Asthma, AllergicPhase 1NCT03112577
Study of REGN3500 and Dupilumab in Patients With Asthma
A Phase 1 study testing REGN3500, Dupilumab and Fluticasone propionate in people with Asthma, Allergic, run by Regeneron Pharmaceuticals at 5 sites in 2 countries.
Trial summary
To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with placebo, on changes in inflammatory gene expression signatures in sputum induced after a bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after treatment initiation compared with those at screening. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma, Allergic
- What is being tested?
- REGN3500, Dupilumab and Fluticasone propionate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Jun 2017to 9 Dec 2019
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female aged between 18 and 60 years
- Has a Body Mass Index {BMI) of 17 to 33 kg/m2 at pre-study screening
- Has a history of mild allergic asthma for at least 6 months
- Is a non-smoker or ex-smoker for at least 12 months
Who cannot join
- Has a history of life-threatening asthma
- Has been hospitalized or has attended the emergency room for asthma in the 12 months prior to screening
- Has a history of severe allergies or history of an anaphylactic reaction
- Has a history of drug or alcohol abuse within a year prior to the screening visit
- Note: other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom4 sites
Celerion
Belfast, BT9 6AD
Hammersmith Medicine Research
London, NW10 7EW
Respiratory Clinical Trials Ltd
London, W1G 8HU
The Medicines Evaluation Unit
Manchester, M23 9QZ
About this study
Official title: A Randomized, Placebo-controlled, Parallel Panel Study to Assess the Effects of REGN3500, Dupilumab, and Combination of REGN3500 Plus Dupilumab on Markers of Inflammation After Bronchial Allergen Challenge in Patients With Allergic Asthma
To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with placebo, on changes in inflammatory gene expression signatures in sputum induced after a bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after treatment initiation compared with those at screening.
- Conditions
- Asthma, Allergic
- Being tested
- REGN3500, Dupilumab, Placebo, Fluticasone propionate
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN3500Drug
Intravenous (IV) use
DupilumabDrug
Also called Dupixent
Subcutaneous (SC) use
PlaceboDrug
Matching placebo
Fluticasone propionateDrug
Inhalation use
| Study group | Role | What they receive |
|---|---|---|
| REGN3500 | Experimental | REGN3500: masked and randomized dosing regimen per protocol (part 1 only) Receives: Drug: REGN3500 |
| Dupilumab | Experimental | Dupilumab: masked and randomized dosing regimen per protocol (part 1 only) Receives: Drug: Dupilumab |
| REGN3500 plus dupilumab | Experimental | REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only) Receives: Drug: REGN3500; Drug: Dupilumab |
| Placebo | Experimental | Placebo: masked and randomized dosing regimen per protocol (part 1 only) Receives: Drug: Placebo |
| Fluticasone propionate | Active comparator | Fluticasone propionate: open label dosing regimen per protocol (part 2 only) Receives: Drug: Fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in bronchial allergen challenge (BAC)-induced changes in sputum inflammatory markers in individuals treated with REGN3500, dupilumab and the combination of REGN3500 plus dupilumab or placebo
Measured: Screening (pre-treatment) to week 4 after treatment initiation
Secondary outcomes (8)
Incidence of Treatment Emergent Adverse Events (TEAEs)
Measured: Baseline to week 42
Severity of TEAEs
Measured: Baseline to week 42
Serum concentration-time profile of REGN3500
Assessed by maximum plasma concentration [Cmax]
Measured: Baseline to week 42
Serum concentration-time profile of REGN3500: Tmax (time at Cmax)
Measured: Baseline to week 42
Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration)
Measured: Baseline to week 42
Immunogenicity of REGN3500 and dupilumab
Assessed by measurement of anti-drug antibodies (ADAs)
Measured: Baseline to week 42
Serum concentration of total IL-33 after single IV dose
Measured: Up to Week 42
Difference in the BAC-induced changes in sputum inflammatory mRNA signature in individual patients treated with fluticasone
Measured: Screening (pre-treatment) to day 4 after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start15 Jun 2017
- Primary completion20 Mar 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, AllergicStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112577
- Sponsor's protocol ID
- R3500-AS-1633
- Other IDs
- 2016-003165-26, SAR440340, 2016
- Status last verified
- Jan 2020
- First submitted
- 4 Apr 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Parallel Panel Study to Assess the Effects of REGN3500, Dupilumab, and Combination of REGN3500 Plus Dupilumab on Markers of Inflammation After Bronchial Allergen Challenge in Patients With Allergic Asthma
- ClinicalTrials.gov ID
- NCT03112577
- Acronym / sponsor ID
- R3500-AS-1633
- Conditions
- Asthma, Allergic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 13 Apr 2017 (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.
