AsthmaPhase 1NCT02999711
Study of Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REGN3500 in Adults With Moderate Asthma
A Phase 1 study testing REGN3500 in people with Asthma and Moderate Asthma, run by Regeneron Pharmaceuticals at 3 sites in United Kingdom.
Trial summary
Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma, Moderate Asthma
- What is being tested?
- REGN3500
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 3 Feb 2017to 10 Sep 2018
- 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
- Body mass index (BMI) of 18 to 32 kg/m2
- A diagnosis of moderate asthma (according to GINA 2015) for a period of at least 2 years prior to screening.
- Patient must use a stable medium daily dose level of inhaled corticosteroids (ICS) as defined by GINA guidelines, ie, total daily dose of ICS >400 μg and ≤800 μg/day of budesonide or equivalent for at least 1 month prior to screening and during the study
- A pre-bronchodilator forced expiratory volume in the first sec (FEV1) ≥60% and ≤90% of the predicted normal values at screening and pre-dose at screening
- A documented positive response to the reversibility test at the screening, defined as improvement in FEV1 ≥12% and ≥200 mL over baseline after 400 μg salbutamol Pmdi
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent.
Who cannot join
- Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening.
- Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to screening.
- History of life-threatening asthma
- Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to screening.
- Diagnosis of any other airway/pulmonary disease such as Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD 2016); or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency or restrictive lung disease).
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening.
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- Use of oral antibiotics/anti-infectives within 2 weeks prior to screening.
- Known sensitivity to doxycycline or tetracyclines, or to any of the components of the investigational product formulation.
- Recent (within the previous 2 months) bacterial, protozoal, viral, or parasite infection.
- History of tuberculosis or systemic fungal diseases
- Patients treated with a monoclonal antibody based therapy (such as an anti-IgE, anti-IL-5), a biologic therapy or immunotherapy (subcutaneous immunotherapy [SCIT], sublingual immunotherapy [SLIT], or oral immunotherapy [OIT]) in the previous 12 weeks prior to screening and during the study
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Regeneron Research Site
Belfast, Northern Ireland
Regeneron Research Site
London
Regeneron Research Site
Manchester
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Effects of Subcutaneously Administered REGN3500 in Adult Patients With Moderate Asthma
Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics.
- Conditions
- Asthma, Moderate Asthma
- Being tested
- REGN3500, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN3500Drug
REGN3500 dose
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | REGN3500 low dose or placebo Receives: Drug: REGN3500; Drug: Placebo |
| Cohort 2 | Experimental | REGN3500 medium dose or placebo Receives: Drug: REGN3500; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs) after repeat subcutaneous administration
Measured: Up to 36 weeks
Severity of TEAEs after repeat subcutaneous administration
Measured: Up to 36 weeks
Secondary outcomes (8)
The concentration-time profile of REGN3500 after repeat subcutaneous administration
Measured: Up to 36 weeks
Immunogenicity of REGN3500 assessed by measurement of anti-drug antibodies
Measured: Up to 36 weeks
Percent change in total from baseline forced expiratory volume (FEV) at day 29
Measured: Baseline to week 4
Percent change of the average of the prior 7 days of FEV1 at day 29 compared to average daily FEV1 during the last 14 days of screening
Measured: From -14 days screening to week 4
Absolute change from baseline fractional exhaled nitric oxide (FeNO) at day 29
Measured: Baseline to week 4
Percent change from baseline FeNO at day 29
Measured: Baseline to week 4
Change from baseline in biomarkers at day 29
Measured: Baseline to week 4
Percent change from baseline in biomarkers at day 29
Measured: Baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start3 Feb 2017
- Primary completion30 Aug 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 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
- NCT02999711
- Sponsor's protocol ID
- R3500-AS-1619
- Other IDs
- 2016-002979-95, 2016
- Status last verified
- Dec 2018
- First submitted
- 19 Dec 2016
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kosloski MP, Kalliolias GD, Xu CR, Harel S, Lai CH, Zheng W, Davis JD, Kamal MA. Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. Clin Transl Sci. 2022 Feb;15(2):384-395. doi: 10.1111/cts.13157. Epub 2021 Sep 29.
PubMed 34523807
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Effects of Subcutaneously Administered REGN3500 in Adult Patients With Moderate Asthma
- ClinicalTrials.gov ID
- NCT02999711
- Acronym / sponsor ID
- R3500-AS-1619
- Conditions
- Asthma, Moderate Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 21 Dec 2016 (estimated)
- 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.
Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: REGN3500, Drug: PlaceboREGN3500 low dose or placebo |
| Cohort 2 | Experimental | Drug: REGN3500, Drug: PlaceboREGN3500 medium dose or placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body mass index (BMI) of 18 to 32 kg/m2
- A diagnosis of moderate asthma (according to GINA 2015) for a period of at least 2 years prior to screening.
- Patient must use a stable medium daily dose level of inhaled corticosteroids (ICS) as defined by GINA guidelines, ie, total daily dose of ICS >400 μg and ≤800 μg/day of budesonide or equivalent for at least 1 month prior to screening and during the study
- A pre-bronchodilator forced expiratory volume in the first sec (FEV1) ≥60% and ≤90% of the predicted normal values at screening and pre-dose at screening
- A documented positive response to the reversibility test at the screening, defined as improvement in FEV1 ≥12% and ≥200 mL over baseline after 400 μg salbutamol Pmdi
Key exclusion criteria (12 listed)
- Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening.
- Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to screening.
- History of life-threatening asthma
- Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to screening.
- Diagnosis of any other airway/pulmonary disease such as Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD 2016); or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency or restrictive lung disease).
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 |
|---|---|---|
| REGN3500REGN3500 dose | Drug | Cohort 1, Cohort 2 |
| PlaceboMatching placebo | Drug | Cohort 1, Cohort 2 |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs) after repeat subcutaneous administration
Time frame: Up to 36 weeks
Severity of TEAEs after repeat subcutaneous administration
Time frame: Up to 36 weeks
8 secondary outcomes
The concentration-time profile of REGN3500 after repeat subcutaneous administration
Time frame: Up to 36 weeks
Immunogenicity of REGN3500 assessed by measurement of anti-drug antibodies
Time frame: Up to 36 weeks
Percent change in total from baseline forced expiratory volume (FEV) at day 29
Time frame: Baseline to week 4
Percent change of the average of the prior 7 days of FEV1 at day 29 compared to average daily FEV1 during the last 14 days of screening
Time frame: From -14 days screening to week 4
Absolute change from baseline fractional exhaled nitric oxide (FeNO) at day 29
Time frame: Baseline to week 4
Percent change from baseline FeNO at day 29
Time frame: Baseline to week 4
Change from baseline in biomarkers at day 29
Time frame: Baseline to week 4
Percent change from baseline in biomarkers at day 29
Time frame: Baseline to week 4
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 Dec 2018.
- Derived from this study: PubMed 34523807Kosloski MP, Kalliolias GD, Xu CR, Harel S, Lai CH, Zheng W, Davis JD, Kamal MA. Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. Clin Transl Sci. 2022 Feb;15(2):384-395. doi: 10.1111/cts.13157. Epub 2021 Sep 29.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN3500 in people with Asthma and Moderate Asthma, run by Regeneron Pharmaceuticals at 3 sites in United Kingdom.
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 7 inclusion and 12 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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Incidence of treatment emergent adverse events (TEAEs) after repeat subcutaneous administration (time frame: Up to 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02999711, which also lists 1 linked publication.
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 Dec 2018.