Evaluating the Effectiveness and Safety of LAD191 Compared to Placebo and Adalimumab in Adults Aged 18 to 65 With Moderate-to-Severe Hidradenitis Suppurativa

What this Trial Is About

Researchers are evaluating the effects of different dosing schedules of LAD191 in adults with moderate-to-severe Hidradenitis Suppurativa HS. This phase 2 study aims to compare LAD191 with a placebo and adalimumab, focusing on how well the treatments work, their safety, tolerability, how the body processes the drug, and immune system responses. The study uses an adaptive design with interim data to assess whether to continue certain doses. Participants will undergo up to 4 weeks of screening before entering a 16-week double-blind, placebo-controlled treatment period Treatment Period 1. Then, all participants will receive LAD191 in a 16-week double-blind period Treatment Period 2. The study includes five groups three doses of LAD191, placebo during the first period then LAD191, or adalimumab during the first period then LAD191. After these treatment periods, there is a 12-week safety follow-up. During the study, participants will receive subcutaneous injections as per their assigned group. Researchers will assess the proportion of participants achieving significant reductions in HS lesions at week 16 using clinical response scores. Additional measures include skin pain levels and quality of life related to HS. Safety, tolerability, and other health evaluations will occur throughout the trial. Total participation spans screening, two treatment periods, and safety monitoring until study completion.

A Study of LAD191 in Adults With Hidradenitis Suppurativa