Trial Outcomes & Findings for Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis (NCT NCT05436535)

Last Updated: 2026-06-04

Results Overview

Eczema Area and Severity Index (EASI) is a composite score (range: 0-72) measuring physical signs of atopic dermatitis (AD), including area of involvement and severity. Severity components include: erythema, papulation, excoriation and lichenification \[0=absent, 1=mild, 2=moderate, 3=severe\] for each body region (head/neck, trunk, arms, legs). Area of involvement (%) is assessed for each body region. Area and severity of each body region is weighted based on size of region, and region scores are added for the total score. Scores ≤7 are considered mild AD severity, \>7 are considered moderate-to-severe.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

433 participants

Primary outcome timeframe

Day 7

Results posted on

2026-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Non-AD Participants without atopic dermatitis (AD), who applied Vanicream at least twice daily to the specified target skin area over two time periods (Day 0-7 and Day 140-168) during the study. See Arms and Interventions for more detail.	Dupilumab-naive AD Participants with AD who have never been treated with dupilumab at the time of study enrollment, who apply Vanicream at least twice daily to the specified target skin area over two time periods (Day 0-7 and Day 140-168), receive topical corticosteroids (Day 7-35), and - depending on steroid response - may receive dupilumab (Day 35-140) or remain on steroids (Day 35-140). See Arms and Interventions for more detail.	Long-term Dupilumab AD Participants with AD who have been treated with dupilumab for at least 4 months prior to study enrollment and continue to be treated as prescribed by their physician outside of the study while enrolled in the study.
Overall Study STARTED	129	240	64
Overall Study COMPLETED	117	190	61
Overall Study NOT COMPLETED	12	50	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-AD Participants without atopic dermatitis (AD), who applied Vanicream at least twice daily to the specified target skin area over two time periods (Day 0-7 and Day 140-168) during the study. See Arms and Interventions for more detail.	Dupilumab-naive AD Participants with AD who have never been treated with dupilumab at the time of study enrollment, who apply Vanicream at least twice daily to the specified target skin area over two time periods (Day 0-7 and Day 140-168), receive topical corticosteroids (Day 7-35), and - depending on steroid response - may receive dupilumab (Day 35-140) or remain on steroids (Day 35-140). See Arms and Interventions for more detail.	Long-term Dupilumab AD Participants with AD who have been treated with dupilumab for at least 4 months prior to study enrollment and continue to be treated as prescribed by their physician outside of the study while enrolled in the study.
Overall Study Withdrawal by Subject	4	20	2
Overall Study Lost to Follow-up	5	15	0
Overall Study Protocol Violation	2	2	1
Overall Study Dupilumab-naïve AD participant terminated prior to Day 140-196 due to treatment failure	0	4	0
Overall Study Investigator no longer believes participation is in the best interest of the participant	0	4	0
Overall Study Participant initiated systemic therapies after the Baseline Assessment Visit	1	1	0
Overall Study Participant was diagnosed with an exclusionary medical condition during the study	0	1	0
Overall Study Incarceration	0	1	0
Overall Study Participant moved.	0	2	0

