LAD328 in adults with hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, randomized, double-blind trial compares LAD328 to placebo in adults with moderate-to-severe hidradenitis suppurativa over 12 weeks of treatment, with safety follow-up. Participants will be assigned to receive either LAD328 or placebo, with up to 4 weeks of screening and up to 8 weeks of safety monitoring after the treatment period. The study will evaluate efficacy signals, safety, tolerability, pharmacokinetics, and immunogenicity, alongside standard care practices. Eligibility requires adults aged 18-65 with a defined lesion burden across at least two anatomic areas and a history of inadequate response to systemic antibiotics.

Why it matters

Who can join: the full rules

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.

Where it's running

• Alm Site 1
  Warsaw, Masovian Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Estrella Garcia
• Email: gco@almirall.com
• Phone: +34620985953

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight

  This study tests whether olatorepatide can help people with hidradenitis suppurativa who are overweight or obese.

  Recruiting Phase 2 Regeneron Pharmaceuticals · The Bronx, New York · NCT07830329

• Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa

  This extension study tests whether continuing remibrutinib is safe and helps skin symptoms in adults who completed prior HS trials.

  Recruiting at 61 sites Phase 3 Novartis · Birmingham, Alabama and 60 other locations · NCT07665437

• Long-term real-world tracking of secukinumab treatment for moderate to severe hidradenitis suppurativa in Italy

  This project will see how secukinumab works and is used in adults with moderate to severe hidradenitis suppurativa in Italy.

  Recruiting at 16 sites Novartis · Ancona, AN and 15 other locations · NCT07543419

• Secukinumab outcomes in Canadians with hidradenitis suppurativa

  It will see how well secukinumab works and how safe it is for adults in Canada with moderate-to-severe hidradenitis suppurativa who were newly prescribed it in routine care.

  Recruiting at 15 sites Novartis · Calgary, Alberta and 14 other locations · NCT07282015

• Post-marketing surveillance of Cosentyx (secukinumab) for hidradenitis suppurativa, pediatric plaque psoriasis, and juvenile idiopathic arthritis in Korea

  This study will see how Cosentyx (secukinumab) works and is tolerated in people in Korea with moderate-to-severe hidradenitis suppurativa, pediatric plaque psoriasis, or juvenile idiopathic arthritis who are being treated in routine care.

  Recruiting Novartis · Seoul, Seoul · NCT07243782

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.