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A Phase 2 Study of LAD603 in Adults with Systemic Lupus Erythematosus and Active Skin Rash

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What is this trial about?

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

Systemic lupus erythematosus is an autoimmune disease in which the body’s immune system attacks its own tissues, often causing pain, fatigue, and skin problems. In this trial, an experimental medication called LAD603 is given by a small injection under the skin (subcutaneous use) to people who have active skin involvement. A matching placebo is also used for comparison.

The study aims to find out whether the medication can lower skin disease activity more than the placebo. Participants receive the study drug or placebo for several weeks, with regular visits to check their skin condition, overall health, and any side effects. The skin condition is measured using a scoring system called CLASI-A, which rates the severity of skin lesions; a higher score means more severe disease.

Throughout the trial, participants have scheduled appointments where doctors assess the skin score, record any changes, and monitor safety. The trial follows a double‑blind design, meaning neither the participants nor the study staff know which treatment is being given, to keep the results unbiased.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Visit

    You will attend an initial clinic visit after joining the study. During this visit, the study team will record your medical history, perform a physical examination, and collect blood samples. Your skin involvement will be measured using the CLASI‑A score, which evaluates the severity of cutaneous disease in systemic lupus erythematosus.

  2. Step 2

    Randomisation

    After the baseline assessments, you will be randomly assigned to receive either the investigational product LAD603 or a matching placebo. The assignment is double‑blind, meaning neither you nor the study staff will know which treatment you receive.

  3. Step 3

    First Injection

    At the same visit, you will receive a subcutaneous injection of the assigned study medication. The injection contains the active substance lad603 when you are in the active group, or an identical‑appearing solution without active drug when you are in the placebo group. The exact dose amount is specified by the study protocol and is administered by a qualified professional.

  4. Step 4

    Scheduled Follow‑up Visits

    You will return to the clinic at regular intervals defined by the study schedule, typically every four weeks. At each visit, the study staff will check your safety by reviewing any symptoms, performing physical examinations, and collecting blood samples. The skin assessment using the CLASI‑A score will be repeated to monitor changes in disease activity.

  5. Step 5

    Ongoing Injections

    During each scheduled visit, you will receive another subcutaneous injection of the same product you were assigned at the first injection. These injections will continue for the duration of the trial, which may last up to approximately 18 months, covering the period from the estimated recruitment start date (5 December 2026) to the estimated study end date (13 June 2028).

  6. Step 6

    End‑of‑Study Visit

    At the final visit, you will undergo a comprehensive evaluation similar to the baseline visit. This includes a physical examination, blood tests, and a final CLASI‑A assessment. The results will be used to determine the overall effect of the treatment on skin disease activity and safety.

Who can join the trial?

7 criteria

  • Be between 18 and 70 years old when you sign the consent form.
  • Be able to understand the study and willing to follow its requirements, as judged by the doctor.
  • Sign a written informed consent form, which means you agree to take part after the study is explained to you.
  • Have a diagnosis of Systemic lupus erythematosus (SLE) that meets official classification criteria and has been confirmed for at least six months before screening.
  • Show at least one sign of active lupus‑related skin disease, and have a skin activity score of 8 or higher on the CLASI‑A scale at both the screening visit and the start of the study. (The CLASI‑A score measures how severe the skin rash is.)
  • Be on a stable dose of your usual SLE medicines (the standard‑of‑care treatment) at the beginning of the trial.
  • If you are a male or a woman who could become pregnant (called a woman of childbearing potential), you must agree to use birth control and avoid exposing a partner to the study drug during the trial.

Who cannot join the trial?

3 criteria

  • Having any of the following special types of lupus: lupus tumidus (a skin‑only form that causes raised red patches), lupus panniculitis (inflammation of the fatty layer under the skin), bullous SLE (blister‑forming lupus), the toxic epidermal necrolysis variant of lupus (a severe skin reaction), chilblain lupus (painful red or purple skin lesions triggered by cold), hypertrophic or verrucous discoid lupus (thick, wart‑like skin lesions), or lichen planus overlap syndrome (a condition where lupus and lichen planus skin changes occur together).
  • Having a history of active kidney problems caused by lupus, such as lupus‑driven renal disease or severe active lupus nephritis (significant inflammation of the kidneys due to lupus).
  • Having active brain or nerve involvement from lupus within the past 24 weeks, including any of the following: seizure (sudden uncontrolled shaking or loss of awareness), impaired level of consciousness (being less alert or responsive), psychosis (loss of contact with reality), delirium (confused mental state), aseptic meningitis (inflammation of the brain coverings not caused by bacteria), cerebral vasculitis (inflammation of brain blood vessels), demyelinating syndromes (damage to the protective coating of nerve fibers), myelopathy (spinal cord problems), acute stroke or stroke syndrome (sudden loss of brain blood flow), cranial neuropathy (damage to nerves that control the head and face), cerebellar ataxia (loss of coordination caused by cerebellum problems), chorea (involuntary jerky movements), mononeuritis multiplex (damage to several separate nerves), or plexopathy (injury to a network of nerves).
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Investigated drugs

LAD603 is an experimental medication being given as a liquid that is injected under the skin. In this study, it is being tested to see if it can safely reduce the skin symptoms of systemic lupus erythematosus, such as rashes and lesions. Participants receive the injection while the researchers compare the changes in their skin condition to those who receive a placebo, to determine whether the medication helps improve the disease.

What is already known about the treatment

LAD603 - This medication is given as a solution for injection that is administered under the skin (subcutaneous injection). It is currently an investigational drug being studied in clinical trials and has not yet been approved for general medical use. The drug is being tested for treating systemic lupus erythematosus, especially the skin rash that often occurs with this disease. It works by targeting specific immune system signals to reduce inflammation, classifying it as an immunomodulatory biologic agent.

Investigated diseases

Systemic lupus erythematosus (SLE) - Systemic lupus erythematosus is an autoimmune disorder in which the immune system mistakenly attacks healthy tissues throughout the body. It commonly involves the skin, joints, kidneys, and blood cells, leading to inflammation and damage. The disease often begins with mild symptoms such as rash or joint pain and can evolve to affect internal organs over time. Activity levels may rise and fall, causing periods of increased symptoms followed by quieter phases. As the condition progresses, new organ systems may become involved, requiring ongoing monitoring.
Trial detailsLast updated 12 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-527200-24-00Protocol codeM-00223-10Estimated enrolment15 patientsSponsorAlmirall S.A.

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