Phase 2 Success: Lutikizumab Advances to Phase 3 in Treating Moderate to Severe HS

In a recent clinical trial, patients suffering from moderate to severe hidradenitis suppurativa (HS), a chronic inflammatory skin condition, demonstrated improved outcomes when treated with lutikizumab (ABT-981), a novel drug developed by AbbVie. The Phase 2 study involved individuals who had not responded to anti-TNF treatments and indicated that those receiving weekly or bi-weekly doses of 300 mg of lutikizumab had a higher rate of response in terms of HS Clinical Response (HiSCR 50) at the 16-week mark when compared to placebo recipients. Notably, the response rates were 59.5% and 48.7% for the two lutikizumab dosing groups, respectively, as opposed to 35.0% for the placebo group.
The study also observed secondary benefits in skin pain reduction, with patients on lutikizumab showing more significant improvements in skin pain, as measured by the NRS30 (a 30% or greater reduction in pain), particularly among those with a baseline Numeric Rating Scale score of 3 or higher. The drug was well-tolerated, with adverse events occurring at a similar rate across both the treatment and placebo groups.
HS, often referred to as "acne inversa," is characterized by painful lumps, abscesses, and scarring, typically in areas like the armpits and groin. It is a debilitating disease with a significant impact on patients' quality of life, and despite some treatment advancements, there is still a considerable need for new therapeutic options. AbbVie's lutikizumab is an interleukin (IL) 1α/1β antagonist, targeting proteins that are found at elevated levels in HS lesions, which could potentially offer relief for those struggling with this condition.
The positive results from the Phase 2 trial have prompted AbbVie to progress the lutikizumab clinical program into Phase 3, reflecting the company's commitment to advancing immunology research and addressing the unmet needs of HS patients. The trial's primary endpoint, HiSCR 50, measures a 50% or greater reduction in abscess and inflammatory nodule counts without an increase in abscess or draining fistula counts from baseline. The secondary endpoint, NRS30, evaluates a 30% or more reduction in skin pain as assessed by patient global assessment.
AbbVie's dermatology division has been dedicated to finding solutions for serious skin diseases for over ten years, and the company's pipeline continues to evolve to meet the needs of the dermatology community. Lutikizumab's progression to Phase 3 trials signifies a promising step forward in the treatment of HS.

AbbVie, a company with a mission to deliver innovative medicines to address health challenges, has announced the advancement of its drug candidate Lutikizumab (ABT-981) into Phase 3 clinical trials for the treatment of Hidradenitis Suppurativa (HS), a chronic skin condition. The decision follows the positive results of a Phase 2 trial, which showed that Lutikizumab significantly improved the condition of adult patients with moderate to severe HS who had not responded to previous anti-TNF therapies.
The Phase 2 study was a randomized, double-blind, placebo-controlled, dose-ranging, multicenter trial involving 153 patients. The primary endpoint of the study was the achievement of HiSCR 50 at week 16, which measures at least a 50% reduction in the total abscess and inflammatory nodule count without an increase in abscess or draining fistula counts from baseline. Lutikizumab was administered at doses of 100 mg every other week, 300 mg every other week, or 300 mg every week, with the two higher dosages showing a higher rate of response compared to placebo.
The study also found that Lutikizumab improved skin pain, as measured by the NRS30, a secondary endpoint that defines a 30% or greater reduction in skin pain from baseline. Lutikizumab was generally well-tolerated, with adverse events occurring at a rate similar to that of the placebo group. The most common adverse events included HS, diarrhea, headache, pruritus, contact dermatitis, eczema, and nasopharyngitis.
Dr. Roopal Thakkar, AbbVie's Senior Vice President and Chief Medical Officer, emphasized the company's dedication to researching new treatment options for HS, a condition that often goes overlooked and can significantly affect patients' quality of life. The positive outcomes of the Phase 2 trial have encouraged AbbVie to move forward with Phase 3 trials, building on their extensive experience in immune-mediated diseases.
Lutikizumab is an investigational drug that targets interleukin (IL) 1α and 1β, which are known to be elevated in HS lesions. While HS affects up to 1% of the global population and can take an average of 7-10 years for diagnosis, current treatment options are limited. AbbVie's ongoing research and clinical trials aim to provide much-needed relief for patients suffering from this debilitating disease.
The data from the Phase 2 trial will be presented at an upcoming medical congress, and more information about the clinical program can be found on ClinicalTrials.gov under the identifier NCT05139602. AbbVie's dermatology division has been committed to improving care for individuals with serious skin diseases, including HS, psoriasis, psoriatic arthritis, and atopic dermatitis, for over a decade. The company's broad clinical trial program and pipeline reflect its ongoing efforts to meet the evolving needs of the dermatology community.