Study of Autologous Total Immunoglobulin G Therapy for Atopic Dermatitis

NCT ID: NCT02835170

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-02
• Study Completion Date: 2017-03-27

Brief Summary

This is a randomized, double-blind, placebo-controlled parallel group study on the efficacy and safety of intramuscular injections of autologous immunoglobulin in patients with moderate-to-severe atopic dermatitis.

Detailed Description

Children and adult patients with moderate-to-severe atopic dermatitis (age ≥ 13 years) whose clinical conditions have not been effectively controlled by current standard medical therapies (topical moisturizers, topical corticosteroids, topical calcineurin inhibitors, and oral antihistamines) for more than 2 months will be include.

This is a randomized, double-blind, placebo-controlled parallel group study on the efficacy and safety of intramuscular injections of autologous immunoglobulin in patients with moderate-to-severe atopic dermatitis. After providing informed consent, patients will be assessed for study eligibility at the baseline visit. Patients will undergo screening within 28 days prior to randomization as "wash out period", and during the screening period, treatment with medications (including systemic corticosteroids and systemic immunomodulating agents) for atopic dermatitis will be wash-out for at least 28 days prior to baseline (exclude moisturizers).

At screening, plasma will be separated from patients' venous blood (400ml) aseptically and autologous immunoglobulin (total IgG) will be purified from the plasma by chromatography using Protein A during the screening period. Patients will be randomized in a 1:1 ratio to receive weekly treatment with autologous immunoglobulin or placebo (normal saline) will be administrated by intramuscular injection, once a week for 7 weeks (total 8 injections).

The investigators will evaluate the clinical efficacy and safety of intramuscular injections of autologous immunoglobulin in those patients with moderate-to-severe atopic dermatitis by measuring changes in the standardized clinical severity scoring system for atopic dermatitis (SCORAD) values, Eczema Area and Severity index (EASI) and quality of life together with laboratory parameters in blood samples before and after treatment. Systemic corticosteroids as a rescue treatment will be prescribed to control unacceptable symptoms of atopic dermatitis at the investigator's discretion.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Autologous immunoglobulin

Intramuscular injection of autologous immunoglobulin (IgG)

Group Type: EXPERIMENTAL

Autologous immunoglobulin

Intervention Type: BIOLOGICAL

Autologous immunoglobulin (total IgG) aseptically purified from the autologous plasma will be administered to the patients by intramuscular injection, once a week for 7 weeks (total 8 injections).

Placebo

Intramuscular injection of normal saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Saline will be administered to the patients by intramuscular injection, once a week for 7weeks (total 8 injections).

(In addition, autologous immunoglobulin is colorless and odorless, injection volume is same between autologous immunoglobulin and saline)

Interventions

Autologous immunoglobulin

Autologous immunoglobulin (total IgG) aseptically purified from the autologous plasma will be administered to the patients by intramuscular injection, once a week for 7 weeks (total 8 injections).

Intervention Type: BIOLOGICAL

Placebo

Saline will be administered to the patients by intramuscular injection, once a week for 7weeks (total 8 injections).

(In addition, autologous immunoglobulin is colorless and odorless, injection volume is same between autologous immunoglobulin and saline)

Intervention Type: OTHER

Other Intervention Names

AIGT

Eligibility Criteria

Inclusion Criteria

1. Suitability of autologous blood donation criteria

2. Current standard medical therapies more than 2 months and moderate-to-severe atopic dermatitis

3. ≥10% lesion body surface area (BSA) of atopic dermatitis involvement in area

Exclusion Criteria

1. Patients under the age of 13 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.

4. Pregnancy or planned pregnancy within 1 year

5. Skin condition not appropriate for blood sampling and transfusion

6. The standardized clinical severity scoring system for atopic dermatitis (SCORAD) values <25 (Mild atopic dermatitis)

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Dong-Ho Nahm

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong-Ho Nahm, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

Ajou university hosiptal

Suwon, Gyeong-gi Do, South Korea

Countries

South Korea

Other Identifiers

AJIRB-MED-SMP-13-359

Identifier Type: -

Identifier Source: org_study_id