A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis
Status:
Terminated
Trial end date:
2015-04-07
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)