2026-527200-24-00Not yet recruitingPhase 2
A Trial of LAD603 in Patients with Systemic Lupus Erythematosus
A Phase 2, multicentre, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of LAD603 in patients with systemic lupus erythematosus
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 30 Jul 2026
- Start date
- 5 Dec 2026
- Lead sponsor
- Almirall S.A.
- Diseases
- Lupus (SLE)
- EU CT number
- 2026-527200-24-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- 16 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center MedTech Services Ltd. | Haskovo | Bulgaria | Not yet recruiting |
| University Multiprofile Hospital For Active Treatment Kaspela EOOD | Plovdiv | Bulgaria | Not yet recruiting |
| Medical Center Teodora EOOD | Ruse | Bulgaria | Not yet recruiting |
| DCC 1 Sevlievo EOOD | Sevlievo | Bulgaria | Not yet recruiting |
| University Hospital Lozenetz | Sofia | Bulgaria | Not yet recruiting |
| Medical Center Excelsior OOD | Sofiya | Bulgaria | Not yet recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario de Navarra | Pamplona | Spain | Not yet recruiting |
| Obudai Egeszseguegyi Centrum Kft. | Budapest III | Hungary | Not yet recruiting |
| Complex Rendelo Med Zrt. | Székesfehérvár | Hungary | Not yet recruiting |
| Obudai Egeszseguegyi Centrum Kft. | Zalaegerszeg | Hungary | Not yet recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. | Cracow | Poland | Not yet recruiting |
| Biomedical Centers Sp. z o.o. | Janki | Poland | Not yet recruiting |
| Medyczne Centrum Hetmańska | Poznan | Poland | Not yet recruiting |
| Rheuma Medicus Sp z o o | Warsaw | Poland | Not yet recruiting |
| Care Access Polska Sp. Z o.o. | Warsaw | Poland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.