Study of Autologous Total Immunoglobulin G Therapy for Atopic Dermatitis

Evaluation of Efficacy and Safety of Intramuscular Administration of Autologous Total Immunoglobulin G in Adolescent and Adult Patients With Moderate-to-severe Atopic Dermatitis: A Randomized, Double-blind, Placebo-controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Biological: Autologous immunoglobulin; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeong-gi Do
    • Suwon, Gyeong-gi Do, Korea, Republic of, 16499
      • Ajou university hosiptal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Autologous immunoglobulin; Intramuscular injection of autologous immunoglobulin (IgG)	Biological: 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).; Other Names: AIGT
PLACEBO_COMPARATOR: Placebo; Intramuscular injection of normal saline	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EASI index	The Eczema Area and Severity index (EASI) is a used in clinical practice and clinical trials to evaluates the clinical severity of atopic dermatitis	baseline to week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EASI-50	Achieving reduction in the EASI score greater than index from baseline	baseline to week 16
Change in SCORAD values	Standardized clinical severity scoring system for atopic dermatitis (SCORAD) value is a used in clinical practice and clinical trials to evaluates the clinical severity of atopic dermatitis	baseline to week 16
Change in BSA	percentage change in body surface area	baseline to week 16
Change in DLQI index	Dermatologic assessment tools that patients to test the reliability and validity 10-item Dermatology Life Quality Index (DLQI) questionnaire in patients with atopic dermatitis	baseline to week 16

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Dong-Ho Nahm, M.D., Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2015
• Primary Completion (ACTUAL): March 27, 2017
• Study Completion (ACTUAL): March 27, 2017

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (ESTIMATE): July 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Treatment; Immunoglobulin G
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: AJIRB-MED-SMP-13-359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES