A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 17 January 2022
• Main ID: NCT04078386
• Date of registration: 18/07/2019
• Prospective Registration: Yes
• Primary sponsor: RemeGen Co., Ltd.
• Public title: A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome
• Scientific 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
• Date of first enrolment: November 21, 2019
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04078386
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Xiaofeng Zeng, M.D.
• Affiliation: Peking Union Medical College Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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;

- 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sjögren's Syndrome

Intervention(s)

Biological: RC18 240 mg

Biological: Placebo

Biological: RC18 160 mg

Primary Outcome(s)

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]

Secondary Outcome(s)

Changes in short form(SF)-36 relative to baseline at week 12 and week 24 [Time Frame: week 12,24]

The amount of change of ESSDAI score compared to the baseline at week 12. [Time Frame: week 12]

Statistical Analysis of the variation of multidimensional fatigue inventory relative to baseline at week 12 and week 24 [Time Frame: week 12,24]

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]

Overall patient assessment of disease activity compared to 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]

Secondary ID(s)

18C012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors