Clinical Trials/NCT02999711

NCT02999711

Completed

Phase 1

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

Regeneron Pharmaceuticals1 site in 1 country23 target enrollmentFebruary 3, 2017

ConditionsAsthma Moderate Asthma

InterventionsREGN3500 Placebo

DrugsREGN3500 Placebo

Overview

Phase: Phase 1
Intervention: REGN3500
Conditions: Asthma
Sponsor: Regeneron Pharmaceuticals
Enrollment: 23
Locations: 1
Primary Endpoint: Severity of TEAEs after repeat subcutaneous administration
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics.

Registry

clinicaltrials.gov

Start Date

February 3, 2017

End Date

September 10, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•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

Arms & Interventions

Cohort 1

REGN3500 low dose or placebo

Intervention: REGN3500

Cohort 1

REGN3500 low dose or placebo

Intervention: Placebo

Cohort 2

REGN3500 medium dose or placebo

Intervention: REGN3500

Cohort 2

REGN3500 medium dose or placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Severity of TEAEs after repeat subcutaneous administration

Time Frame: Up to 36 weeks

Incidence of treatment emergent adverse events (TEAEs) after repeat subcutaneous administration

Time Frame: Up to 36 weeks

Secondary Outcomes

Percent change in total from baseline forced expiratory volume (FEV) at day 29(Baseline to week 4)
Change from baseline in biomarkers at day 29(Baseline to week 4)
Immunogenicity of REGN3500 assessed by measurement of anti-drug antibodies(Up to 36 weeks)
Percent change from baseline in biomarkers at day 29(Baseline to week 4)
The concentration-time profile of REGN3500 after repeat subcutaneous administration(Up to 36 weeks)
Absolute change from baseline fractional exhaled nitric oxide (FeNO) at day 29(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(From -14 days screening to week 4)
Percent change from baseline FeNO at day 29(Baseline to week 4)