A Study of LAD191 in Adults With Hidradenitis Suppurativa

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат LAD191
  LAD191 subcutaneous injection.
• Другое Placebo
  LAD191 Placebo subcutaneous injection.
• Препарат Adalimumab
  Adalimumab subcutaneous injection.

Первичные конечные точки

• Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50) [Срок оценки: At Week 16]

Вторичные конечные точки (5)

• Proportion of Participants Achieving 75% Reduction from Baseline in HiSCR-75 at Week 16 [Срок оценки: At Week 16]
• Proportion of Participants Achieving 90% Reduction from Baseline in HiSCR-90 at Week 16 [Срок оценки: At Week 16]
• Proportion of Participants Achieving 55% Reduction from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4-55) at Week 16 [Срок оценки: At Week 16]
• Change from Baseline in Skin Pain Numerical Rating Scale (NRS) at Week 16 [Срок оценки: At Week 16]
• Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) at Week 16 [Срок оценки: At Week 16]

Критерии участия

Критерии включения

• Aged greater than or equal to (>=) 18 to less than or equal to (<=) 65 years.
• A diagnosis of moderate-to-severe HS defined as a total of >= 5 inflammatory lesions (i.e., number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline/Day 1 visits, with signs and symptoms of HS for at least 6 months.
• HS lesions present in at least 2 distinct anatomic areas (e.g., left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline/Day 1 visits.
• History of inadequate response, intolerance, or contraindication to a course of a systemic antibiotics for treatment of HS at the screening visit.
• Regular use of over-the-counter topical antiseptics on HS lesions and agrees to regular use, throughout the entirety of the study.
• Participants who are women of child-bearing potential (WOBCP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD191 during the study.

Критерии исключения

• HS with >20 draining tunnels at the Screening or Baseline/Day 1 visit.
• Ongoing medical conditions requiring systemic immunosuppressive/immunomodulating treatments during the study.
• Known hypersensitivity to LAD191 or any of its excipients.
• Known hypersensitivity to adalimumab or biosimilar or any of its excipients or meeting any warning or contraindication to adalimumab treatment as per the approved product information, and as per the Investigator's judgment.
• Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy, regardless of indication, that was clinically significant, as per the Investigator's judgment.
• Prior treatment with LAD191.
• Live or attenuated vaccinations 4 weeks prior to Baseline/Day 1 or is planning to receive any such vaccine during the study.
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
• Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to meet the required washout period for a particular prohibited medication prior to Baseline/Day 1.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital de Manises — Manises

Идентификаторы

NCT: NCT07151937 · M-27134-10 · 2025-521293-34-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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