A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis

NCT01122914 | Terminated Phase 1

• 2 other identifiers: 10010010-I-0100
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• Severe atopic dermatitis, also known as eczema, is a chronic inflammatory skin condition that affects both children and adults and causes severe itching and skin redness. Current treatments of atopic dermatitis include topical creams and lotions, light therapy, and medications. However, the difficulty with long-term treatment for the chronic and severe nature of the disease requires more effective and better-tolerated therapeutic options.
• Anakinra is a drug that blocks a substance called interleukin-1 (IL-1), which may be important in causing the inflammation in atopic dermatitis. Researchers are interested in determining whether anakinra can be used to help treat atopic dermatitis. Anakinra has been approved by the Food and Drug Administration to treat rheumatoid arthritis in adults and children, but it has not been approved for use in adults or children with atopic dermatitis and is considered an experimental treatment in this study. In this study Anakinra will be administered as an injection under the skin every day for 3 months Objectives: \- To assess the safety and effectiveness of using anakinra to treat severe atopic dermatitis in children. Eligibility: \- Children between 10 and 18 years of age who have been diagnosed with severe atopic dermatitis that has not responded to standard treatment. Design:
• Initial Screening: Participants will have an initial screening visit with a complete physical examination and medical history, blood and urine tests, photographs of the skin ,skin biopsy, and other tests as required.
• Run-in Period: At the screening visit, participants will receive a diary card and will be asked to track their atopic dermatitis symptoms on standard treatment for 2 months.
• Start of Treatment: At the end of the 2 month Run-in period participants will return for an inpatient visit (2 days) to receive the initial dose of anakinra and will be watched for any side effects. During the inpatient visit, participants will have additional examinations and blood and urine tests, and will be instructed on how to administer the anakinra injections at home. Treatment Period: - Participants will return once a week for the first 2 weeks of treatment, at the end of the first month, and then once a month for the following 2 months, for a physical exam and blood tests. Participants will be asked to record symptoms related to their atopic dermatitis, anakinra administration and any side effects related to the anakinra on the diary card. The diary cards will be reviewed and collected at each visit.- End of Treatment Period: At the end of 3 months of treatment with anakinra, participants will again be asked to record symptoms related to their atopic dermatitis on the diary card. Participants will be seen once a month for 3 months for a physical exam, blood tests and review of the diary card. . The final study visit will take place at the end of the 3rd month and will include a physical exam, blood tests, photographs and skin biopsy.

Conditions

Anakinra; Kineret; Atopic Dermatitis; Eczema; Allergic Disease

Keywords

Kineret; Anakinra; Atopic Dermatitis; Eczema; Allergic Disease

Outcome Measures

Primary Outcomes (1)

• Improvement of Atopic Dermatitis symptoms without increase in serious infections; Response to treatment with a 30 percent decrease in SCORAD score.

  2 years

Secondary Outcomes (1)

• Determine immunological phenotype and cytokine profile of peripheral blood before and after treatment with Anakinra; Determine impact of IL-1 r neutralization on total and antigen specific allergen sensitivity.

  2 years

Interventions

Anakinra DRUG

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• To be eligible for enrollment in this protocol, participants must fulfill all of the following criteria:
• Must be 10 years to 30 years of age
• Patient or legal guardian must be able to give informed consent
• Must have evidence of severe atopic dermatitis as determined by the investigators and a SCORAD score \>40 performed within 90 days of study entry
• Must have report from primary physician documenting lack of sufficient response to topical corticosteroids for \> 6 months
• Must have skin test or radioallergosorbent test (RAST) showing sensitivity to greater than or equal to 3 food and/or airborne allergens
• Must have a baseline CBC that demonstrates:
• White Blood Cell Count (WBC) greater than or equal to lower limit of normal for age
• Absolute Neutrophil Count (ANC) greater than or equal to lower limit of normal for age
• c. Platelet Count greater than or equal to lower limit of normal for age
• Must not be pregnant or breastfeeding
• If subject is a female that has begun menstruation, and is sexually active, she must agree to consistently use contraception throughout study participation. Acceptable forms of contraception are:
• Condoms, male or female, with spermicide
• Diaphragm or cervical cap with spermicide
• Intrauterine device

You may not qualify if:

• A patient will be ineligible to participate in this protocol if any of the following criteria are fulfilled:
• Patient is taking oral or injectable immunomodulators (such as methotrexate, imuran, and cyclosporine) or biologics (such as etanercept or omalizumab).
• Patient requires systemic immunosuppression at any time during the study
• Patient has known diseases of immunodysregulation or immunodeficiency.
• Any chronic medical condition other than atopic dermatitis, allergy/asthma and infection, such as heart disease, diabetes and autoimmunity that, in the investigator s opinion, places the patient at undue risk by participating in the study.
• History of anaphylactic reaction or hypersensitivity to anakinra.
• The presence of any dermatologic diagnosis which, in the investigator's opinion, is not consistent with atopic dermatitis and would impair the ability to assess drug response.
• Has a diagnosis of active tuberculosis with consistent findings from a PPD skin test, computerized tomography (CT) scan or Chest x-ray. Those subjects found to have a positive PPD will be referred back to their primary care physician for appropriate management.
• Has received a live vaccine within 4 weeks prior to therapy or potential need for a live vaccine during the study.
• Is unwilling to undergo testing or procedures associated with this protocol.
• The patient or guardian is unable or unwilling to give daily injections.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Leung DY, Boguniewicz M, Howell MD, Nomura I, Hamid QA. New insights into atopic dermatitis. J Clin Invest. 2004 Mar;113(5):651-7. doi: 10.1172/JCI21060.

  PMID: 14991059 BACKGROUND

• Adjers K, Pessi T, Karjalainen J, Huhtala H, Hurme M. Epistatic effect of IL1A and IL4RA genes on the risk of atopy. J Allergy Clin Immunol. 2004 Mar;113(3):445-7. doi: 10.1016/j.jaci.2003.12.582.

  PMID: 15007345 BACKGROUND

• Schmitt J, Schakel K, Schmitt N, Meurer M. Systemic treatment of severe atopic eczema: a systematic review. Acta Derm Venereol. 2007;87(2):100-11. doi: 10.2340/00015555-0207.

  PMID: 17340015 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Joshua D Milner, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 13, 2010
• Study Start: April 14, 2010
• Primary Completion: April 7, 2015
• Study Completion: April 7, 2015
• Last Updated: December 17, 2019

Record last verified: 2015-04-07

Locations

US (1)