Anakinra for Inflammatory Pustular Skin Diseases
Study Purpose
Background:
- - Inflammatory pustular skin diseases are a type of autoinflammatory disease in which the immune system attacks the body s tissues.
- - IL-1 is a small protein that may be important in causing the inflammation seen in pustular skin disease.
- - To see if anakinra can be used to treat inflammatory pustular skin disease.
- - Individuals at least 18 years of age who have inflammatory pustular skin disease.
- - Participants will be screened with a physical exam and medical history.
- - Participants will have an initial visit to receive the first dose of anakinra.
- - Participants will take anakinra for up to 12 weeks as long as there are no severe side effects.
- - Participants will have study visits at weeks 4, 8 and 12.
- - Participants will have a final study visit 4 weeks after they stop taking anakinra.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT01794117 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Edward W Cowen, M.D. |
Principal Investigator Affiliation | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
NIH |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Sneddon-Wilkinson, Acrodermatitis Continua of Hallopeau, Pustular Psoriasis, Palmoplantar Pustulosis |
Study Website: | View Trial Website |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.