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Not yet recruiting Phase 2 NCT07547813

A Proof-of-Concept Study of LAD328 in Adults With Hidradenitis Suppurativa

Phase 2 – studying effectiveness and dosage
Conditions: Hidradenitis Suppurativa

Sponsor: Almirall, S.A.

trial.available_in: БГ
Overview
The main purpose of this study is to evaluate the effect of LAD328 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.
Description
Hidradenitis suppurativa (HS) is a chronic skin disease of unclear etiology that affects approximately 1% of the general population. The purpose of this study is to assess the efficacy of LAD328 compared to placebo in participants with moderate-to-severe HS. The study participants will be randomized to one of the following treatment arms: LAD328 or Placebo. The study includes up to 4 weeks screening period 12-week double-blind, placebo-controlled period and 8-week safety follow-up. The total duration of study participation will be up to 20 weeks
Who can participate
Inclusion Criteria: * Male or female between 18 and 65 years old inclusive. * 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 visits, with a clinical history 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 visits. * History of inadequate response, or intolerance or contraindication, to a course of a systemic antibiotics for treatment of HS at the Screening visit. * Agree to regularly use, over-the-counter topical antiseptics on their HS lesions throughout the entirety of the study. * Participants who are woman of child-bearing potential (WOCBP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD328 during the trial. Exclusion Criteria: * HS with \>20 draining tunnels either at the Screening or Baseline visits. * Ongoing medical conditions (e.g., inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus and sarcoidosis) requiring systemic immunosuppressive/immunomodulating treatments (e.g., methotrexate, ciclosporin, corticosteroids, cytokine-targeted therapy and JAK inhibitors) during the trial. * Known or suspected hypersensitivity to trial product or any of its excipients. * Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator. * Prior treatment with LAD328. * Live and attenuated vaccinations 4 weeks prior Pre-treatment or is planning to receive any such vaccine during the trial. * Females who are pregnant or breast-feeding or seeking to become pregnant during the trial.
Interventions
LAD328
DRUG
Placebo
OTHER
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.04.2027
Registry ID
NCT07547813
Source
clinicaltrials.gov
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