Nektar Therapeutics Completes Enrollment for Phase 2b Alopecia Areata Trial
The company announced completion of target enrollment in the REZOLVE-AA study of rezpegaldesleukin in people with severe-to-very-severe alopecia areata.
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Nektar Therapeutics has completed target enrollment for its REZOLVE-AA phase 2b clinical trial evaluating rezpegaldesleukin in patients with severe-to-very-severe alopecia areata, the company announced Wednesday.1
Rezpegaldesleukin is an investigational biologic therapy designed to stimulate regulatory T cells, which help regulate immune system activity. The study enrolled 84 patients across 30 global sites, with 62% in Poland, 24% in Canada, and 14% in the US.1
“There is a high unmet need for better treatment options in alopecia areata as the standard of care therapies available have significant relapse rates and carry potential long-term safety challenges,” Howard W. Robin, president and CEO of Nektar Therapeutics, said in a February 26, 2025, press release. “This creates an opportunity for rezpegaldesleukin to emerge as the first novel treatment option targeting T regulatory cell dysfunction in the hair follicles of patients battling this chronic condition. We look forward to reporting our topline data from this study in the fourth quarter of this year.”1
Alopecia areata is an autoimmune disorder that leads to hair loss, affecting approximately 700 000 people in the US.2 Current treatments have high relapse rates and potential long-term safety concerns, according to the company.1
The REZOLVE-AA study, initiated in March 2024, is evaluating 2 dose regimens of rezpegaldesleukin against a placebo over a 36-week induction period. The primary endpoint measures changes in the Severity of Alopecia Tool (SALT) score, with additional assessments of treatment response over time.1
Rezpegaldesleukin is also being studied in a Phase 2b trial for moderate-to-severe atopic dermatitis and received Fast Track designation from the US FDA for that indication earlier this month.3
References:
1. Nektar Therapeutics announces completion of target enrollment in REZOLVE-AA phase 2b clinical trial of rezpegaldesleukin in patients with severe-to-very severe alopecia areata. News release. Nektar Therapeutics. February 26, 2025. Accessed February 28, 2025. https://ir.nektar.com/news-releases/news-release-details/nektar-therapeutics-announces-completion-target-enrollment-0
2. Alopecia Areata. National Alopecia Areata Foundation Web site. https://www.naaf.org/alopecia-areata/. Accessed February 28, 2025.
3. Jennings S. FDA grants fast track designation to rezpegaldesleukin for atopic dermatitis. Patient Care Online. February 10, 2025. Accessed February 28, 2025. https://www.patientcareonline.com/view/fda-grants-fast-track-designation-to-rezpegaldesleukin-for-atopic-dermatitis
