A Trial of LAD603 in Patients with Systemic Lupus Erythematosus
Key facts
- Where
- Budapest III, Székesfehérvár és Zalaegerszeg, MagyarországSee the 3 sites
- Phase
- 2. fázis
Where in Magyarország
- Obudai Egeszseguegyi Centrum Kft.Budapest III, MagyarországToborzás még nem indult
- Complex Rendelo Med Zrt.Székesfehérvár, MagyarországToborzás még nem indult
- Obudai Egeszseguegyi Centrum Kft.Zalaegerszeg, MagyarországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Almirall S.A.
- Trial code
- EU 2026-527200-24-00
- Record updated
- 2026. október 29.
- Original description
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.Read full original descriptionShow less
A Phase 2, multicentre, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of LAD603 in patients with systemic lupus erythematosus
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.
Inclusion: 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.
Exclusion: 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.