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Recruitment underway for atopic dermatitis serlopitant trial

An investigational treatment that inhibits a receptor implicated in itch may hold promise for treatment of chronic pruritus, recent data suggest.

Serlopitant, an oral neurokinin 1 (NK-1) receptor antagonist, has been evaluated in two trials that met their primary endpoints, according to investigators. Now, recruitment is underway for a randomized, double-blind, placebo-controlled study of serlopitant for treatment of pruritus in atopic dermatitis.

In some of the most recent data on serlopitant, presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress recently held in Geneva, patients randomized to receive the oral NK-1 antagonist had a statistically significant change in pruritus score as compared with placebo.

“We have no approved treatment for chronic pruritus,” said investigator Sonja Ständer, M.D., head of the Center for Chronic Pruritus of the University Hospital Münster, Germany. “So this study is giving hope that in the future, we will have a safe and effective treatment for severely affected patients.”

SIGNIFICANT REDUCTION IN ITCH

The multi-center study, conducted at 25 sites in the United States, included 257 patients with severe pruritus as determined by a visual analog scale (VAS) pruritus score of at least seven on a scale of 1 to 10. They were randomized to six weeks of treatment with oral, once-daily serlopitant, given at doses of 0.25 mg, 1 mg, or 5 mg, or placebo.

The reduction in pruritus for serlopitant 1 or 5 mg vs placebo was statistically significant at weeks 4, 5, and 6 (P < 0.05), Dr. Ständer reported. Mean reduction in VAS pruritus scores from baseline to 6 weeks was 41.4% and 42.5% in the serlopitant 1 mg and 5 mg groups, respectively, compared with 28.3% in the placebo group.

In post-hoc analysis, investigators found that the reduction in pruritus score for serlopitant 1 mg and 5 mg vs placebo was significant by day 3 of treatment (P < 0.05). Serlopitant was well tolerated, they reported, with treatment-emergent side effects that were primarily mild to moderate in severity.

This particular study allowed chronic pruritus of any type as a “proof of principle,” and about 30% of patients enrolled had atopic disposition, Dr. Ständer said in an interview with Dermatology Times.

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About Dr. J. Kim

Dr Kim developed (and is continuing to develop) dermatology research news as we way from dermatologists to stay on top of the latest advances in the field of dermatology.

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