Phase 2
N=194
Study to Evaluate the Safety and Efficacy of CAT-354
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00873860 ↗Enrolled (actual)
194
Serious AEs
3.1%
Results posted
Feb 2017
Primary outcome: Primary: Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 — 2.63; 2.72; 2.62; 2.72 units on a scale — p=0.573
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Other); CAT-354 150 mg (Biological); CAT-354 300 mg (Biological); CAT-354 600 mg (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 |
2.63; 2.72; 2.62; 2.72; -0.61; -0.73 | 0.573 |
| SECONDARY Time to First Observed Asthma Control |
25.5; 22.0; 15.0; 15.0; 25.5; 22.0 | 0.4686 |
| SECONDARY 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 |
1.949; 2.178; 1.907; 1.977; 0.019; 0.122 | — |
| SECONDARY Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 |
282.63; 351.06; 291.54; 325.23; -5.77; 1.91 | — |
| SECONDARY Number of Puffs of Rescue Beta-2 Agonist Per Week |
2.58; 2.84; 2.04; 2.62; 2.5; 2.4 | — |
| SECONDARY Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores |
4.22; 3.96; 4.12; 4.11; 4.39; 4.39 | — |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 |
0.32; 0.38; 0.39; 0.66; 0.45; 0.70 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
5.1; 5.3; 5.3; 5.2; 5.1; 5.3 | — |
| SECONDARY Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 |
13.0; 19.6; 11.8; 17.0; 15.2; 13.0 | 0.934 |
| SECONDARY Serum Concentration for CAT-354 |
14.5; 27.8; 56.4; 20.8; 40.2; 81.9 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
17; 20; 25; 25; 3; 2 | — |
| SECONDARY Percentage of Participants With at Least 1 Moderate or Severe Exacerbation |
4.3; 2.2; 2.0; 4.3; 4.3; 4.3 | 1.0000 |
| SECONDARY Moderate or Severe Asthma Exacerbations Per Person Per Annum |
0.26; 0.09; 0.08; 0.25; 0.23; 0.14 | 0.551 |
| SECONDARY Time to First Moderate or Severe Asthma Exacerbation |
89.67; 90.43; 88.16; 89.94; 162.24; 163.50 | 0.546 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- History suggestive of chronic obstructive pulmonary disease (COPD) and of cigarette smoking >=10 pack-years
- Evidence of any systemic disease on physical examination
- History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy less than or equal to (<=)1 year prior to Study Day 1 or other malignancies treated wit
Data sourced from ClinicalTrials.gov (NCT00873860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.