Primary Sjögren's SyndromePhase 1NCT06484855
Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome
A Phase 1 study testing IBI355 in people with Primary Sjögren's Syndrome, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- IBI355
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2024to 25 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
- Unstimulated whole salivary flow rate > 0 ml/min;
Who cannot join
- 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;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
About this study
Official title: 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.
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- IBI355, IBI355 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI355Drug
IBI355 IV. Q4W
IBI355 placeboDrug
IBI355 placebo IV. Q4W
| Study group | Role | What they receive |
|---|---|---|
| IBI355 7.5mg/kg | Experimental | IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (8:2) Receives: Drug: IBI355; Drug: IBI355 placebo |
| IBI355 15mg/kg | Experimental | IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (8:2) Receives: Drug: IBI355; Drug: IBI355 placebo |
| IBI355 30mg/kg | Experimental | IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (8:2) Receives: Drug: IBI355; Drug: IBI355 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and serious adverse events
Measured: up to week 24
Secondary outcomes (5)
Area under the Curve(AUC) of multi-dose of IBI355
Measured: Up to week 16
Peak serum concentration(Cmax) of multi-dose of IBI355
Measured: Up to week 16
Clearance (CL) of multi-dose of IBI355
Measured: Up to week 16
Half-life (t1/2) of multi-dose of IBI355
Measured: Up to week 16
The ratio of Anti-drug antibody of multi-dose of IBI355
Measured: Up to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start14 Jul 2024
- Primary completion21 Jun 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484855
- Sponsor's protocol ID
- CIBI355A102
- Status last verified
- Sep 2025
- First submitted
- 26 Jun 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06484855
- Acronym / sponsor ID
- CIBI355A102
- Conditions
- Primary Sjögren's Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2024 (actual)
- Primary completion
- 21 Jun 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI355 7.5mg/kg | Experimental | Drug: IBI355, Drug: IBI355 placeboIBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (8:2) |
| IBI355 15mg/kg | Experimental | Drug: IBI355, Drug: IBI355 placeboIBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (8:2) |
| IBI355 30mg/kg | Experimental | Drug: IBI355, Drug: IBI355 placeboIBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (8:2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI355IBI355 IV. Q4W | Drug | IBI355 15mg/kg, IBI355 30mg/kg, IBI355 7.5mg/kg |
| IBI355 placeboIBI355 placebo IV. Q4W | Drug | IBI355 15mg/kg, IBI355 30mg/kg, IBI355 7.5mg/kg |
Primary outcome
Incidence of adverse events and serious adverse events
Time frame: up to week 24
5 secondary outcomes
Area under the Curve(AUC) of multi-dose of IBI355
Time frame: Up to week 16
Peak serum concentration(Cmax) of multi-dose of IBI355
Time frame: Up to week 16
Clearance (CL) of multi-dose of IBI355
Time frame: Up to week 16
Half-life (t1/2) of multi-dose of IBI355
Time frame: Up to week 16
The ratio of Anti-drug antibody of multi-dose of IBI355
Time frame: Up to week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI355 in people with Primary Sjögren's Syndrome, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and serious adverse events (time frame: up to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.