In short
LAD191 is an investigational protein-based medicine being studied for moderate-to-severe hidradenitis suppurativa (HS), a chronic inflammatory skin condition. It is given by subcutaneous injection and has no marketing authorisation in the product records, meaning it is not yet an approved medicine. One Phase 2 trial is currently authorised, planning to enrol 153 adults, and it compares LAD191 against placebo and adalimumab.
Key points
- LAD191 is a protein-based investigational substance with no marketing authorisation.
- It is being studied in moderate-to-severe hidradenitis suppurativa.
- The single authorised trial is a Phase 2 study planning to enrol 153 adults.
- LAD191 is given by subcutaneous injection as a solution for injection.
- The main efficacy measure is the proportion of participants achieving HiSCR 50.
- The trial also compares LAD191 with adalimumab and placebo.
What is LAD191?
LAD191 is a protein-based investigational substance developed by Almirall, S.A. It is classified in the therapeutic area of skin and connective tissue diseases. The product records list no marketing authorisation for LAD191, meaning it is still an investigational medicine and not yet approved for routine use. The substance appears under the single name LAD191 in the registry.
How does LAD191 work?
The registry records do not describe the molecular target or mechanism of action of LAD191. As a protein-based substance given by subcutaneous injection, it belongs to the broader class of biologic therapies, but the specific pathway it affects is not stated in the available data.
Which conditions is LAD191 being studied for?
- Moderate-to-severe hidradenitis suppurativa — a chronic inflammatory skin disease characterised by painful lumps, abscesses and scarring, mainly in skin folds such as the armpits and groin.
How is LAD191 given?
LAD191 is formulated as a solution for injection and is given by subcutaneous use, meaning it is injected under the skin. The trial also uses adalimumab and sodium chloride by subcutaneous injection as comparison arms.
What do the clinical trials show?
One Phase 2 trial of LAD191 is authorised in the EU Clinical Trials Information System. The study plans to enrol 153 adults with moderate-to-severe hidradenitis suppurativa. Its main efficacy measure is the proportion of participants achieving HiSCR 50, a standard score reflecting at least a 50% reduction in inflammatory lesions such as abscesses and nodules without an increase in draining tunnels. Safety is assessed through the frequency and severity of treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and adverse events of special interest, as well as local tolerance, vital signs, ECGs and clinical laboratory parameters. The trial compares multiple dosing regimens of LAD191 with placebo and with adalimumab.
What side effects are known?
The available registry records do not report side effects for LAD191. The authorised trial is designed to collect safety information, including the frequency and severity of treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and adverse events of special interest.