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

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ClinicalTrials.gov Identifier: NCT02999711
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics.

Condition or disease Intervention/treatment Phase
Asthma Moderate Asthma Drug: REGN3500 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cohort 1
REGN3500 low dose or placebo
Drug: REGN3500 Drug: Placebo
Experimental: Cohort 2
REGN3500 medium dose or placebo
Drug: REGN3500 Drug: Placebo


Outcome Measures

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

Secondary Outcome Measures :
  1. The concentration-time profile of REGN3500 after repeat subcutaneous administration [ Time Frame: Baseline to week 20 ]
  2. Immunogenicity of REGN3500 assessed by measurement of anti-drug antibodies [ Time Frame: Baseline to week 20 ]
  3. Percent change in total from baseline forced expiratory volume (FEV) at day 29 [ Time Frame: Baseline to week 4 ]
  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 ]
  5. Absolute change from baseline fractional exhaled nitric oxide (FeNO) at day 29 [ Time Frame: Baseline to week 4 ]
  6. Percent change from baseline FeNO at day 29 [ Time Frame: Baseline to week 4 ]
  7. Change from baseline in biomarkers at day 29 [ Time Frame: Baseline to week 4 ]
  8. Percent change from baseline in biomarkers at day 29 [ Time Frame: Baseline to week 4 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

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

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
Germany
Not yet recruiting
Berlin, Germany
United Kingdom
Recruiting
Belfast, Northern Ireland, United Kingdom
Recruiting
London, 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 Posted: December 21, 2016    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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