Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome

A Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of IBI355 in Patients With Primary Sjogren's Syndrome

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in primary Sjogren's syndrome (pSS) patients. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in pSS patients.

Study Overview

• Status: Completed
• Conditions: Primary Sjögren's Syndrome
• Intervention / Treatment: Drug: IBI355; Drug: IBI355 placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • The First Affiliated Hospital of University of Science and Technology of China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Understand and sign the informed consent form;
2. Age ≥ 18 years, male or female；
3. Body Mass Index (BMI) within the range of 18.0 to 28.0 kg/m² (inclusive);
4. Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for Sjögren's Syndrome;
5. Positive for anti-Sjögren's syndrome A autoantibodies (SSA) and/or anti-Sjögren's syndrome B autoantibodies (SSB);
6. Unstimulated whole salivary flow rate > 0 ml/min;

Exclusion Criteria:

1. Individuals who have had allergic reactions to any components of IBI355, have allergic diseases, or possess an allergic constitution;
2. Those who cannot tolerate frequent venipuncture procedures;
3. Participants diagnosed with secondary Sjögren's syndrome, or whose clinical symptoms (or laboratory abnormalities) require explanation by another connective tissue disease (such as systemic lupus erythematosus, mixed connective tissue disease, etc.).
4. Subjects paticipated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
5. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
6. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
7. There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;

6.Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases; 7. Subject with a hcg positive; 8.Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial; 9.Patients with pulmonary interstitial fibrosis, or those requiring combined antifibrotic drug therapy, or those with abnormal lung function that the investigators determined was not suitable for this study; 10. Need to use other drugs that could cause xerostomia during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI355 7.5mg/kg; IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (8:2)	Drug: IBI355; IBI355 IV. Q4W; Drug: IBI355 placebo; IBI355 placebo IV. Q4W
Experimental: IBI355 15mg/kg; IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (8:2)	Drug: IBI355; IBI355 IV. Q4W; Drug: IBI355 placebo; IBI355 placebo IV. Q4W
Experimental: IBI355 30mg/kg; IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (8:2)	Drug: IBI355; IBI355 IV. Q4W; Drug: IBI355 placebo; IBI355 placebo IV. Q4W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events and serious adverse events	up to week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
The ratio of Anti-drug antibody of multi-dose of IBI355	Up to week 24
Area under the Curve(AUC) of multi-dose of IBI355	Up to week 16
Peak serum concentration(Cmax) of multi-dose of IBI355	Up to week 16
Clearance (CL) of multi-dose of IBI355	Up to week 16
Half-life (t1/2) of multi-dose of IBI355	Up to week 16

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2024
• Primary Completion (Actual): June 21, 2025
• Study Completion (Actual): July 25, 2025

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Disease; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: CIBI355A102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No