Dermatitis AtopicPhase 3EXTENSANCT07919899
Pharmacokinetics, Immunogenicity and Safety of Subcutaneous Dupilumab and Berahyaluronidase Alfa (ALT-B4) Coformulation
A Phase 3 study testing Dupilumab coformulated with berahyaluronidase alfa and Dupilumab in people with Dermatitis Atopic, run by Sanofi.
Trial summary
This is a Phase 3, open label, randomized, parallel-group, 2-arm study. The purpose of this study is to measure PK, immunogenicity, safety and, tolerability of dupilumab hyaluronidase coformulation compared with dupilumab approved formulation in male or female participants with moderate-to-severe atopic dermatitis… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dermatitis Atopic
- What is being tested?
- Dupilumab coformulated with berahyaluronidase alfa and Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 25 Jul 2028
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant must be ≥12 years of age at the time of signing the informed consent.
- Participants with chronic AD, (according to American Academy of Dermatology Consensus Criteria, that has been present for at least 12 months before the screening visit.
- Participants with ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits.
- Participant's AD must be graded as Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits.
- Validated Investigator Global Assessment for Atopic Dermatitis (v-IGA) ≥3 at the screening and baseline visits.
- Worst-Itch Numerical Rating Scale (WI-NRS) weekly average score ≥4 in the 7 days before randomization.
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- Documented recent history (within 6 months before the screening visit) of inadequate response* to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
- Inadequate response to topical therapy is defined as persistent moderate-to-severe AD (EASI ≥16, vIGA-AD ≥3, BSA ≥10%) despite ≥4 weeks of optimized topical anti-inflammatory treatment (medium/high potency corticosteroids ± calcineurin inhibitors), or documented intolerance/contraindication to such therapies.
- For adolescents (≥12 and <18 years old) only, body weight ≥60 kg.
Who cannot join
- Any history or presence of severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. Examples include, but are not limited to participants with short life expectancy, participants with uncontrolled diabetes (hemoglobin A1c ≥9%), participants with cardiovascular conditions (e.g, cardiomyopathy, thromboembolism, Class III or IV cardiac failure according to the New York Heart Association classification), severe hematological conditions (e.g. hyperviscosity), severe renal conditions (e.g, participants on dialysis), hepato-biliary conditions (e.g, Child-Pugh class B or C), neurological conditions (e.g, demyelinating diseases), active major autoimmune diseases (e.g, lupus, inflammatory bowel disease, rheumatoid arthritis, etc), other severe endocrinological, gastrointestinal, metabolic, pulmonary, or lymphatic diseases. The specific justification for participants excluded under this criterion will be noted in study documents (chart notes, case report forms [CRF], etc).
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: participants may be rescreened after infection resolves.
- Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, suggesting immunocompromised status per Investigator judgment.
- Presence of any skin comorbidities other than AD that, in the opinion of the Investigator, may interfere with the assessment of the study outcomes. For example: scabies, insect bite, folliculitis, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease, or others.
- History of malignancy within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
- Diagnosed with, suspected of, or at high risk for endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before Screening (Visit 1) or during the Screening period.
- Previously treated with marketed dupilumab or having received dupilumab in a prior dupilumab clinical study.
- The above information is not intended to contain all considerations relevant to a participant'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 Randomized, Open-label, Multiple-dose Phase 3 Study to Evaluate Pharmacokinetics, Immunogenicity and Safety of Subcutaneous Dupilumab and Berahyaluronidase Alfa (ALT-B4) Coformulation Compared to the Approved Subcutaneous Dupilumab Formulation in Adults and Adolescents With Moderate-to-severe Atopic Dermatitis
This is a Phase 3, open label, randomized, parallel-group, 2-arm study. The purpose of this study is to measure PK, immunogenicity, safety and, tolerability of dupilumab hyaluronidase coformulation compared with dupilumab approved formulation in male or female participants with moderate-to-severe atopic dermatitis (AD) aged ≥12 years of age. Study details as follows:
- The study duration includes screening period up to 4 weeks + treatment period of 20 weeks (± 3 days) and follow-up of 12 weeks (± 7 days).
- The number of on-site visits will be 10 and one phone contact will be scheduled (during the follow-up period).
- Conditions
- Dermatitis Atopic
- Being tested
- Dupilumab coformulated with berahyaluronidase alfa, 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.
Dupilumab coformulated with berahyaluronidase alfaDrug
Also called SAR231893 + ALT-B4
Pharmaceutical form: solution for injection Route of administration: SC injection
DupilumabDrug
Also called SAR231893
Pharmaceutical form: solution for injection Route of administration: SC injection
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab coformulated with berahyaluronidase alfa | Experimental | dupilumab coformulated with berahyaluronidase alfa SC injection as per protocol Receives: Drug: Dupilumab coformulated with berahyaluronidase alfa |
| Dupilumab approved formulation | Active comparator | Approved dupilumab SC injection as per protocol Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ctrough,ss at Week 20
Concentration observed before treatment administration during repeated dosing at steady state (SS).
Measured: Week 20
Secondary outcomes (6)
AUC0-4 weeks,ss
Area under curve from time point 0 to 28 days at steady state
Measured: Week 0 through Week 4
Cmax,ss
Maximum observed concentration during repeated dosing at steady state.
