AbbVie has reported encouraging topline outcomes from the first of two replicate trials of the Phase III UP-AA programme, assessing Rinvoq (upadacitinib), at both 15mg and 30mg doses in adult and adolescent subjects with severe alopecia areata (AA) with a mean baseline SALT score of 83.8.
The UP-AA programme was structured as a single protocol comprising two double-blind, randomised, placebo-controlled trials (Study 1 and Study 2), each with its own investigative centres, randomisation, data collection, analysis and reporting.
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The two trials of the programme assessed the efficacy and safety of the therapy in this patient group.
In Period A of these studies, subjects are allocated to one of three groups in a random manner. They are given either 15mg or 30mg of upadacitinib or a placebo for 24 weeks.
Following this, in Period B of both studies, those subjects who were initially assigned to receive a specific dose of upadacitinib during Period A will maintain their respective treatment for 28 weeks.
For those subjects who were initially given a placebo in Period A will continue to receive a placebo in Period B or will be allocated to one of two groups, depending on their SALT score at the 24-week mark.
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By GlobalDataPeriods A and B of the two trials spanned 52 weeks. These studies randomised 1,399 severe AA subjects aged 12 to 64 across 248 centres worldwide.
The primary endpoint was met in Study 2, with 44.6% and 54.3% of subjects treated with 15mg and 30mg doses of upadacitinib, respectively, achieving scalp hair coverage of 80% or above at week 24.
This was a significant increase in comparison to 3.4% of subjects on placebo. Furthermore, 36.0% and 47.1% of subjects on the 15mg and 30mg doses achieved 90% or above scalp hair coverage, compared to 1.4% on placebo.
Key secondary goals were also achieved, including improvements in eyebrows and eyelashes and complete scalp hair coverage.
The safety profile was found to be consistent with that observed in approved indications.
It is important to note that the use of upadacitinib in AA is not yet approved, and its efficacy and safety are still under evaluation by regulatory bodies.
Rinvoq, a Janus kinase (JAK) inhibitor discovered and developed by Abbvie, is being studied for various immune-mediated inflammatory conditions.
Last month, the company announced that its Phase III TEMPLE trial, which compared atogepant to topiramate’s highest tolerated dose for migraine in adults, had met its primary goal.
