Core Insights - Innovent Biologics announced that PECONDLE® (picankibart injection) achieved both primary and key secondary efficacy endpoints in the Phase 3 CLEAR-2 study for moderate-to-severe plaque psoriasis, marking it as the first China-developed IL-23p19 monoclonal antibody to receive market approval from the NMPA in November 2025 [1][11]. Study Design and Results - The CLEAR-2 study was a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial involving 566 participants, focusing on the efficacy of picankibart during maintenance treatment and after withdrawal [2]. - At Week 56, 89.3% of participants in the 100 mg group and 90.1% in the 200 mg group maintained a PASI 90 response, significantly higher than the withdrawal groups [3]. - All key secondary endpoints were met, showing significant improvements in skin clearance and quality of life for participants receiving picankibart compared to those in withdrawal [4]. Efficacy and Safety - Picankibart demonstrated durable efficacy post-withdrawal, with maintenance treatment significantly reducing the risk of losing PASI 90 response compared to withdrawal groups [5]. - The safety profile of picankibart remained favorable throughout the study, with no new safety signals identified [6]. Clinical Implications - The results of the CLEAR-2 study provide critical insights into the necessity of maintenance therapy and the durability of post-withdrawal responses, offering assurance for chronic psoriasis patients [7]. - The successful Phase 3 results validate picankibart's advantages as a next-generation IL-23p19 inhibitor, emphasizing its potential for deep, durable remission and improved quality of life for patients [8]. Background on Psoriasis and Treatment - Psoriasis is a chronic inflammatory disease affecting a significant portion of the population, with moderate-to-severe cases representing nearly 30% of patients [9]. - Current systemic treatments in China include various agents, with biologics, particularly IL-23 inhibitors, gaining prominence due to their efficacy and safety [9]. About PECONDLE® - PECONDLE® is a monoclonal antibody developed by Innovent that targets the IL-23p19 subunit, offering a potential treatment option for psoriasis and other autoimmune diseases [10]. - The product has received approval for treating moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy, with ongoing studies exploring additional indications [11]. Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer and autoimmune disorders, and has launched 17 products to date [12][13].
Innovent Announces PECONDLE® (Picankibart Injection) Phase 3 Study (CLEAR-2) Meets Endpoints, Delivering Superior Long-Term Management Solution for Moderate-to-Severe Psoriasis