In the second replicate study (Study 1) of the pivotal Phase 3 UP-AA clinical program, upadacitinib (RINVOQ®) achieved the primary endpoint, demonstrating that 45.2% and 55.0% of patients with severe alopecia areata treated with upadacitinib 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤ 201
Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤ 10) and complete scalp hair coverage (SALT=0) at week 24, were also met 1
The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study1
These results are consistent with the topline results from the first parallel replicate study (Study 2) of the Phase 3 UP-AA clinical program
NORTH CHICAGO, Ill., Aug. 21, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 84.0 (approximately 16% scalp hair coverage).1
In Study 1, both doses of upadacitinib achieved the primary endpoint, with 45.2% and 55.0% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reaching 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 1.5% of patients receiving placebo (p<0.001).1 These results are consistent with the topline results previously announced from the first parallel replicate study (Study 2) of the Phase 3 UP-AA clinical program.
"These positive results strengthen the growing body of evidence supporting the potential of upadacitinib to improve the lives of people with AA," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "We are very encouraged by the improvements in both scalp and non-scalp hair regrowth observed with both doses of upadacitinib and look forward to submitting these data to regulatory bodies, bringing us one step closer to delivering upadacitinib to those living with this complex immune-mediated disease."
35.2% and 45.8% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage (SALT ≤ 10), compared to 0.7% of patients receiving placebo at week 24 (p<0.001).1 Additional key secondary endpoints that were met included percentage of subjects with improvements in eyebrows and eyelashes, as well as the percentage of subjects with complete scalp hair coverage (SALT=0) with both doses of upadacitinib at week 24.1
"People living with AA often face considerable uncertainty related to both the severity and duration of hair loss, despite current treatment options," said Arash Mostaghimi, M.D., M.P.A., M.P.H., associate professor of dermatology and vice chair of clinical trials and innovation, Brigham & Women's Hospital, Harvard Medical School. "These encouraging results are consistent with and reinforce the outcomes observed in the first pivotal trial. Together, these findings underscore the potential of upadacitinib to provide meaningful hair regrowth, offering hope for those enduring the psychosocial burden associated with this disease."
The safety profile of both doses of upadacitinib in the 24-week, placebo-controlled period (Period A) was generally consistent with that observed in approved indications.1 Treatment-emergent serious adverse events occurred in 1.9% and 1.8% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and 0.7% in the placebo group.1 Discontinuations due to treatment-emergent adverse events (TEAEs) occurred in 1.1% and 1.5% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and none in the placebo group.1 The most common TEAEs observed were upper respiratory tract infection, acne, blood creatine phosphokinase increased and nasopharyngitis.1 Serious infections were reported infrequently with one in the placebo group and one in the upadacitinib 30 mg group, and none in the upadacitinib 15 mg group group.1 There were no adjudicated MACE, adjudicated venous thromboembolic events or deaths reported.1 One malignancy (breast cancer) was reported in the upadacitinib 15 mg group.1
Use of upadacitinib in AA is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
About UP-AA Clinical Trial
UP-AA M23-716 was conducted as a single protocol that includes two replicate pivotal studies (Study 1 and Study 2) with randomization, investigative sites, data collection, analysis and reporting independent for each study. The Phase 3 randomized, placebo-controlled, double-blind studies evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata. In Study 1 and Study 2 Period A, participants are randomized to one of three groups to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for 24 weeks. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose groups in Period A will continue their same treatment in Period B for 28 weeks. Participants originally randomized to placebo in Period A will either remain on placebo in Period B, or be randomized in one of two groups, based off of their SALT score at week 24. In total, Study 1 and Study 2 Periods A and B span 52 weeks. Participants who complete Study 1 or Study 2, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. The two trials randomized 1,399 participants with severe AA ages 12 to 64 across 248 sites worldwide. More information on this trial can be found at www.clinicaltrials.gov (NCT06012240).
About RINVOQ
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human leukocyte cellular assays, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation.2 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.
Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.3,4,5,6,7
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio.
1 AbbVie. Data on file ABVRRTI81580.
2 RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025.
3 A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants with Takaysu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT04161898. Accessed January 15, 2025.
4 Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05843643. Accessed January 15, 2025.
5 A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05889182. Accessed January 15, 2025.
6 A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06118411. Accessed January 15, 2025.
7 A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06012240. Accessed January 15, 2025.