Measured: Week 20
Incidence of TEAEs, TE-AESIs, TE-SAEs, and TEAEs leading to permanent treatment discontinuation in the treatment-emergent period
TEAEs: treatment-emergent adverse events TE-AESIs: treatment-emergent adverse events of special interest TE-SAE: treatment-emergent serious adverse events
Measured: Week 0 up to week 32
Incidence of potentially clinically significant abnormalities in laboratory test, vital signs, and ECGs abnormalities in the treatment-emergent period
Measured: Week 0 up to week 32
Incidence of treatment-emergent anti-drug antibody (ADA) to dupilumab through Week 20
Measured: Week 0 up to week 20
Incidence of treatment-emergent ADA to ALT-B4 through Week 20
Measured: Week 0 up to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion2 May 2028 (estimated)
- Study completion25 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis AtopicStudies 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
- None (open label)
- Enrolment
- 150 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
- NCT07919899
- Sponsor's protocol ID
- EFC20385
- Other IDs
- 2026-526619-13, U1111-1333-0202
- Acronym
- EXTENSA
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose Phase 3 Study to Evaluate Pharmacokinetics, Immunogenicity and Safety of Subcutaneous Dupilumab and Berahyaluronidase Alfa (ALT-B4) Coformulation Compared to the Approved Subcutaneous Dupilumab Formulation in Adults and Adolescents With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07919899
- Acronym / sponsor ID
- EXTENSA / EFC20385
- Conditions
- Dermatitis Atopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 2 May 2028 (estimated)
- Study completion
- 25 Jul 2028 (estimated)
- First posted
- 5 Nov 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 is a Phase 3, open label, randomized, parallel-group, 2-arm study. The purpose of this study is to measure PK, immunogenicity, safety and, tolerability of dupilumab hyaluronidase coformulation compared with dupilumab approved formulation in male or female participants with moderate-to-severe atopic dermatitis (AD) aged ≥12 years of age. Study details as follows:
- The study duration includes screening period up to 4 weeks + treatment period of 20 weeks (± 3 days) and follow-up of 12 weeks (± 7 days).
- The number of on-site visits will be 10 and one phone contact will be scheduled (during the follow-up period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab coformulated with berahyaluronidase alfa | Experimental | Drug: Dupilumab coformulated with berahyaluronidase alfadupilumab coformulated with berahyaluronidase alfa SC injection as per protocol |
| Dupilumab approved formulation | Active comparator | Drug: DupilumabApproved dupilumab SC injection as per protocol |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Participant must be ≥12 years of age at the time of signing the informed consent.
- Participants with chronic AD, (according to American Academy of Dermatology Consensus Criteria, that has been present for at least 12 months before the screening visit.
- Participants with ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits.
- Participant's AD must be graded as Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits.
- Validated Investigator Global Assessment for Atopic Dermatitis (v-IGA) ≥3 at the screening and baseline visits.
Key exclusion criteria (8 listed)
- Any history or presence of severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. Examples include, but are not limited to participants with short life expectancy, participants with uncontrolled diabetes (hemoglobin A1c ≥9%), participants with cardiovascular conditions (e.g, cardiomyopathy, thromboembolism, Class III or IV cardiac failure according to the New York Heart Association classification), severe hematological conditions (e.g. hyperviscosity), severe renal conditions (e.g, participants on dialysis), hepato-biliary conditions (e.g, Child-Pugh class B or C), neurological conditions (e.g, demyelinating diseases), active major autoimmune diseases (e.g, lupus, inflammatory bowel disease, rheumatoid arthritis, etc), other severe endocrinological, gastrointestinal, metabolic, pulmonary, or lymphatic diseases. The specific justification for participants excluded under this criterion will be noted in study documents (chart notes, case report forms [CRF], etc).
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: participants may be rescreened after infection resolves.
- Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, suggesting immunocompromised status per Investigator judgment.
- Presence of any skin comorbidities other than AD that, in the opinion of the Investigator, may interfere with the assessment of the study outcomes. For example: scabies, insect bite, folliculitis, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease, or others.
- History of malignancy within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
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 |
|---|---|---|
| Dupilumab coformulated with berahyaluronidase alfaAlso: SAR231893 + ALT-B4Pharmaceutical form: solution for injection Route of administration: SC injection | Drug | Dupilumab coformulated with berahyaluronidase alfa |
| DupilumabAlso: SAR231893Pharmaceutical form: solution for injection Route of administration: SC injection | Drug | Dupilumab approved formulation |
Primary outcome
Ctrough,ss at Week 20
Time frame: Week 20
Concentration observed before treatment administration during repeated dosing at steady state (SS).
6 secondary outcomes
AUC0-4 weeks,ss
Time frame: Week 0 through Week 4
Cmax,ss
Time frame: Week 20
Incidence of TEAEs, TE-AESIs, TE-SAEs, and TEAEs leading to permanent treatment discontinuation in the treatment-emergent period
Time frame: Week 0 up to week 32
Incidence of potentially clinically significant abnormalities in laboratory test, vital signs, and ECGs abnormalities in the treatment-emergent period
Time frame: Week 0 up to week 32
Incidence of treatment-emergent anti-drug antibody (ADA) to dupilumab through Week 20
Time frame: Week 0 up to week 20
Incidence of treatment-emergent ADA to ALT-B4 through Week 20
Time frame: Week 0 up to week 20
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 5 Nov 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 3 study testing Dupilumab coformulated with berahyaluronidase alfa and Dupilumab in people with Dermatitis Atopic, 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 9 inclusion and 8 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 5 Nov 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 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?
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?
Ctrough,ss at Week 20 (time frame: Week 20). 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 5 Nov 2026.