Clinical trial

Ritlecitinib in Alopecia Areata: ALLEGRO 2b/3 Pivotal Phase 3 Clinical Trial

Pfizer Dermatology

DOI: 10.26303/snym-qg68

What is it about?

Ritlecitinib is an oral, selective dual JAK3/TEC family kinase inhibitor that helps hair regrowth in adults and adolescents with severe alopecia areata.¹ The approved dose for ritlecitinib for treatment of severe alopecia areata is 50 mg.¹ In a large international study, patients aged 12 and older with at least 50% scalp hair loss took ritlecitinib daily for up to 48 weeks. At 24 weeks, 23% of patients treated with 50 mg ritlecitinib achieved 80% scalp hair coverage (SALT≤20) versus 2% in placebo (p<0.0001).² Among patients treated with ritlecitinib 50 mg with SALT score ≤20 at week 24, 89.3% sustained this response through week 48.³ Of those with a SALT score >20 at week 24, 34% achieved a SALT score ≤20 at week 48.³ At 24 weeks, 49% of patients treated with 50 mg ritlecitinib reported their alopecia areata moderately or greatly improved versus 9% in placebo (p<0.0001).² The most common adverse events in any treatment group were upper respiratory tract infection, nasopharyngitis, and headache.² The data reported in adolescent patients were consistent with the overall population.⁴

Why is it important?

Ritlecitinib offers an advanced treatment for severe alopecia areata (AA). Until recently, treatment options for severe AA were limited and not approved for use in patients 12 years or older. Clinical trials have demonstrated efficacy and tolerability of ritlecitinib in both adults and adolescents with extensive hair loss. 5 key takeaways from clinical studies evaluating the efficacy and safety of ritlecitinib in treating alopecia areata:

• Hair Regrowth: In both adults and adolescents with ≥50% scalp hair loss, ritlecitinib led to significant improvements compared to placebo. At 24 weeks, 23% of patients treated with 50 mg ritlecitinib achieved 80% scalp hair coverage (SALT<20) versus 2% in placebo (p<0.0001).²

• Efficacy in Adults and Adolescents: Ritlecitinib showed consistent benefits in adults and adolescents, including those with alopecia totalis and universalis.² ⁴

• Patient-Reported Outcomes: “At 24 weeks, 49% of patients treated with 50 mg ritlecitinib reported their alopecia areata moderately or greatly improved versus 9% in placebo (p<0.0001).²

• Safety Profile: The most common adverse events in any treatment group were upper respiratory tract infection, nasopharyngitis, and headache. . No deaths, serious infections, or long-term safety concerns were reported in the study.²

• Approved Option for Ages 12 and Older: Ritlecitinib 50 mg is an oral treatment approved for adolescents (12+) with severe alopecia areata.¹

References: 1. Ritlecitinib Prescribing Information 2023 2. King B, Zhang X, Harcha WG, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. Lancet. 2023 May 6;401(10387):1518-1529. 3. Piliang M, Lynde C, King B, et al. Sustained hair regrowth with continued ritlecitinib treatment through week 48 in patients with alopecia areata with or without early target responses: Post hoc analysis of the ALLEGRO phase 2b/3 trial. J Am Acad Dermatol. 2025 Feb;92(2):276-284. 4. Hordinsky M, Hebert AA, Gooderham M, et al. Efficacy and safety of ritlecitinib in adolescents with alopecia areata: Results from the ALLEGRO phase 2b/3 randomized, double-blind, placebo-controlled trial. Pediatr Dermatol. 2023 Nov-Dec;40(6):1003-1009.

EM-GLB-RITA-0048 | December 2025 Page published: 03-Feb-2026

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Who is involved?