Atopic DermatitisPhase 3NCT04678882
Dupilumab in Japanese Patients With Atopic Dermatitis
A Phase 3 study testing Dupilumab SAR231893 in people with Atopic Dermatitis, run by Sanofi at 19 sites in Japan.
Trial summary
Primary Objective: To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) Secondary Objective: To evaluate the efficacy of dupilumab administered concomitantly with TCS. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupilumab SAR231893
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 19 sitesJapan
- Study dates
- 15 Jan 2021to 28 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Japanese and ≥6 months to <18 years of age, at the time of signing the informed consent and/or assent.
- Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit.
- Chronic AD diagnosed at least 1 year prior to the screening visit (for participants between 6 months to <1 year of age, the requirement is to have had chronic AD for 3 months).
- (Investigator's Global Assessment) IGA ≥ 3 at screening and baseline visits. (Eczema Area and Severity Index) EASI ≥16 at screening and baseline visits. Baseline peak pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4 for participants ≥12 to <18 years of age.
- Baseline worst itch NRS or worst scratch/itch NRS weekly average score for maximum itch or scratch/itch intensity ≥4 for participants ≥6 months to <12 years of age.
- Body surface area (BSA) of AD involvement >10% at screening and baseline visits.
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- With documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s).
- At least 11 (of a total of 14) applications of a stable dose of topical emollient (moisturizer) twice daily immediately before the baseline visit.
- Willing and able to comply with all clinic visits and study-related procedures. Participant, either alone or with help of parents/legal guardians (for 6 years old to less than18 years of age) or parents/caregiver or legal guardians (for 6 months to less than 6 years of age) as appropriate, must be able to understand and complete study-related questionnaires.
- Body weight ≥5 kg at baseline. Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit or during the screening period.
- Known or suspected immunodeficiency, including history of invasive opportunistic infections Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist.
- Known history of human immunodeficiency virus (HIV)-1 and HIV-2 infection or HIV seropositivity at the screening
- Participants with any of the following result at the screening:
- Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or,
- Positive hepatitis B core antibody (HBc Ab) confirmed by positive hepatitis B virus (HBV) DNA or,
Show all 20Show fewer
- Positive hepatitis C antibody (HCV Ab) confirmed by positive hepatitis C virus (HCV) RNA.
- Presence of skin comorbidities that may interfere with study assessments History of malignancy within 5 years before the baseline visit History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy.
- Known or suspected alcohol and/or drug abuse. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection.
- Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
- Participant with any other medical or psychological condition including relevant laboratory or electrocardiogram (ECG) abnormalities at screening Exposure to another systemic or topical investigative drug within a certain time period prior to Visit 1 (screening), Having used any of immunosuppressive/immunomodulating drugs and phototherapy within 4 weeks before the screening visit.
- Past Treatment with biologics as follows:
- Any cell-depleting agents within 6 months before the screening visit.
- Anti-IgE therapy within 4 months before the screening visit.
- Other monoclonal antibodies (which are biological response modifiers): within 5 half-lives (if known) or 16 weeks before the screening visit (Visit 1), whichever is longer.
- History of important side effects to medium potency TCS Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit.
- Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to screening visit.
- Planned or anticipated use of any prohibited medications and procedures during screening and study treatment period.
- Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period Participation in a prior dupilumab clinical study or have been treated with commercially available dupilumab.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
Investigational Site Number : 3920023
Chuo-ku, Tokyo, 104-0031
Investigational Site Number : 3920015
Fukutsu-shi, Fukuoka, 811-3217
Investigational Site Number : 3920021
Habikino-shi, 583-8588
Investigational Site Number : 3920001
Hiroshima, Hiroshima, 734-8551
Investigational Site Number : 3920008
Kobe, Hyōgo, 653-0836
Investigational Site Number : 3920007
Kobe, Hyōgo, 658-0082
Investigational Site Number : 3920012
Koto-ku, Tokyo, 136-0074
Investigational Site Number : 3920016
Kumagaya-shi, Saitama, 360-0018
Investigational Site Number : 3920011
Nagoya, Aichi-ken, 457-8510
Investigational Site Number : 3920003
Sagamihara-shi, Kanagawa, 252-0392
Investigational Site Number : 3920020
Sakai-shi, Osaka, 593-8324
Investigational Site Number : 3920013
Sapporo, Hokkaido, 004-0063
Investigational Site Number : 3920009
Sapporo, Hokkaido, 060-0807
Investigational Site Number : 3920022
Toshima-ku, Tokyo, 170-0002
Investigational Site Number : 3920014
Toyoake-shi, Aichi-ken, 470-1192
Investigational Site Number : 3920019
Toyonaka-shi, Osaka, 560-0085
Investigational Site Number : 3920006
Tsu, Mie-ken, 514-0125
Investigational Site Number : 3920017
Yokohama, Kanagawa, 221-0825
Investigational Site Number : 3920010
Yokohama, Kanagawa, 225-0015
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Dupilumab Compared to Placebo in Japanese Patients With Atopic Dermatitis Aged 6 Months to <18 Years Whose Disease is Not Adequately Controlled With Existing Therapies
Primary Objective:
To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS)
Secondary Objective:
To evaluate the efficacy of dupilumab administered concomitantly with TCS. To assess the safety of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants.
To assess immunogenicity as determined by the incidence, titer, and clinical impact of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time in pediatric patients with atopic dermatitis (AD) (aged ≥6 months to <18 years old) To assess the concentration of dupilumab in serum following administration concomitantly with TCS.
Read the detailed description
For participant who declines to enter open-lebal extension (OLE), the duration of the study for each participant is approximately 33 weeks (including screening and follow-up) For participant choosing enter OLE, the duration is approximately 21 weeks (including screening) plus 3 years OLE period or until approval of the indication in Japan whichever is sooner.
- Conditions
- Atopic Dermatitis
- Being tested
- Placebo, Dupilumab SAR231893
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)
Dupilumab SAR231893Drug
Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks Receives: Drug: Dupilumab SAR231893 |
| Placebo | Placebo comparator | Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline EASI)
The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition
Measured: At Week 16
Secondary outcomes (20)
Percent change in EASI score
The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition
Measured: From baseline to week 16
Percent change in weekly average of daily worst itch numerical rating scale (NRS) for participants aged ≥6 years to <12 years old
The worst itch NRS is a simple assessment tool those participants ≥6 years old to <12 years old will use to report the intensity of their pruritus (itch). This is an 11-point scale (0 to 10) in which 0 indicates no itching while 10 indicate worst itching possible.
Measured: From baseline to week 16
Proportion of participants with Investigator's Global Assessment (IGA) 0 or 1
The IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe)
Measured: At Week 16
Percent change in weekly average of daily worst peak pruritus NRS for participants aged ≥12 years to <18 years old
The peak pruritus NRS is a simple assessment tool that participants ≥ 12 to <18 years old will use to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the' worst itch imaginable'
Measured: From baseline to week 16
Percent change in weekly average of daily worst scratch/itch NRS for participants aged ≥6 months to <6 years old
The worst scratch/itch NRS is a simple assessment tool those participants ≥6 years old to <6 years old range from 1 to 10 in which 0 indicates no itching while 10 indicate worst itching possible
Measured: From baseline to week 16
Percent change for intensity of pruritus
The intensity is assessed by numerical rating scale ranging from 0 to 10 which higher scale indicate worse itch condition
Measured: From baseline to week 16
Proportion of participants with EASI-50 (≥50% improvement from baseline)
The EASI is a composite index with scores ranging from 0 to 72.Higher scores is worse condition
Measured: At Week 16
Proportion of participants with EASI-90 (≥90% improvement from baseline)
The EASI is a composite index with scores ranging from 0 to 72.Higher scores is worse condition
Measured: At Week 16
Change in percent body surface area (BSA) affected by atopic dermatitis (AD)
BSA affected by atopic dermatitis will be assessed for each major section of the body (head, trunk, arms, and legs).
