Study to Evaluate the Safety and Efficacy of CAT-354
A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Parallel-Arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults With Uncontrolled, Moderate-to-severe, Persistent Asthma
2 other identifiers
interventional
357
5 countries
57
Brief Summary
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Jun 2009
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2009
CompletedFirst Posted
Study publicly available on registry
April 2, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
February 23, 2017
CompletedMarch 24, 2017
February 1, 2017
1.2 years
April 1, 2009
August 26, 2016
February 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92
Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.
Day 1 and 92
Secondary Outcomes (15)
Time to First Observed Asthma Control
Day 1 to Day 92 and Day 169
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Day -7 to 1 (predose), Day 2 to 169
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day -7 to 169
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Day 1, 29, 57, 92, 127 and 169
- +10 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 150 mg
EXPERIMENTALCAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 300 mg
EXPERIMENTALCAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 600 mg
EXPERIMENTALCAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
Interventions
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
Eligibility Criteria
You may qualify if:
- Male or female subjects
- Age 18 to 65 years at the time of Screening
- Subjects must have a body mass index (BMI) between 18 and 40 kilogram per square meter (kg/m\^2)
- Written informed consent obtained from the subject prior to performing any protocol related procedures, including Screening evaluations
- Physician-diagnosed moderate-to-severe, persistent asthma requiring treatment with appropriate asthma controller medication
- Shows forced expiratory volume in 1 second (FEV1) reversibility postbronchodilator of greater than or equal to (\>=)12 percent and \>=200 milliliter (mL) or have shown such values in a previous test within the last year, or have a positive airway hyperresponsiveness (AHR) test result in the last year
- Pre-bronchodilator FEV 1 value \>=40 percent of individual predicted value at Visits 1 and 3
- Uncontrolled asthma consistent with Expert Panel Report (EPR)-3. In the 2 to 4 weeks preceding Screening, subjects should have a history of 1 or more of the following: Daytime asthma symptoms \>=2 days/week, Nighttime awakening \>=1 night/week, Salbutamol use \>=2 days/week
- An Asthma control questionnaire (ACQ) score \>=1.5 at Visits 1 and 3
- At least 1 occurrence of asthma exacerbation in the past year that required an unscheduled medical encounter
- Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide) and must use such precautions from Day 1 through Study Day 169
- Otherwise healthy by medical history and physical examination for that age group
- A chest x-ray or computed tomography (CT) scan within the previous 12 months with no findings suggestive of acute or chronic respiratory pathology other than asthma
- Ability and willingness to complete the follow-up period until Day 169 as required by the protocol.
You may not qualify if:
- Known history of allergy or reaction to any component of the investigational product formulation
- Acute illness other than asthma at the start of the study
- History of an active infection within 4 weeks prior to Screening, or evidence of clinically significant active infection, including ongoing chronic infection
- History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or a diagnosis of parasitic infection within 6 months prior to Screening
- Use of immunosuppressive medication (except oral prednisone up to 10 milligram/day (mg/day) and inhaled and topical corticosteroids) within 30 days before randomization into the study
- Receipt of immunoglobulin or blood products within 30 days before randomization into the study
- Receipt of any investigational drug therapy or use of any biologicals including omalizumab within 6 months before the first dose of investigational product in this study or within 5 half-lives of an investigational agent or biologic, whichever is longer
- History of any known immunodeficiency disorder
- A positive hepatitis B surface antigen, or hepatitis C virus antibody
- A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report
- A live or attenuated vaccination received within 4 weeks prior to Screening
- Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study
- History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator
- Lactation (women)
- History of treatment for alcohol or drug abuse within the past year
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (57)
Research Site
Burgas, 8000, Bulgaria
Research Site
Plovdiv, 4000, Bulgaria
Research Site
Rousse, 7000, Bulgaria
Research Site
Rousse, Bulgaria
Research Site
Sofia, 1000, Bulgaria
Research Site
Sofia, 1431, Bulgaria
Research Site
Sofia, 1606, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Sofia III, Bulgaria
Research Site
Sofia II, Bulgaria
Research Site
Stara Zagora, 6000, Bulgaria
Research Site
Stara Zagora, Bulgaria
Research Site
Varna, 9000, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Berlin, 10117, Germany
Research Site
Berlin, 14057, Germany
Research Site
Berlin, Germany
Research Site
Frankfurt am Main, 60389, Germany
Research Site
Frankfurt am Main, Germany
Research Site
Landsberg A. Lech, Germany
Research Site
Lich, 86899, Germany
Research Site
Mainz, 55131, Germany
Research Site
Mainz, Germany
Research Site
Bielsko-Biala, Poland
Research Site
Gdansk, 80-211, Poland
Research Site
Lodz, 90-153, Poland
Research Site
Lodz, Poland
Research Site
Pikary Slaskie, Poland
Research Site
Skalskie, 41-940, Poland
Research Site
Warsaw, 00-909, Poland
Research Site
Warsaw, Poland
Research Site
Warsazawa, 01-138, Poland
Research Site
Warszawa II, Poland
Research Site
Wroclaw, 54-239, Poland
Research Site
Wroclaw, Poland
Research Site
Zabrze, 41-800, Poland
Research Site
Zabrze, Poland
Research Site
Zabrze II, Poland
Research Site
Arad, 310011, Romania
Research Site
Arad, 310085, Romania
Research Site
Arad, Romania
Research Site
Bucharest, 030303, Romania
Research Site
Bucharest, 050159, Romania
Research Site
Bucharest, 050554, Romania
Research Site
Bucharest, Romania
Research Site
Cluj-Napoca, 400371, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Deva, 050554, Romania
Research Site
Deva, Romania
Research Site
Timisoara Timis, 300310, Romania
Research Site
Timișoara, Romania
Research Site
Wythenshawe, Manchester, M23 9QZ, United Kingdom
Research Site
Cambridge, CB23 2TN, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
Leicester, LE3 9QP, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
Manchester, United Kingdom
Related Publications (3)
Piper E, Brightling C, Niven R, Oh C, Faggioni R, Poon K, She D, Kell C, May RD, Geba GP, Molfino NA. A phase II placebo-controlled study of tralokinumab in moderate-to-severe asthma. Eur Respir J. 2013 Feb;41(2):330-8. doi: 10.1183/09031936.00223411. Epub 2012 Jun 27.
PMID: 22743678BACKGROUNDBaverel PG, White N, Vicini P, Karlsson MO, Agoram B. Dose-Exposure-Response Relationship of the Investigational Anti-Interleukin-13 Monoclonal Antibody Tralokinumab in Patients With Severe, Uncontrolled Asthma. Clin Pharmacol Ther. 2018 May;103(5):826-835. doi: 10.1002/cpt.803. Epub 2017 Sep 28.
PMID: 28758192DERIVEDWilkes DS, Chew T, Flaherty KR, Frye S, Gibson KF, Kaminski N, Klemsz MJ, Lange W, Noth I, Rothhaar K. Oral immunotherapy with type V collagen in idiopathic pulmonary fibrosis. Eur Respir J. 2015 May;45(5):1393-402. doi: 10.1183/09031936.00105314. Epub 2015 Jan 22.
PMID: 25614165DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Meena Jain, MB BChir/Associate Medical Director
- Organization
- MedImmune, LLC
Study Officials
- STUDY DIRECTOR
MedImmune LLC
MedImmune LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2009
First Posted
April 2, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
March 24, 2017
Results First Posted
February 23, 2017
Record last verified: 2017-02