AbbVie's Autoimmune Drug Rinvoq Achieves Endpoints In Two Replicate Phase 3 Vitiligo Studies

(RTTNews) - AbbVie's (ABBV) autoimmune drug Rinvoq has successfully met the endpoints in two replicate phase 3 studies in adult and adolescent patients with non-segmental vitiligo.

Non-segmental vitiligo (NSV), the most common form of vitiligo affecting over 90% of patients, is characterized by symmetrical and bilateral white patches on both sides of the body, commonly on the face, feet, hands and groin.

According to the topline results announced today, the two phase 3 trials achieved the co-primary endpoints of 50% reduction in Total Vitiligo Area Scoring Index (T-VASI 50) from baseline and 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 48. The studies also met the key ranked secondary endpoints, including F-VASI 50 at week 48. The two trials randomized 614 participants with NSV across 90 sites worldwide.

The Total Vitiligo Area Scoring Index (T-VASI) is a tool that measures the extent of de-pigmentation over the entire body, while F-VASI measures de-pigmentation of the face, an area among the most visible and psychosocially impactful for people living with non-segmental vitiligo.

Commenting on the study results, Kori Wallace, vice president, global head of immunology clinical development, AbbVie, said, "There are no approved systemic medical therapies for achieving re-pigmentation in vitiligo. These Phase 3 results represent a significant milestone in AbbVie's commitment to supporting patients and expanding our immunology portfolio to deliver innovative solutions."

Rinvoq is already approved for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis. The drug generated global net revenues of $2.028 billion in the second quarter of 2025, an increase of 41.8% over the year-ago quarter.

In addition to vitiligo, the drug is also being studied in phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, and systemic lupus erythematosus.

ABBV has traded in a range of $163.81 to $244.81 in the last 1 year. The stock closed yesterday's trading at $227.54, down 0.21%.