Evaluating TQH3906 Capsules for Adults With Moderate to Severe Plaque Psoriasis A Randomized, Double-Blind Study Comparing TQH3906, Deucravacitinib, and Placebo Including an Open-Label Extension Phase

What This Trial Is About

Researchers are evaluating the effectiveness and safety of TQH3906 capsules, a once-daily oral medication, in adults aged 18 to 75 with moderate to severe plaque psoriasis. This multicenter, randomized, double-blind, placebo- and active-controlled Phase III trial compares TQH3906 with deucravacitinib and placebo. TQH3906 selectively inhibits TYK2, targeting inflammatory pathways involved in psoriasis, aiming to support its approval for treating this condition. Participants are randomly assigned in a 221 ratio to receive TQH3906 capsules 24 mg, deucravacitinib tablets 6 mg, or placebos matching each drug during a 16-week double-blind treatment phase. After this, all participants enter a 36-week open-label extension where they receive TQH3906 capsules alone. Following treatment, there is a 4-week safety follow-up period to monitor any lasting effects. Throughout the study, participants undergo regular assessments including the static Physicians Global Assessment sPGA and Psoriasis Area and Severity Index PASI to measure skin improvement up to 16 and 52 weeks. Additional evaluations focus on scalp, nail, and palmoplantar psoriasis, quality of life via the Dermatology Life Quality Index DLQI, and drug levels in the body. Safety is closely monitored during and after the treatment periods to gather comprehensive data over a year.

A Clinical Trial of TQH3906 Capsules in Adult Patients With Moderate to Severe Plaque Psoriasis