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

• ClinicalTrials.gov Identifier: NCT04078386
• Recruitment Status: Completed
• First Posted: September 6, 2019
• Last Update Posted: January 11, 2022
• Sponsor: RemeGen Co., Ltd.
• Information provided by (Responsible Party): RemeGen Co., Ltd.

Tracking Information

• First Submitted Date: July 18, 2019
• First Posted Date: September 6, 2019
• Last Update Posted Date: January 11, 2022
• Actual Study Start Date: November 21, 2019
• Actual Primary Completion Date: June 23, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 1, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 1, 2019)

• The amount of change of ESSDAI score compared to the baseline at week 12. [ Time Frame: 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.
• 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 ]
  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.
• Doctors assess overall changes in disease activity relative to baseline at week 12 and week 24 [ Time Frame: week 12,24 ]
  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.
• Overall patient assessment of disease activity compared to baseline at week 12 and week 24 [ Time Frame: week 12,24 ]
  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.
• Changes in short form(SF)-36 relative to baseline at week 12 and week 24 [ Time Frame: week 12,24 ]
  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.
• Statistical Analysis of the variation of multidimensional fatigue inventory relative to baseline at week 12 and week 24 [ Time Frame: week 12,24 ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Brief Summary: The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Primary Sjögren's Syndrome

Intervention

• Biological: Placebo
  Patients received the test group Placebo weekly administered subcutaneously for 24 times.
• Biological: RC18 240 mg
  Arm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
• Biological: RC18 160 mg
  Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.

Study Arms

• Experimental: RC18 240mg
  Intervention: Biological: RC18 240 mg
• Experimental: RC18 160 mg
  Intervention: Biological: RC18 160 mg
• Placebo Comparator: Placebo
  Intervention: Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 26, 2021): 42
• Original Estimated Enrollment (submitted: September 1, 2019): 30
• Actual Study Completion Date: October 26, 2021
• Actual Primary Completion Date: June 23, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04078386
• Other Study ID Numbers: 18C012
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: RemeGen Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: RemeGen Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Xiaofeng Zeng, M.D.; Peking Union Medical College Hospital

• PRS Account: RemeGen Co., Ltd.
• Verification Date: January 2022