Clinical trial results published for further treatment for severe alopecia areata

Recently, a clinical trial has been taking place to test the safety and effectiveness of upadacitinib for treating severe alopecia areata (greater than 50% scalp hair loss). Upadacitinib (commercial name RINVOQ®) is a JAK inhibitor medicine which is licensed for use in other health conditions like inflammatory bowel disease and arthritis.  

It is not yet approved for alopecia areata by the U.S. Food and Drug Administration (FDA), which typically happens before any approvals in the UK. For a treatment to be licensed for use in a particular health condition in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) have to approve it. For it to then also become available on the NHS, the National Institute for Health and Care Excellence (NICE) would need to recommend it for routine commissioning. These organisations use data from clinical trials to see if the medicine is in fact safe and effective for people to use.  

AbbVie have now announced the first results of their clinical trial of upadacitinib. In two parallel studies, a total of 1,400 adults and adolescents (aged 12+) with severe alopecia areata were given a 15mg, 30mg or placebo dose. After 24 weeks of receiving the treatment: 

• 44.6% of people in the 15mg group, 54.3% of people in the 30mg group, and 3.4% of people in the placebo group, reached 80% scalp hair coverage.  

• 36.0% of people in the 15mg group, 47.1% of people in the 30mg group, and 1.4% of people in the placebo group, reached 90% scalp hair coverage. 

The company announce they also met secondary endpoints for eyebrow and eyelash regrowth, and the number of people achieving 100% scalp hair coverage (SALT0). 

Serious adverse advents were observed in 2.8% of people in the 30mg group, and 1.4% in the 15mg group, and none in the placebo group. The most common adverse events reported were the common cold, upper respiratory tract infections, and acne. One case of venous thromboembolism was reported in the 15mg upadacitinib group, in a person with multiple risk factors. 

The results from the second study are expected later this summer. We will continue to follow developments around this medicine and what this means for patients in the UK.  

Update Thursday 21 August 2025:  

The results from the second parallel study of the UP-AA clinical trial have now also been announced. The primary outcomes of this study are similar to the first one, as after 24 weeks: 

• 45.2% of people in the 15mg group, 55.0% in the 30mg group, and 1.5% in the placebo group reached 80% scalp hair coverage. 
• 35.2% of people in the 15mg group, 45.8% in the 30mg group, and 0.7% in the placebo group reached 90% scalp hair coverage. 

The company announce they also met secondary endpoints for eyebrow and eyelash regrowth, and the number of people reaching 100% scalp hair coverage (SALT0). 

Serious adverse advents* were observed in 1.8% of people in the 30mg and 1.9% in the 15mg group, and 0.7% in the placebo group. The most common adverse events were upper respiratory tract infections, acne, increased blood creatine phosphokinase levels, and the common cold. One case of breast cancer was reported in the 15mg upadacitinib group. 

*An adverse event is an unintended symptom that happens during treatment, no matter what causes it. These are reported because it is not always possible to know if something happened because of the treatment or is unrelated. This is different from a side effect, which is a direct result of the medicine.

See also:

What is a clinical trial?