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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID

NCT07547813

Run by

Almirall, S.A.

People needed

50

Starts

2026-04-01

Expected to finish

2027-04-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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