Measured: From baseline to week 16
Change in Children's Dermatology Life Quality Index (CDLQI) (≥4 years)
The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life
Measured: From baseline to week 16
Change in Infants' Dermatitis Quality of Life Index (IDQOL) (<4 years)
The IDQOL is a validated questionnaire developed to measure the impact of skin disease on the QOL of infants and preschool children <4 years of age wil completed by the child's parent or caregiver. The higher the score, the greater the impact is on the quality of life. -
Measured: From baseline to week 16
Change in Patient Oriented Eczema Measure (POEM)
The POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire used to assess disease symptoms with a scoring system of 1 to 28. The higher score, the higher morbidity
Measured: From baseline to week 16
Change in weekly average of daily worst peak pruritus NRS for participants aged ≥12 years to <18 years old
The peak pruritus NRS is a simple assessment tool that participants ≥ 12 to <18 years old will use to report the intensity of their pruritus (itch) ranges from 0 to 10 with 1 being 'no itch' and 10 being the' worst itch imaginable'
Measured: From baseline to week 16
Change in weekly average of daily worst itch NRS for participants aged ≥6 years to <12 years old
The worst itch NRS is a simple assessment tool those participants ≥6 years old to <12 years old range from 1 to 10 in which 1 indicates no itching while 10 indicate worst itching possible -
Measured: From baseline to week 16
Change in weekly average of daily worst scratch/itch NRS for participants aged ≥6 months to <6 years old
The worst scratch/itch NRS is a simple assessment tool those participants ≥6 years old to <12 years old range from 1 to 10 in which 1 indicates no itching while 10 indicate worst itching possible
Measured: From baseline to week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interest (AESI) From Baseline to 16 Weeks of Treatment
Measured: Baseline (Day 1) to Week 16
Number of Participants With Skin-Infection TEAEs (Excluding Herpetic Infections) From Baseline to 16 Weeks of Treatment
Measured: Baseline (Day 1) to Week 16
Number of Participants With TEAEs, SAEs, and AESI From Baseline of open-label extension (OLE) Through the Last Study Visit
Measured: Week 16 to Week 116
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) to Dupilumab Over Time in Pediatric Participants with AD (Aged ≥6 Months to <18 Years old)
Measured: Baseline (Day 1) to Week 116
Serum Concentration of Dupilumab up to Week 116
Measured: Pre-dose at Baseline (Day 1), and Weeks 4, 12, 16, 24, 32, 52, 68, 92, and 116
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start15 Jan 2021
- Primary completion14 Dec 2021
- Study completion28 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678882
- Sponsor's protocol ID
- EFC16823
- Other IDs
- U1111-1301-1257, 2020-002601-26
- Status last verified
- Sep 2025
- First submitted
- 17 Dec 2020
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Dupilumab Compared to Placebo in Japanese Patients With Atopic Dermatitis Aged 6 Months to <18 Years Whose Disease is Not Adequately Controlled With Existing Therapies
- ClinicalTrials.gov ID
- NCT04678882
- Acronym / sponsor ID
- EFC16823
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 28 Oct 2023 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS)
Secondary Objective:
To evaluate the efficacy of dupilumab administered concomitantly with TCS. To assess the safety of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants.
To assess immunogenicity as determined by the incidence, titer, and clinical impact of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time in pediatric patients with atopic dermatitis (AD) (aged ≥6 months to <18 years old) To assess the concentration of dupilumab in serum following administration concomitantly with TCS.
Detailed description
For participant who declines to enter open-lebal extension (OLE), the duration of the study for each participant is approximately 33 weeks (including screening and follow-up) For participant choosing enter OLE, the duration is approximately 21 weeks (including screening) plus 3 years OLE period or until approval of the indication in Japan whichever is sooner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: Dupilumab SAR231893Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboDouble dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Japanese and ≥6 months to <18 years of age, at the time of signing the informed consent and/or assent.
- Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit.
