In short
ENV-294 is an investigational substance being studied as a potential oral treatment for moderate-to-severe atopic dermatitis, a chronic inflammatory skin condition. One Phase 2 clinical trial is currently authorised in the EU, planning to enrol 142 adult participants to compare two doses of ENV-294 against placebo. The trial will measure changes in the Eczema Area and Severity Index (EASI) score over 12 weeks.
Key points
- ENV-294 is an investigational substance with no marketing authorisation in these records.
- The only registered trial is a Phase 2 study in moderate-to-severe atopic dermatitis.
- The trial plans to enrol 142 adult participants and is currently authorised in the EU.
- Participants receive one of two oral doses of ENV-294 or a placebo tablet.
- The main outcome is the percent change in EASI score from baseline at Week 12.
- The study is interventional and randomised with a placebo control arm.
What is ENV-294?
ENV-294 is an investigational substance being developed as a potential treatment for atopic dermatitis, also known as atopic eczema. It is not yet authorised as a medicine in the European Union or elsewhere based on the available registry records. The substance is administered by oral use, which means it is taken by mouth, and the trial records describe it as a drug given in tablet form alongside a matching placebo.
How does ENV-294 work?
The available registry data does not describe the specific mechanism of action of ENV-294. The trial is designed to evaluate whether ENV-294 can reduce the severity and extent of atopic dermatitis compared with placebo. Atopic dermatitis is a chronic inflammatory skin condition characterised by itchy, inflamed patches of skin, and the trial measures changes in the Eczema Area and Severity Index (EASI), a standard scoring tool used to assess how much of the skin is affected and how severe the eczema is.
Which conditions is ENV-294 studied for?
ENV-294 is currently studied in one condition:
- Moderate-to-severe atopic dermatitis — a long-lasting inflammatory skin disease that causes dry, itchy skin and rashes, which can significantly affect quality of life.
How is ENV-294 given?
In the registered trial, ENV-294 is given by oral use, meaning it is taken by mouth. The trial includes two different dose levels of ENV-294, although the exact milligram amounts are not reported in the registry record (listed as 0 mg). A matching placebo tablet is used as the comparison arm.
What do the clinical trials show?
One Phase 2 clinical trial of ENV-294 is registered in the EU Clinical Trials Information System (CTIS). The trial is currently authorised, meaning it has received regulatory approval to proceed, and plans to enrol 142 adult participants with moderate-to-severe atopic dermatitis.
The study is interventional and compares two doses of ENV-294 against placebo. The main outcome measure is the percent change from baseline in EASI score at Week 12 (Day 85). The EASI score combines the extent of affected skin and the severity of redness, thickening, scratching and oozing in four body regions, so a reduction in EASI indicates improvement in the eczema.
Because the trial is still in its early phase and has not reported results, there are no efficacy findings available yet. The study is designed to evaluate whether ENV-294 doses are more effective than placebo in reducing the severity and extent of atopic dermatitis.
What side effects are known?
No side effect data for ENV-294 is available in the registry record. As a Phase 2 trial, one of the aims is to evaluate the safety of ENV-294 in adult participants, but results have not yet been published in the registry.