Study of Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REGN3500 in Adults With Moderate Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999711
• Other study ID #: R3500-AS-1619
• Secondary ID: 2016-002979-95
• Status: Completed
• Phase: Phase 1
• Start date: February 3, 2017
• Est. completion date: September 10, 2018

Study information

• Verified date: December 2018
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 10, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Key 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.

Key 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

• 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

Related Conditions & MeSH terms

• Asthma
• Moderate Asthma

Intervention

Drug:
• REGN3500
REGN3500 dose
• Placebo
Matching placebo

Locations

Country	Name	City	State
United Kingdom	Regeneron Research Site	Belfast	Northern Ireland
United Kingdom	Regeneron Research Site	London
United Kingdom	Regeneron Research Site	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events (TEAEs) after repeat subcutaneous administration		Up to 36 weeks
Primary	Severity of TEAEs after repeat subcutaneous administration		Up to 36 weeks
Secondary	The concentration-time profile of REGN3500 after repeat subcutaneous administration		Up to 36 weeks
Secondary	Immunogenicity of REGN3500 assessed by measurement of anti-drug antibodies		Up to 36 weeks
Secondary	Percent change in total from baseline forced expiratory volume (FEV) at day 29		Baseline to week 4
Secondary	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
Secondary	Absolute change from baseline fractional exhaled nitric oxide (FeNO) at day 29		Baseline to week 4
Secondary	Percent change from baseline FeNO at day 29		Baseline to week 4
Secondary	Change from baseline in biomarkers at day 29		Baseline to week 4
Secondary	Percent change from baseline in biomarkers at day 29		Baseline to week 4