18 and older, any sex, with Dermatitis Atopic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Week 17Primary· Baseline, Week 17
Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker protein gene product 9.5 (PGP9.5); and the basement membrane was visualized by staining for collagen type 4. Quantification of intraepidermal nerve fiber density was calculated by assessing nerve fibers crossing the basement membrane per square millimeter (F/mm\^2). Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
Baseline
Group
Value
95% CI
Participants With AD: Dupilumab
8.4567
± 7.2502
Change at Week 17
Group
Value
95% CI
Participants With AD: Dupilumab
4.2618
± 6.7538
Percentage of Participants With Change From Baseline in Nerve Fiber Branching on Lesional Skin at Week 17Primary· Baseline, Week 17
Skin biopsies were used to analyze the epidermal nerve fiber branching. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker PGP9.5; and the basement membrane was visualized by staining for collagen type 4. Branching of epidermal nerve fibers was assessed semi-quantitatively by classifying participants into 4 groups depending on the predominant intraepidermal nerve fiber branching pattern as follows: only linear (100% linear), mainly linear (\>60% linear), mainly branched (\>60% branched), only branched (100% branched). Percentage of participants with change
Only linear
Group
Value
95% CI
Participants With AD: Dupilumab
0
Mainly linear
Group
Value
95% CI
Participants With AD: Dupilumab
60.0
Mainly branched
Group
Value
95% CI
Participants With AD: Dupilumab
40.0
Only branched
Group
Value
95% CI
Participants With AD: Dupilumab
0
Change From Baseline in Peak Pruritus Assessed by Numeric Rating Scale (NRS) Scores at Weeks 17 and 21Secondary· Baseline, Weeks 17 and 21
Peak Pruritus NRS was an assessment tool used to report the intensity of participant's pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 ("No itch") to 10 ("Worst itch imaginable") NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated greater severity.
Week 17
Group
Value
95% CI
Participants With AD: Dupilumab
-6.6
± 3.6
Week 21
Group
Value
95% CI
Participants With AD: Dupilumab
-7.4
± 1.4
Change From Baseline in Eczema and Severity Index (EASI) Total Score at Weeks 17 and 21Secondary· Baseline, Weeks 17 and 21
EASI was a validated measure used to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness \[induration, papulation, and edema\], scratching \[excoriation\], and lichenification) were each assessed for severity by the Investigator on a scale of "0" (absent) through "3" (severe). EASI area score was based upon percent (%) body surface area (BSA) with AD in each body region: 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), and 6 (90% to 100%). Total EASI score was derived as the sum of the 4 region scores and ranged from 0 (min
Week 17
Group
Value
95% CI
Participants With AD: Dupilumab
-18.9
± 6.4
Week 21
Group
Value
95% CI
Participants With AD: Dupilumab
-19.5
± 6.4
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 17 and 21Secondary· Baseline, Weeks 17 and 21
SCORAD was used to standardize the extent and severity of AD. It consisted of 3 components i.e., A =extent or affected BSA assessed as a % of each defined body area and reported as sum of all areas, with a maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points) and C=subjective symptoms scored by participants on VAS, where "0"=no itch (or no sleeplessness) and "10"=worst imaginable i
Week 17
Group
Value
95% CI
Participants With AD: Dupilumab
-77.2
± 32.3
Week 21
Group
Value
95% CI
Participants With AD: Dupilumab
-81.3
± 35.0
Change From Baseline in Patient-Reported Outcomes Measurement Information (PROMIS-itch) Itch-Severity Total Score at Weeks 17 and 21Secondary· Baseline, Weeks 17 and 21
PROMIS-itch represents a novel suite of participant-reported outcome (PRO) measures for the itch. The PROMIS-Itch severity score consists of 7 questions: 4 questions scored on a scale of 1 to 5: 1) How intense was your itch at its worst; 2) How intense was your itch in general; 3) What is your level of itch right now; 4) How often did you feel the itch; and rest 3 questions (same questions as 1 to 3 mentioned before but scaled on a scale of 0 to 10) were scored on a scale of 0 to 10. Higher scores for each question indicated worse outcome. The total PROMIS-itch score was calculated as the sum
Week 17
Group
Value
95% CI
Participants With AD: Dupilumab
-30.8
± 9.0
Week 21
Group
Value
95% CI
Participants With AD: Dupilumab
-28.8
± 11.5
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Weeks 17 and 21Secondary· Baseline, Weeks 17 and 21
The POEM was a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults with AD. The format is participant response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (i.e., 0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.
