A Study of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease
ConditionSjögren's Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI355 in participants with moderate-to-severe Sj?gren's disease (SjD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 and ≤75 years.
Diagnosis of Sjögren's syndrome per 2016 ACR/EULAR classification criteria.
Duration of Sjögren's syndrome diagnosis ≤7.5 years.
Serum anti-Ro/SSA (Ro60 and/or Ro52) positive.
Disqualifiers
Known hypersensitivity to IBI355 or its excipients.
Pregnancy or breastfeeding.
Uncontrolled interstitial lung disease (ILD) associated with Sjögren's syndrome (e.g., FVC <70% predicted, ClinESSDAI pulmonary domain indicating severe activity, or NYHA Class III/IV dyspnea).
Active or untreated latent tuberculosis (IGRA-positive without ≥1 month prophylactic treatment).
Trial design
Design model
Parallel
Treatments tested in this trial
Part A - Placebo for IBI355
DrugMatching placebo of IBI355， IV ，corresponding dose regimen according to study design
Part B -Telitacicept
DrugTelitacicept 160 mg SC QW × 24 doses (Weeks 0-24).
PartB -Placebo for Telitacicept
DrugMatching placebo of Talitacicept ，SC QW × 24 doses.
Part A - IBI355
DrugIBI355,IV,corresponding dose regimen according to study design
Treatment groups
198 Participants
are divided into 4 treatment groupsGroup A: Part A: IBI355 groupExperimental treatment 2 interventions
Group B: Part B: Telitacicept 160 mg groupExperimental treatment 1 intervention
Group C: Part A: Placebo group（IBI355-matched）Experimental treatment 2 interventions
Group D: Part B: Placebo group (Telitacicept-matched)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 24
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a physician-assessed index used to evaluate systemic disease activity in Sjögren's disease. The total score ranges from 0 to 123, with higher scores indicating greater systemic disease activity. A decrease from baseline indicates improvement.
Time frame
Baseline and Week 24Secondary outcomes
1
Change from Baseline in ESSDAI Score at Weeks 12 and 48
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a physician-assessed index used to evaluate systemic disease activity in Sjögren's disease. The total score ranges from 0 to 123, with higher scores indicating greater systemic disease activity. A decrease from baseline indicates improvement.
Time frame
Baseline to Weeks 12 and 482
Change from Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 12, 24, and 48
The EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a patient-reported measure assessing dryness, fatigue, and pain. Each domain is rated on a 0-to-10 numerical rating scale, and the total ESSPRI score is calculated as the mean of the three domain scores, ranging from 0 to 10. Higher scores indicate greater symptom severity. A decrease from baseline indicates improvement.
Time frame
Baseline to Weeks 12, 24, and 483
Change from Baseline in Stimulated Salivary Flow (sSF) Rate at Weeks 12, 24, and 48
Stimulated salivary flow rate will be measured according to the protocol-specified procedure. An increase from baseline indicates an improvement in stimulated salivary gland function.
Time frame
Baseline to Weeks 12, 24, and 484
Change from Baseline in Schirmer Test at Week 48
The Schirmer test is used to assess tear production and is reported as the length of wetting of the test strip over 5 minutes, measured in millimeters (mm/5 min). Higher values indicate greater tear production.
Time frame
Baseline to Week 48Sponsors and contacts
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Source ClinicalTrials.gov
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