AbbVie (NYSE:ABBV) said on Thursday that it met the main goal in the second of two pivotal late-stage trials testing 15 mg and 30 mg daily doses of Rinvoq (upadacitinib), for treating severe alopecia areata.
In the study, both the 15 mg and 30 mg once-daily doses of upadacitinib enabled a significant number of patients to achieve at least 80% scalp hair coverage after 24 weeks, with 45.2% for the 15 mg dose and 55% for the 30 mg dose, compared to just 1.5% in the placebo group.
In addition to scalp hair regrowth, the trials also met key secondary endpoints, showing improvements in eyebrow and eyelash hair, as well as a notable percentage of patients achieving more than 90% scalp hair coverage by week 24.
On the safety front, upadacitinib demonstrated a favorable profile similar to its use in other approved indications.
Serious adverse events were rare, occurring in 1.9% of patients on the 15 mg dose and 1.8% on the 30 mg dose, compared to 0.7% in the placebo group, the company added.
These results are consistent with those from the first parallel replicate study in the UP-AA clinical program.