Atopic DermatitisPhase 4NCT07905547
A Study to Investigate Dupixent/ Dupilumab in Adult Indian Participants With Moderate-to-severe Atopic Dermatitis
A Phase 4 study testing Dupilumab in people with Atopic Dermatitis, run by Sanofi.
Trial summary
This study will describe safety of dupilumab in adult participants with atopic dermatitis. It will also look at the improvement of atopic dermatitis signs and symptoms in these participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2026to 2 Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atopic dermatitis (AD) as defined by American Academy of Dermatology Consensus Criteria, that has been present for at least more than equal to (≥)1 year prior to screening.
- Participants with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
- Candidate for systemic therapy (disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable)
- Participant with pruritus NRS ≥ 4 at baseline.
- Capable of giving signed informed consent (including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol).
Who cannot join
- Any contraindications according to the principal investigator.
- Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening.
- Participants with known helminth infection (current and/or past infection).
- Current enrolment or past participation within the last 30 days before signing of informed consent in any other clinical study involving an investigational study treatment or any other type of medical research.
- Participation in a prior dupilumab clinical trial or any prior use of dupilumab.
- Immunosuppressive/immunomodulating drugs or live vaccines or phototherapy for AD within 4 weeks before baseline, or any condition that in the opinion of the investigator, is likely to require such treatments during the first 2 weeks of study treatment.
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- Has a history of or ongoing drug or alcohol abuse.
- Immunosuppressive/immunomodulating drugs or live vaccines or phototherapy for AD within 4 weeks before baseline, or any condition that in the opinion of the investigator, is likely to require such treatments during the first 2 weeks of study treatment
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
About this study
Official title: A Multi-center, Single-arm Phase IV Clinical Trial to Evaluate the Safety of Dupilumab in Adult Indian Patients With Moderate-to-severe Atopic Dermatitis
This study will describe safety of dupilumab in adult participants with atopic dermatitis. It will also look at the improvement of atopic dermatitis signs and symptoms in these participants.
The maximum study duration would be 32 weeks which includes the below:
Read more
- Up to 28 days of screening period in which the doctor will assess if the participant can be recruited in this study
- Treatment duration is 16 weeks
- Follow up period: during which the participant will be followed for 12 weeks to check for any safety events.
Visit frequency: The visit frequency will be every 4 weeks during the 16 weeks treatment duration and then 12 weeks after the last dose of the study treatment. Total number of visits will be 7.
- Conditions
- Atopic Dermatitis
- Being tested
- Dupilumab
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent
Each single-use pre-filled syringe with needle shield contains 300 mg dupilumab in 2 mL solution.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Participants will receive initial dose of 600 mg, followed by 300 mg given every other week. Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who Experienced Treatment-Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to Week 16
Secondary outcomes (4)
Proportion of Participants Reaching 75% Reduction from Baseline in Eczema Area and Severity Index (EASI) score (EASI-75)
The final EASI score is the summation of the 4 regional scores, ranging from 0 to 72. A score of 0 indicates clear or no eczema, 0.1 to 1.0 indicates almost clear, 1.1 to 7 indicates mild disease, 7.1 to 21 indicates moderate disease, 21.1 to 50 indicates severe disease, and greater than 51 indicates very severe disease.
Measured: Week 16
Proportion of Participants with more than equal to (≥) 4-point Reduction in Weekly Average of Daily Pruritus-Numerical Rating Scale (Pruritus NRS)
The Peak Pruritus NRS is a single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 h based on the following question: 'On a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?'. Proportion of participants with ≥4-point reduction in weekly average of daily Pruritus NRS from baseline in participants with baseline weekly average of daily Pruritus-NRS ≥4 will be reported.
Measured: Up to Week 16
Change from Baseline in Body Surface Area (BSA) Affected by Atopic Dermatitis
The BSA affected by AD will be assessed for each major section with the rules of 9 : head and neck [9 percent], anterior trunk [18 percent], back [18 percent], upper limbs [18 percent], lower limbs [36 percent], and genitals [1 percent].
Measured: Baseline to up to Week 16
Percentage of Participants who Experienced TEAE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to 32 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start28 Oct 2026 (estimated)
- Primary completion7 Feb 2027 (estimated)
- Study completion2 Aug 2028 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905547
- Sponsor's protocol ID
- LPS18048
- Other IDs
- U1111-1295-2993
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-arm Phase IV Clinical Trial to Evaluate the Safety of Dupilumab in Adult Indian Patients With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07905547
- Acronym / sponsor ID
- LPS18048
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 7 Feb 2027 (estimated)
- Study completion
- 2 Aug 2028 (estimated)
- First posted
- 29 Oct 2026 (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.
This study will describe safety of dupilumab in adult participants with atopic dermatitis. It will also look at the improvement of atopic dermatitis signs and symptoms in these participants.
The maximum study duration would be 32 weeks which includes the below:
- Up to 28 days of screening period in which the doctor will assess if the participant can be recruited in this study
- Treatment duration is 16 weeks
- Follow up period: during which the participant will be followed for 12 weeks to check for any safety events.
Visit frequency: The visit frequency will be every 4 weeks during the 16 weeks treatment duration and then 12 weeks after the last dose of the study treatment. Total number of visits will be 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: DupilumabParticipants will receive initial dose of 600 mg, followed by 300 mg given every other week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Atopic dermatitis (AD) as defined by American Academy of Dermatology Consensus Criteria, that has been present for at least more than equal to (≥)1 year prior to screening.
- Participants with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
- Candidate for systemic therapy (disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable)
- Participant with pruritus NRS ≥ 4 at baseline.
- Capable of giving signed informed consent (including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol).
Key exclusion criteria (9 listed)
- Any contraindications according to the principal investigator.
- Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening.
- Participants with known helminth infection (current and/or past infection).
- Current enrolment or past participation within the last 30 days before signing of informed consent in any other clinical study involving an investigational study treatment or any other type of medical research.
- Participation in a prior dupilumab clinical trial or any prior use of dupilumab.
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 |
|---|---|---|
| DupilumabAlso: DupixentEach single-use pre-filled syringe with needle shield contains 300 mg dupilumab in 2 mL solution. | Drug | Dupilumab |
Primary outcome
Percentage of participants who Experienced Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 16
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
4 secondary outcomes
Proportion of Participants Reaching 75% Reduction from Baseline in Eczema Area and Severity Index (EASI) score (EASI-75)
Time frame: Week 16
Proportion of Participants with more than equal to (≥) 4-point Reduction in Weekly Average of Daily Pruritus-Numerical Rating Scale (Pruritus NRS)
Time frame: Up to Week 16
Change from Baseline in Body Surface Area (BSA) Affected by Atopic Dermatitis
Time frame: Baseline to up to Week 16
Percentage of Participants who Experienced TEAE
Time frame: Up to 32 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- 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.
Trial Transparency email recommended (Toll free for US & Canada) contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab in people with Atopic Dermatitis, run by Sanofi.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who Experienced Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 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 29 Oct 2026.