NCT05781516

Brief Summary

Evaluation of efficacy and safety of Baricitinib combined with glucocorticoid in patients of IgG4-related disease with eosinophilia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

March 12, 2023

Last Update Submit

March 23, 2023

Conditions

IgG4-related Disease With Eosinophilia

Keywords

IgG4-related diseaseeosinophilia

Outcome Measures

Primary Outcomes (1)

  • The difference of recurrent rate of IgG4-RD between the two groups

    Clinical recurrence definition: any item of IgG4-RD Responder Index ≥2 (without treatment), or ≥ 3 (with treatment) or new organ involvement; with or without elevated serum IgG4 levels.

    52 weeks

Secondary Outcomes (10)

  • The time of recurrence

    0-52 weeks

  • The changes of IgG4-related disease Responder Index

    52 weeks

  • The changes of blood Eosinophil cells

    52 weeks

  • The changes of serum IgG levels

    52 weeks

  • The changes of serum IgG4 levels

    52 weeks

  • +5 more secondary outcomes

Study Arms (2)

Prednisolone monotherapy

PLACEBO COMPARATOR

Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.

Drug: Prednisolone

Prednisolone plus Baricitinib

EXPERIMENTAL

Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. Oral Baricitinib 2mg daily for 12 months.

Drug: PrednisoloneDrug: Baricitinib

Interventions

PrednisoloneDRUG

Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.

Prednisolone monotherapyPrednisolone plus Baricitinib
BaricitinibDRUG

Oral Baricitinib 2mg daily for 12 months.

Prednisolone plus Baricitinib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Active IgG4-RD (Responder Index ≥ 2 points for each involved organ)
  • The counts of peripheral blood eosinophil cells ≥0.75×109/L

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Bejing, 100050, China

RECRUITING

MeSH Terms

Conditions

Immunoglobulin G4-Related DiseaseEosinophilia

Interventions

Prednisolonebaricitinib

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System DiseasesLeukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Wen Zhang, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linyi Peng, MD

CONTACT

+8615810395901drpenglinyi@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2023

First Posted

March 23, 2023

Study Start

January 20, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

CN(1)