In short
LAD603 is an investigational protein-based medicine being studied for alopecia areata, a condition causing hair loss. It is given by subcutaneous injection and is currently being tested in one Phase 2 clinical trial with 144 participants. The trial compares LAD603 against placebo in adults with severe to very severe alopecia areata. LAD603 has no marketing authorisation yet, meaning it is not approved as a medicine.
Key points
- LAD603 is an investigational protein-based substance, not yet authorised as a medicine.
- It is being studied in alopecia areata, specifically in adults with severe to very severe forms.
- The current trial is a Phase 2 dose-finding study with 144 participants.
- LAD603 is given by subcutaneous injection as a solution for injection.
- The trial measures the SALT score change from baseline at Week 36.
- The study is currently authorised and compares LAD603 against a placebo.
What is LAD603?
LAD603 is an investigational protein-based substance. In the EU Clinical Trials Information System, it is classified under diseases of the skin and connective tissue. The product records list it as originating from a protein source, described as "Protein - Other", meaning it is a protein-based substance rather than a chemically synthesised small molecule. LAD603 has no marketing authorisation in the product records, so it is still an investigational substance and is not approved as a medicine. The company listed as the authorisation holder or supplier in the trial record is ALMIRALL, S.A.
How does LAD603 work?
The registry records included here do not describe the molecular target or mechanism of action of LAD603. The trial record identifies it as a protein-based substance given by subcutaneous injection, but no further detail on how it acts in the body is provided in the available data.
Which conditions is LAD603 being studied for?
- Alopecia areata — an autoimmune condition in which the immune system attacks hair follicles, leading to patchy or complete hair loss. The trial focuses on adults with severe to very severe alopecia areata.
How is LAD603 given?
LAD603 is given as a solution for injection by subcutaneous injection, meaning it is injected under the skin. The trial record lists the intervention as "LAD603 (000 Other, SUBCUTANEOUS INJECTION)".
What do the clinical trials show?
There is one registered clinical trial of LAD603 in the EU Clinical Trials Information System. It is a Phase 2 dose-finding study in adults with alopecia areata. The trial has a planned enrollment of 144 participants and is currently authorised.
The study compares LAD603 against a placebo. The main outcome measure is the percent change from baseline in the SALT score at Week 36. The SALT score (Severity of Alopecia Tool) is a standard way of measuring how much of the scalp is affected by hair loss.
The trial is designed for adult patients with severe to very severe alopecia areata. This means the study focuses on people with extensive hair loss rather than mild or limited forms of the condition.
What side effects are known?
No side effect information is provided in the available sources for LAD603. As an investigational substance, its safety profile is still being studied in clinical trials.