AbbVie’s upadacitinib (Rinvoq) has met the primary endpoint in a Phase 2b clinical trial in adults with non-segmental vitiligo (NSV), a chronic, immune condition.

Upadacitinib is a JAK inhibitor that has seven approved indications. It is currently being assessed in multiple immune-mediated diseases.

In the trial, Rinvoq showed a percent change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 with the 11mg and 22mg doses against placebo.

F-VASI is used to calculate re-pigmentation of the face and evaluate the extent of re-pigmentation and treatment response in clinical studies.

For all upadacitinib doses, the outcomes at week 24 were quantitatively superior to the percent reduction from baseline in F-VASI at week 52.

Beyond the existing safety profile for the JAK inhibitor, no additional safety signals were found.

In secondary endpoints, higher response rates were also seen with upadacitinib compared to placebo including F-VASI 75 at week 24 with the 11mg and 22mg dosages and Total Vitiligo Area Scoring Index (T-VASI) 50 at week 24 with the 22mg dose.

Based on the findings, AbbVie said that it is advancing upadacitinib to Phase 3 clinical programme in vitiligo.

AbbVie chief medical officer and development and regulatory affairs SVP Roopal Thakkar said: “There is a high unmet need in vitiligo, with no systemic treatment options approved, leaving patients frustrated in seeking options for re-pigmentation of the skin.

“We will continue to apply our significant experience in advancing research and driving innovation in treatments for immune-mediated diseases, including underserved diseases with high burden on patients, such as vitiligo.”

For all upadacitinib dose groups, the mean percent change from baseline in F-VASI was numerically larger at week 52 than it was at week 24.

Additionally, for all dose groups of JAK inhibitor, the response rates shown for F-VASI 75 and T-VASI 50 at week 52 were numerically higher than those seen at week 24.

The Phase 2b multicentre, 52-week, randomised, double-blind, placebo-controlled trial included two periods.