Type 1 AIPPhase 4NCT07862075
Inebilizumab for the Treatment of Patients With Type 1 Autoimmune Pancreatitis
A Phase 4 study testing Inebilizumab in people with Type 1 AIP, run by Ruijin Hospital at 1 site in China.
Trial summary
Autoimmune pancreatitis (AIP) is an immune-related inflammatory disease of the pancreas. Relapse can occur after treatment, and long-term treatment with glucocorticoids and conventional immunosuppressants can cause significant side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 AIP
- What is being tested?
- Inebilizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- A signed and dated informed consent form;
- A commitment to adhere to the study protocol and to cooperate throughout the entire study;
- Aged 18 years or over, regardless of gender;
- Diagnosed with Type I AIP;
- Indications for treatment: (1) For symptomatic participants, evidence of pancreatic involvement (e.g. obstructive jaundice, abdominal pain, lower back pain) and extra-pancreatic organ involvement (e.g. jaundice caused by bile duct stricture); (2) Asymptomatic participants with subclinical AIP that may progress to severe, irreversible damage to vital organs (e.g. persistent pancreatic mass, abnormal liver function accompanied by proximal IgG4-related sclerosing cholangitis);
- Be able to adhere to and cooperate with study interventions, such as taking oral medication;
- If a woman of childbearing potential, she must have used contraception for at least one month prior to screening and undertake to use contraception throughout the study period and for a specified period following the study's conclusion;
Who cannot join
- Participants meeting any of the following criteria will be excluded from this study:
- Women who are trying to conceive, are pregnant or are breastfeeding;
- Those who are unable or refuse to sign the informed consent form;
- History of mental illness;
- Allergy to the study intervention;
- Concurrent malignant tumours;
- Infectious diseases such as active hepatitis or tuberculosis;
- Concurrent uncontrolled underlying conditions, such as severe heart failure or respiratory failure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai
Shanghai
Duowu Zou, Doctor, 18817554263 ext. 8613901617608, zdw_pi@126.com
About this study
Official title: Inebilizumab for the Treatment of Patients With Relapsing Type 1 Autoimmune Pancreatitis: A Multicenter, Single-Arm, Open-Label Study
Autoimmune pancreatitis (AIP) is an immune-related inflammatory disease of the pancreas. Relapse can occur after treatment, and long-term treatment with glucocorticoids and conventional immunosuppressants can cause significant side effects.
This multicenter, single-arm, open-label study aims to evaluate the efficacy and safety of inebilizumab in patients with AIP. Inebilizumab targets CD19 and reduces B cells, including plasmablasts.
Read more
The study plans to enroll 50 patients with confirmed AIP, including both newly diagnosed patients and patients with relapsing disease. All eligible participants will receive inebilizumab and follow a standardized glucocorticoid dose-reduction regimen.
The primary objective is to assess whether inebilizumab can reduce the relapse rate within 32 weeks. Secondary objectives are to assess its effects on glucocorticoid use, serum IgG4 levels, B-cell counts, and other immune cells.
Peripheral blood samples and lymph node samples will be collected for exploratory mechanistic analyses to characterize circulating and tissue immune-cell populations and blood-based biomarkers during treatment and follow-up.
Read the detailed description
Type 1 autoimmune pancreatitis (AIP) is a manifestation of IgG4-related disease and is associated with a high relapse rate. Long-term treatment with glucocorticoids and conventional immunosuppressants can cause significant adverse effects. Inebilizumab is a CD19-targeted B-cell-depleting agent that acts on the B-cell lineage, including plasmablasts. This study aims to further investigate its efficacy and safety in patients with type 1 AIP.
This prospective, multicenter, single-arm, open-label study plans to enroll a total of 50 patients with confirmed type 1 AIP across 14 participating centers in China. Both newly diagnosed patients and patients with relapsing disease are eligible, provided they meet the study's eligibility criteria. Prior treatment with glucocorticoids or immunosuppressants and a history of relapse are not prerequisites for enrollment.
The primary objective is to assess whether inebilizumab can reduce the relapse rate within 32 weeks in patients with type 1 AIP. Secondary objectives are to assess its effects on glucocorticoid use, serum IgG4 levels, B-cell counts, and other immune cells.
All participants will receive inebilizumab and follow a standardized glucocorticoid tapering regimen. Glucocorticoids will initially be administered at 30 mg/day for one month. The daily dose will then be reduced by one tablet every two weeks until a dose of 20 mg/day is reached. Inebilizumab treatment will subsequently begin, with 300 mg administered intravenously on Day 1 and Day 15. Maintenance treatment will consist of 300 mg administered intravenously every 24 weeks thereafter until the end of the study.
Peripheral blood samples will be collected at baseline before the first dose of inebilizumab, on Day 15, and at Months 6, 12, and 18 after treatment initiation. Lymph node samples will be collected at baseline and at Month 1 or Months 6. These samples will be used for exploratory mechanistic analyses to characterize circulating and tissue immune-cell populations and blood-based biomarkers during treatment and follow-up.
Additional peripheral blood and lymph node samples will be collected if disease relapse occurs during follow-up. These samples will be used to investigate immunological changes associated with disease relapse.
- Conditions
- Type 1 AIP
- Being tested
- Inebilizumab
- Keywords
- Type 1 AIP, Inebilizumab, Anti-CD19, Treatment
- Medical subject headings
- Autoimmune Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InebilizumabDrug
All patients with type 1 AIP received a standardised glucocorticoid tapering regimen: 30 mg/day for one month, followed by a reduction of one tablet every two weeks to 20 mg/day. Treatment with inelizumab was initiated as follows: Day 1: intravenous infusion of inelizumab 300 mg; Day 15: intravenous infusion of inelizumab 300 mg. Maintenance phase: Thereafter, one infusion of 300 mg every 24 weeks (6 months) until the end of the study. Peripheral blood and lymph node sampling is planned at specified study visits and at disease relapse for exploratory mechanistic analyses, as detailed in the study description.
| Study group | Role | What they receive |
|---|---|---|
| Inebilizumab Treatment | Experimental | All patients with type 1 AIP received a standardised glucocorticoid tapering regimen: 30 mg/day for one month, followed by a reduction of one tablet every two weeks to 20 mg/day. Treatment with Inelizumab was initiated as follows: Day 1: intravenous infusion of Inelizumab 300 mg; Day 15: intravenous infusion of Inelizumab 300 mg. Maintenance phase: Thereafter, one infusion of 300 mg every 24 weeks (6 months) until the end of the study.Peripheral blood and lymph node sampling is planned at specified study visits and at disease relapse for exploratory mechanistic analyses, as detailed in the study description. Receives: Drug: Inebilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate within 6 months
The proportion of participants with type 1 autoimmune pancreatitis who experience disease relapse within 6 months. Disease relapse will be assessed using clinical symptoms and signs, laboratory findings, including serum IgG4, IgG, liver function, erythrocyte sedimentation rate, complete blood count, and B-cell counts, and contrast-enhanced pancreatic MRI.
Measured: 6 months
Secondary outcomes (4)
Daily Glucocorticoid Dose
The daily dose of glucocorticoids taken by each participant will be recorded in mg/day at baseline and at scheduled follow-up visits. Daily doses will be summarized separately for each assessment time point.
Measured: Baseline through 6 months
Serum IgG4 level
Serum IgG4 level will be measured at baseline and at scheduled follow-up visits. Measured level will be summarized separately for each assessment time point.
Measured: Baseline through 6 months
Peripheral Blood B-Cell Count
B-cell counts in peripheral blood will be measured at baseline and at scheduled follow-up visits. Measured counts will be summarized separately for each assessment time point.
Measured: Baseline through 6 months
Other immune cells in Peripheral Blood
The count of other immune cells in peripheral blood will be measured at baseline and at scheduled follow-up visits. Measured counts will be summarized separately for each assessment time point.
Measured: Baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Oct 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 AIPStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, The First Affiliated Hospital of University of Science and Technology of China, First Hospital of China Medical University, The First Affiliated Hospital of Nanchang University, The First People's Hospital of Yunnan, Zhongshan Hospital Affiliated to Xiamen University, Second Affiliated Hospital of Soochow University, Zunyi Medical College, Shengjing Hospital, The Affiliated Hospital of Qingdao University, Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, The Third Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University
- Responsible party
- Principal investigator, ZOU DUOWU, Ruijin Hospital
- Investigators
- Duowu Zou, Doctor, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862075
- Sponsor's protocol ID
- RuijinH2025634
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inebilizumab for the Treatment of Patients With Relapsing Type 1 Autoimmune Pancreatitis: A Multicenter, Single-Arm, Open-Label Study
- ClinicalTrials.gov ID
- NCT07862075
- Acronym / sponsor ID
- RuijinH2025634
- Conditions
- Type 1 AIP
- Keywords
- Type 1 AIP, Inebilizumab, Anti-CD19, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, The First Affiliated Hospital of University of Science and Technology of China, First Hospital of China Medical University, The First Affiliated Hospital of Nanchang University, The First People's Hospital of Yunnan, Zhongshan Hospital Affiliated to Xiamen University, Second Affiliated Hospital of Soochow University, Zunyi Medical College, Shengjing Hospital, The Affiliated Hospital of Qingdao University, Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, The Third Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 7 Oct 2026 (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.
Autoimmune pancreatitis (AIP) is an immune-related inflammatory disease of the pancreas. Relapse can occur after treatment, and long-term treatment with glucocorticoids and conventional immunosuppressants can cause significant side effects.
This multicenter, single-arm, open-label study aims to evaluate the efficacy and safety of inebilizumab in patients with AIP. Inebilizumab targets CD19 and reduces B cells, including plasmablasts.
The study plans to enroll 50 patients with confirmed AIP, including both newly diagnosed patients and patients with relapsing disease. All eligible participants will receive inebilizumab and follow a standardized glucocorticoid dose-reduction regimen.
The primary objective is to assess whether inebilizumab can reduce the relapse rate within 32 weeks. Secondary objectives are to assess its effects on glucocorticoid use, serum IgG4 levels, B-cell counts, and other immune cells.
Peripheral blood samples and lymph node samples will be collected for exploratory mechanistic analyses to characterize circulating and tissue immune-cell populations and blood-based biomarkers during treatment and follow-up.
Detailed description
Type 1 autoimmune pancreatitis (AIP) is a manifestation of IgG4-related disease and is associated with a high relapse rate. Long-term treatment with glucocorticoids and conventional immunosuppressants can cause significant adverse effects. Inebilizumab is a CD19-targeted B-cell-depleting agent that acts on the B-cell lineage, including plasmablasts. This study aims to further investigate its efficacy and safety in patients with type 1 AIP.
This prospective, multicenter, single-arm, open-label study plans to enroll a total of 50 patients with confirmed type 1 AIP across 14 participating centers in China. Both newly diagnosed patients and patients with relapsing disease are eligible, provided they meet the study's eligibility criteria. Prior treatment with glucocorticoids or immunosuppressants and a history of relapse are not prerequisites for enrollment.
The primary objective is to assess whether inebilizumab can reduce the relapse rate within 32 weeks in patients with type 1 AIP. Secondary objectives are to assess its effects on glucocorticoid use, serum IgG4 levels, B-cell counts, and other immune cells.
All participants will receive inebilizumab and follow a standardized glucocorticoid tapering regimen. Glucocorticoids will initially be administered at 30 mg/day for one month. The daily dose will then be reduced by one tablet every two weeks until a dose of 20 mg/day is reached. Inebilizumab treatment will subsequently begin, with 300 mg administered intravenously on Day 1 and Day 15. Maintenance treatment will consist of 300 mg administered intravenously every 24 weeks thereafter until the end of the study.
Peripheral blood samples will be collected at baseline before the first dose of inebilizumab, on Day 15, and at Months 6, 12, and 18 after treatment initiation. Lymph node samples will be collected at baseline and at Month 1 or Months 6. These samples will be used for exploratory mechanistic analyses to characterize circulating and tissue immune-cell populations and blood-based biomarkers during treatment and follow-up.
Additional peripheral blood and lymph node samples will be collected if disease relapse occurs during follow-up. These samples will be used to investigate immunological changes associated with disease relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inebilizumab Treatment | Experimental | Drug: InebilizumabAll patients with type 1 AIP received a standardised glucocorticoid tapering regimen: 30 mg/day for one month, followed by a reduction of one tablet every two weeks to 20 mg/day. Treatment with Inelizumab was initiated as follows: Day 1: intravenous infusion of Inelizumab 300 mg; Day 15: intravenous infusion of Inelizumab 300 mg. Maintenance phase: Thereafter, one infusion of 300 mg every 24 weeks (6 months) until the end of the study.Peripheral blood and lymph node sampling is planned at specified study visits and at disease relapse for exploratory mechanistic analyses, as detailed in the study description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A signed and dated informed consent form;
- A commitment to adhere to the study protocol and to cooperate throughout the entire study;
- Aged 18 years or over, regardless of gender;
- Diagnosed with Type I AIP;
- Indications for treatment: (1) For symptomatic participants, evidence of pancreatic involvement (e.g. obstructive jaundice, abdominal pain, lower back pain) and extra-pancreatic organ involvement (e.g. jaundice caused by bile duct stricture); (2) Asymptomatic participants with subclinical AIP that may progress to severe, irreversible damage to vital organs (e.g. persistent pancreatic mass, abnormal liver function accompanied by proximal IgG4-related sclerosing cholangitis);
Key exclusion criteria (8 listed)
- Women who are trying to conceive, are pregnant or are breastfeeding;
- Those who are unable or refuse to sign the informed consent form;
- History of mental illness;
- Allergy to the study intervention;
- Concurrent malignant tumours;
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 |
|---|---|---|
| InebilizumabAll patients with type 1 AIP received a standardised glucocorticoid tapering regimen: 30 mg/day for one month, followed by a reduction of one tablet every two weeks to 20 mg/day. Treatment with inelizumab was initiated as follows: Day 1: intravenous infusion of inelizumab 300 mg; Day 15: intravenous infusion of inelizumab 300 mg. Maintenance phase: Thereafter, one infusion of 300 mg every 24 weeks (6 months) until the end of the study. Peripheral blood and lymph node sampling is planned at specified study visits and at disease relapse for exploratory mechanistic analyses, as detailed in the study description. | Drug | Inebilizumab Treatment |
Primary outcome
Recurrence rate within 6 months
Time frame: 6 months
The proportion of participants with type 1 autoimmune pancreatitis who experience disease relapse within 6 months. Disease relapse will be assessed using clinical symptoms and signs, laboratory findings, including serum IgG4, IgG, liver function, erythrocyte sedimentation rate, complete blood count, and B-cell counts, and contrast-enhanced pancreatic MRI.
4 secondary outcomes
Daily Glucocorticoid Dose
Time frame: Baseline through 6 months
Serum IgG4 level
Time frame: Baseline through 6 months
Peripheral Blood B-Cell Count
Time frame: Baseline through 6 months
Other immune cells in Peripheral Blood
Time frame: Baseline through 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. No plan to share IPD
Related trials for Type 1 AIP
RecruitingPhase 4
A Trial on the Remission Rates of Type I Autoimmune Pancreatits With High-risk of Recurrence
Type 1 AIP
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.
Duowu Zou, Doctor principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inebilizumab in people with Type 1 AIP, run by Ruijin Hospital 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 7 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaonan Shen, Doctor (18817554263, hgssldsxn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate within 6 months (time frame: 6 months). 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 7 Oct 2026.