In short
Enpatoran hemihydrate is an investigational oral medicine being studied for cutaneous manifestations of lupus erythematosus, a condition causing skin rashes and lesions, with or without systemic disease. It is currently being evaluated in two authorised Phase 3 clinical trials, each planning to enrol 202 participants. The trials measure whether enpatoran can reduce skin disease activity by at least 70% on a standard scoring system called CLASI-A after 24 weeks of treatment.
Key points
- Enpatoran hemihydrate is an investigational oral medicine, not yet authorised for marketing.
- It is being studied in Phase 3 trials for cutaneous manifestations of lupus erythematosus.
- Two authorised trials are listed, each planning to enrol 202 participants.
- The main goal is a CLASI-70 response: at least 70% reduction in skin disease activity at week 24.
- Participants receive either enpatoran or a placebo, both given by mouth.
- Both trials are currently in the authorised status, meaning they are approved to proceed.
What is enpatoran hemihydrate?
Enpatoran hemihydrate is an investigational oral medicine. In the EU Clinical Trials Information System (CTIS), it is listed as a test drug in interventional trials, meaning it is the substance being actively investigated. It is not described as an authorised medicine in the registry records, and no marketing authorisation is mentioned in the data provided. The substance is being studied in the therapeutic area of autoimmune and inflammatory diseases, specifically for skin manifestations of lupus erythematosus.
The name "enpatoran hemihydrate" refers to the hemihydrate salt form of the active substance enpatoran. In the trial records, the intervention is listed simply as "Enpatoran" with an oral route of administration. No trade names or development codes other than enpatoran itself appear in the provided data.
How does enpatoran hemihydrate work?
The provided trial records do not include a description of the mechanism of action of enpatoran. The registry data focuses on the clinical trial design rather than the molecular target of the substance. Without supplementary sources, the precise way enpatoran acts in the body cannot be stated from the available information. The trials measure its effect on skin disease activity in lupus, but the biological pathway through which it may work is not described in the source data.
Which conditions is enpatoran hemihydrate studied for?
- Cutaneous manifestations of lupus erythematosus with or without systemic disease — a condition in which lupus causes skin rashes, lesions or other skin problems, sometimes alongside internal organ involvement. Both listed trials focus on this condition.
The trials specifically measure skin disease activity using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A), a scoring system that assesses the extent and severity of lupus skin lesions. A CLASI-70 response means the skin score has fallen by at least 70% from the starting value, indicating a substantial improvement in skin disease.
How is enpatoran hemihydrate given?
Enpatoran is given by mouth (oral route of administration). The trial records list the pharmaceutical form as oral, with the dose reported as 0 mg in the registry — a placeholder indicating that the specific dose is not reported in the public record. The trials compare enpatoran with a placebo matched to enpatoran, also given orally. No other formulations or routes of administration appear in the provided data.
What do the clinical trials show?
Two authorised Phase 3 trials of enpatoran are listed in the EU Clinical Trials Information System. Both trials study the same condition — cutaneous manifestations of lupus erythematosus with or without systemic disease — and both plan to enrol 202 participants each.
What phase and status are the trials?
Both trials are Phase 3 studies, the stage of clinical research that typically involves larger numbers of participants and aims to confirm effectiveness and safety before any potential regulatory approval. Both trials are listed with the status "Authorised", meaning they have received approval to proceed in the EU clinical trials system. Neither trial reports a start date or completion date in the provided data.
What do the trials measure?
The primary outcome in both trials is the percentage of participants achieving a CLASI-70 response at week 24. This is defined as at least a 70% decrease in the CLASI-A score from baseline, a measure of skin disease activity. The brief summaries state that the aim is to demonstrate the efficacy of enpatoran in reducing cutaneous disease activity by achieving at least 70% reduction from baseline in CLASI-A total score at week 24.
Who can take part in the trials?
The trial records identify participants as people with cutaneous manifestations of lupus erythematosus, with or without systemic disease. The records do not provide detailed eligibility criteria such as age limits, previous treatments, or specific laboratory values. Both trials are interventional studies, meaning participants receive either enpatoran or a placebo as part of the study design.
What side effects are known?
The provided data does not include information on side effects of enpatoran. The trial records do not list adverse events, and no supplementary sources describing the safety profile of enpatoran are available. Side effects would typically be reported once trial results are published or when the substance is assessed by regulatory authorities.