A Phase 2 Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LAD328 in Adults with Moderate to Severe Hidradenitis Suppurativa
- Trial ID
- 2025-521865-29-00
- Protocol
- M-00401-10
- Sponsor
- Almirall S.A.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the efficacy of LAD328, a human IgG1 monoclonal antibody against interleukin 21, compared to placebo in adult subjects diagnosed with moderate-to-severe hidradenitis suppurativa. Additionally, the study aims to assess the safety and tolerability of the investigational product.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of male and female patients diagnosed with hidradenitis suppurativa. Eligible individuals are between 18 and 65 years of age with a body mass index of ≤40 kg/m² and a weight of ≥45 kg. Clinical requirements include a history of the disease for at least 6 months and the presence of at least 5 inflammatory lesions at both screening and baseline visits. These lesions must be located in at least 2 distinct anatomic areas, with one area classified as Hurley Stage II or Hurley Stage III. Participants must have a history of inadequate response, intolerance, or contraindication to systemic antibiotics. A requirement for the study is the use of over-the-counter topical antiseptics on the lesions. Women of child-bearing potential and male participants must adhere to pregnancy avoidance protocols.
Plans and Procedures
This Phase 2, randomized, placebo-controlled, double-blind clinical study is designed to evaluate the efficacy and safety of LAD328, a human IgG1 monoclonal antibody against interleukin 21, in adult subjects diagnosed with hidradenitis suppurativa. Participants will be assigned to receive either LAD328 or a placebo consisting of sodium chloride via intravenous infusion. The clinical investigation includes a screening visit to assess eligibility based on disease severity, body mass index, and medical history, followed by a baseline visit. The primary efficacy endpoint is the proportion of participants achieving the IHS4-55 response. Safety assessments will involve monitoring treatment-emergent adverse events, serious adverse events, adverse events of special interest, vital signs, electrocardiogram, and clinical laboratory parameters. The trial is estimated to conclude by March 31, 2027. Early termination from the study may occur due to adverse events leading to discontinuation.
Treatment
The experimental medication is LAD328, a human IgG1 monoclonal antibody against interleukin 21. This substance is prepared as a solution for injection and is administered via intravenous infusion.
The control group receives sodium chloride as a placebo, which is also administered through intravenous infusion.
Efficacy
The efficacy of LAD328 in adult subjects with moderate to severe hidradenitis suppurativa will be assessed by evaluating the proportion of participants achieving IHS4-55. This primary endpoint measures the clinical response of the disease during the study period.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male or female between 18 and 65 years old inclusive.
- A body mass index (BMI) of ≤40 kg/m2 and body weight of ≥45 kg at the time of signing the informed consent.
- Ability to understand and willing to comply with trial requirements as per Investigator’s opinion.
- Provide written informed consent in accordance with institutional and regulatory guidelines.
- 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.
- 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.
- 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.
- 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.
- 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
- Syndromic HS, ie, HS associated with genetic background, follicular plugging or structural disorders, autoinflammatory pathogenesis, as per Investigator’s judgment.
- Active tuberculosis (TB), a positive TB test at Screening, or history of active or latent TB, regardless of prior treatment.
- 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.
- History of liver disease or clinically significant abnormal (as per judgment of Investigator) liver function test(s) at Screening.
- HS with >20 draining tunnels either at the Screening or Baseline visits.
- 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).
- Surgical intervention for the treatment of HS within 3 months prior to Baseline.
- 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.
- 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.
- 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.
- 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.
- 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).
- History within 1 year prior to Screening of alcohol or drug abuse, as per Investigator’s judgment.
- 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.
- Prior treatment with LAD328
- Live and attenuated vaccinations 4 weeks prior to XXXX or is planning to receive any such vaccine during the trial.
- 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
- Inadequate response to 2 or more biologics for HS (eg, adalimumab, secukinumab and bimekizumab) having different MoAs (classes), as per the Investigator’s judgment.
- 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).
- Institutionalised because of legal or regulatory order.
- 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.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Bulgaria | Recruiting | 01 Apr 2026 | 999999 |
 France | Recruiting | 01 Apr 2026 | 999999 |
 Germany | Recruiting | 01 Apr 2026 | 999999 |
 Poland | Recruiting | 01 Apr 2026 | 999999 |
 Spain | Recruiting | 01 Apr 2026 | 999999 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
LAD328 | Test | SOLUTION FOR INJECTION | INTRAVENIOUS INFUSION | 00000 | 1 | PRD12911049 |
SODIUM CHLORIDE | Placebo | — | INTRAVENIOUS INFUSION | 00000 | 1 | SUB12581MIG |