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

NCT ID: NCT06811558

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-12-31

Brief Summary

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

Detailed Description

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.

Conditions

Over 70-year-old Patients with Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ixe. group

Group Type: ACTIVE_COMPARATOR

Ixekizumab

Intervention Type: BIOLOGICAL

injected with ixekizumab

Sec. group

Group Type: ACTIVE_COMPARATOR

Secukizumab

Intervention Type: BIOLOGICAL

injected with secukizumab

Interventions

Ixekizumab

injected with ixekizumab

Intervention Type: BIOLOGICAL

Secukizumab

injected with secukizumab

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Men or women aged ≥70 years; and

2. Diagnosis of plaque psoriasis ≥6 months with or without psoriatic arthritis; and

3. Plaque psoriasis involving ≥3% of body surface area (BSA) at screening and baseline,/Psoriasis Disease Area and Severity Index (PASI) score ≥3, / Static Physician Overall Score (sPGA) ≥ 2 points / DLQI >= 6

4. the subject is suitable for biologic and/or systemic therapy for psoriasis; and

5. The purpose of the trial is well understood, and the pharmacological effects and possible adverse reactions of the test drug are well understood; the subject will be treated according to Hull's guidelines.

6. The subject has a basic understanding of the purpose of the trial, the pharmacological effects of the test drug and the possible adverse effects; and (6) The subject has voluntarily signed an informed consent form in the spirit of the Declaration of Helsinki.

Exclusion Criteria

1. With other severe skin diseases, tumors, other systemic diseases (e.g., inflammatory bowel disease), or psychiatric disorders;

2. With tuberculosis, HIV, hepatitis B, hepatitis C and other infections;

3. Those who are allergic to ezekizumab or stavudine;

4. Those who have received other systemic therapies (including but not limited to glucocorticoids, cyclosporine, methotrexate, avitamin A, azathioprine, hydroxychloroquine, thalidomide, etc.) within the previous 4 weeks;

5. Those who have participated in other clinical trials in the previous 3 months;

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2024-0283

Identifier Type: -

Identifier Source: org_study_id