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

NCT ID: NCT06945107

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-27
• Study Completion Date: 2027-01-19

Brief Summary

This multicenter, randomized, double-blind, active-controlled study aims to evaluate the efficacy and safety of picankibart in Chinese patients with plaque psoriasis who demonstrated inadequate responses to interleukin-17 (IL-17) monoclonal antibody therapy and subsequently switched to picankibart. The trial will enroll approximate 310 participants with confirmed plaque psoriasis diagnosis and a poor response to IL-17 monoclonal antibody treatment. The study includes a 4-week screening phase, followed by an active treatment period of either 36 weeks, and concludes with a safety follow-up assessment at Week 48.

Conditions

Plaque Psoriasis

Study Design

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

Study Groups

Picankibart treatment group

The participants in this group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32.

Group Type: EXPERIMENTAL

Picankibart

Intervention Type: DRUG

The participants in picankibart treatment group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32.

The participants in IL-17 mAb continued treatment group will receive picankibart 200mg SC at Weeks 16, 20, 24 and 36.

Placebo

Intervention Type: DRUG

The participants in picankibart treatment group will receive placebo SC at Weeks 12, 16, 24 and 36.

The participants in IL-17 mAb continued treatment group will receive placebo SC at Week 32.

IL-17 mAb continued treatment group

The participants in this group will receive the original IL-17 mAb at Weeks 0, 4, 8 and 12, followed by picankibart 200mg SC at Weeks 16, 20, 24 and 36.

Group Type: ACTIVE_COMPARATOR

Picankibart

Intervention Type: DRUG

The participants in picankibart treatment group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32.

The participants in IL-17 mAb continued treatment group will receive picankibart 200mg SC at Weeks 16, 20, 24 and 36.

Secukinumab

Intervention Type: DRUG

The participants in IL-17 mAb continued treatment group who have received secukinumab before enrollment, will receive secukinumab 300mg SC at Weeks 0, 4, 8 and 12.

Placebo

Intervention Type: DRUG

The participants in picankibart treatment group will receive placebo SC at Weeks 12, 16, 24 and 36.

The participants in IL-17 mAb continued treatment group will receive placebo SC at Week 32.

Ixekizumab

Intervention Type: DRUG

The participants in IL-17 mAb continued treatment group who have received ixekizumab before enrollment, will receive ixekizumab 80mg SC at Weeks 0, 4, 8 and 12.

Interventions

Picankibart

The participants in picankibart treatment group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32.

The participants in IL-17 mAb continued treatment group will receive picankibart 200mg SC at Weeks 16, 20, 24 and 36.

Intervention Type: DRUG

Secukinumab

The participants in IL-17 mAb continued treatment group who have received secukinumab before enrollment, will receive secukinumab 300mg SC at Weeks 0, 4, 8 and 12.

Intervention Type: DRUG

Placebo

The participants in picankibart treatment group will receive placebo SC at Weeks 12, 16, 24 and 36.

The participants in IL-17 mAb continued treatment group will receive placebo SC at Week 32.

Intervention Type: DRUG

Ixekizumab

The participants in IL-17 mAb continued treatment group who have received ixekizumab before enrollment, will receive ixekizumab 80mg SC at Weeks 0, 4, 8 and 12.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology)

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Aoling Chen

Role: CONTACT

aoling.chen@innoventbio.com

15950023301

Facility Contacts

Furen Zhang

Role: primary

ZhangFuRenlcsy@163.com

13608921718

Other Identifiers

CIBI112A303CN

Identifier Type: -

Identifier Source: org_study_id