NCT07547813 A Proof-of-Concept Study of LAD328 in Adults With Hidradenitis Suppurativa
| NCT ID | NCT07547813 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Almirall, S.A. |
| Condition | Hidradenitis Suppurativa |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-05-13 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Study Director
STUDY DIRECTOR
Almirall, S.A.
Frequently Asked Questions
Who can join the NCT07547813 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hidradenitis Suppurativa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07547813 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07547813 currently recruiting?
Yes, NCT07547813 is actively recruiting participants. Contact the research team at gco@almirall.com for enrollment information.
Where is the NCT07547813 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT07547813 clinical trial?
NCT07547813 is sponsored by Almirall, S.A.. The principal investigator is Study Director at Almirall, S.A.. The trial plans to enroll 50 participants.