Evaluation of clinical efficacy of intramuscular of autologous total IgG in patient with severe atopic dermatitis of refractory to dupilumab therapy

Administration of autologous total IgG in patient with severe atopic dermatitis of refractory to dupilumab treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0006092

Enrollment

Registered

2021-04-23

Start date

2021-04-28

Completion date

Unknown

Last updated

2023-02-08

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

Conditions

None listed

Interventions

Procedure/Surgery : Autologous total IgG purified from the autologous plasma will be administered to the patients by intramuscular injection, once a week for 7 weeks from week 0 to week 7 (total 8 inj

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients with recalcitrant atopic dermatitis (age = 19 years) whose clinical conditions has not been effectively controlled by dupilumab treatment. 2. Compatible with the criteria for autologous blood donation (body weight =32 kg)

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Patients under the age of 19 year. 2) Patients who are unable to agree on their own (emergency patients, patients with mental disability, patients with limited capacity to consent due to stroke or delirium caused by diabetes). 3) Patients with severe disease whose expected survival duration is less than 3 months.

Design outcomes

Primary

Measure	Time frame
Evaluation of clinical efficacy	—

Secondary

Measure	Time frame
Evaluation of anti-allergy effect;Evaluation of immunomodulatory effect;Evaluation of quality of life effect	—

Countries

Korea, Republic of

Contacts

Public ContactDong-Ho Nahm

Ajou University Hospital

dhnahm@gmail.com+82-31-219-7255

Outcome results