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Anakinra clinical trials

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NCT ID: NCT05611710 Recruiting - Dengue Clinical Trials

Anakinra in Dengue With Hyperinflammation ( AnaDen )

Start date: January 2, 2023
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the effect of anakinra in dengue patients with hyperinflammation as compared to placebo Primary Objective: To evaluate the efficacy of Anakinra in moderate-severe dengue patients with hyperinflammation. Secondary Objectives: - To assess the safety of anakinra therapy in dengue with hyperinflammation - To assess the effect of anakinra therapy in patients with dengue on physiological, clinical and virological parameters - To assess the immunomodulation effects of anakinra in dengue - Immune cell signatures in dengue with and without anakinra - To assess difference in gene expression between treatment group compared to non-treatment population

NCT ID: NCT03991520 Recruiting - Endometriosis Clinical Trials

Pilot Study of the IL-1 Antagonist Anakinra for the Treatment of Endometriosis Related Symptoms

Start date: June 16, 2020
Phase: Early Phase 1
Study type: Interventional

All current FDA approved medications to treat endometriosis pain including danazol, GnRH agonists (Lupron, Zoladex and Synarel), GnRH antagonist (elagolix) and depo-provera prevent or contradict pregnancy. Therefore women suffering from endometriosis and trying to conceive have no medical options apart from pain meds. The purpose of this pilot study is to determine whether the anti-inflammatory, IL-1 inhibitor (anakinra) reduces pelvic pain due to endometriosis without altering menstrual cycles, which is an indicator of ovulatory function. Anakinra is an FDA approved injectable medication for the treatment of rheumatoid arthritis that is pregnancy category B.

NCT ID: NCT01122914 Terminated - Atopic Dermatitis Clinical Trials

A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis

Start date: April 14, 2010
Phase: Phase 1
Study type: Interventional

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.