We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified January 2017 by Regeneron Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT02999711
First Posted: December 21, 2016
Last Update Posted: January 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
  Purpose
Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics.

Condition Intervention Phase
Asthma Moderate Asthma Drug: REGN3500 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Adults Patients With Moderate Asthma

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of treatment emergent adverse events (TEAEs) after repeat subcutaneous administration [ Time Frame: Baseline to week 20 ]
  • Severity of TEAEs after repeat subcutaneous administration [ Time Frame: Baseline to week 20 ]

Secondary Outcome Measures:
  • The concentration-time profile of REGN3500 after repeat subcutaneous administration [ Time Frame: Baseline to week 20 ]
  • Immunogenicity of REGN3500 assessed by measurement of anti-drug antibodies [ Time Frame: Baseline to week 20 ]
  • 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 ]

Estimated Enrollment: 24
Study Start Date: January 2017
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
REGN3500 low dose or placebo
Drug: REGN3500 Drug: Placebo
Experimental: Cohort 2
REGN3500 medium dose or placebo
Drug: REGN3500 Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female between the age of 18 and 55 years,
  • 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 ≤85% of the predicted normal values at screening and pre-dose at randomization
  • 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 (GINA 2015); 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999711


Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United Kingdom
Recruiting
Manchester, United Kingdom
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02999711     History of Changes
Other Study ID Numbers: R3500-AS-1619
2016-002979-95 ( EudraCT Number )
First Submitted: December 19, 2016
First Posted: December 21, 2016
Last Update Posted: January 19, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases