Pfizer announces positive top-line results from the Phase 2b/3 ALLEGRO trial of once-daily ritlecitinib for the treatment of alopecia areata. Ritlecitinib 50 mg and 30 mg showed significantly a greater proportion of patients with 20 percent or less scalp hair loss after 24 weeks of treatment versus placebo, achieving the primary efficacy endpoint of the study.
Ritlecitinib has shown to have a safety profile consistent with previous studies, and percentages of patients with AEs were similar across all treatment groups.
Positive results have been announced from Pfizer’s Phase 2b/3 ALLEGRO trial of oral once-daily ritlecitinib in patients with alopecia areata. This autoimmune disease occurs when the body’s immune system attacks hair follicles, resulting in hair loss on the scalp, and potentially also on the face and body.
All entrants to the study had at least 50 percent hair loss due to alopecia areata as per the Severity of Alopecia Tool (SALT) score. Ritlecitinib 50 mg and 30 mg showed a significantly greater proportion of patients with 20% or less scalp hair loss after 24 weeks of treatment versus placebo, achieving the primary efficacy endpoint of improving scalp hair regrowth.
Michael Corbo, Chief Development Officer at Pfizer Inflammation and Immunology, said “…there are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency approved treatments,” for alopecia areata and that Pfizer hopes to make this potential treatment available to patients as soon as possible.
The overall percentage of patients with adverse events (AEs), serious AEs, and discontinuing due to AEs was similar across the different treatment groups. Nasopharyngitis, headache, and upper respiratory tract infection were among the common AEs, with instances of shingles, pulmonary embolism, and malignancies. Laboratory studies have demonstrated ritlecitinib’s ability to block the activity of signaling molecules and immune cells believed to contribute to loss of hair in people with alopecia areata. Ritlecitinib was granted Breakthrough Therapy designation by the U.S. FDA in 2018 for the treatment of alopecia areata and is also being tested for various other diseases.
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