Clinical efficacy of dupilumab treatment in patients with IgG4-related disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0006819

Enrollment

Registered

2021-12-08

Start date

2021-12-01

Completion date

Unknown

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : After administering 600mg of dupilumab as a loading dose, administer 300mg of dupilumab once every 2 weeks for 52 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Among patients over 19 years old who are diagnosed with IgG4-related disease and treated with standard drug (systemic steroid, systemic immunosuppressant), ones who are partially controlled or unable to be controlled using standard drug (2) Ones who are willing to and able to comply with outpatient visits and procedures and surveys related to trial (3) Ones who have provided written consent as mentioned in agreement procedure (4) In case of women of childbearing age, ones who have agreed to use a highly effective contraception method

Exclusion criteria

Exclusion criteria: (1) Ones who have anaphylaxis in his or her medical history (2) Ones who have been administered with biological inhibitors including, but not limited to, dupilumab within 3 months period. (3) Ones who are diagnosed with malignant tumor within 5 years period prior to screening visit. (4) Ones who have comorbid conditions and when those conditions are considered to have negative influence on participation of study subject in clinical study. (5) Women who are pregnant or are breast-feeding or women who are planning on becoming pregnant or breast feeding (6) Based on investigator’s decision, ones who are ineligible to participate due to other reasons

Design outcomes

Primary

Measure	Time frame
Complete or partial response (treatment response will be evaluated based on IgG4-RD responder index).	—

Secondary

Measure	Time frame
Complete or partial response (treatment response will be evaluated based on IgG4-RD responder index).;aggravation of disease activity and adverse drug events (treatment response will be evaluated based on IgG4-RD responder index).;reduction in systemic corticosteroids requirement	—

Countries

Korea, Republic of

Contacts

Public ContactYoungsoo Lee

Ajou University Hospital

thejadelight@gmail.com+82-31-219-4890

Outcome results