Trial Outcomes & Findings for Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis (NCT NCT03293030)

Last Updated: 2025-11-14

Results Overview

The percent change in CD4+ T effector cells expressing IL-4 in dupilumab-treated subjects at week 12 vs week 0 was calculated as follows. A single value was derived for the entire population with pooled samples from pre- and post-intervention time points, which was then used to calculate a percent change between the two periods. Specifically, the mean M1 across subjects of the percentage of CD4+ T effector cells expressing IL4 was computed at week 0. The mean M2 across subjects of the percentage of CD4+ T effector cells expressing IL4 was computed at week 12. The final result was calculated as: (M1-M2)/M1\*100. Therefore, the result is a number and there is no central tendency metric.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Dupilumab Treatment Single group study. Approximately 15 subjects will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). All subjects will undergo skin biopsies for molecular profiling as well as skin and stool microbiome sampling and patch testing and different points of the study. Dupilumab: Dupilumab treatment After completion of the study, 17 were enrolled and 14 participants total completed the study.
Overall Study STARTED	17
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Dupilumab Treatment Single group study. Approximately 15 subjects will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). All subjects will undergo skin biopsies for molecular profiling as well as skin and stool microbiome sampling and patch testing and different points of the study. Dupilumab: Dupilumab treatment After completion of the study, 17 were enrolled and 14 participants total completed the study.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dupilumab Treatment n=17 Participants 14 subjects competed (3 withdrew during course of study). Subjects will received dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). All subjects will undergo skin biopsies for molecular profiling. Dupilumab: Dupilumab treatment
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=10 Participants
Age, Categorical >=65 years	1 Participants n=10 Participants
Age, Continuous	38.1 years n=10 Participants
Sex: Female, Male Female	8 Participants n=10 Participants
Sex: Female, Male Male	9 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants
Race (NIH/OMB) Asian	10 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants
Race (NIH/OMB) White	3 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=10 Participants
Region of Enrollment United States	17 participants n=10 Participants
EASI score	21.98 units on a scale n=10 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Number of subjects with atopic dermatitis with single cell data

Outcome measures

Outcome measures
Measure	Dupilumab Treatment n=12 Participants 14 subjects competed (3 withdrew during course of study). Subjects will received dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). All subjects will undergo skin biopsies for molecular profiling. Dupilumab: Dupilumab treatment
Percent Change in CD4+ T Effector Cells Expressing IL4 in Dupilumab-treated Subjects at Week 12 vs Week 0 Percent change in lesional skin	68.4 Percent change
Percent Change in CD4+ T Effector Cells Expressing IL4 in Dupilumab-treated Subjects at Week 12 vs Week 0 Percent change in non-lesional skin	100.0 Percent change

SECONDARY outcome

Timeframe: 12 weeks

Population: Number of subjects with atopic dermatitis with single cell data available

A single value was derived for the entire population with pooled samples from pre- and post-intervention time points, which was then used to calculate an percent change between the two periods. Specifically, single cell RNA-sequencing was used to calculate the number of differentially expressed genes in cutaneous CD4+ T cells between week 0 and week 12 in dupilumab-treated subjects. The calculation was performed in the software package Seurat (RRID:SCR\_016341) using the FindMarkers function, which utilizes a non-parametric Wilcoxon rank-sum test. Genes were considered significantly differentially expressed if the adjusted p-value \< 0.05 and the absolute value of log2(Fold Change) \> 1.0. Therefore, this measure is reported as a number and there is no central tendency metric.

Outcome measures

Outcome measures
Measure	Dupilumab Treatment n=12 Participants 14 subjects competed (3 withdrew during course of study). Subjects will received dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). All subjects will undergo skin biopsies for molecular profiling. Dupilumab: Dupilumab treatment
Number of Differentially Expressed Genes in Cutaneous CD4+ T Cells Between Week 0 and Week 12 in Dupilumab-treated Subjects DEG in lesional skin	81 differentially expressed genes
Number of Differentially Expressed Genes in Cutaneous CD4+ T Cells Between Week 0 and Week 12 in Dupilumab-treated Subjects DEG in non-lesional skin	186 differentially expressed genes

Adverse Events

Dupilumab Treatment

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dupilumab Treatment n=17 participants at risk 14 subjects competed (3 withdrew during course of study). Subjects will received dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). All subjects will undergo skin biopsies for molecular profiling. Dupilumab: Dupilumab treatment
Eye disorders Eye irritation	35.3% 6/17 • Number of events 8 • Through study completion, up to 52 weeks. Patient reported
Musculoskeletal and connective tissue disorders Deep root cavity	5.9% 1/17 • Number of events 1 • Through study completion, up to 52 weeks. Patient reported
Nervous system disorders migraine	5.9% 1/17 • Number of events 1 • Through study completion, up to 52 weeks. Patient reported
Infections and infestations Oral/facial herpes simplex	17.6% 3/17 • Number of events 4 • Through study completion, up to 52 weeks. Patient reported
Infections and infestations upper respiratory illness not otherwise defined	5.9% 1/17 • Number of events 1 • Through study completion, up to 52 weeks. Patient reported
Infections and infestations COVID19 (moderate)	5.9% 1/17 • Number of events 1 • Through study completion, up to 52 weeks. Patient reported
Ear and labyrinth disorders Right ear hearing loss 2/2 Meniere's Disease	5.9% 1/17 • Number of events 1 • Through study completion, up to 52 weeks. Patient reported
Skin and subcutaneous tissue disorders Facial dermatitis	5.9% 1/17 • Number of events 1 • Through study completion, up to 52 weeks. Patient reported

Additional Information

Wilson Liao

University of California San Francisco

Phone: 415-476-8364

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place