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Not yet taking people in SpainPhase 2

LAD603 for Skin Symptoms in Adults With Systemic Lupus Erythematosus

Tests LAD603 against placebo in adults with lupus and active skin disease.

Key facts

Who runs it
Almirall S.A.
Where
Barcelona and Pamplona, SpainSee the 2 sitesAlso in 3 other countries, 14 sites
Registry title
A Trial of LAD603 in Patients with Systemic Lupus Erythematosus
Status
Not yet recruiting
Phase
Phase 2
People taking part
20 people, planned
Starts
5 Dec 2026
Expected to end
13 Jun 2028
Type of study
Interventional
Record updated
29 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with systemic lupus erythematosus (SLE) who have active lupus skin disease. It compares LAD603 with placebo.

Age
18 to 70 years
Sex
Men and women can join.
Disease stage
SLE diagnosed at least 6 months before screening, with active lupus skin disease (CLASI-A score of 8 or more at screening and at baseline).
Earlier treatment
Must be on stable standard-of-care SLE treatment at baseline.

Main reasons for not taking part

  • Certain lupus skin types, such as lupus tumidus, lupus panniculitis, bullous SLE or chilblain lupus
  • History of active lupus kidney disease or severe active lupus nephritis
  • Active lupus affecting the brain or nerves within 24 weeks before baseline

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Participant is a male or female between 18 and 70 years old at the time of signing the informed consent
  • Participant is able to understand and willing to comply with trial requirements as per Investigator’s opinion
  • Participant provides written informed consent in accordance with institutional and regulatory guidelines
  • Meet the classification criteria for SLE with a diagnosis established for at least 6 months prior to Screening
  • Have at least one sign of active lupus-related skin disease such as, XXXXXX, with skin activity defined by a CLASI-A score ≥ 8 at both Screening and Baseline
  • Have stable SLE standard-of-care treatment at baseline
  • Participants who are WOCBP or male must agree to the requirements for the avoidance of pregnancy and exposure of the participant’s partner to LAD603 during the trial

Who cannot take part

  • Have active neuropsychiatric SLE including but not limited to the following: seizure, impaired level of consciousness, psychosis, delirium, aseptic meningitis, cerebral vasculitis, demyelinating syndromes, myelopathy, acute stroke or stroke syndrome, cranial neuropathy, cerebellar ataxia, chorea, mononeuritis multiplex, or plexopathy, within 24 weeks before baseline
  • Have any of the following subtypes of lupus: lupus tumidus, lupus panniculitis, bullous SLE, the toxic epidermal necrolysis variant of lupus, chilblain lupus, hypertrophic or verrucous discoid lupus, and lichenoid cutaneous lupus-lichen planus overlap syndrome
  • History of active SLE-driven renal disease, or history of severe active lupus nephritis

Where in Spain

Also in 3 other countries, 14 sites

  • Hospital Universitari Vall d'HebronBarcelona, SpainNot yet recruiting
  • Hospital Universitario de NavarraPamplona, SpainNot yet recruiting

About the trial

What the trial wants to find out

To evaluate whether adults with SLE and active cutaneous manifestations (CLASI-A ≥8) treated with LAD603 XXXXX achieve a greater reduction in cutaneous disease activity XXXXX than those treated with placebo.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Phase 2, multicentre, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of LAD603 in patients with systemic lupus erythematosus
Plain-language title
LAD603 for Skin Symptoms in Adults With Systemic Lupus ErythematosusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
29 October 2026