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

A Multicenter Head-to-head Comparison of Ixekizumab Vs. Secukizumab in Over 70-year-old Patients with Moderate-to-severe Plaque Psoriasis

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

Study Overview

• Status: Not yet recruiting
• Conditions: Over 70-year-old Patients with Psoriasis
• Intervention / Treatment: Biological: Ixekizumab; Biological: Secukizumab

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ixe. group	Biological: Ixekizumab; injected with ixekizumab
Active Comparator: Sec. group	Biological: Secukizumab; injected with secukizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with 100% improvement in PASI score from baseline at Week 16	Week 16
At Week 16, the proportion of subjects with an sPGA score of 0	Week 16
Absolute value of change from baseline in subjects' PASI, sPGA, BSA, DLQI, and NRS at Week 16	Week 16
atients who achieved a PASI of 90 at week 16.	Week 16
patients who achieved PASI 75 at week 16	Week 16

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Dermatologic Agents; Ixekizumab
• Other Study ID Numbers: 2024-0283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No