Baseline Characteristics

The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-AD n=129 Participants Participants without atopic dermatitis (AD).	Dupilumab-naive AD n=240 Participants Participants with AD who have never been treated with dupilumab at the time of study enrollment.	Long-term Dupilumab AD n=64 Participants Participants with AD who have been treated with dupilumab for at least 4 months prior to study enrollment and continue to be treated as prescribed by their physician outside of the study while enrolled in the study.	Total n=433 Participants Total of all reporting groups
Age, Continuous	27.3 years n=129 Participants	24.9 years n=240 Participants	31.4 years n=64 Participants	26.6 years n=433 Participants
Age, Customized Children (6-17 years old)	37 Participants n=129 Participants	90 Participants n=240 Participants	19 Participants n=64 Participants	146 Participants n=433 Participants
Age, Customized Adults (18 years old or older)	92 Participants n=129 Participants	150 Participants n=240 Participants	45 Participants n=64 Participants	287 Participants n=433 Participants
Sex/Gender, Customized Female	79 Participants n=129 Participants	144 Participants n=240 Participants	38 Participants n=64 Participants	261 Participants n=433 Participants
Sex/Gender, Customized Male	50 Participants n=129 Participants	94 Participants n=240 Participants	26 Participants n=64 Participants	170 Participants n=433 Participants
Sex/Gender, Customized Unknown or Not Reported	0 Participants n=129 Participants	2 Participants n=240 Participants	0 Participants n=64 Participants	2 Participants n=433 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=129 Participants	47 Participants n=240 Participants	10 Participants n=64 Participants	77 Participants n=433 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=129 Participants	188 Participants n=240 Participants	54 Participants n=64 Participants	350 Participants n=433 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=129 Participants	5 Participants n=240 Participants	0 Participants n=64 Participants	6 Participants n=433 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=129 Participants	0 Participants n=240 Participants	0 Participants n=64 Participants	0 Participants n=433 Participants
Race (NIH/OMB) Asian	16 Participants n=129 Participants	44 Participants n=240 Participants	11 Participants n=64 Participants	71 Participants n=433 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=129 Participants	2 Participants n=240 Participants	0 Participants n=64 Participants	2 Participants n=433 Participants
Race (NIH/OMB) Black or African American	21 Participants n=129 Participants	57 Participants n=240 Participants	14 Participants n=64 Participants	92 Participants n=433 Participants
Race (NIH/OMB) White	73 Participants n=129 Participants	99 Participants n=240 Participants	28 Participants n=64 Participants	200 Participants n=433 Participants
Race (NIH/OMB) More than one race	8 Participants n=129 Participants	24 Participants n=240 Participants	8 Participants n=64 Participants	40 Participants n=433 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=129 Participants	14 Participants n=240 Participants	3 Participants n=64 Participants	28 Participants n=433 Participants
Region of Enrollment United States	129 participants n=129 Participants	240 participants n=240 Participants	64 participants n=64 Participants	433 participants n=433 Participants
Baseline Total EASI Categories Clear (0)	0 Participants The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	0 Participants n=240 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	21 Participants n=64 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	21 Participants n=304 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.
Baseline Total EASI Categories Almost Clear (0.1-1.0)	0 Participants The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	7 Participants n=240 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	10 Participants n=64 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	17 Participants n=304 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.
Baseline Total EASI Categories Mild (1.1-7.0)	0 Participants The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	85 Participants n=240 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	24 Participants n=64 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	109 Participants n=304 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.
Baseline Total EASI Categories Moderate (7.1-21.0)	0 Participants The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	98 Participants n=240 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	9 Participants n=64 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	107 Participants n=304 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.
Baseline Total EASI Categories Severe (21.1-50.0)	0 Participants The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	49 Participants n=240 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	0 Participants n=64 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	49 Participants n=304 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.
Baseline Total EASI Categories Very Severe (50.1-72.0)	0 Participants The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	1 Participants n=240 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	0 Participants n=64 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.	1 Participants n=304 Participants • The Eczema Area and Severity Index (EASI) assessment is not applicable to Non-AD participants who do not have eczema.

PRIMARY outcome

Timeframe: Day 7

Population: Per protocol, Non-AD and Long-term Dupilumab AD are excluded from the primary objective. Thus, the analysis population includes only Dupilumab-naïve adults (18 years old or older) and children (6-17 years old). Of the total 240 Dupilumab-naïve adults and children enrolled, 220 were included in the analysis because 5 participants early terminated prior to Day 7 and 15 participants had unsuccessful transcriptomic gene sequencing from their non-lesional skin tape strip samples.