- Chronic AD diagnosed at least 1 year prior to the screening visit (for participants between 6 months to <1 year of age, the requirement is to have had chronic AD for 3 months).
- (Investigator's Global Assessment) IGA ≥ 3 at screening and baseline visits. (Eczema Area and Severity Index) EASI ≥16 at screening and baseline visits. Baseline peak pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4 for participants ≥12 to <18 years of age.
- Baseline worst itch NRS or worst scratch/itch NRS weekly average score for maximum itch or scratch/itch intensity ≥4 for participants ≥6 months to <12 years of age.
Key exclusion criteria (20 listed)
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit or during the screening period.
- Known or suspected immunodeficiency, including history of invasive opportunistic infections Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist.
- Known history of human immunodeficiency virus (HIV)-1 and HIV-2 infection or HIV seropositivity at the screening
- Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or,
- Positive hepatitis B core antibody (HBc Ab) confirmed by positive hepatitis B virus (HBV) DNA or,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPharmaceutical form: solution for injection Route of administration: subcutaneous (SC) | Drug | Placebo |
| Dupilumab SAR231893Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC) | Drug | Dupilumab |
Primary outcome
Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline EASI)
Time frame: At Week 16
The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition
20 secondary outcomes
Percent change in EASI score
Time frame: From baseline to week 16
Percent change in weekly average of daily worst itch numerical rating scale (NRS) for participants aged ≥6 years to <12 years old
Time frame: From baseline to week 16
Proportion of participants with Investigator's Global Assessment (IGA) 0 or 1
Time frame: At Week 16
Percent change in weekly average of daily worst peak pruritus NRS for participants aged ≥12 years to <18 years old
Time frame: From baseline to week 16
Percent change in weekly average of daily worst scratch/itch NRS for participants aged ≥6 months to <6 years old
Time frame: From baseline to week 16
Percent change for intensity of pruritus
Time frame: From baseline to week 16
Proportion of participants with EASI-50 (≥50% improvement from baseline)
Time frame: At Week 16
Proportion of participants with EASI-90 (≥90% improvement from baseline)
Time frame: At Week 16
Change in percent body surface area (BSA) affected by atopic dermatitis (AD)
Time frame: From baseline to week 16
Change in Children's Dermatology Life Quality Index (CDLQI) (≥4 years)
Time frame: From baseline to week 16
Change in Infants' Dermatitis Quality of Life Index (IDQOL) (<4 years)
Time frame: From baseline to week 16
Change in Patient Oriented Eczema Measure (POEM)
Time frame: From baseline to week 16
Change in weekly average of daily worst peak pruritus NRS for participants aged ≥12 years to <18 years old
Time frame: From baseline to week 16
Change in weekly average of daily worst itch NRS for participants aged ≥6 years to <12 years old
Time frame: From baseline to week 16
Change in weekly average of daily worst scratch/itch NRS for participants aged ≥6 months to <6 years old
Time frame: From baseline to week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interest (AESI) From Baseline to 16 Weeks of Treatment
Time frame: Baseline (Day 1) to Week 16
Number of Participants With Skin-Infection TEAEs (Excluding Herpetic Infections) From Baseline to 16 Weeks of Treatment
Time frame: Baseline (Day 1) to Week 16
Number of Participants With TEAEs, SAEs, and AESI From Baseline of open-label extension (OLE) Through the Last Study Visit
Time frame: Week 16 to Week 116
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) to Dupilumab Over Time in Pediatric Participants with AD (Aged ≥6 Months to <18 Years old)
Time frame: Baseline (Day 1) to Week 116
Serum Concentration of Dupilumab up to Week 116
Time frame: Pre-dose at Baseline (Day 1), and Weeks 4, 12, 16, 24, 32, 52, 68, 92, and 116
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- 2020-002601-26 EudraCT resultsLink provided by the sponsor.
- EFC16823 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dupilumab SAR231893 in people with Atopic Dermatitis, run by Sanofi at 19 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline EASI) (time frame: At Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.