Phase 3 Data Highlight Hair Regrowth With Deuruxolitinib in AA

For adults living with severe alopecia areata, meaningful scalp hair regrowth remained difficult to achieve despite the growing number of Janus kinase (JAK) inhibitors entering the treatment landscape. New phase 3 data suggest that deuruxolitinib, an oral selective JAK1/JAK2 inhibitor, improved scalp hair regrowth and patient-reported satisfaction compared with placebo in adults with chronic severe disease.¹

Investigators reported findings from the THRIVE-AA2 phase 3 randomized controlled trial (NCT04797650) published in Journal of the American Academy of Dermatology. The study evaluated the efficacy and safety of twice-daily deuruxolitinib in adults with AA who had experienced at least 50% scalp hair loss for 6 months or longer.

“A significantly greater percentage of patients receiving either dose of deuruxolitinib achieved SALT20 [Severity of Alopecia Tool score of 20 or less] at week 24 vs placebo,” the authors wrote.

AA is an immune-mediated disease characterized by patchy or complete hair loss and is associated with substantial psychosocial burden. The investigators noted that currently available therapies have produced variable hair regrowth outcomes and dissatisfaction among both patients and clinicians. Although several JAK inhibitors have entered the AA treatment space in recent years, researchers said additional therapies remained needed because of inconsistent response rates and concerns about long-term durability.

A growing body of research has highlighted the expanding role of JAK inhibitors in treating AA, particularly among younger patients who often experience substantial psychosocial effects from visible hair loss. In the phase 2b/3 ALLEGRO trial (NCT03732807), ritlecitinib demonstrated significant scalp hair regrowth in adults and adolescents 12 years and older with severe alopecia areata, helping establish JAK inhibition as a viable therapeutic strategy for hair regrowth in this population.² Although the present THRIVE-AA2 study evaluated adults aged 18 to 65 years, the findings add to broader evidence supporting oral JAK inhibitors such as deuruxolitinib for severe alopecia areata, an autoimmune disease that frequently begins during adolescence and young adulthood. Researchers in the current trial reported clinically meaningful scalp hair regrowth and improved patient satisfaction after 24 weeks of treatment with deuruxolitinib.¹

The multicenter, double-blind, placebo-controlled trial enrolled adults aged 18 to 65 years across 63 sites in the US, Canada, and Europe between June and December 2021. Eligible participants had a SALT score of at least 50, indicating at least 50% scalp hair loss and a current AA episode lasting between 6 months and 10 years.

A total of 517 participants were randomized in a 1:2:1 ratio to receive deuruxolitinib 12 mg twice daily, deuruxolitinib 8 mg twice daily, or placebo for 24 weeks. Overall, 515 participants received at least 1 dose of study medication and 468 patients completed the phase 3 portion of the trial.

Baseline demographic characteristics were similar across treatment groups. The mean age was 39 years, approximately 68% of participants were female, and nearly 80% were White. More than 60% of participants had complete or near-complete scalp hair loss at baseline, defined as a SALT score of at least 95. Participants had experienced their current episode for a mean duration of 3.8 years.

The primary end point was the proportion of participants achieving a SALT score of 20 or less at week 24, representing 20% or less scalp hair loss.

At week 24, 33.0% of participants receiving deuruxolitinib 8 mg twice daily and 38.3% of those receiving 12 mg twice daily achieved the primary end point compared with 0.8% in the placebo group (P < .0001 for both comparisons). Investigators also reported that significant differences vs placebo emerged by week 12 and continued through week 24.

Among participants with partial scalp hair loss at baseline, response rates were higher. SALT20 was achieved by 54.1% of patients receiving the 8-mg dose and 57.4% receiving the 12-mg dose compared with 2.2% in the placebo arm. Even among patients with near-total hair loss at baseline, response rates favored active treatment.

Patient-reported satisfaction findings paralleled the clinical outcomes. At week 24, 46.5% of participants receiving deuruxolitinib 8 mg twice daily and 51.7% receiving 12 mg twice daily reported being “satisfied” or “very satisfied” with their scalp hair compared with 1.7% of placebo-treated participants.

Investigators additionally assessed more stringent outcomes using SALT10, which reflected 10% or less scalp hair loss. Approximately one-quarter of participants receiving either deuruxolitinib dose achieved SALT10 at week 24, while no placebo-treated participants met that threshold.

Safety findings showed that most treatment-emergent adverse events (TEAEs) were mild or moderate. TEAEs occurred in 80.5% of participants receiving deuruxolitinib 8 mg twice daily, 81.4% receiving 12 mg twice daily, and 70.0% receiving placebo.

The most commonly reported adverse events included COVID-19, asymptomatic COVID-19, nasopharyngitis, headache, acne vulgaris, and elevated creatine phosphokinase levels. Serious adverse events occurred infrequently, affecting 1.2% of patients in the 8-mg group and 1.6% in the 12-mg group. No deaths, thromboembolic events, myocardial infarctions, or strokes occurred during the 24-week study period.

However, investigators acknowledged that longer-term safety monitoring remained necessary. They noted that thromboembolic events had been observed during ongoing open-label extension studies in some patients treated for at least 1 year.

The authors also highlighted several study limitations. The 24-week double-blind period may not have been long enough to fully capture maximal treatment response or durability of benefit after discontinuation. Additionally, the study population was predominantly White and female, which may limit generalizability to broader patient populations.

Still, the researchers concluded that the findings supported deuruxolitinib as an additional treatment option for adults with severe AA.

“Patient-reported satisfaction with hair regrowth was consistent with improvement in hair regrowth,” the authors wrote. “These data support deuruxolitinib as a treatment option in adults with severe AA.”

References

1. Tsianakas A, Passeron T, Magnolo N, et al. Efficacy and safety of deuruxolitinib, an oral selective Janus kinase 1/2 inhibitor, in adults with alopecia areata: results from the THRIVE-AA2 phase 3, randomized, double-blind, controlled trial. J Am Acad Dermatol. 2026;94(4):1134-1143. doi:10.1016/j.jaad.2025.11.070

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;401(10387):1518-1529. doi:10.1016/S0140-6736(23)00222-2