Week 17
Group
Value
95% CI
Participants With AD: Dupilumab
-17.2
± 5.3
Week 21
Group
Value
95% CI
Participants With AD: Dupilumab
-16.1
± 5.9
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 17 and 21Secondary· Baseline, Weeks 17 and 21
DLQI was a 10-item PRO questionnaire that measured the impact of AD disease symptoms and treatment on quality of life. Each question was evaluated on a 4-point scale ranged from 0 to 3 where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score that ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Week 17
Group
Value
95% CI
Participants With AD: Dupilumab
-16.1
± 7.4
Week 21
Group
Value
95% CI
Participants With AD: Dupilumab
-14.8
± 8.1
Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Total Score at Weeks 17 and 21Secondary· Baseline, Weeks 17 and 21
ADCT was a PRO questionnaire designed to assess participant-self-perceived control of their eczema. ADCT contained 6 items allowing a comprehensive coverage of the dimensions defining AD control, i.e., overall severity of AD symptoms, frequency of intense episodes of itching, extent of AD related bother, impact on sleep, impact on daily activities, impact on mood or emotions. Each item of the ADCT is rated from 0 (no problem) to 4 (worst) Likert scale and is equally weighted. The sum of the 6 items gives the total score that ranged from 0 (best disease control) to 24 (worst disease control). H
Week 17
Group
Value
95% CI
Participants With AD: Dupilumab
-17.9
± 4.1
Week 21
Group
Value
95% CI
Participants With AD: Dupilumab
-15.9
± 6.2
Change From Baseline in Sleep Quality Numerical Rating Scale Score at Weeks 17 and 21Secondary· Baseline, Weeks 17 and 21
Sleep quality NRS was used to assess the quality of the participant's previous night's sleep using a 0 ("Worst possible sleep") to 10 ("Best possible sleep") NRS. Participants were asked to complete the following question upon awakening: "Select the number (0 to 10) that best describes the quality of your sleep last night". Higher score indicated better outcome.
Week 17
Group
Value
95% CI
Participants With AD: Dupilumab
0.7
± 5.0
Week 21
Group
Value
95% CI
Participants With AD: Dupilumab
3.0
± 5.4
Change From Baseline in Skin Pain Numerical Rating Scale Score at Weeks 17 and 21Secondary· Baseline, Weeks 17 and 21
Skin pain NRS was used to assess participant's skin pain at its worst in the past 24 hours using a 0 ("Not at all") to 10 ("Very much") NRS. Participants were asked the following question: "Think about all the areas of your skin with eczema. How much did your skin burn at its worst in the past 24 hours?" Lower score indicated better outcome.
Week 17
Group
Value
95% CI
Participants With AD: Dupilumab
-5.3
± 2.9
Week 21
Group
Value
95% CI
Participants With AD: Dupilumab
-5.3
± 2.2
Change From Baseline in Skin Sensitivity Numerical Rating Scale Score at Weeks 17 and 21Secondary· Baseline, Weeks 17 and 21
Skin sensitivity NRS was a 1 item PRO measure asking the participants to rate their skin sensitivity to touch using a 0 ("Normal") to 10 ("Extremely sensitive") NRS. Participants were asked the following question: "Think about all the areas of your skin with eczema. How sensitive was your skin at its worst in the past 24 hours?" Lower score indicated better outcome.
Week 17
Group
Value
95% CI
Participants With AD: Dupilumab
-7.7
± 1.5
Week 21
Group
Value
95% CI
Participants With AD: Dupilumab
-7.3
± 2.2
Adverse events — posted to ClinicalTrials.gov
Time frame: For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Primary Objective:
\- Assess change in neuronal architecture following long term treatment with dupilumab in skin biopsies from atopic dermatitis (AD) participants with chronic pruritus.
Secondary Objectives:
* Assess change in neuronal architecture following short term treatment with dupilumab and during follow-up in skin biopsies from AD participants with chronic pruritus.
* To evaluate the efficacy of dupilumab in AD participants with chronic pruritus.
* To evaluate the safety of dupilumab in adult participants with moderate-to-severe AD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 16 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04823130.