A Proof-of-Concept Study of LAD328 in Adults With Hidradenitis Suppurativa
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
It has sites in 5 countries. Choose a country to see its sites.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07547813, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Almirall, S.A.
- Trial code
- NCT07547813EU 2025-521865-29-00
- Record updated
- 17 August 2026
- Original description
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.Read full original descriptionShow less
A Phase 2, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate Efficacy and Safety of LAD328 in Adult Subjects With Moderate-to-Severe Hidradenitis Suppurativa
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.
Inclusion: 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: 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; 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; HS with >20 draining tunnels either at the Screening or Baseline visits; Females who are pregnant or breast-feeding or seeking to become pregnant during the trial.