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A Phase 2b Study Evaluating the Efficacy and Safety of ENV-294 in Adults with Moderate-to-Severe Atopic Dermatitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at adults who have moderate‑to‑severe Atopic Dermatitis, a long‑lasting skin condition that causes red, itchy patches and can affect large areas of the body. The experimental medicine being tested is called ENV-294, which is taken as an oral tablet. The purpose of the study is to find out whether different doses of this drug can reduce the severity and extent of the rash compared with a placebo.

Participants will be randomly assigned to receive either one of several dose levels of the study drug or a placebo, and neither the participants nor the study staff will know which treatment each person receives (double‑blind). Over about 12 weeks, participants will take the tablet each day and attend regular visits where their skin will be examined, they will answer questions about itch and daily life, and basic safety checks such as blood tests and heart monitoring will be done. The main result that will be measured is the change in a scoring system called EASI, which rates how much of the body is affected and how severe the rash is.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and receipt of study tablets
After joining the study, you will be assigned by a computer system to receive either env-294 tablets or a placebo tablet. the assignment is unknown to you and to the study staff (double‑blind). you will be given a supply of tablets for the first period of the trial.
Step 2
Daily tablet administration
You will take one tablet by mouth each day for a total of 12 weeks (approximately 84 days). the tablet contains a dose of 00 mg as specified in the study protocol. the tablet should be swallowed with water and taken at the same time each day.
Step 3
Baseline assessments (day 0)
On the first day of taking the study tablet, a study visit will be scheduled. during this visit you will:
easi (eczema area and severity index) will be measured to record the severity of your skin condition.
The poem (patient‑oriented eczema measure) questionnaire will be completed to capture your symptoms.
A blood sample will be taken for clinical laboratory tests.
An electrocardiogram (ecg) will be performed to check heart rhythm.
Vital signs such as blood pressure, pulse, and temperature will be recorded.
Step 4
Ongoing safety monitoring
Throughout the 12‑week period you will be asked to report any new symptoms, side effects, or health problems. the study team may request additional blood tests, ecg recordings, or vital‑sign checks at any time to monitor safety.
Step 5
Final visit (week 12, day 85)
At the end of week 12 you will return for a final study visit. the same assessments performed at baseline will be repeated, including:
Repeat measurement of easi to determine the percent change from baseline.
Completion of the poem questionnaire and the itch rating scale (peak pruritus numerical rating scale).
Blood laboratory tests, ecg, and vital‑sign measurements.
Evaluation of whether you achieved at least a 75% reduction in easi score (easi‑75) and other secondary outcomes.

Who can join the trial?

6 criteria

Must be 18 years old or older when you sign the informed consent form (ICF), the document that explains the study and your participation.
Must have had chronic atopic dermatitis (also called atopic eczema) for at least one year, meet the standard diagnostic rules called the Hanifin and Rajka criteria, and not have had a noticeable flare‑up in the four weeks before the screening visit.
Must have tried topical steroid creams or other skin‑topical medicines for atopic dermatitis without enough benefit or with intolerance, and must not have responded well to any oral or injected (systemic) therapy in the past year.
Must have moderate‑to‑severe atopic dermatitis at the screening and baseline visits, which means a global skin‑severity score (vIGA‑AD) of 3 (moderate) or 4 (severe), an eczema area and severity score (EASI) of 16 or higher, and at least 10 % of the body’s surface (excluding scalp and groin) showing eczema.
Must report an itch level of 4 or higher on a 0‑10 scale (PP‑NRS) at screening and baseline, based on the average of daily ratings during the week before the first study day, and you must have completed at least four of the seven daily ratings.
Must have used a simple, fragrance‑free moisturizer (called a bland emollient) without special ingredients like urea every day for at least one week before the first study day, and you must agree to keep using the same moisturizer once a day for the entire study.

Who cannot join the trial?

5 criteria

Have any serious health problem or abnormal test result (such as blood tests, heart‑electrical test ECG, or vital signs) that the doctor believes could put you at risk or make it difficult to understand the study results, and you cannot join if you test positive for HIV (a virus that weakens the immune system), hepatitis B (a liver infection) or hepatitis C (another liver infection).
Have had thoughts of suicide with a real plan and intention in the past year, or have tried to harm yourself in the past five years, as identified by specific questions on a suicide‑risk questionnaire.
Show important abnormal results on laboratory tests (blood or urine tests) during the screening that the doctor thinks could put you at risk or affect the study’s findings.
Have other skin conditions (for example, psoriasis, which causes red scaly patches, or seborrheic dermatitis, a rash that often appears on the scalp or oily skin) or have large tattoos that would make it hard for doctors to see or measure the eczema.
Have a current serious skin infection or are receiving treatment for a skin infection that could interfere with the evaluation of the eczema.

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Verified sites

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Responsive
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Sosnowiec, Poland
Responsive
Fakultni Nemocnice Kralovske Vinohrady
Prague, Czechia
Verified
Synexus Polska Sp. z o.o.
Poznan, Poland

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Investigated drugs

ENV-294 is an experimental oral tablet being studied to see if it can improve the skin condition of adults who have moderate-to‑severe atopic dermatitis (a type of eczema). In this trial, participants take the tablet by mouth, and researchers compare how well it works and how safe it is against a placebo. The goal is to find out whether the medication can reduce the severity and the area of skin affected by the disease.

What is already known about the treatment

ENV-294 - This experimental drug is taken as a tablet by mouth. It is currently in phase 2b clinical trials and is not yet approved for general medical use. The medicine is being studied for the treatment of moderate‑to‑severe atopic dermatitis, a skin condition that causes itching and redness. It works by gently blocking key signals in the immune system that lead to skin inflammation, and it is classified as an oral immunomodulating small‑molecule agent.

Investigated diseases

Atopic dermatitis - Atopic dermatitis is a chronic inflammatory skin disorder that causes dry, red, and itchy patches. It often begins in early childhood but can appear at any age. The rash typically appears on the face, elbows, knees, and hands, and may spread to other areas during flare‑ups. Symptoms tend to wax and wane, with periods of worsening followed by calmer phases. Over time, repeated scratching can thicken the skin and increase the area affected. Environmental triggers, stress, and allergies can influence the severity of the condition.