AbbVie Achieves Phase 3 HiSCR75 Primary Endpoint for Lutikizumab

A successful Phase 3 readout for AbbVie's lutikizumab now positions the dual-variable-domain IL-1α/1β antagonist on a credible path toward regulatory submission, with manufacturing and fill-finish teams for biologics of this structural complexity likely to begin pre-BLA preparatory work in parallel with data package assembly.

In the INTREPID trial, lutikizumab met its primary endpoint of HiSCR75 at Week 16, defined as at least a 75% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count, achieving a 31.4% response rate versus 23.4% for placebo (p≤0.001). The trial enrolled adults and adolescents with moderate-to-severe hidradenitis suppurativa, making INTREPID the first Phase 3 study in this population to demonstrate statistically significant HiSCR75 response rates at Week 16 as the primary endpoint.

Eight ranked secondary endpoints were also met. At Week 8, 26.2% of lutikizumab-treated patients achieved NRS3 (at least a 3-point reduction in HS-related skin pain) versus 15.0% on placebo (p<0.0001), with improvements observed as early as Week 1. Flare occurrence over 16 weeks was 18.4% in the lutikizumab arm versus 28.1% on placebo (p<0.0001). Quality-of-life measures, DLQI and HSIA, also showed statistically significant improvement (p<0.0001 for each). Reductions in IL-17A and IL-17F levels were observed across the double-blind treatment period, providing mechanistic corroboration for the dual IL-1 inhibition approach.

For process development and analytical teams, the dual-variable-domain antibody format carries distinct characterisation and comparability obligations relative to conventional monoclonal antibodies. Sterility assurance protocols, container-closure integrity testing, and potency assay development for a molecule targeting two cytokine pathways simultaneously will require early alignment with 21 CFR Part 211 and ICH Q10 quality system expectations ahead of any pre-BLA meeting with FDA. Regulatory affairs leads tracking the HS biologics space should note that the dataset spans both adult and adolescent populations, adding paediatric data package requirements to the submission planning horizon.

Lutikizumab was reported as generally well tolerated, with no new safety concerns identified in the INTREPID dataset, a finding that will carry weight during benefit-risk assessment at the time of submission review.

The completeness of the secondary endpoint package, including patient-reported pain outcomes and flare frequency data, will be a measurable indicator of how robustly AbbVie can support a labelling negotiation covering both physician- and patient-assessed endpoints.

Source: AbbVie News Center via PR Newswire, 22 October 2026.