Badanie skuteczności i bezpieczeństwa enpatoranu u pacjentów z aktywnymi skórnymi zmianami tocznia (z lub bez ognisk ogólnoustrojowych)

Day 1 – randomisation and first dose

After signing the consent form, you are assigned to receive either enpatoran or a matching placebo without knowing which one you received.

The study medication is an oral film‑coated tablet; the exact dose is set by the study protocol and is taken exactly as instructed.

You receive written instructions on how to take the tablet each day and a schedule of future clinic visits.

Daily medication intake

From day 1 until week 24 you take one tablet by mouth once daily, at the same time each day.

The tablet may be taken with or without food; you should not change the dose unless instructed by the study staff.

Week 4 clinic visit – early efficacy and safety check

You attend a clinic appointment approximately four weeks after the first dose.

The study team measures the cutaneous lupus erythematosus skin score (CLASI‑a) to see if there is at least a 50 % improvement (CLASI‑50).

Blood samples are taken to check laboratory values and to record any adverse events that may have occurred.

The dose of the study tablet is not changed unless safety concerns arise.

Week 12 clinic visit – mid‑study Assessment

You return to the clinic about twelve weeks after starting treatment.

The skin score (CLASI‑a) is measured again, and the study team evaluates whether a clinically meaningful reduction in corticosteroid use is possible.

Additional blood tests are performed to monitor safety and laboratory parameters.

Any side effects that have occurred are recorded and evaluated.

Week 24 clinic visit – final evaluation

The last scheduled visit takes place at week 24, marking the end of the treatment period.

The primary outcome is assessed: a reduction of at least 70 % in the CLASI‑a score compared with the baseline measurement (CLASI‑70).

The study also records the british islands lupus Assessment Group based Composite lupus Assessment (BICLA) response, the number of treatment‑emergent adverse events, serious adverse events, and adverse events of special interest.

Laboratory tests are repeated to detect any grade 3 or higher abnormalities.

The final skin score (CLASI‑a ≤ 3) and any further corticosteroid reductions are documented.