Combining Baricitinib and glucocorticoids for treating eosinophilia in IgG4-related disease

A Prospective, Randomized Controlled Study to Compare the Efficacy and Safety of Baricitinib Combined With Glucocorticoid and Glucocorticoid Monotherapy in Proliferative IgG4-RD Patients With Eosinophilia

This study is testing if adding Baricitinib to glucocorticoids can help people with IgG4-related disease and high eosinophil levels feel better compared to just using glucocorticoids alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: Baricitinib
• Locations: 1 site (Beijing, Bejing)
• Trial ID: NCT05781516 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Baricitinib in combination with glucocorticoids for patients suffering from IgG4-related disease with eosinophilia. It is a multicenter, 52-week prospective, randomized controlled study that compares this combination therapy against glucocorticoid monotherapy. The study aims to determine whether the addition of Baricitinib can improve patient outcomes in terms of disease response and safety. Participants will be closely monitored for changes in their condition and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with IgG4-related disease who exhibit eosinophilia and meet specific diagnostic criteria.

Not a fit: Patients without active IgG4-related disease or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective management option for patients with IgG4-related disease and eosinophilia.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. All patients must meet the following diagnostic criteria of IgG4RD (2020): 1) and radiological features: One or more organs show diffuse or localized swelling or a mass or nodule characteristic of IgG4-RD. In single organ involvement, lymph node swelling is omitted. 2) serological diagnosis: Serum IgG4 levels greater than 135 mg/dl. 3) diagnosis diagnosis: Positivity for two of the following three criteria: a. Dense lymphocyte and plasma cell infiltration with fibrosis. b. Ratio of IgG4-positive plasma cells /IgG-positive cells greater than 40% and the number of IgG4-positive plasma cells greater than 10 per high powered field. c. Typical tissue fibrosis, particularly storiform fibrosis, or obliterative phlebitis.

   Patients fulfill (1) + (2) + (3) are diagnosed as definite IgD4RD; (1) + (2): possible IgG4RD; (1) + (3): probable IgG4RD. exclusion of other diseases.
2. Active IgG4-RD (Responder Index ≥ 2 points for each involved organ)
3. The counts of peripheral blood eosinophil cells ≥0.75×109/L

Exclusion Criteria:

1. Patients who is not able to discontinue GC
2. Pregnancy or breastfeeding or planning to get pregnant within 2 years
3. Received glucocorticoids, immunosuppressants, biological agents or JAK inhibitors within 3 months
4. Allergic to Baricitinib
5. Concomitant other autoimmune diseases
6. Malignancy
7. Chronic HBV infection, latent tuberculosis, or active infection
8. Server liver or renal dysfunction, or heart failure.

Where this trial is running

Beijing, Bejing

• Peking Union Medical College Hospital — Beijing, Bejing, China (Recruiting)

Study contacts

• Principal investigator: Wen Zhang, MD — Peking Union Medical College Hospital
• Study coordinator: Linyi Peng, MD

Conditions IgG4-related Disease With Eosinophilia; IgG4-related disease; eosinophilia