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

NCT07836660 | Not Yet Recruiting Phase 2

• 1 other identifier: CIBI355A201
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Sjögren's Disease

Outcome Measures

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.

  Baseline and Week 24

Secondary Outcomes (8)

• Change from Baseline in ESSDAI Score at Weeks 12 and 48

  Baseline to Weeks 12 and 48

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

  Baseline to Weeks 12, 24, and 48

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

  Baseline to Weeks 12, 24, and 48

• Change from Baseline in Schirmer Test at Week 48

  Baseline to Week 48

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

  Baseline to Week 48

Study Arms (4)

Part A: IBI355 group

EXPERIMENTAL

IBI355，IV,corresponding dose regimen according to study cohort( Part A) .

Drug: Part A - Placebo for IBI355; Drug: Part A - IBI355

Part B: Telitacicept 160 mg group

EXPERIMENTAL

Participants received telitacicept 160 mg SC QW from Week 0 to Week 24. Follow-up through Week 36

Drug: Part B -Telitacicept

Part A: Placebo group（IBI355-matched）

EXPERIMENTAL

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

Drug: Part A - Placebo for IBI355; Drug: Part A - IBI355

Part B: Placebo group (Telitacicept-matched)

EXPERIMENTAL

Participants received matching placebo SC QW from Week 0 to Week 24. Follow-up through Week 36.

Drug: PartB -Placebo for Telitacicept

Interventions

Part A - Placebo for IBI355 DRUG

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

Part A: IBI355 group; Part A: Placebo group（IBI355-matched）

Part B -Telitacicept DRUG

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

Part B: Telitacicept 160 mg group

PartB -Placebo for Telitacicept DRUG

Matching placebo of Talitacicept ，SC QW × 24 doses.

Part B: Placebo group (Telitacicept-matched)

Part A - IBI355 DRUG

IBI355,IV,corresponding dose regimen according to study design

Part A: IBI355 group; Part A: Placebo group（IBI355-matched）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

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

Hefei, Anhui, 230001, China

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

xiaoyan li

CONTACT

18756032014; xiaoyan.li@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

CN (1)