Anakinra for Inflammatory Pustular Skin Diseases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01794117|
Recruitment Status : Recruiting
First Posted : February 18, 2013
Last Update Posted : August 23, 2018
- Inflammatory pustular skin diseases are a type of autoinflammatory disease in which the immune system attacks the body s 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.
- 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.
- 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. 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.
|Condition or disease||Intervention/treatment||Phase|
|Sneddon-Wilkinson Acrodermatitis Continua of Hallopeau Pustular Psoriasis Palmoplantar Pustulosis||Drug: Anakinra||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Anakinra in Inflammatory Pustular Dermatoses: Evaluation of Therapeutic Efficacy and Validation of Pathogenic Mechanisms|
|Study Start Date :||February 15, 2013|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
An initial dose of anakinra 100 mg/day will beadministered daily via self-administered subcutaneousinjection. If pustule formation persists at this dose,anakinra dose may be escalated up to 200 mg/dayinjected subcutaneously daily at week 4
An initial dose of anakinra 100 mg/day will be administered daily via self-administered subcutaneous injection. If pustule formation persists at this dose, anakinra dose may be escalated up to 200 mg/day injected subcutaneously daily at week 4
- Response rate [ Time Frame: 3 months ]Patients who experience at least a 50% improvement in TBSAI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794117
|Contact: Michelle O'Brien, R.N.||(301) firstname.lastname@example.org|
|Contact: Edward W Cowen, M.D.||(301) email@example.com|
|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 National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Edward W Cowen, M.D.||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|