A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy

Launched by INNOVENT BIOPHARMACEUTICAL TECHNOLOGY (HANGZHOU) CO., LTD. · Apr 18, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called picankibart for Chinese patients with plaque psoriasis who haven't responded well to existing medications known as interleukin-17 (IL-17) monoclonal antibodies. The study aims to find out if switching to picankibart can help these patients improve their skin condition. Around 310 participants aged between 18 and 75 years will be enrolled, and they must have had plaque psoriasis for at least six months and not seen enough improvement from their current IL-17 treatment.

Participants can expect to go through a screening process for 4 weeks, followed by 36 weeks of treatment with picankibart, and then a follow-up for safety assessments at 48 weeks. To join the trial, they need to have a specific level of psoriasis severity and a documented lack of response to their previous treatment. It's important for potential participants to fully understand the study's goals and give their written consent before joining. This trial is not yet recruiting, so interested individuals will need to wait for further announcements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, aged ≥18 years and ≤75 years.
• • 2. Diagnosed with plaque psoriasis for ≥6 months, with or without psoriatic arthritis.
• • 3. Regular use of secukinumab or ixekizumab according to the label information for at least 16 weeks prior to baseline (actual dose received ≥80% of the standard dose per instructions during the 16 weeks before baseline), with sufficient documented rationale for medication use.
• • 4. At both screening and baseline, meet the criteria of sPGA (Static Physician's Global Assessment) ≥2 and body surface area (BSA) involvement ≥3%, along with the investigator's assessment of inadequate response to the original IL-17 monoclonal antibody therapy, warranting a switch to biologic treatment.
• • 5. Full understanding of the trial objectives, basic knowledge of the pharmacological effects and potential adverse reactions of the investigational product, and voluntary provision of written informed consent in accordance with the principles of the Helsinki Declaration.
• Exclusion Criteria:
• • 1. Diagnosed with guttate psoriasis, pustular psoriasis, or erythrodermic psoriasis during screening or at baseline;
• • 2. Previous diagnosis of drug-induced psoriasis (e.g., psoriasis induced by beta blockers, calcium channel inhibitors, etc.);
• • 3. Prior use of picankibart or IL-23 inhibitors;
• • 4. Received two biological agents for psoriasis treatment within 16 weeks prior to screening;
• • 5. Received topical treatments that may affect psoriasis evaluation within 2 weeks before the first administration of the investigational product (including but not limited to glucocorticoids, vitamin D3 derivatives, retinoids, calcineurin inhibitors, keratoplastics, and combination therapies);
• • 6. Received conventional systemic medications that may affect psoriasis evaluation within 4 weeks before the first administration of the investigational product (including but not limited to methotrexate, cyclosporine, retinoids, azathioprine, leflunomide, mycophenolate mofetil, sulfasalazine, glucocorticoids, apremilast, JAK inhibitors such as tofacitinib/baricitinib/upadacitinib, TYK2 inhibitors such as deucravacitinib, or Chinese herbal medicines for psoriasis);
• • 7. Use of natalizumab, or B-cell/T-cell modulators (e.g., rituximab, abatacept, visilizumab) within 12 months before the first administration of the investigational product;
• • 8. Received phototherapy for psoriasis within 1 month before the first administration of the study drug, and/or unwillingness to avoid prolonged sun exposure and other UV light sources (e.g., sunbathing/tanning devices) during the study;
• • 9. Received investigational biological agents within 6 months, any investigational therapy within 30 days, study drugs within 5 half-lives (whichever is longer), or current participation in clinical trials before the first administration of the investigational product.