Evaluating the effects of stopping ixekizumab treatment in plaque psoriasis patients

Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis Compared to Standard Care --- a Pragmatic Observational Study

This study is testing what happens to people with moderate to severe plaque psoriasis after they stop taking ixekizumab treatment to see how it affects their skin, relapse rates, and overall quality of life over two years.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 22 Years to 90 Years
• Sex: All
• Sponsor: Singapore General Hospital (Academic / other)
• Drugs / interventions: methotrexate, Ixekizumab
• Locations: 1 site (Outram Park)
• Trial ID: NCT04537689 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the outcomes of patients with moderate to severe plaque psoriasis who discontinue a short course of ixekizumab treatment. The study aims to assess the clinical course, relapse rates, and quality of life over two years following treatment withdrawal. Additionally, it seeks to identify genomic and immunomic signatures in skin biopsies and blood samples to understand the factors contributing to sustained good outcomes. The trial will compare these signatures between patients who maintain improvement and those who experience relapse.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 21 years old with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Not a fit: Patients with forms of psoriasis other than plaque-type or those with active infections or malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify which patients can safely discontinue ixekizumab treatment while maintaining their psoriasis control, potentially reducing treatment costs and side effects.

How similar studies have performed: While there have been studies on the efficacy of ixekizumab, this specific approach of treatment withdrawal and its genomic implications is relatively novel.

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

Where this trial is running

Outram Park

• Singapore General Hospital — Outram Park, Singapore (Recruiting)

Study contacts

• Principal investigator: Ying Ying Leung, MD — Singapore General Hospital
• Study coordinator: Ying Ying Leung, MD

Conditions Plaque Psoriasis