Ixekizumab Versus Secukizumab in Over 70-year-old Patients with Psoriasis

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT06811558
Status
Not Yet Recruiting

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Conditions

  • Over 70-year-old Patients with Psoriasis

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ixekizumab — BIOLOGICAL
    injected with ixekizumab
  • Secukizumab — BIOLOGICAL
    injected with secukizumab

Study Details

Currently, the main systemic drug therapies in China include methotrexate (MTX), cyclosporine A, retinoids, and biologics. In recent years, monoclonal antibody biologics targeting cellular inflammatory factors have been used in the treatment of severe psoriasis, which is poorly treated with conventional systemic medications, severely affects the quality of life, and is accompanied by significant arthritic symptoms, including tumor necrosis factor-alpha (TNF-alpha) antagonists (etanercept, infliximab, adalimumab); IL-12/23 antagonists (ursodiol, ibuprofen); and IL-12/23 antagonists (ubuntu, ubiquinone). IL-12/23 antagonists (ustekinumab) and IL-17A antagonists (skutecimab). Among them, ezekizumab and stuccizumab are more widely used at present. However, the efficacy, safety, and tolerability of ezekizumab and stuclizumab in the treatment of plaque psoriasis in elderly patients over 70 years of age are not known. Primary objective: To evaluate the efficacy of ezekizumab versus secukizumab in patients over 70 years of age with plaque psoriasis. Secondary objectives: 1. To assess the safety of ezekizumab versus secukizumab in the treatment of patients over 70 years of age with plaque psoriasis; 2. To evaluate the tolerability of ezekizumab versus secukizumab in patients over 70 years of age with plaque psoriasis

Key Dates

Start date
Feb 1, 2025
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ixe. group
  • Active Comparator: Sec. group

Primary Outcome Measure

Proportion of subjects who improved their PASI score by 90% (PASI 90) or more from baseline or achieved an sPGA score of 0 or 1 at Week 16. [ Time Frame: Week 16 ]