CompletedPhase 3

A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome

China381 participantsStarted 2023-04-06

Plain-language summary

The purpose of this study is to evaluate the efficacy and safety of subcutaneous Telitacicept versus placebo in subjects with active primary Sjogren's Syndrome.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Written informed consent provided.
✓. Males and females, 18-70 years of age.
✓. Fulfilled the classification criteria of pSS according to ACR/EULAR (2016).
✓. Anti-SSA antibody tested positive at screening.
✓. ESSDAI score ≥ 5 at screening.

Exclusion criteria

✕. Secondary Sjogren's syndrome.
✕. Severe organ involvement related to pSS in the opinion of the investigator, including but not limited to a) severe vasculitis (not cutaneous vasculitis) affecting the kidney, gastrointestinal system, cardiac, pulmonary or central nervous system (CNS); b) active CNS or peripheral nervous system involvement requiring high dose corticosteroids; c) severe kidney involvement, e.g. GFR \< 60 ml/min, serum creatinine \> 2 mg/dL, or proteinuria \> 3g/d; d) severe pulmonary involvement, e.g. shortness of breath at rest, FVC \< 60% or DLCO \< 40%; e) muscle diseases requiring high dose corticosteroids; f) lymphoma.
✕. Received sodium hyaluronate eye drops, artificial tears or artificial saliva within 7 days prior to screening.
✕. Received live vaccine within 28 days prior to randomization.
✕. Active hepatitis or history of severe liver diseases.
✕. HIV positive.
✕. Patients with malignant tumors.
✕. Received investigational pharmaceutical within 28 days or 5 half-lives prior to randomization, whichever is longer.

What they're measuring

Change from baseline in ESSDAI score

Timeframe: Week 24

Trial details

NCT IDNCT05673993

SponsorRemeGen Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-29

View on ClinicalTrials.gov More Primary Sjogren's Syndrome trials