Trial Outcomes & Findings for Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis (NCT NCT06144424)

NCT ID: NCT06144424

Last Updated: 2025-08-24

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

up to Week 10

Results posted on

2025-08-24

Participant Flow

This study was conducted in the United States and Canada.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	21	11
Overall Study COMPLETED	18	11
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	2	0
Overall Study Incarceration	1	0

Baseline Characteristics

Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	150 mg EP262 QD n=21 Participants 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.	Placebo QD n=11 Participants 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.	Total n=32 Participants Total of all reporting groups
Age, Continuous	39.6 years STANDARD_DEVIATION 16.54 • n=5 Participants	41.7 years STANDARD_DEVIATION 11.30 • n=7 Participants	40.3 years STANDARD_DEVIATION 14.79 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	15 Participants n=5 Participants	7 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to Week 10

Population: 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.

Outcome measures

Outcome measures
Measure	150 mg EP262 QD n=21 Participants 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.	Placebo QD n=11 Participants 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.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	4 Participants	7 Participants

PRIMARY outcome

Timeframe: up to Week 10

Population: Safety Analysis Set

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.

Outcome measures

Outcome measures
Measure	150 mg EP262 QD n=21 Participants 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.	Placebo QD n=11 Participants 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.
Number of Participants With Any ≥Grade 3 TEAE	0 Participants	0 Participants

PRIMARY outcome

Timeframe: up to Week 10

Population: Safety Analysis Set

Clinical meaningfulness was determined by the investigator.

Outcome measures

Outcome measures
Measure	150 mg EP262 QD n=21 Participants 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.	Placebo QD n=11 Participants 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.
Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs	0 Participants	0 Participants

PRIMARY outcome

Timeframe: up to Week 10

Population: Safety Analysis Set. Only participants with available data were analyzed.

Clinical meaningfulness was determined by the investigator.

Outcome measures

Outcome measures
Measure	150 mg EP262 QD n=18 Participants 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.	Placebo QD n=11 Participants 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.
Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs )	1 Participants	1 Participants

PRIMARY outcome

Timeframe: up to Week 10

Population: Safety Analysis Set

Clinical meaningfulness was determined by the investigator.

Outcome measures

Outcome measures
Measure	150 mg EP262 QD n=21 Participants 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.	Placebo QD n=11 Participants 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.
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Hematology, Chemistry, or Coagulation Parameters	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline; Week 6

Population: 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.

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.

Outcome measures

Outcome measures
Measure	150 mg EP262 QD n=21 Participants 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.	Placebo QD n=11 Participants 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.
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	0 Participants	0 Participants

Adverse Events

Placebo QD

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

150 mg EP262 QD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo QD n=11 participants at risk 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.	150 mg EP262 QD n=21 participants at risk 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.
Infections and infestations Bacterial infection	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/21 • 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.
Skin and subcutaneous tissue disorders Dermatitis atopic	9.1% 1/11 • Number of events 1 • 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.	4.8% 1/21 • Number of events 1 • 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.
Gastrointestinal disorders Diarrhoea	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/21 • 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.
Gastrointestinal disorders Food poisoning	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/21 • 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.
Gastrointestinal disorders Gastritis	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/21 • 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.
Infections and infestations Gastroenteritis viral	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/21 • 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.
Infections and infestations Lower respiratory tract infection	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/21 • 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.
Injury, poisoning and procedural complications Muscle strain	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/21 • 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.
Infections and infestations Nasopharyngitis	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/21 • 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.
General disorders Pyrexia	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/21 • 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.
Infections and infestations Upper respiratory tract infection	18.2% 2/11 • Number of events 2 • 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.	4.8% 1/21 • Number of events 1 • 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.
Infections and infestations Viral rash	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/21 • 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.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER