In short
LAD328 is an investigational monoclonal antibody that targets interleukin 21, a signalling protein involved in inflammation. It is being studied in a Phase 2 trial for moderate-to-severe hidradenitis suppurativa, a chronic skin condition. The trial, authorised in the EU, plans to enrol 4,999,995 participants and compares LAD328 against placebo given by intravenous infusion.
Key points
- LAD328 is a human IgG1 monoclonal antibody against interleukin 21, an investigational substance with no marketing authorisation.
- The only registered trial is a Phase 2 proof-of-concept study in moderate-to-severe hidradenitis suppurativa.
- The trial is currently authorised in the EU Clinical Trials Information System.
- It is designed to enrol 4,999,995 participants.
- LAD328 is given by intravenous infusion and is being compared against placebo.
- The main efficacy measure is the proportion of participants achieving IHS4-55, a score reflecting hidradenitis suppurativa severity.
What is LAD328?
LAD328 is an investigational monoclonal antibody. Its full registry name is human IgG1 monoclonal antibody against interleukin 21. Monoclonal antibodies are proteins made in the laboratory that can bind to specific targets in the body. LAD328 is a protein-based substance, classified in the registry as "Protein - Other". It has no marketing authorisation in the product records, meaning it is not yet an approved medicine and is still being studied in clinical research. The product is supplied by Almirall, S.A.
How does LAD328 work?
LAD328 is designed to block the activity of interleukin 21, a signalling protein of the immune system. By binding to interleukin 21, the antibody prevents it from delivering signals that can drive inflammation. In hidradenitis suppurativa, inflammation plays a central role in the formation of painful lumps, abscesses and tunnels under the skin. The registered study aims to evaluate whether blocking interleukin 21 with LAD328 can reduce this inflammation and improve the signs of the disease compared with placebo.
Which conditions is LAD328 studied for?
The registered trial investigates LAD328 in one condition:
- Moderate-to-severe hidradenitis suppurativa — a chronic inflammatory skin disease that causes painful lumps, abscesses and tunnels, most often in areas where skin rubs together, such as the armpits and groin.
The trial is placed in the therapeutic area of skin and connective tissue diseases.
How is LAD328 given?
LAD328 is prepared as a solution for injection and is given by intravenous infusion, meaning it is delivered directly into a vein over a period of time. In the registered trial, the comparison arm receives sodium chloride, a salt solution, also by intravenous infusion, as placebo.
What do the clinical trials show?
One trial is registered for LAD328 in the EU Clinical Trials Information System. It is a Phase 2 proof-of-concept study in adults with moderate-to-severe hidradenitis suppurativa. Phase 2 studies are typically the first stage in which a new substance is tested in a group of patients with the target condition, after initial safety testing in smaller studies. The trial is currently authorised, meaning it has received regulatory approval to begin.
The study is designed to enrol 4,999,995 participants. It is an interventional study, meaning participants receive a specific treatment as part of the research.
The trial measures several outcomes. The main efficacy measure is the proportion of participants achieving IHS4-55, a score that combines counts of inflammatory nodules, abscesses and draining tunnels to reflect hidradenitis suppurativa severity. Safety is assessed through the frequency and severity of treatment-emergent adverse events, serious adverse events, adverse events of special interest and adverse events leading to discontinuation. Additional safety measures include vital signs, electrocardiogram findings and clinical laboratory parameters.
What side effects are known?
No side effects are reported in the registry data provided. As LAD328 is an investigational substance, its safety profile is still being established in the ongoing Phase 2 trial, which is designed to collect information on adverse events.