Type 2 Inflammatory DisordersNCT04776694
Compassionate Use or Expanded Access of Dupilumab
A study testing Dupilumab in people with Type 2 Inflammatory Disorders, run by Regeneron Pharmaceuticals.
Trial summary
Provide Compassionate Use or Expanded Access of Dupilumab Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Type 2 Inflammatory Disorders
- What is being tested?
- Dupilumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 and older
- All sexes
- Child, Adult, Older adult
Eligibility will be determined during the application review process.
Trial locations and contacts
No sites are listed yet.
Requests must be initiated by a treating physician. Physicians should contact contact
About this study
Official title: Unapproved Dupilumab Indications for Potential Compassionate Use or Expanded Access
Provide Compassionate Use or Expanded Access of Dupilumab
Read the detailed description
Compassionate Use or Expanded Access requests are only being considered in response to Individual Patient or Treatment Investigational New Drug (IND) applications. Availability will depend on location.
- Conditions
- Type 2 Inflammatory Disorders
- Being tested
- Dupilumab
- Keywords
- Allergies, Hand and Foot Dermatits, Eosinophilic Esophagitis (EoE) - Pediatrics, Hailey-Hailey Disease, Nasal Polysposis (NP), Idiopathic Urticaria, Dermal Hypersensitivity Reaction, Eosinophilic Gastrointestinal Disease (EGID), Actinic Prurigo, Eosinophilic Cystitis, Allergic Rhinitis with Nasal Polyposis, Epidermolysis Bullousa Simplex (EBS), Chronic Spontaneous Urticaria (CSU), Cicatricial Pemphigoid, Pemphigus Foliaceus, Disseminated Coccidiomycosis, Topical steroid withdrawal syndrome, Middle ear disease, Eosinophilic Enterocolitis
- Medical subject headings
- Hypersensitivity, Eosinophilic Esophagitis, Pemphigus, Benign Familial, Actinic Prurigo, Chronic Urticaria, Pemphigoid, Benign Mucous Membrane, Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called REGN668, DUPIXENT®, SAR231893
To be provided by Regeneron
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Inflammatory DisordersStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776694
- Sponsor's protocol ID
- R668-Dupilumab
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2021
- Last updated
- 1 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unapproved Dupilumab Indications for Potential Compassionate Use or Expanded Access
- ClinicalTrials.gov ID
- NCT04776694
- Acronym / sponsor ID
- R668-Dupilumab
- Conditions
- Type 2 Inflammatory Disorders
- Keywords
- Allergies, Hand and Foot Dermatits, Eosinophilic Esophagitis (EoE) - Pediatrics, Hailey-Hailey Disease, Nasal Polysposis (NP), Idiopathic Urticaria, Dermal Hypersensitivity Reaction, Eosinophilic Gastrointestinal Disease (EGID)
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 2 Mar 2021 (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.
Provide Compassionate Use or Expanded Access of Dupilumab
Detailed description
Compassionate Use or Expanded Access requests are only being considered in response to Individual Patient or Treatment Investigational New Drug (IND) applications. Availability will depend on location.
Study design
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
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: REGN668, DUPIXENT®, SAR231893To be provided by Regeneron | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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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.
Requests must be initiated by a treating physician. Physicians should contact contact
Questions about this trial
What is this clinical trial studying?
A study testing Dupilumab in people with Type 2 Inflammatory Disorders, run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 1 Sep 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Requests must be initiated by a treating physician. Physicians should contact (844-734-6643, compassionateuserequests@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 1 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.