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

NCT02999711 | Completed Phase 1 FDA Drug

• 2 other identifiers: R3500-AS-16192016-002979-95
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

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

  Up to 36 weeks

• Severity of TEAEs after repeat subcutaneous administration

  Up to 36 weeks

Secondary Outcomes (8)

• The concentration-time profile of REGN3500 after repeat subcutaneous administration

  Up to 36 weeks

• Immunogenicity of REGN3500 assessed by measurement of anti-drug antibodies

  Up to 36 weeks

• Percent change in total from baseline forced expiratory volume (FEV) 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

• Absolute change from baseline fractional exhaled nitric oxide (FeNO) at day 29

  Baseline to week 4

Study Arms (2)

Cohort 1

EXPERIMENTAL

REGN3500 low dose or placebo

Drug: REGN3500; Drug: Placebo

Cohort 2

EXPERIMENTAL

REGN3500 medium dose or placebo

Drug: REGN3500; Drug: Placebo

Interventions

REGN3500 DRUG

REGN3500 dose

Cohort 1; Cohort 2

Placebo DRUG

Matching placebo

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (3)

Regeneron Research Site

Belfast, Northern Ireland, United Kingdom

Location

Regeneron Research Site

London, United Kingdom

Location

Regeneron Research Site

Manchester, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34523807 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

itepekimab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 21, 2016
• Study Start: February 3, 2017
• Primary Completion: August 30, 2018
• Study Completion: September 10, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

GB (3)