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

NCT04078386 | Completed Phase 2 DMC

• 1 other identifier: 18C012
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  week 24

Secondary Outcomes (6)

• The amount of change of ESSDAI score compared to the baseline at week 12.

  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

  week 12，24

• Doctors assess overall changes in disease activity relative to baseline at week 12 and week 24

  week 12,24

• Overall patient assessment of disease activity compared to baseline at week 12 and week 24

  week 12,24

• Changes in short form(SF)-36 relative to baseline at week 12 and week 24

  week 12,24

Study Arms (3)

RC18 240mg

EXPERIMENTAL

Biological: RC18 240 mg

RC18 160 mg

EXPERIMENTAL

Biological: RC18 160 mg

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Placebo BIOLOGICAL

Patients received the test group Placebo weekly administered subcutaneously for 24 times.

Placebo

RC18 240 mg BIOLOGICAL

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

RC18 240mg

RC18 160 mg BIOLOGICAL

Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.

RC18 160 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Remegen,Ltd.

Yantai, Shandong, 264006, China

Location

Related Publications (1)

• 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.

  PMID: 37399108 DERIVED

MeSH Terms

Interventions

RC-18

Study Officials

• Xiaofeng Zeng, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: September 6, 2019
• Study Start: November 21, 2019
• Primary Completion: June 23, 2021
• Study Completion: October 26, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CN (1)