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

NCT06945107 | Active Not Recruiting Phase 3

• 1 other identifier: CIBI112A303CN
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The percentage of participants achieving static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1)

  The static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.

  Week 16

Secondary Outcomes (19)

• The percentage of participants achieving a Psoriasis Area and Severity Index (PASI) 75 response

  Week 16

• The percentage of participants achieving a PASI 90 response

  Week 16

• The percentage of participants achieving sPGA=0

  Week 16

• The percentage of participants with involved body surface area (BSA) <3% (or ≥75% reduction relative to baseline)

  Week 16

• The percentage of participants achieving sPGA=0/1 and with involved BSA <3% (or ≥75% reduction relative to baseline)

  Week 16

Study Arms (2)

Picankibart treatment group

EXPERIMENTAL

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

Drug: Picankibart; Drug: Placebo

IL-17 mAb continued treatment group

ACTIVE COMPARATOR

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.

Drug: Picankibart; Drug: Secukinumab; Drug: Placebo; Drug: Ixekizumab

Interventions

Picankibart 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.

IL-17 mAb continued treatment group; Picankibart treatment group

Secukinumab 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.

IL-17 mAb continued treatment group

Placebo 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; Picankibart treatment group

Ixekizumab 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.

IL-17 mAb continued treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18 years and ≤75 years.
• Diagnosed with plaque psoriasis for ≥6 months, with or without psoriatic arthritis.
• 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.
• 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.
• 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.

You may not qualify if:

• Diagnosed with guttate psoriasis, pustular psoriasis, or erythrodermic psoriasis during screening or at baseline;
• Previous diagnosis of drug-induced psoriasis (e.g., psoriasis induced by beta blockers, calcium channel inhibitors, etc.);
• Prior use of picankibart or IL-23 inhibitors;
• Received two biological agents for psoriasis treatment within 16 weeks prior to screening;
• 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);
• 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);
• 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;
• 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;
• 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.

Sponsors & Collaborators

• Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.: lead

Study Sites (1)

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

Jinan, Shandong, 250000, China

Location

MeSH Terms

Interventions

secukinumab; ixekizumab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): June 7, 2026
• Study Completion (Estimated): January 19, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)