Ongoing, Recruiting Therapeutic Exploratory (Phase Ii) moderate-to-severe hidradenitis suppurativa

Phase 2 Proof-of-Concept Study of LAD328 in Adults with Hidradenitis Suppurativa

EU CTIS ID: 2025-521865-29-00

What this study is testing

- To evaluate the efficacy of LAD328 compared to placebo in patients with moderate-to-severe HS. - To evaluate the safety and tolerability of LAD328.

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Male or female between 18 and 65 years old inclusive.
2. A body mass index (BMI) of ≤40 kg/m2 and body weight of ≥45 kg at the time of signing the informed consent.
3. Ability to understand and willing to comply with trial requirements as per Investigator’s opinion.
4. Provide written informed consent in accordance with institutional and regulatory guidelines.
5. A diagnosis of moderate-to-severe HS defined as a total of ≥5 inflammatory lesions (ie, 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.
6. HS lesions present in at least 2 distinct anatomic areas (eg, 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.

You likely can't join if

1. Syndromic HS, ie, HS associated with genetic background, follicular plugging or structural disorders, autoinflammatory pathogenesis, as per Investigator’s judgment.
7. Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.
8. Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the trial participant’s ability to participate to comply with the trial requirements, as determined by the Investigator based on protocol required assessments.
9. Active chronic or acute infection requiring treatment with systemic antimicrobials, antivirals, antiparasitic, antiprotozoals, or antifungals within 2 weeks before Baseline, or fever > 38°C during within 1 week before Baseline.
13. Positive test result at Screening for hepatitis B surface antigen (HBsAg), or antibody to hepatitis B core antigen (anti-HBc antibody), or antibody to the hepatitis C virus (anti-HCV), or antibody to the human immunodeficiency virus (anti-HIV-1/2 antibody).
14. History within 1 year prior to Screening of alcohol or drug abuse, as per Investigator’s judgment.

See the full eligibility criteria

Who can join

1. Male or female between 18 and 65 years old inclusive.
2. A body mass index (BMI) of ≤40 kg/m2 and body weight of ≥45 kg at the time of signing the informed consent.
3. Ability to understand and willing to comply with trial requirements as per Investigator’s opinion.
4. Provide written informed consent in accordance with institutional and regulatory guidelines.
5. A diagnosis of moderate-to-severe HS defined as a total of ≥5 inflammatory lesions (ie, 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.
6. HS lesions present in at least 2 distinct anatomic areas (eg, 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.
7. History of inadequate response, or intolerance or contraindication, to a course of a systemic antibiotics for treatment of HS at the Screening visit, including participants who responded to course(s) of systemic antibiotic(s) and subsequently exhibited recurrence after discontinuation of the antibiotic, as assessed by the Investigator through trial participant interview and review of medical history.
8. Agree to use, preferably daily but at least 3 days per week, over-the-counter topical antiseptics on their HS lesions throughout the entirety of the study from at least 2 weeks prior to the Baseline visit.
9. 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

What rules you out

1. Syndromic HS, ie, HS associated with genetic background, follicular plugging or structural disorders, autoinflammatory pathogenesis, as per Investigator’s judgment.
7. Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.
8. Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the trial participant’s ability to participate to comply with the trial requirements, as determined by the Investigator based on protocol required assessments.
9. Active chronic or acute infection requiring treatment with systemic antimicrobials, antivirals, antiparasitic, antiprotozoals, or antifungals within 2 weeks before Baseline, or fever > 38°C during within 1 week before Baseline.
13. Positive test result at Screening for hepatitis B surface antigen (HBsAg), or antibody to hepatitis B core antigen (anti-HBc antibody), or antibody to the hepatitis C virus (anti-HCV), or antibody to the human immunodeficiency virus (anti-HIV-1/2 antibody).
14. History within 1 year prior to Screening of alcohol or drug abuse, as per Investigator’s judgment.
15. Major surgery (eg, open-heart surgery or organ transplant surgery) within the 3 months prior to the Baseline visit or has major surgery pre-planned for the time of participation in this trial at XXXX.
16. Prior treatment with LAD328
17. Live and attenuated vaccinations 4 weeks prior to XXXX or is planning to receive any such vaccine during the trial.
18. Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to meet the required wash-out period for a particular prohibited medication prior to XXXX
19. Inadequate response to 2 or more biologics for HS (eg, adalimumab, secukinumab and bimekizumab) having different MoAs (classes), as per the Investigator’s judgment.
10. Active tuberculosis (TB), a positive TB test at Screening, or history of active or latent TB, regardless of prior treatment.
20. Females who are pregnant or breast-feeding or seeking to become pregnant during the trial or for approximately XXXX after the last dose of investigational medicinal product (IMP).
21. Institutionalised because of legal or regulatory order.
22. An employee or relative of the Sponsor, Clinical Research Organization (CRO) or other vendor, clinical trial site, or is an individual or employee otherwise directly involved with the conduct of the trial or is an immediate family member of such an individual.
11. History of malignancy within past 5 years prior to Baseline (other than successfully treated basal cell or squamous cell carcinoma of the skin), regardless of outcome.
12. History of liver disease or clinically significant abnormal (as per judgment of Investigator) liver function test(s) at Screening.
2. HS with >20 draining tunnels either at the Screening or Baseline visits.
3. Presence of skin comorbidities that may interfere with trial assessments, in the opinion of the Investigator (eg, cystic acne, follicular pyodermas, bacterial cellulitis, actinomycosis, candida intertrigo and extensive condyloma).
4. Surgical intervention for the treatment of HS within 3 months prior to Baseline.
5. Ongoing medical conditions (eg, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus and sarcoidosis) requiring systemic immunosuppressive/immunomodulating treatments (eg, methotrexate, ciclosporin, corticosteroids, XXXX agents and JAK inhibitors) during the trial.
6. Known or suspected hypersensitivity to trial product or any of its excipients.

The study team makes the final eligibility decision.

Where it's taking place

Bulgaria
Spain
France
Poland
Germany

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Bulgaria; Spain; France; Poland; Germany. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.