Researchers to conduct study on rezpegaldesleukin for severe, very severe alopecia areata

Key takeaways:

• Rezpegaldesleukin is an interleukin-2 receptor pathway agonist that may stimulate regulatory T-cell expansion and function.
• The phase 2b trial will evaluate the drug’s potential in alopecia areata.

A phase 2b study of rezpegaldesleukin for treating alopecia areata is underway following the drug’s success in other autoimmune diseases, according to a poster presented at the European Academy of Dermatology and Venerology Congress.

According to the poster, 6.7 million people in the U.S. and 160 million worldwide have alopecia areata (AA), a condition which causes emotional and psychosocial distress and may be accompanied by other autoimmune conditions.

“The majority of patients do not achieve adequate disease control with the standard of care therapies (baricitinib and ritlecitinib),” Adam Reich, MD, PhD, professor and head of the department of dermatology at the University of Rzeszów in Poland, and colleagues wrote. “New strategies aimed at inducing deep and potentially therapy-free remission are needed.”

One such option that the researchers will be investigating is rezpegaldesleukin, an interleukin-2 receptor pathway agonist that has shown success in treating other conditions such as atopic dermatitis and psoriasis.

In fact, a phase 1b study of rezpegaldesleukin in AD showed that patients treated with 12 µg/kg and 24 µg/kg saw a 65% and 83% improvement from baseline, respectively, after 12 weeks of treatment vs. 47% of placebo-treated patients.

The idea is that these successes will translate to AA treatment as rezpegaldesleukin has been shown to stimulate the expansion and function of regulatory T-cells, which are impaired in patients with AA, the poster explained.

As a result, the researchers are beginning to conduct a randomized, double-blinded, placebo-controlled phase 2b study which will compare the efficacy of rezpegaldesleukin vs. placebo for the treatment of severe to very severe AA in Janus kinase inhibitor- and biologic-naïve patients.

The study’s primary endpoint will be a least square mean percent change from baseline in Severity of Alopecia Tool score at week 36. It will be conducted internationally at approximately 26 clinical sites in the United States, Canada and Poland.