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Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT06484855•Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

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

Hefei, Anhui, China

Key Dates

Start Date

July 14, 2024

Primary Completion Date

June 21, 2025

Completion Date

July 25, 2025

Last Updated

September 15, 2025

Enrollment

ACTUAL participants

Conditions

Primary Sjögren's Syndrome

Interventions

IBI355

DRUG

IBI355 placebo

DRUG

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NOT_YET_RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary Sjögren's Syndrome

Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome

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