The goal of this clinical trial is to learn about the safety and tolerability of ENV-294 in adults with moderate to severe atopic dermatitis. It may also learn about the changes ENV-294 may have on the severity of atopic dermatitis symptoms. The main questions it will answer are: * Is ENV-294 safe and well tolerated in adults with moderate to severe atopic dermatitis? * Is there an impact on the severity of atopic dermatitis symptoms when participants take ENV-294? Researchers will review the atopic dermatitis present at the beginning of the study against the atopic dermatitis present at the end of the study. Participants will: * Take drug ENV-294 once every day for 28 days * Visit the clinic weekly for 4 weeks for checkups and tests * Keep a diary of their symptoms and when they took their study drug ENV-294
Age range
18 Years – 75 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
To assess the safety and tolerability of ENV-294 when administered to adult participants with moderate-to-severe atopic dermatitis.
Timeframe: From enrollment through treatment and the final study visit at approximately day 42.
Incidence of abnormalities in clinical chemistry parameters as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through end of study at approximately Day 42.
To assess the safety and tolerability of ENV-294 when administered to adult participants with moderate-to-severe atopic dermatitis
Timeframe: From first dose through treatment and the final study visit at approximately day 42.
Incidence of clinically significant changes in systolic blood pressure (mmHg) as a measure of safety and tolerability of ENV-294.
Timeframe: From first dose through treatment and the final study visit at approximately day 42.
Incidence of clinically significant changes in heart rate (beats per minute) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through treatment and the final study visit at approximately day 42.
Incidence of abnormalities in hematology parameters as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through the end of the study at approximately Day 42.
Incidence of abnormalities in coagulation parameters as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through the end of the study at approximately Day 42.
Incidence of abnormalities in urinalysis parameters as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through the end of the study at approximately Day 42.
Incidence of clinically significant changes in diastolic blood pressure (mmHg) as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in heart rate as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in respiratory rate as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in body temperature as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in RR interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in PR interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through the end of the study at approximately Day 42.
Incidence of clinically significant changes in QRS duration (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in QT interval (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through treatment and the final study visit (approximately Day 42).
Incidence of clinically significant changes in QTc Bazett (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Timeframe: Baseline through treatment and the final study visit (approximately Day 42)
Incidence of clinically significant changes in QTc Fridericia (milliseconds) measured by 12-lead ECG as a measure of safety and tolerability of ENV-294.
Timeframe: From enrollment through treatment and the final study visit (approximately Day 42)