IBI355 for Adults With Moderate-to-Severe Sjögren's Disease
Tests IBI355 against a placebo in adults with moderate-to-severe Sjögren's disease.
Plain-language title generated from the registry record
Registry title: A Study of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease
Key facts
- Where
- Hefei, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07836660, who can take part
Where in China
- The First Affiliated Hospital of University of Science and Technology of ChinaHefei, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Innovent Biologics (Suzhou) Co. Ltd.
- Trial code
- NCT07836660
- Record updated
- 23 September 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: 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; Known hypersensitivity to IBI355 or its excipients; 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; Pregnancy or breastfeeding.