Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma

NCT01405963 | Completed Phase 1 Results

• 1 other identifier: 20101183
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to assess the late and early asthmatic response after an allergen inhalation challenge in adults with mild atopic asthma after receiving multiple doses of tezepelumab (AMG 157), as well as the safety, tolerability, immunogenicity, and pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.

Conditions

Asthma

Keywords

Amgen; AMG 157; Asthma

Outcome Measures

Primary Outcomes (2)

• Maximum Percentage Decrease in Forced Expiratory Volume in 1 Second (FEV1) at 3 to 7 Hours Post Allergen Challenge

  Participants underwent allergen inhalation challenge on study days 42 and 84 to induce airway bronchoconstriction (measured by a fall in FEV1). FEV1 was measured prior to the challenge and between 3 to 7 hours post allergen challenge to assess late asthmatic response (LAR). The percent change in FEV1 from pre-challenge was calculated to each time point between 3 to 7 hours post challenge. The maximum percent decrease in FEV1 from pre-allergen challenge is the percent change in FEV1 representing the largest percentage decrease (or minimum percentage increase) from pre-allergen challenge FEV1 during late (3-7 hour) asthmatic response time frame.

  Days 42 and 84 at pre-allergen challenge and at 180, 240, 300, 360, and 420 minutes (3-7 hours) post allergen challenge

• Time-Adjusted Area Under the Curve for the Percent Decrease From Pre-Allergen Challenge in Forced Expiratory Volume in 1 Second (FEV1) From 3 to 7 Hours Post Allergen Challenge

  Participants underwent allergen inhalation challenge on study days 42 and 84 to induce airway bronchoconstriction. FEV1 was measured prior to the challenge and between 3 to 7 hours post challenge to assess late asthmatic response (LAR). The percent change in FEV1 from pre-challenge was calculated to each time point between 3 to 7 hours post challenge. The area under the curve for the percent change at each time point was calculated using the linear trapezoidal rule, then time adjusted by dividing by the length of time over which the AUC was calculated.

  Days 42 and 84 at pre-challenge and at 180, 240, 300, 360, and 420 minutes (3-7 hours) post challenge

Secondary Outcomes (17)

• Number of Participants With Adverse Events

  Up to 169 days

• Number of Participants With Grade ≥ 3 Laboratory Values

  Up to 169 days

• Number of Participants Who Developed Anti-tezepelumab Antibodies After Initiation of Treatment

  Days 29, 57, 85, 113, and 169

• Maximum Percentage Decrease in FEV1 From 0 to 2 Hours Post Allergen Challenge

  Days 42 and 84 at pre-allergen challenge and at 10, 20, 30, 45, 60, 90, and 120 minutes (0-2 hours) post allergen challenge

• Time-Adjusted AUC for the Percent Decrease From Pre-Allergen Challenge in FEV1 From 0 to 2 Hours Post Allergen Challenge

  Days 42 and 84 at pre-challenge and at 10, 20, 30, 45, 60, 90, and 120 minutes (0-2 hours) post challenge

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received placebo to tezepelumab administered by intravenous infusion on study days 1, 29, and 57.

Drug: Placebo

Tezepelumab 700 mg

EXPERIMENTAL

Participants received 700 mg tezepelumab administered by intravenous infusion on study days 1, 29, and 57.

Biological: Tezepelumab

Interventions

Placebo DRUG

Administered in a 1-hour intravenous infusion

Placebo

Tezepelumab BIOLOGICAL

Administered in a 1-hour intravenous infusion

Also known as: AMG 157, Tezspire

Tezepelumab 700 mg

Eligibility Criteria

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

You may qualify if:

• Male or female subjects with history of mild atopic asthma between 18 and 60 years-of-age
• Body mass index (BMI) between 18 and 35 kg/m\^2
• Normal or clinically acceptable physical examination (PE), clinical laboratory values, and electrocardiogram (ECG); clinically acceptable PE includes history of mild atopic asthma
• Used only inhaled short-acting β2-agonists infrequently to treat asthma
• No current exposure to allergens to which subject experiences asthmatic responses
• No other lung disease, exacerbations of asthma or lower respiratory tract infections for at least 6 weeks prior to screening
• Positive skin prick test to common aeroallergens at screening

You may not qualify if:

• History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
• History or current medical conditions that are contraindicated for methacholine challenge, such as myocardial infarction or stroke within previous 3 months, known cardiac disease, uncontrolled hypertension and aortic or cerebral aneurysm
• Evidence of active or suspected bacterial, viral, fungal or parasitic infections within past 6 weeks
• Subject has know type I/II diabetes
• History of residential exposure to tuberculosis or has a positive purified protein derivative (PPD) or QuantiFERON test within 4 weeks before randomization
• Subject who has history of malignancy of any type within 5 years prior to enrollment
• Subjects tested positive for drugs/alcohol or nicotine use at screening
• Subjects tested positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C

Sponsors & Collaborators

• Amgen: lead

Study Sites (5)

Research Site

Calgary, Alberta, T2N 4Z6, Canada

Location

Research Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Research Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Research Site

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Research Site

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

• Gauvreau GM, O'Byrne PM, Boulet LP, Wang Y, Cockcroft D, Bigler J, FitzGerald JM, Boedigheimer M, Davis BE, Dias C, Gorski KS, Smith L, Bautista E, Comeau MR, Leigh R, Parnes JR. Effects of an anti-TSLP antibody on allergen-induced asthmatic responses. N Engl J Med. 2014 May 29;370(22):2102-10. doi: 10.1056/NEJMoa1402895. Epub 2014 May 20.

  PMID: 24846652 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Asthma

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 29, 2011
• Study Start: October 31, 2011
• Primary Completion: April 5, 2013
• Study Completion: April 5, 2013
• Last Updated: October 17, 2022
• Results First Posted: October 17, 2022

Record last verified: 2022-03

Locations

CA (5)