Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility
NCT01902290 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 421
Last updated 2022-09-21
Summary
The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.
Conditions
Interventions
- BIOLOGICAL
-
Placebo administered subcutaneously
- BIOLOGICAL
-
Brodalumab
Brodalumab administered subcutaneously
Sponsors & Collaborators
-
Kyowa Kirin Co., Ltd.
collaborator INDUSTRY - collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-22
- Primary Completion
- 2015-05-15
- Completion
- 2015-05-15
Countries
- United States
- Australia
- Canada
- France
- Germany
- Greece
- Hong Kong
- Ireland
- Italy
- New Zealand
- Poland
- Puerto Rico
- Russia
- South Korea
- Taiwan
Study Locations
More Related Trials
-
Chronic Dosing Cross-Over Study to Assess the Efficacy and Safety of Glycopyrronium (PT001) in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma
NCT02433834 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Different Doses of Indacaterol
NCT01079130 ·Status: COMPLETED ·Phase: PHASE3
-
AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma
NCT01018550 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
NCT02513160 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma
NCT01395485 ·Status: WITHDRAWN ·Phase: PHASE1
-
An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
NCT02219048 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
NCT01716754 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
NCT07219173 ·Status: RECRUITING ·Phase: PHASE2
-
A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.
NCT01928368 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment Of Disease Pathology And Key Therapeutic Targets In Severe Asthma
NCT00327197 ·Status: TERMINATED ·Phase: PHASE1
-
Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma
NCT03108027 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-Dose ICS Therapy.
NCT00603278 ·Status: COMPLETED ·Phase: PHASE2
-
Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
NCT01197794 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase IIa Repeat Dose AXP1275 vs Placebo Cross-over Trial With Pulmonary Allergen Challenge in Adults With Asthma
NCT01890161 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of SA09012 in Asthma
NCT01740986 ·Status: COMPLETED ·Phase: PHASE2
-
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma
NCT02031640 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
NCT02918019 ·Status: COMPLETED ·Phase: PHASE2
-
Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3
NCT02322788 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma
NCT02528214 ·Status: COMPLETED ·Phase: PHASE3
-
A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma
NCT02040779 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma
NCT01448954 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication
NCT01868061 ·Status: COMPLETED ·Phase: PHASE3
-
AMG 761 in Adults With Asthma
NCT01514981 ·Status: TERMINATED ·Phase: PHASE1
-
Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Asthma
NCT01103037 ·Status: TERMINATED ·Phase: PHASE2
-
Cross-Over Study of Subcutaneous Study Drug for the Treatment of Patients With Mild to Moderate Asthma
NCT01304628 ·Status: WITHDRAWN ·Phase: PHASE2