A Study of Switching to Picankibart in Chinese Patients W... | NCT06945107

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The percentage of participants achieving a Psoriasis Area and Severity Index (PASI) 75 response	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

ID	Term
C555450	secukinumab
C549079	ixekizumab