NCT07151937

A Study of LAD191 in Adults With Hidradenitis Suppurativa

A Seamless Phase 2a/2b, Randomized, Double-Blind, Placebo- and Active-Controlled, Multiple-Arm, Multiple-Stage, Adaptive Study Evaluating the Efficacy and Safety of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to assess the efficacy of multiple dosing regimens of LAD191 compared to placebo in participants with moderate-to-severe Hidradenitis Suppurativa (HS) and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.

Detailed description

The purpose of this study is to assess the multiple dosing regimens of LAD191 compared to placebo in participants with moderate-to-severe Hidradenitis Suppurativa (HS). The study has a prospectively defined adaptive design that will utilize interim data for futility evaluation. The study includes up to 4 weeks screening period 16-week double-blind, placebo-controlled period (Treatment period 1), 16-weeks LAD191 double-blind period (Treatment period 2), and 12-week safety follow-up. The study participants will be randomized to one of the following treatment arms: LAD191 dose A, LAD191 dose B; LAD191 dose C, Adalimumab or Placebo.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	LAD191	LAD191 subcutaneous injection.
OTHER	Placebo	LAD191 Placebo subcutaneous injection.
DRUG	Adalimumab	Adalimumab subcutaneous injection.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-05-01
• Completion: 2027-11-01
• First posted: 2025-09-03
• Last updated: 2025-09-23

Regulatory

• FDA-regulated drug study