Clinical trialNCT01794117CompletedPhase 2Interventional

Anakinra for Inflammatory Pustular Skin Diseases

SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Enrollment18Acrodermatitis Continua of HallopeauPalmoplantar PustulosisPustular PsoriasisSneddon-Wilkinson

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Background: * Inflammatory pustular skin diseases are a type of autoinflammatory disease in which the immune system attacks the bodys tissues. These diseases cause painful and itchy skin rashes, eye and mouth irritation, joint pain and fever. Several drugs for treating these diseases suppress the immune system. However, they can cause severe side effects when taken over a long period of time. * Interleukin 1 (IL-1) is a small protein that may be important in causing the inflammation seen in pustular skin disease. Anakinra is a drug that works by blocking IL-1. It has been effective in treating some inflammatory conditions such as rheumatoid arthritis. However, anakinra has not been studied for use in patients with pustular skin disease. Researchers want to see whether anakinra will be effective in treating pustular skin disease. Objectives: \- To see if anakinra can be used to treat inflammatory pustular skin disease. Eligibility: \- Individuals at least 18 years of age who have inflammatory pustular skin disease. Design: * Participants will be screened with a physical exam and medical history. Their disease will be evaluated with blood tests, urine tests and imaging studies. Skin biopsies may also be collected. * Participants will have an initial visit to receive the first dose of anakinra. They will be shown how to give themselves daily injections of anakinra. * Participants will take anakinra for up to 12 weeks as long as there are no severe side effects. During this time, they will keep a study diary to record the severity of any rashes, pustules, itching, fevers, and skin or joint pain. They will bring this diary to their study visits. * Participants will have study visits at weeks 4, 8 and 12. Treatment will be monitored at these visits with blood tests, urine tests and physical exams. Depending on the effects of the treatment, participants may have the dose of anakinra increased or decreased. * Participants will have a final study visit 4 weeks after they stop taking anakinra.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Edward W Cowen, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Anakinra →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 22 Jul 2013
Primary completion: 19 Mar 2019
Completion: 7 Oct 2019
Last update posted: 30 Apr 2021
Registered enrollment: 18
Registry id: NCT01794117

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.