Anti–IL-23 monoclonal antibody promising in plaque psoriasis

The investigational anti–IL-23 monoclonal antibody QX004N appears to be well tolerated and have superior efficacy vs placebo in the treatment of patients with moderate to severe plaque psoriasis, according to a phase I study from China.

The study was conducted in two phases. Phase 1a included 55 healthy participants (mean age 35.9 years, 54.5 percent female) who were randomly assigned to receive a single subcutaneous injection of QX004N (ranging from 10 to 600 mg) or placebo. Part 1b included 30 patients with moderate to severe plaque psoriasis who were randomly assigned to receive QX004N (mean age 41.4 years, 79.2 percent male) at doses of 150, 300, and 600 mg or placebo (mean age 35.3 years, 83.3 percent male) once every 2 weeks.

The primary outcome was the safety of a single dose of QX004N, while the secondary outcome was the pharmacokinetic profile in phase 1a. In phase 1b, the primary efficacy endpoint was the proportion of patients achieving at least 75-percent improvement in Psoriasis Area and Severity Index (PASI 75) by week 12. Other efficacy endpoints were considered secondary.

QX004N showed linear pharmacokinetics and was well tolerated in both healthy participants and patients with psoriasis. Adverse events (AEs) were largely mild to moderate in severity, and there were no reports of drug-related serious AEs.

At week 12, PASI 75 was achieved in all patients across the 150-, 300-, and 600-mg QX004N groups as opposed to only 33.3 percent of those in the placebo group (p=0.02 for all). Similarly, all QX004N-treated patients achieved PASI 90 (90-percent improvement in PASI) at week 16 compared with only 33.3 percent in the placebo group.

The maximum proportion of patients achieving Investigator’s Global Assessment score of 0 or 1 was 100 percent in the three QX004N groups.