NCT07836660Not yet recruitingPhase 2
A Study of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease
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
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- First submitted
- 13 Sept 2026
- Start date
- 15 Oct 2026
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Sjögren's disease
- NCT number
- NCT07836660
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 198
- From 15 Oct 2026 to the primary completion date, 1 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.