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A study to evaluate the effectiveness and safety of LAD603 in adults with severe to very severe alopecia areata

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Alopecia areata, an autoimmune condition that causes hair loss in patches on the scalp or body. The purpose of the study is to evaluate the efficacy and safety of a medication called LAD603 in adults experiencing severe to very severe forms of this condition. LAD603 is administered as a subcutaneous injection, which is a method where the medicine is delivered through a small needle into the fatty layer of the skin just under the surface.

Participants in this trial will be randomly assigned to receive either LAD603 or a placebo. The study is double-blind, meaning that neither the participants nor the researchers know which specific treatment is being administered during the process. This approach helps ensure that the results are measured objectively. Over the course of the study, the effects of the medication will be monitored to determine how well it works compared to the placebo.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    You will receive either the investigational drug, known as lad603, or a placebo, which is a substance with no active medicine. the assignment to a specific group is determined by chance and is part of a double-blind process, meaning neither you nor the medical staff will know which substance is being administered during the study.

  2. Step 2

    Medication administration

    The lad603 or placebo is administered as a subcutaneous injection, which means the liquid is injected into the fatty layer of skin just beneath the surface. the specific dose for lad603 is provided as a solution for injection.

  3. Step 3

    Evaluation of results

    The effectiveness of the treatment is measured by observing changes in the salt score, which is a method used to track the amount of hair loss in alopecia areata (a condition that causes hair loss). this evaluation occurs at week 28 of the study to determine the percentage of change in hair coverage compared to the start of the trial.

Who can join the trial?

7 criteria

  • You must be a male or female between the ages of 18 and 65 at the time you agree to join the study.
  • You must be able to understand and follow all the rules and instructions of the study as decided by the investigator (the main doctor in charge of the study).
  • You must sign a written informed consent form, which is a document you read and sign to show you understand the study and agree to participate before any study activities begin.
  • You must have alopecia areata, which is a condition that causes hair loss, specifically in one of the following ways: patchy hair loss on the scalp, alopecia totalis (total loss of all hair on the scalp), or alopecia universalis (total loss of hair on the scalp, face, and entire body).
  • You must have lost at least 50% of your scalp hair as measured by a tool called SALT (Scalp Area Los Hair Tool), and you must not have seen any terminal hair (thick, permanent hair) growing back in the last 6 months.
  • Your current period of hair loss must have lasted for at least 6 months but no longer than 7 years.
  • Women of childbearing potential (women who are able to become pregnant) or males must agree to follow strict rules to avoid pregnancy and prevent their partner from being exposed to the study medicine, LAD603, during the study.

Who cannot join the trial?

7 criteria

  • You have other types of alopecia, which is a medical term for hair loss, such as traction alopecia (hair loss caused by pulling on the hair) or scarring alopecia (permanent hair loss caused by damage to the hair follicle).
  • You have the diffuse type of alopecia areata, which means the hair loss is spread widely across the scalp rather than in distinct patches.
  • You have a history of male-pattern or female-pattern hair loss, which refers to specific patterns of thinning hair commonly seen as people age.
  • You have previously had or currently have hair transplants, which is a surgery to move hair from one part of the body to another.
  • You use adhesive wigs, which are hairpieces that are glued or stuck to the scalp, except for banded perimeter wigs that stay in place using a band.
  • You have an active inflammatory skin disease, which is a condition where the skin becomes red, swollen, or irritated, such as psoriasis, seborrheic dermatitis (a common skin condition that causes flaky, itchy skin), or lupus (a disease where the body's immune system attacks its own tissues).
  • You have any skin condition that might make it difficult for doctors to accurately measure how severe your alopecia areata is.
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Investigated drugs

LAD603 is a medication given as a shot under the skin. It is being tested to see if it can help adults with severe to very severe hair loss caused by an immune system issue called alopecia areata.

What is already known about the treatment

  • LAD603

    This medication is administered as a solution through an injection under the skin. It is currently being studied in clinical trials to determine its effectiveness for treating severe cases of alopecia areata, a condition that causes hair loss. This substance works by targeting specific parts of the immune system to stop it from attacking hair follicles. It is classified as an experimental immunotherapy treatment designed to restore hair growth.

  • Placebo for LAD603

    This is an inactive substance administered through an injection under the skin that contains no medicinal ingredients. It is used in clinical studies as a control to compare against the active test drug to ensure the results are accurate. It has no therapeutic effect and does not interact with the body at a molecular level. In medical research, it serves as a standard tool to help researchers understand if the actual medication is truly effective.

Investigated diseases

Alopecia areata - This is an autoimmune condition that causes hair to fall out. It occurs when the body's immune system mistakenly attacks the hair follicles. The condition typically begins with small, round patches of hair loss on the scalp. In more severe cases, the hair loss can spread to cover large areas of the head or the entire body. The patches may appear suddenly and can change in size over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523342-27-00Protocol codeM-00223-20Estimated enrolment144 patientsSponsorAlmirall S.A.

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