Anti–IL-23 monoclonal antibody shows promise in plaque psoriasis

QX004N, a humanized IgG1λ monoclonal antibody targeting IL-23, is superior to placebo in the treatment of patients with moderate to severe plaque psoriasis, according to a phase I trial.

The trial was conducted in two parts. Part 1 was a single-ascending-dose trial in 55 healthy participants (mean age 35.9 years, 54.5 percent female). These participants were randomly assigned to receive a single subcutaneous injection of QX004N (ranging from 10 mg to 600 mg) or placebo.

Part 2 was a multiple dose-escalation phase 1b clinical trial involving 30 patients with moderate to severe plaque psoriasis. These patients were randomly assigned to receive QX004N at doses of 150, 300, and 600 mg once every 2 weeks or placebo. The mean age was 41.4 years in the QX004N group and 35.3 years in the placebo group, with 79.2 percent and 83.3 percent of patients in the respective groups being male.

For part 1, the primary outcome was safety, while the secondary outcome was the pharmacokinetic profile. For part 2, 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.

Overall, QX004N exhibited linear pharmacokinetics and was tolerated well in both healthy participants and patients with psoriasis. Most adverse events (AEs) documented were mild to moderate in intensity, and there were no incidents of drug-related serious AEs.

All patients in the three QX004N dose groups achieved PASI 75 at week 12 and PASI 90 at week 16 (100 percent) as opposed to only 33.3 percent in the placebo group. All patients in the three QX004N dose groups achieved Investigator’s Global Assessment score of 0 or 1 by week 12.