A Study of LAD191 in Adults With Hidradenitis Suppurativa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LAD191, Placebo, Adalimumab.
- Who it may be relevant to
- Registry conditions: Hidradenitis Suppurativa. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug LAD191
LAD191 subcutaneous injection. - Other Placebo
LAD191 Placebo subcutaneous injection. - Drug Adalimumab
Adalimumab subcutaneous injection.
Primary outcome measures
- Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50) [Time frame: At Week 16]
Secondary outcome measures (5)
- Proportion of Participants Achieving 75% Reduction from Baseline in HiSCR-75 at Week 16 [Time frame: At Week 16]
- Proportion of Participants Achieving 90% Reduction from Baseline in HiSCR-90 at Week 16 [Time frame: At Week 16]
- Proportion of Participants Achieving 55% Reduction from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4-55) at Week 16 [Time frame: At Week 16]
- Change from Baseline in Skin Pain Numerical Rating Scale (NRS) at Week 16 [Time frame: At Week 16]
- Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) at Week 16 [Time frame: At Week 16]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital de Manises — Manises
Identifiers
NCT: NCT07151937 · M-27134-10 · 2025-521293-34-00