Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis

Launched by SINGAPORE GENERAL HOSPITAL · Aug 28, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called ixekizumab on patients with moderate to severe plaque psoriasis, a skin condition that can cause discomfort and impact daily life. Researchers want to understand if patients can stop using ixekizumab after their psoriasis improves and whether they can safely switch to other treatments if their symptoms return. The goal is to learn more about the best ways to manage psoriasis while keeping treatment costs reasonable.

To participate in the trial, you need to be an adult over 21 years old with a diagnosis of plaque psoriasis that is moderate to severe. This means your psoriasis score, which measures the severity and area affected, must meet certain criteria. Participants will receive ixekizumab and be monitored for their response to the treatment. If your psoriasis clears up and you stop the treatment, the study will track how long it takes for your symptoms to return and how well you respond if you resume treatment. It’s important to know that certain conditions, like other types of skin diseases or severe health issues, could make you ineligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults (\>21-year-old).
• • Diagnosed by dermatologist as plague-type PsO.
• * Having moderate to severe plague-type PsO as defined by the following:
• • Psoriasis Area and Severity Index (PASI) ≥12/72,
• • And, investigator Global Assessment Score (IGA) ≥3,
• • And, PsO involving body surface area involvement (BSA) ≥10%
• • And Candidate for phototherapy and/or systemic therapy
• • Topical corticosteroid up to moderate potencies are allowed
• • Able to provide informed consent.
• Exclusion Criteria:
• • Forms of PsO other than plaque-type.
• • Evidence of skin conditions at the time of the screening visit (e.g. eczema) that would interfere with evaluation of the effect of the investigational product on PsO.
• • Evidence of active tuberculosis or other active infections (like Hepatitis C/B), malignancy; active or known use of other immunosuppressive drugs (eg. AIDS, rheumatoid arthritis, organ rejection etc) at the screening visit.
• • Previous exposure to any systemic immunosuppressants (eg. methotrexate) or phototherapy
• • History or current signs of a severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
• • Having current or history of malignancy, except non-melanoma skin cancer, within the previous 5 years that have been adequately treated.
• • History of inflammatory bowel disease.
• • Pregnancy or lactating mothers.
• • As treatment regimen is different, participants with evidence of PsA will be excluded