Clinical trial NCT04078386: A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Sjögren's Syndrome
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.


Eligibility 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

Primary outcomes:
measure: The amount of change of European League Against Rheumatism Sjögren's syndrome disease activity(ESSDAI) score compared to the baseline at week 24.
timeFrame: week 24
Secondary outcomes:
measure: The amount of change of ESSDAI score compared to the baseline at week 12.
timeFrame: week 12
measure: 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
timeFrame: week 12，24
measure: Doctors assess overall changes in disease activity relative to baseline at week 12 and week 24
timeFrame: week 12,24
measure: Overall patient assessment of disease activity compared to baseline at week 12 and week 24
timeFrame: week 12,24
measure: Changes in short form(SF)-36 relative to baseline at week 12 and week 24
timeFrame: week 12,24
measure: Statistical Analysis of the variation of multidimensional fatigue inventory relative to baseline at week 12 and week 24
timeFrame: week 12,24
Other outcomes:
Locations:
city: Yantai
country: China
facility: Remegen,Ltd.
state: Shandong
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xiaofeng Zeng, M.D.
role: PRINCIPAL_INVESTIGATOR
References: