Inebilizumab for Type 1 Autoimmune Pancreatitis in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm, open-label Phase 4 trial enrolling about 50 adults with confirmed type 1 AIP across 14 centers in China. All participants will receive inebilizumab and follow a fixed glucocorticoid taper to assess whether relapse within 32 weeks decreases. Secondary measures include changes in steroid use, serum IgG4 levels, B-cell counts, and other immune cells, with peripheral blood and lymph node samples collected for exploratory analyses. The trial focuses on evaluating safety and efficacy of a CD19-targeted B-cell depleting therapy in this IgG4-related disease manifestation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. A signed and dated informed consent form;
2. A commitment to adhere to the study protocol and to cooperate throughout the entire study;
3. Aged 18 years or over, regardless of gender;
4. Diagnosed with Type I AIP;
5. 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);
6. Be able to adhere to and cooperate with study interventions, such as taking oral medication;
7. 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;

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from this study:

1. Women who are trying to conceive, are pregnant or are breastfeeding;
2. Those who are unable or refuse to sign the informed consent form;
3. History of mental illness;
4. Allergy to the study intervention;
5. Concurrent malignant tumours;
6. Infectious diseases such as active hepatitis or tuberculosis;
7. Concurrent uncontrolled underlying conditions, such as severe heart failure or respiratory failure.

Where it's running

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Duowu Zou, Doctor — Ruijin Hospital
• Study coordinator: Xiaonan Shen, Doctor
• Email: hgssldsxn@163.com
• Phone: 18817554263

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.