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This Phase 2a trial will evaluate the effects of EP262 in subjects with atopic dermatitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EP262 150 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral EP262 | Drug | Once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study. | up to Week 10 |
| Number of Participants With Any ≥Grade 3 TEAE | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study. AEs were graded for severity using the the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v.5). CTCAE grades were scored as: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life threatening; Grade 5 = death related to the AE. | up to Week 10 |
| Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs | Clinical meaningfulness was determined by the investigator. | up to Week 10 |
| Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs ) | Clinical meaningfulness was determined by the investigator. | up to Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Change From Baseline to Week 6 in Gene Expression Signature and Skin Histology (Epidermal Thickness, Immune Cell Infiltration, Markers of Epidermal Proliferation) as Assessed From Biopsies of Lesional Skin | Biopsies were taken from lesional and nonlesional skin, and differential gene expression was analyzed by comparing lesional samples at baseline and Week 6 to nonlesional reference samples at baseline. Genes were classified as differentially expressed if they met 2 criteria: an absolute log2 fold change greater than 1.5 and an adjusted p-value less than 0.05 using Wilcoxon signed rank test or paired Students t-test and Bonferroni correction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | 35209 | United States | ||
| RM Medical Research, Inc. |
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This study was conducted in the United States and Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | 150 mg EP262 QD | Participants received oral EP262 150 milligrams (mg) QD during the 6-week Double-blind Treatment Period. After administration of the last dose, participants entered a 4-week Follow-up Period. |
| FG001 | Placebo QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2024 | Jul 22, 2025 |
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| Drug |
Once Daily |
|
| Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Hematology, Chemistry, or Coagulation Parameters | Clinical meaningfulness was determined by the investigator. | up to Week 10 |
| Baseline; Week 6 |
| Miami Lakes |
| Florida |
| 33014 |
| United States |
| Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| Lawrence J. Green, MD LLC | Rockville | Maryland | 20850 | United States |
| Revival Research Institute, LLC | Troy | Michigan | 48084 | United States |
| Optima Research Boardman | Boardman | Ohio | 44512 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
| Jordan Valley Dermatology Center | South Jordan | Utah | 84095 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | United States |
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
Participants received matching oral placebo once daily (QD) during the 6-week Double-blind Treatment Period. After administration of the last dose, participants entered a 4-week Follow-up Period.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 150 mg EP262 QD | Participants received oral EP262 150 milligrams (mg) QD during the 6-week Double-blind Treatment Period. After administration of the last dose, participants entered a 4-week Follow-up Period. |
| BG001 | Placebo QD | Participants received matching oral placebo once daily (QD) during the 6-week Double-blind Treatment Period. After administration of the last dose, participants entered a 4-week Follow-up Period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study. | Safety Analysis Set: all participants who were randomized and took at least 1 dose of randomized study drug. Safety analyses were based upon treatment actually received. | Posted | Count of Participants | Participants | up to Week 10 |
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| Primary | Number of Participants With Any ≥Grade 3 TEAE | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study. AEs were graded for severity using the the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v.5). CTCAE grades were scored as: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life threatening; Grade 5 = death related to the AE. | Safety Analysis Set | Posted | Count of Participants | Participants | up to Week 10 |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs | Clinical meaningfulness was determined by the investigator. | Safety Analysis Set | Posted | Count of Participants | Participants | up to Week 10 |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs ) | Clinical meaningfulness was determined by the investigator. | Safety Analysis Set. Only participants with available data were analyzed. | Posted | Count of Participants | Participants | up to Week 10 |
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| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Hematology, Chemistry, or Coagulation Parameters | Clinical meaningfulness was determined by the investigator. | Safety Analysis Set | Posted | Count of Participants | Participants | up to Week 10 |
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Change From Baseline to Week 6 in Gene Expression Signature and Skin Histology (Epidermal Thickness, Immune Cell Infiltration, Markers of Epidermal Proliferation) as Assessed From Biopsies of Lesional Skin | Biopsies were taken from lesional and nonlesional skin, and differential gene expression was analyzed by comparing lesional samples at baseline and Week 6 to nonlesional reference samples at baseline. Genes were classified as differentially expressed if they met 2 criteria: an absolute log2 fold change greater than 1.5 and an adjusted p-value less than 0.05 using Wilcoxon signed rank test or paired Students t-test and Bonferroni correction. | Full Analysis Set: all participant who were randomized and took at least 1 dose of randomized study drug. Participants were analyzed according to randomized treatment assignment. | Posted | Count of Participants | Participants | No | Baseline; Week 6 |
|
up to Week 10
Analysis was conducted in the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug. Safety analyses were based upon treatment actually received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo QD | Participants received matching oral placebo once daily (QD) during the 6-week Double-blind Treatment Period. After administration of the last dose, participants entered a 4-week Follow-up Period. | 0 | 11 | 0 | 11 | 7 | 11 |
| EG001 | 150 mg EP262 QD | Participants received oral EP262 150 milligrams (mg) QD during the 6-week Double-blind Treatment Period. After administration of the last dose, participants entered a 4-week Follow-up Period. | 0 | 21 | 0 | 21 | 2 | 21 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2024 | Jul 22, 2025 | SAP_001.pdf |
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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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Units | Counts |
|---|---|
| Participants |
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