AMG 761 in Adults With Asthma

NCT01514981 | Terminated Phase 1

• 1 other identifier: 20080451
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine that no significant safety issues will be identified following a single dose of AMG 761 in asthma subjects that would preclude further development of AMG 761.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (2)

• The number of treatment emergent adverse events per subject including clinically significant changes in vital signs, physical examinations, laboratory safety tests and ECGs.

  16 weeks

• The number of subjects with anti-AMG 761 antibodies after a single dose of AMG 761.

  16 weeks

Secondary Outcomes (2)

• The maximum observed concentration, time to maximum concentration and the area under the serum concentration-time curve after a single dose of AMG 761.

  16 weeks

• The circulating CD4+ CCR4+ T cell count.

  16 weeks

Study Arms (2)

AMG 761

EXPERIMENTAL

Drug: AMG 761

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AMG 761 DRUG

Single dose of AMG 761 on study day 1.

AMG 761

Placebo DRUG

Single dose of placebo on study day 1.

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy, with no history or evidence of clinically relevant medical or psychiatric disorders (with the exception of asthma) as determined by the investigator in consultation with the Amgen physician where medically appropriate
• Immunizations up to date, with a minimum of tetanus, diphtheria, pertussis (td/Tdap), pneumococcal (polysaccharide), influenza (during flu season) and H1N1 (where and when available) vaccinations, as determined by the principal investigator
• Body mass index (BMI) in the range of 18 to 35 kg/m2, inclusive
• Is a current non-smoker and has not used any tobacco products within the last 6 months and the cumulative smoking history must be ≤ 10 pack years
• Clinically stable with a physician diagnosis of asthma for a minimum of 6 months prior to enrollment, and with no change in asthma treatment for at least 3 months prior to enrollment. As needed beta-agonist use (ie, PRN) should be considered a stable treatment
• Documented history of atopy to oak, mite, ragweed, timothy grass, Alternaria mold, kochia pollen, aspergillus, or cottonwood within 18 months or positive atopy skin prick test for these specific allergens during the screening period

You may not qualify if:

• Past history of serious skin rash requiring hospitalization
• Active, or history of (within 12 months of enrollment), acute viral infection of the skin (eg, herpes simplex, herpes zoster, or molluscum contagiosum)
• Active or history of psoriasis, or a first degree relative with active or known history of psoriasis
• First degree relatives with active or history of systemic lupus erythematosus or type 1 diabetes, rheumatoid arthritis or other active autoimmune disorder, as determined by the principal investigator
• History of life-threatening anaphylaxis
• Experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room, hospitalization, or an episode treated with oral corticosteroids in dosage of at least 5 mg/day prednisone or equivalent for ≥ 1 week) during the 6 months prior to enrollment

Sponsors & Collaborators

• Amgen: lead

Study Sites (2)

Research Site

Denver, Colorado, 80206, United States

Location

Research Site

Miami, Florida, 33143, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Asthma

Interventions

mogamulizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: January 23, 2012
• Study Start: December 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

US (2)