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NCT Number: NCT07836660

A Study of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease

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).

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Key information

Conditions

Sjögren's Disease Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230001, China

About this study

This study is a randomized, double-blind, placebo-controlled Phase II study in participants with moderate-to-severe Sjögren's disease. Eligible participants will be randomized to receive IBI355 or placebo during the double-blind treatment period.

The study will evaluate the efficacy of IBI355 in reducing systemic disease activity and improving patient-reported symptoms and disease-related functional outcomes. Safety and tolerability will be assessed throughout the study. Pharmacokinetic, immunogenicity, pharmacodynamic, and other relevant clinical assessments will also be performed as specified in the protocol.

The results of this study are intended to characterize the efficacy and safety profile of IBI355 in participants with Sjögren's disease and to support its further clinical development.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

：

  • 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.
  • Stimulated whole saliva flow rate ≥0.05 mL/min at screening.
  • Baseline ESSDAI score ≥5 in ≥1 of the following domains: systemic, lymphadenopathy, glandular, articular, cutaneous, renal, hematologic, biological.
  • Stable background therapy (hydroxychloroquine ≤400 mg/day, methotrexate ≤25 mg/week, or azathioprine ≤150 mg/day) for ≥12 weeks with stable dose ≥8 weeks prior to randomization.
  • Stable oral corticosteroid dose (≤10 mg/day prednisone equivalent) for ≥4 weeks prior to randomization.

Exclusion criteria

：

  • 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).
  • Chronic hepatitis B (HBsAg+), hepatitis C (HCV RNA+), HIV, or syphilis.
  • Prior use of rituximab, other anti-CD20 agents, or other biologics targeting CD40/CD40L, BAFF/APRIL, or CTLA-4 within 6 months prior to randomization.
  • Use of JAK/TYK inhibitors within 8 weeks prior to randomization.

Treatment and study plan

Part A - Placebo for IBI355

Drug

Matching placebo of IBI355， IV ，corresponding dose regimen according to study design

Part B -Telitacicept

Drug

Telitacicept 160 mg SC QW × 24 doses (Weeks 0-24).

PartB -Placebo for Telitacicept

Drug

Matching placebo of Talitacicept ，SC QW × 24 doses.

Part A - IBI355

Drug

IBI355,IV,corresponding dose regimen according to study design

Primary outcomes

  1. Change from Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 24

    Time frame: Baseline and 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.

Secondary outcomes

  1. Change from Baseline in ESSDAI Score at Weeks 12 and 48

    Time frame: Baseline to 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.

  2. Change from Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 12, 24, and 48

    Time frame: Baseline to 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.

  3. Change from Baseline in Stimulated Salivary Flow (sSF) Rate at Weeks 12, 24, and 48

    Time frame: Baseline to 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.

  4. Change from Baseline in Schirmer Test at Week 48

    Time frame: Baseline to 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.

  5. Change from Baseline in Sj?gren's Tool for Assessing Response (STAR) Score at Week 48

    Time frame: Baseline to Week 48

    The Sj?gren's Tool for Assessing Response (STAR) is a composite assessment of treatment response in Sj?gren's disease incorporating systemic disease activity, patient-reported symptoms, and biological and glandular domains. Higher scores indicate a greater treatment response.

  6. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Weeks 12, 24, and 48

    Time frame: Baseline to Weeks 12, 24, and 48

    The FACIT-Fatigue scale is a 13-item patient-reported measure of fatigue. The total score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. An increase from baseline indicates improvement.

  7. Change from Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score at Weeks 12, 24, and 48

    Time frame: Baseline to Weeks 12, 24, and 48

    The EQ-5D-5L is a standardized measure of health status assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity. Responses are converted to an EQ-5D-5L index score using the prespecified value set, with higher index scores indicating better health status.

  8. Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: From the first dose of study intervention through Week 48

    The number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) will be assessed throughout the study.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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