Efficacy and safety of QY201, an oral dual Janus kinase 1/tyrosine kinase 2 inhibitor, in adults with moderate-to-severe atopic dermatitis: a multicenter, randomized, double-blind, placebo-controlled phase 2 dose-finding trial.

Background

QY201 is a novel oral Janus kinase 1 and tyrosine kinase 2 inhibitor.

Objective

To evaluate the efficacy of multiple QY201 doses in moderate-to-severe atopic dermatitis (AD), and to inform dose selection for phase 3 studies.

Methods

In this phase 2, randomized, double-blind, placebo-controlled trial, 200 adults with moderate-to-severe AD were randomized 1:1:1:1 to receive QY201 (5 mg, 10 mg, or 20 mg twice daily [BID]) or placebo for 12 weeks. The primary endpoint was the proportion of patients achieving ≥75% improvement in Eczema Area and Severity Index (EASI-75) at week 12.

Results

EASI-75 response rates at week 12 were 72.9%, 84.7% and 81.4% in the 5 mg BID, 10 mg BID, and 20 mg BID groups, respectively, compared with 18.5% in the placebo group (all P<0.0001). Investigator's Global Assessment response rates were 44.7% (P=0.0011), 64.3% (P<0.0001), and 71.3% (P<0.0001), respectively, versus 12.4% with placebo. Treatment-emergent adverse events occurred in 74.0%, 75.5%, and 90.4% of patients receiving QY201, compared to 69.4% with placebo; most were mild or moderate.

Limitations

Short follow-up and single-country population.

Conclusion

The phase 2 findings support further evaluation of QY201 at doses of 10 mg BID and 20 mg BID in confirmatory phase 3 trials.