MSD's Phase IIb MK-7240-012 trial of tulisokibart met its primary endpoint in moderate-to-severe hidradenitis suppurativa at week 16. High (480 mg Q2W) and medium (480 mg Q4W) doses produced HiSCR50 rates of 72% and 64% versus 35% for placebo; an exploratory low dose (240 mg Q4W) showed 52% response. Secondary measures (HiSCR75 and DLQI) favored higher doses, and safety profiles were comparable across arms with no serious or opportunistic infections. MSD intends to advance tulisokibart into Phase III development for HS.
MSD’s Tulisokibart Meets Primary Endpoint in Phase IIb Hidradenitis Suppurativa Trial; Plans Phase III
In the study
Merck & Co. (MSD) today reported positive Phase IIb results for tulisokibart (MK-7240), an investigational humanised monoclonal antibody, in patients with moderate to severe hidradenitis suppurativa (HS). The multi-centre, randomised, double-blind, placebo-controlled MK-7240-012 trial met its primary endpoint at week 16, with both high- and medium-dose regimens outperforming placebo.
Primary Efficacy Results
At week 16, a Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) was achieved by 72% of participants in the high-dose arm (480 mg every two weeks; n=42) and 64% in the medium-dose arm (480 mg every four weeks; n=42). The placebo arm recorded a 35% HiSCR50 rate (n=44), representing absolute improvements of 37% and 29% for the high- and medium-dose groups, respectively. In an exploratory low-dose cohort (240 mg every four weeks; n=21), 52% of participants achieved HiSCR50 (an absolute improvement of 17% versus placebo).
Secondary Outcomes
Non-ranked key secondary endpoints also favored active treatment. A HiSCR75 response (greater clinical improvement) was observed in 41% of the high-dose group, 40% of the medium-dose group and 29% of the low-dose group, compared with 15% in the placebo cohort. Mean reductions from baseline in the Dermatology Life Quality Index (DLQI) were larger for the high- and medium-dose groups (–5.62 and –3.50, respectively) versus –2.46 for placebo; the low-dose cohort did not show improvement over placebo.
Safety
Overall adverse event rates were similar across arms: 42.9% (high dose), 47.6% (medium dose), 52.4% (low dose) and 40.9% (placebo). Serious adverse events were infrequent: 2.4% in both the high- and medium-dose cohorts, 4.8% in the low-dose cohort and 2.3% in placebo. No serious or opportunistic infections were observed in the study.
“We are excited to expand the clinical data for tulisokibart beyond inflammatory bowel disease with these positive Phase IIb results—the first for the anti-TL1A class in dermatology. We look forward to advancing tulisokibart to Phase III for patients living with HS,” said Dr Aileen Pangan, Vice-President and Head of Immunology Clinical Research, MSD Research Laboratories.
Separately, MSD announced in August a collaboration with Sarah Cannon Research Institute to broaden patient access to oncology clinical trials at community sites across the United States.
Original reporting by Clinical Trials Arena (a GlobalData brand).
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