submitted
- 18 Jul 2019
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu D, Fang J, Zhang S, Huang C, Huang C, Qin L, Li X, Chen M, Liu X, Liu Y, Li Z, Hu J, Bao C, Wei W, Tian J, Duan X, Zeng X. Efficacy and safety of telitacicept in primary Sjogren's syndrome: a randomized, double-blind, placebo-controlled, phase 2 trial. Rheumatology (Oxford). 2024 Mar 1;63(3):698-705. doi: 10.1093/rheumatology/kead265.
PubMed 37399108
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT04078386
- Acronym / sponsor ID
- 18C012
- Conditions
- Primary Sjögren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 6 Sep 2019 (actual)
- 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 observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RC18 240mg | Experimental | Biological: RC18 240 mg |
| RC18 160 mg | Experimental | Biological: RC18 160 mg |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily signed informed consent ;
- Patient with primary Sjögren's syndrome according to the European - American consensus group criteria.
- Seropositive at screening for anti-Ro/Sjögren's syndrome type A(SSA) antibodies
- ESSDAI score ≥ 5.
Key exclusion criteria (16 listed)
- Diagnosis of secondary Sjogren's syndrome, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis and other autoimmune diseases;
- Abnormal laboratory parameters need to be excluded, including but not limited to:
- Immunosuppressive agents were used within 4 weeks prior to randomization.;
- The use of hydroxychloroquine was allowed during the trial, and the pre-randomized drug regimen was stable for less than 12 weeks;
- Use of biological agents for targeted therapy in the first 6 months of randomization;
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 |
|---|---|---|
| PlaceboPatients received the test group Placebo weekly administered subcutaneously for 24 times. | Biological | Placebo |
| RC18 240 mgArm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times. | Biological | RC18 240mg |
| RC18 160 mgPatients received the test group RC18 160mg weekly administered subcutaneously for 24 times. | Biological | RC18 160 mg |
Primary outcome
The amount of change of European League Against Rheumatism Sjögren's syndrome disease activity(ESSDAI) score compared to the baseline at week 24.
Time frame: week 24
ESSDAI= European League Against Rheumatism Sjögren's syndrome disease activity index score.The ESSDAI includes It includes 12 domains (ie, organ systems: cutaneous,respiratory, renal, articular, muscular，peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular,constitutional,lymphadenopathic,biological).. Each domain is divided into 3-4 levels of activity.The higher the score, the more serious the symptoms ,that is,the worse the results.Subscales are combined by summed.
6 secondary outcomes
The amount of change of ESSDAI score compared to the baseline at week 12.
Time frame: week 12
The amount of change of European League Against Rheumatism Sjögren'sSyndrome Patient Reported Index(ESSPRI) score compared to the baseline at week 12 and week 24
Time frame: week 12，24
Doctors assess overall changes in disease activity relative to baseline at week 12 and week 24
Time frame: week 12,24
Overall patient assessment of disease activity compared to baseline at week 12 and week 24
Time frame: week 12,24
Changes in short form(SF)-36 relative to baseline at week 12 and week 24
Time frame: week 12,24
Statistical Analysis of the variation of multidimensional fatigue inventory relative to baseline at week 12 and week 24
Time frame: week 12,24
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 27 May 2026.
- Results publication: PubMed 37399108Xu D, Fang J, Zhang S, Huang C, Huang C, Qin L, Li X, Chen M, Liu X, Liu Y, Li Z, Hu J, Bao C, Wei W, Tian J, Duan X, Zeng X. Efficacy and safety of telitacicept in primary Sjogren's syndrome: a randomized, double-blind, placebo-controlled, phase 2 trial. Rheumatology (Oxford). 2024 Mar 1;63(3):698-705. doi: 10.1093/rheumatology/kead265.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites 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 240 mg and RC18 160 mg in people with Primary Sjögren's Syndrome, run by RemeGen Co., Ltd. at 14 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 16 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 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
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?
The amount of change of European League Against Rheumatism Sjögren's syndrome disease activity(ESSDAI) score compared to the baseline at 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 NCT04078386, 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 27 May 2026.