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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label with once per day dosing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENV-294 Capsule | Drug | ENV-294 formulated as 200mg capsules for oral administration will be used for this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of ENV-294 when administered to adult participants with moderate-to-severe atopic dermatitis. | Incidence and severity of adverse events, serious adverse events and adverse events leading to the discontinuation of treatment. | 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. | The number of participants with clinically significant abnormalities in clinical chemistry parameters will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294. | 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 | Incidence of clinically significant changes in physical exam findings after ENV-294 administration. | 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. | The number of participants with clinically significant increases or decreases in systolic blood pressure, measured in millimeters of mercury (mmHg), will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis. | 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. | The number of participants with clinically significant changes in heart rate, measured in beats per minute from 12-lead ECG recordings, will be assessed to evaluate the cardiac safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of ENV-294 | Maximum observed plasma concentration (Cmax) of ENV-294 will be determined from plasma samples collected at scheduled time points following oral administration to evaluate pharmacokinetic properties. | Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States | ||
| Skin Sciences, PLLC |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| 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. | The number of participants with clinically significant abnormalities in hematology parameters (e.g., hemoglobin, hematocrit, red blood cell count, white blood cell count, platelet count) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294. | 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. | The number of participants with clinically significant abnormalities in coagulation parameters (e.g., PT, aPTT, INR) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294. | 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. | The number of participants with clinically significant abnormalities in urinalysis parameters (e.g., specific gravity, protein, glucose, blood, leukocytes) will be assessed to evaluate safety and tolerability of multiple escalating doses of ENV-294. | 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. | The number of participants with clinically significant increases or decreases in diastolic blood pressure, measured in millimeters of mercury (mmHg), will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis. | 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. | The number of participants with clinically significant changes in heart rate (beats per minute) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis. | 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. | The number of participants with clinically significant changes in respiratory rate (breaths per minute) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis | 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. | The number of participants with clinically significant changes in body temperature (°C) will be assessed to evaluate the safety and tolerability of ENV-294 in adults with moderate-to-severe atopic dermatitis. | 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. | The number of participants with clinically significant changes in RR interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate the cardiac safety and tolerability of ENV-294. | 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. | The number of participants with clinically significant changes in PR interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac conduction safety of ENV-294. | 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. | The number of participants with clinically significant changes in QRS duration, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac conduction safety of ENV-294. | 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. | The number of participants with clinically significant changes in QT interval, measured in milliseconds (ms) from 12-lead ECG recordings, will be assessed to evaluate cardiac repolarization safety of ENV-294. | 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. | The number of participants with clinically significant changes in QTc Bazett (QT corrected for heart rate using Bazett's formula), measured in milliseconds (ms), will be assessed to evaluate cardiac safety of ENV-294. | 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. | The number of participants with clinically significant changes in QTc Fridericia (QT corrected for heart rate using Fridericia's formula), measured in milliseconds (ms), will be assessed to evaluate cardiac safety of ENV-294. | From enrollment through treatment and the final study visit (approximately Day 42) |
| Time to reach maximum plasma concentration (Tmax) of ENV-294 |
Time to reach maximum observed plasma concentration (Tmax) of ENV-294 will be determined from plasma concentrations measured at scheduled post-dose time points. |
| Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42. |
| Area under the plasma concentration-time curve from time zero to 24 hours (AUC₀-₂₄h) of ENV-294 | Area under the plasma concentration-time curve from time zero to 24 hours (AUC₀-₂₄h) will be calculated from measured plasma concentrations of ENV-294 to assess systemic drug exposure after multiple oral doses. | Pre and/or post-dose on days 1, 8, 15 and 28, and on day 42. |
| Louisville |
| Kentucky |
| 40217 |
| United States |
| J & S Studies | College Station | Texas | 77845 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Virginia Dermatology & Skin Cancer Center | Norfolk | Virginia | 23502 | United States |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |