AbbVie doses first patient in phase 3 study of Rinvoq in hidradenitis suppurativa

2023-07-26

临床3期临床结果

AbbVie doses first patient in phase 3 study of Rinvoq in hidradenitis suppurativa

Preview

来源: PMLiVE

AbbVie has announced that the first patient has been dosed in a late-stage study of its selective JAK inhibitor JAK inhibitor, Rinvoq (upadacitinib), in adults and adolescents with moderate-to-severe hidradenitis suppurativa (HS).

HS is a long-term skin condition that causes painful bumps, nodules or abscesses that can leak fluid and lead to scarring.

An estimated 1% of the global population is affected by HS, but patients can experience increasing disease severity and symptoms for as long as ten years before receiving an accurate diagnosis.

"There is no cure for HS, and there are limited treatment options, making further study of this disease critical to better understand its impact and help meet patients' unmet needs,” AbbVie said in a statement.

The company's phase 3 Step-Up HS trial will aim to enrol about 1,300 patients who have failed anti-TNF therapy and/or one approved non-anti-TNF inhibitor TNF inhibitor therapy for the condition. These patients will be randomised to receive Rinvoq or placebo.

The study's primary endpoint will measure the percentage of participants achieving at least a 50% reduction in the total abscess and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline at week 16, the company outlined.

The launch follows the completion of a mid-stage study of Rinvoq in patients with moderate-to-severe HS.

The results, which were presented at this year's American Academy of Dermatology Annual Meeting in March, showed that a higher proportion of Rinvoq-treated patients achieved at least a 50% reduction in abscess and inflammatory nodule count without an increase in abscess or draining fistula count compared to those receiving placebo.

Roopal Thakkar, senior vice president, development and regulatory affairs and chief medical officer, AbbVie, said: "HS is a chronic, inflammatory disease that often leads to irreversible skin damage and extreme pain for patients.

"Leveraging our proven expertise in immunology and experience in HS, we continue to drive innovation and pursue advancement of care in patient populations with difficult-to-treat immune-mediated diseases that have limited therapeutic options.”