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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT01122914 |
Purpose
Background:
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:
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anakinra Kineret Atopic Dermatitis Eczema Allergic Disease |
Drug: Anakinra |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis |
| Estimated Enrollment: | 8 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Severe refractory atopic dermatitis is a chronic inflammatory pruritic skin condition that affects both children and adults. The disease is marked by periods of exacerbation and remission. Symptoms of atopic dermatitis may resolve by adolescence; however, it is estimated that the disease may persist in 50 percent of affected children well into adulthood.
Current possible treatments of atopic dermatitis include the use of topical corticosteroids, calcineurin inhibitors, phototherapy, as well as systemic medications i.e., methotrexate, cyclosporine, azathioprine, mycophenolate mofetil and interferon gamma. The difficulty with long-term treatment of this disease lies in its chronic nature associated with severe episodes. The combination of chronicity and severity of episodes of this diseases demands more effective and better-tolerated therapeutic options than those that are currently available. While the pathways of allergic inflammation are different than those of other inflammatory conditions, certain elements may overlap, providing targets for immune modulation. One of these targets is the interleukin-1 (IL-1) receptor.
The IL-1 receptor plays an important role in the development and maintenance of Th2 responses. Genetic, in vivo and in vitro data demonstrate a significant role for IL-1 signaling allergic and skin inflammatory conditions. This pilot study is therefore designed to assess the safety and efficacy of IL-1ra, a natural inhibitor of the IL-1 receptor, in disrupting atopic pathophysiologic pathways. Specifically, we will treat severe refractory atopic dermatitis associated with evidence of multiple specific allergic sensitivities. Up to 8 patients ages 10-18 with severe refractory dermatitis will be enrolled. Patients will be initially evaluated to establish the diagnosis of severe refractory AD as evidenced by SCORAD score greater than 40, followed by a 2 month (8 week) run-in period, a 3 month (12 week) treatment period of 3mg/kg/day anakinra given subcutaneously, followed by a 3 month (12 week) post-treatment evaluation period. In order to be considered evaluable for response, patients must have received a minimum of 67 out of 84 doses (80 percent) of anakinra. The primary endpoint is lack of an increase in serious infections, the secondary endpoint is a reduction of 30 percent or more in SCORAD score, and tertiary endpoints are cellular phenotypic and cytokine responses to IL-1 receptor blockade in atopic patients.
Eligibility| Ages Eligible for Study: | 10 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
To be eligible for enrollment in this protocol, participants must fulfill all of the following criteria:
Must have a baseline CBC that demonstrates:
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
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:
EXCLUSION CRITERIA:
A patient will be ineligible to participate in this protocol if any of the following criteria are fulfilled:
Contacts and Locations| Contact: Michelle R O'Brien, R.N. | (301) 443-8341 | obrienm@mail.nih.gov |
| Contact: Joshua D Milner, M.D. | (301) 640-6130 | jdmilner@niaid.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Joshua D Milner, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
More Information
| Responsible Party: | RCHSPB |
| ClinicalTrials.gov Identifier: | NCT01122914 History of Changes |
| Other Study ID Numbers: | 100100, 10-I-0100 |
| Study First Received: | May 11, 2010 |
| Last Updated: | March 20, 2012 |
| Health Authority: | United States: Federal Government |
|
Kineret Anakinra Atopic Dermatitis Eczema Allergic Disease |
|
Dermatitis Dermatitis, Atopic Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents Therapeutic Uses Pharmacologic Actions |