Home / Psoriasis / Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies

Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies

Brief Summary:
This study will evaluate the safety and efficacy of brodalumab in the treatment of moderate-to-severe psoriasis in patients who have previously failed treatment with interleukin (IL)-17A therapies. Forty patients will be enrolled in this 16-week open-label study. Patients will receive 210 mg of brodalumab subcutaneous injection at weeks 0, 1, and 2, followed by 210 mg every 2 weeks. The primary efficacy endpoint will be the proportion of patients achieving a score of “0-clear” or “1-almost clear” in the sPGA score after 16 weeks of treatment. After completion of the 16-week trial, patients may desire to continue treatment with brodalumab.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Brodalumab Phase 4

Detailed Description:
This study will evaluate the safety and efficacy of brodalumab in the treatment of moderate-to-severe psoriasis in patients who have previously failed treatment with interleukin (IL)-17A therapies. Failure of IL-17A therapy will be defined as previous treatment with either secukinumab or ixekizumab for at least 3 months without achieving PASI-75 response or a 50% loss of original improvement. Forty patients will be enrolled in this 16-week open-label study. Patients will be enrolled at three to four different sites in the US. After enrollment, study visits will occur at monthly intervals, with patients receiving 210 mg of brodalumab subcutaneous injection at weeks 0, 1, and 2, followed by 210 mg every 2 weeks. At each visit, patients will be evaluated for change in sPGA (Physician’s Global Assessment), PASI score, and any signs or symptoms of adverse events. Laboratory screening will include tests for tuberculosis and neutropenia. After completion of the 16-week trial, patients may desire to continue treatment with brodalumab. Efforts will be made to provide drug to these study patients, including those who do not have insurance.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment :40 participants
Intervention Model:Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:A Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies
Actual Study Start Date :October 31, 2017
Estimated Primary Completion Date :June 30, 2018
Estimated Study Completion Date :June 30, 2018
Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

About

Check Also

Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation (IMMPRESS)

Study Description Go to  Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Brief Summary: The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation. Condition …

Leave a Reply

Your email address will not be published. Required fields are marked *