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

NCT ID: NCT02999711

Last Updated: 2018-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-03
• Study Completion Date: 2018-09-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

REGN3500 low dose or placebo

Group Type: EXPERIMENTAL

REGN3500

Intervention Type: DRUG

REGN3500 dose

Placebo

Intervention Type: DRUG

Matching placebo

Cohort 2

REGN3500 medium dose or placebo

Group Type: EXPERIMENTAL

REGN3500

Intervention Type: DRUG

REGN3500 dose

Placebo

Intervention Type: DRUG

Matching placebo

Interventions

REGN3500

REGN3500 dose

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Regeneron Research Site

Belfast, Northern Ireland, United Kingdom

Regeneron Research Site

London, , United Kingdom

Regeneron Research Site

Manchester, , United Kingdom

Countries

Germany; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34523807 (View on PubMed)

Other Identifiers

2016-002979-95

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R3500-AS-1619

Identifier Type: -

Identifier Source: org_study_id