To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with placebo, on changes in inflammatory gene expression signatures in sputum induced after a bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after treatment initiation compared with those at screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| REGN3500 | Experimental | Drug: REGN3500REGN3500: masked and randomized dosing regimen per protocol (part 1 only) |
| Dupilumab | Experimental | Drug: DupilumabDupilumab: masked and randomized dosing regimen per protocol (part 1 only) |
| REGN3500 plus dupilumab | Experimental | Drug: REGN3500, Drug: DupilumabREGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only) |
| Placebo | Experimental | Drug: PlaceboPlacebo: masked and randomized dosing regimen per protocol (part 1 only) |
| Fluticasone propionate | Active comparator | Drug: Fluticasone propionateFluticasone propionate: open label dosing regimen per protocol (part 2 only) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female aged between 18 and 60 years
- Has a Body Mass Index {BMI) of 17 to 33 kg/m2 at pre-study screening
- Has a history of mild allergic asthma for at least 6 months
- Is a non-smoker or ex-smoker for at least 12 months
Key exclusion criteria (5 listed)
- Has a history of life-threatening asthma
- Has been hospitalized or has attended the emergency room for asthma in the 12 months prior to screening
- Has a history of severe allergies or history of an anaphylactic reaction
- Has a history of drug or alcohol abuse within a year prior to the screening visit
- Note: other protocol defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| REGN3500Intravenous (IV) use | Drug | REGN3500, REGN3500 plus dupilumab |
| DupilumabAlso: DupixentSubcutaneous (SC) use | Drug | Dupilumab, REGN3500 plus dupilumab |
| PlaceboMatching placebo | Drug | Placebo |
| Fluticasone propionateInhalation use | Drug | Fluticasone propionate |
Primary outcome
Difference in bronchial allergen challenge (BAC)-induced changes in sputum inflammatory markers in individuals treated with REGN3500, dupilumab and the combination of REGN3500 plus dupilumab or placebo
Time frame: Screening (pre-treatment) to week 4 after treatment initiation
8 secondary outcomes
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline to week 42
Severity of TEAEs
Time frame: Baseline to week 42
Serum concentration-time profile of REGN3500
Time frame: Baseline to week 42
Serum concentration-time profile of REGN3500: Tmax (time at Cmax)
Time frame: Baseline to week 42
Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration)
Time frame: Baseline to week 42
Immunogenicity of REGN3500 and dupilumab
Time frame: Baseline to week 42
Serum concentration of total IL-33 after single IV dose
Time frame: Up to Week 42
Difference in the BAC-induced changes in sputum inflammatory mRNA signature in individual patients treated with fluticasone
Time frame: Screening (pre-treatment) to day 4 after treatment initiation
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 18 Jan 2020.
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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 Trial Management study director
Regeneron Pharmaceuticals
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN3500, Dupilumab and Fluticasone propionate in people with Asthma, Allergic, run by Regeneron Pharmaceuticals at 5 sites in 2 countries.
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 4 inclusion and 5 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Difference in bronchial allergen challenge (BAC)-induced changes in sputum inflammatory markers in individuals treated with REGN3500, dupilumab and the combination of REGN3500 plus dupilumab or placebo (time frame: Screening (pre-treatment) to week 4 after treatment initiation). 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 18 Jan 2020.