Innovent Biologics has initiated dosing in a landmark Phase 3 clinical trial evaluating picankibart (IBI112), an anti-IL-23p19 monoclonal antibody, for psoriasis patients who experienced inadequate response to prior IL-17 inhibitor therapy. This represents the first randomized, double-blind, controlled Phase 3 study specifically designed to evaluate biologic switching strategies in this challenging patient population.
Study Design and Objectives
The multi-center trial (NCT06945107) plans to enroll approximately 310 participants with plaque psoriasis who have inadequate response to prior anti-IL-17 monoclonal antibody treatment, defined as a static Physician's Global Assessment (sPGA) score of ≥2 and body surface area (BSA) of ≥3%. Participants will be randomized in a 1:1 ratio to either switch to picankibart treatment or continue their current IL-17 monoclonal antibody therapy.
The primary endpoint is the proportion of participants achieving an sPGA score of clear (0) or almost clear (1) at week 16. This head-to-head comparison design will provide direct evidence of picankibart's efficacy compared to continued IL-17 inhibitor treatment in patients with treatment-resistant psoriasis.
Promising Phase 2 Results Support Advancement
Previous Phase 2 data (NCT05970978) demonstrated encouraging efficacy signals for biologic switching to picankibart. Among participants with inadequate response to prior biologics treatment, 48.2% (40/83) reached the primary endpoint of sPGA 0 or 1 and BSA <3%. Notably, response rates remained stable at 54.2% (45/83) through week 44 with continued picankibart maintenance dosing every 12 weeks.
In the subset of participants with baseline sPGA ≥2 and BSA ≥3%, 64.6% (42/65) achieved sPGA of 0 or 1, while 16.9% (11/65) achieved complete skin lesion clearance (sPGA of 0). Quality of life measures, assessed by the Dermatology Life Quality Index (DLQI), also showed improvement.
Addressing Treatment Failure in Psoriasis
The study addresses a significant clinical challenge in psoriasis management. According to real-world data cited by the investigators, 28.5% of patients discontinue IL-17 therapy due to primary failure (failing to meet minimum efficacy criteria after 12 weeks of treatment), while 24.3% experience secondary failure (loss of efficacy over time despite initial response).
Professor Furen Zhang from the Dermatology Hospital Affiliated to Shandong First Medical University, the study's principal investigator, emphasized the clinical significance: "For patients experiencing treatment failure, there is an urgent medical need for optimized treatment strategy. This randomized controlled Phase 3 study will evaluate the efficacy and safety of picankibart in patients with inadequate response to previous IL-17 monoclonal antibody treatment."
Clinical Context and Unmet Need
Psoriasis affects over 7 million patients in China alone, with approximately 80-90% having plaque psoriasis and nearly 30% presenting with moderate-to-severe disease. While IL-17 monoclonal antibodies have shown significant efficacy in moderate-to-severe psoriasis, treatment failure remains a substantial clinical challenge requiring evidence-based switching strategies.
Professor Jun Gu from Suzhou Municipal Hospital, another principal investigator, noted: "A study on the biologics switching for psoriasis implied that the switching between biologics with different targets may provide better efficacy to patients, but rigorous clinical research evidence remain essential to validate this therapeutic approach."
Regulatory Progress and Development Pipeline
Picankibart represents the first IL-23p19 monoclonal antibody independently developed by a Chinese biopharmaceutical company. In September 2024, the National Medical Products Administration (NMPA) accepted the first new drug application for picankibart for treating moderate-to-severe plaque psoriasis.
The compound is currently being evaluated in multiple clinical studies, including completed Phase 3 studies in treatment-naïve moderate-to-severe plaque psoriasis patients (CLEAR-1, which reached study endpoints in May 2024), ongoing Phase 3 studies with randomized withdrawal and re-treatment designs, and Phase 2 studies in moderate-to-severe active ulcerative colitis.
Dr. Lei Qian from Innovent Biologics stated: "This head-to-head Phase 3 randomized, double-blind clinical study will compare picankibart with IL-17 monoclonal antibody to strengthen picankibart clinical benefits for patients with inadequate response. I look forward to the success of this study, which will provide strong evidence and guidance for the clinical practice of psoriasis biologics switching."
The study results are expected to provide crucial evidence for optimizing treatment pathways in psoriasis patients who have experienced biologic treatment failure, potentially establishing picankibart as a valuable therapeutic option for this challenging patient population.
