Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome (NCT06484855) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome
China30 participantsStarted 2024-07-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Understand and sign the informed consent form;
. Age ≥ 18 years, male or female；
. Body Mass Index (BMI) within the range of 18.0 to 28.0 kg/m² (inclusive);
. Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for Sjögren's Syndrome;
. Positive for anti-Sjögren's syndrome A autoantibodies (SSA) and/or anti-Sjögren's syndrome B autoantibodies (SSB);
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events and serious adverse events
. Individuals who have had allergic reactions to any components of IBI355, have allergic diseases, or possess an allergic constitution;
. Those who cannot tolerate frequent venipuncture procedures;
. 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.).
. Subjects paticipated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
. 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;
.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.