Outcome measures

Outcome measures
Measure	Type 2-high Endotype n=101 Participants Participants in this group have high levels of gene expression across the cluster of genes nominated as representing the 'type 2' endotype in non-lesional skin. The genes comprising the type 2 endotype were identified using a clustering approach based on networks of co-expressed genes and subsequent enrichment analysis of published type 2 inflammation gene sets.	Type 2-low Endotype n=119 Participants Participants in this group have low levels of gene expression across the cluster of genes nominated as representing the 'type 2' endotype in non-lesional skin.
Number of Dupilumab-naïve AD Participants With Mild (EASI ≤ 7) vs. Moderate-to-severe (EASI > 7) AD Severity Between Type 2-high vs. Type 2-low Endotype From Non-lesional Skin Transcriptome. Dupilumab-naïve adults (18 years old or older) · Mild (EASI ≤ 7) AD severity	20 Participants	43 Participants
Number of Dupilumab-naïve AD Participants With Mild (EASI ≤ 7) vs. Moderate-to-severe (EASI > 7) AD Severity Between Type 2-high vs. Type 2-low Endotype From Non-lesional Skin Transcriptome. Dupilumab-naïve adults (18 years old or older) · Moderate-to-severe (EASI > 7) AD severity	34 Participants	44 Participants
Number of Dupilumab-naïve AD Participants With Mild (EASI ≤ 7) vs. Moderate-to-severe (EASI > 7) AD Severity Between Type 2-high vs. Type 2-low Endotype From Non-lesional Skin Transcriptome. Dupilumab-naïve children (6-17 years old) · Mild (EASI ≤ 7) AD severity	16 Participants	18 Participants
Number of Dupilumab-naïve AD Participants With Mild (EASI ≤ 7) vs. Moderate-to-severe (EASI > 7) AD Severity Between Type 2-high vs. Type 2-low Endotype From Non-lesional Skin Transcriptome. Dupilumab-naïve children (6-17 years old) · Moderate-to-severe (EASI > 7) AD severity	31 Participants	14 Participants
Number of Dupilumab-naïve AD Participants With Mild (EASI ≤ 7) vs. Moderate-to-severe (EASI > 7) AD Severity Between Type 2-high vs. Type 2-low Endotype From Non-lesional Skin Transcriptome. Dupilumab-naïve participants of all ages · Mild (EASI ≤ 7) AD severity	36 Participants	61 Participants
Number of Dupilumab-naïve AD Participants With Mild (EASI ≤ 7) vs. Moderate-to-severe (EASI > 7) AD Severity Between Type 2-high vs. Type 2-low Endotype From Non-lesional Skin Transcriptome. Dupilumab-naïve participants of all ages · Moderate-to-severe (EASI > 7) AD severity	65 Participants	58 Participants

SECONDARY outcome

Timeframe: Day 7, Day 168-224 (End of Study)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 7, Day 168-224 (End of Study)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 7 and Day 168-224 (End of Study)

Gene counts are produced by whole transcriptome sequencing (WTS) on the non-lesional skin tape strips collected at Day 7 and Day 168-224 (End of Study). These counts are then normalized by variance stabilizing transformation (VST). The change in normalized gene counts is calculated from Day 7 to Day 168-224 (End of Study) within each group.

Outcome measures

Outcome data not reported

Adverse Events

Non-AD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dupilumab-naive AD

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Long-term Dupilumab AD

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Non-AD n=129 participants at risk Participants without atopic dermatitis (AD).	Dupilumab-naive AD n=240 participants at risk Participants with AD who have never been treated with dupilumab at the time of study enrollment.	Long-term Dupilumab AD n=64 participants at risk Participants with AD who have been treated with dupilumab for at least 4 months prior to study enrollment and continue to be treated as prescribed by their physician outside of the study while enrolled in the study.
Eye disorders Keratitis	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/240 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	1.6% 1/64 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
General disorders Medical device site haemorrhage	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.42% 1/240 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Infections and infestations COVID-19	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/240 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	1.6% 1/64 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Infections and infestations Nasopharyngitis	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.42% 1/240 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Infections and infestations Pharyngitis	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.42% 1/240 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Infections and infestations Upper respiratory tract infection	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.83% 2/240 • Number of events 2 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/240 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	1.6% 1/64 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.42% 1/240 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Investigations Blood pressure increased	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.42% 1/240 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.42% 1/240 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Nervous system disorders Headache	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.42% 1/240 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Nervous system disorders Presyncope	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.42% 1/240 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.42% 1/240 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/240 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	1.6% 1/64 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.42% 1/240 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.42% 1/240 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/64 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Skin and subcutaneous tissue disorders Rash	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/240 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	1.6% 1/64 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/129 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	0.00% 0/240 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.	1.6% 1/64 • Number of events 1 • Reported adverse events occurring between the time of enrollment and Day 7. Events of any grade that were recorded in EDC.