AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants with Moderate-to-Severe Atopic Dermatitis

Atopic dermatitis, commonly known as eczema, can cause dry, itchy, red, and painful skin that is hard to manage. This clinical trial is looking at an experimental tablet called ENV-294 to see if it can help adults with moderate-to-severe eczema. Researchers want to find out how well the medicine works compared to a dummy tablet, known as a placebo. They will test different doses to discover the best amount to give. During the 12-week study, doctors will track how much the skin improves, whether itching decreases, and how patients feel overall. Safety is a top priority throughout the study. The research team will closely monitor all participants with regular health checks, blood tests, and heart tracings to watch for any side effects.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Enveda Therapeutics Inc.

Enrolment target

Start

10 Sep 2026

Atopic Dermatitis

What is this study about?

Atopic dermatitis, commonly called eczema, is a long-term condition that makes the skin dry, cracked, sore, and intensely itchy. For many people, everyday creams and moisturisers are simply not enough to control severe flare-ups. This can make sleeping difficult and get in the way of daily life. Researchers are looking for new, convenient treatments that work from the inside out to soothe the skin.

This study focuses on an experimental medicine called ENV-294, which comes as a daily tablet. The main goal is to see whether ENV-294 can significantly clear up skin patches and relieve severe itching over 12 weeks of treatment. Because the drug is still being developed, researchers also need to test different strengths to find the dose that offers the best balance of effectiveness and safety.

To ensure fair results, this is a 'double-blind, placebo-controlled' trial. This means some participants will receive the real medicine at different doses, while others will receive a dummy tablet that looks identical. Neither the participants nor the clinic doctors will know who is taking which tablet until the study ends. Comparing the real drug against a placebo helps scientists prove whether any improvements are truly caused by ENV-294.

Key takeaways

Tests a new daily tablet called ENV-294 for moderate-to-severe eczema.
Open to adults aged 18 and over.
Compares different doses of the active medicine against a dummy tablet (placebo).
Treatment lasts for about 12 weeks with regular clinic check-ups.
Participation is completely voluntary and you can stop at any time.

Who may be eligible?

This trial is designed for adults aged 18 and older who are living with moderate-to-severe atopic dermatitis. Both men and women can apply. It is intended for people whose eczema covers a noticeable area of their body and continues to cause troublesome symptoms despite their usual skincare treatments.

Because this is an early-stage study, participants must be in generally stable health apart from their skin condition. The study doctors will review your medical history to check if the trial is safe for you.

You may not be able to join if you have certain other serious medical conditions, are pregnant or breastfeeding, or are taking specific medicines that could interfere with the study drug. The clinic team will run routine checks to confirm if this trial is a suitable option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been diagnosed with atopic dermatitis (eczema).
My eczema is currently moderate or severe.
My skin symptoms are not well controlled by standard creams.
I am able to attend regular clinic appointments over a 12-week period.

Answer every question to see your result.

What does participation involve?

If you decide to join, your participation will last for at least 12 weeks, with extra time set aside for initial screening and a follow-up check. You will be asked to take a tablet once a day. You will have a chance of receiving one of a few doses of ENV-294 or a dummy tablet without active medicine.

You will need to attend regular appointments at a clinical trial centre. During these visits, doctors will examine your skin to measure redness, swelling, and coverage. You will also answer simple questions about your itching and sleep quality.

To keep you safe, the team will perform routine health assessments. These include checking your blood pressure, taking small blood and urine samples, and carrying out an electrocardiogram (ECG) to check your heart rhythm. You can leave the study at any point if your circumstances change.

Potential risks and benefits

Taking part in this study may help your eczema improve, leading to clearer skin and less itching, though benefits cannot be guaranteed. You will also receive careful, regular health monitoring from skin specialists throughout the trial. However, there are potential risks. Because ENV-294 is an experimental medicine, you might experience side effects, which could include mild stomach upset, headaches, or allergic reactions. There is also a chance you receive the placebo tablet, which will not treat your eczema. Remember, joining is entirely voluntary, and you have the right to withdraw from the study at any time without it affecting your standard NHS care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Germany
—
Unverified
Czechia
—
Unverified
Bulgaria
—
Unverified
Poland
—
Unverified
Spain

Common questions

What is a placebo and why is it used?

A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. It helps scientists tell if the health improvements seen are truly caused by the study drug.

Will I have to pay for the study treatment?

No, all study tablets, medical visits, and tests are provided free of charge during the trial.

Can I keep using my normal moisturiser?

In most trials, standard bland moisturisers are encouraged, but the study team will give you clear instructions on which creams are allowed.

Can I leave the study if I change my mind?

Yes, you are free to leave the trial at any time, for any reason, without giving an explanation and without losing your standard medical care.

How will I know if the medicine is working?

The study team will measure your skin at each visit and ask you about changes in your itching to see how well the treatment is working.