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A Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 in Subjects With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00640016
Recruitment Status : Terminated (The study was terminated prematurely by the sponsor due to slow recruitment.)
First Posted : March 20, 2008
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Collaborators:
Cambridge Antibody Technology
PRA Health Sciences
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Other: Placebo
Biological: CAT-354 1 mg/kg
Biological: CAT-354 5 mg/kg
Other: CAT-354 10 mg/kg
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
Hide Arm/Group Description Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56. CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Period Title: Overall Study
Started 3 3 4 4
Treated 3 2 4 4
Completed 1 1 1 1
Not Completed 2 2 3 3
Reason Not Completed
Withdrawal by Subject             0             1             0             0
Study termination             2             1             3             2
Adverse Event             0             0             0             1
Arm/Group Title Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg Total
Hide Arm/Group Description Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56. CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. Total of all reporting groups
Overall Number of Baseline Participants 3 3 4 4 14
Hide Baseline Analysis Population Description
Analysis population included all participants who were enrolled.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 4 participants 4 participants 14 participants
34.00  (11.136) 34.00  (14.933) 37.75  (9.878) 40.75  (15.086) 37.00  (11.708)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 4 participants 14 participants
Female
3
 100.0%
3
 100.0%
2
  50.0%
3
  75.0%
11
  78.6%
Male
0
   0.0%
0
   0.0%
2
  50.0%
1
  25.0%
3
  21.4%
1.Primary Outcome
Title Change From Baseline in Doubling Concentration of Methacholine at Day 28
Hide Description Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 milligram/kilogram [mg/kg]) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
Hide Arm/Group Description:
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 8 5
Mean (Standard Deviation)
Unit of Measure: log2 milligram/deciliter (mg/dL)
Baseline (n=8, 5) -0.604  (2.4080) -1.545  (0.8952)
Change at Day 28 (n=5, 4) -0.207  (1.0450) 0.125  (2.3433)
2.Secondary Outcome
Title Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination
Hide Description Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame Baseline, Day 56, 84 or early termination (any time before Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure, and 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
Hide Arm/Group Description:
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: log2 mg/dL
Change at Day 56 (n=2, 2) 0.062  (1.1309) -1.423  (0.4059)
Change at Day 84 (n=2, 2) -0.038  (0.1410) -1.846  (0.0431)
Change at Early termination (n=3, 2) -0.514  (0.8636) 0.417  (0.9840)
3.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1)
Hide Description The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
Hide Arm/Group Description:
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 8 5
Mean (Standard Deviation)
Unit of Measure: liters
Day 0: Predose (n=8, 5) 2.718  (0.5458) 2.640  (0.3994)
Day 0: 30 minutes postdose (n=8, 5) 2.684  (0.5695) 2.624  (0.4126)
Day 0: 6 hours postdose (n=8, 5) 2.606  (0.5731) 2.550  (0.4304)
Day 4 (n=8, 5) 2.814  (0.6048) 2.606  (0.2919)
Day 14 (n=6, 5) 2.323  (0.5703) 2.520  (0.0812)
Day 28: Predose (n=5, 4) 2.598  (0.4676) 2.850  (0.2082)
Day 28: 30 minutes postdose (n=4, 4) 2.535  (0.5639) 2.918  (0.2822)
Day 28: 6 hours postdose (n=4, 4) 2.400  (0.5254) 2.665  (0.2748)
Day 35 (n= 4, 4) 2.260  (0.5464) 2.778  (0.4228)
Day 56: Predose (n=2, 2) 2.555  (0.6718) 2.700  (0.3677)
Day 56: 30 minutes postdose (n=2, 2) 2.705  (0.7990) 2.830  (0.1697)
Day 56: 6 hours postdose (n=2, 2) 2.510  (0.7071) 2.690  (0.2404)
Day 63 (n= 2, 2) 2.505  (0.6859) 2.580  (0.0283)
Day 84: (n=2, 2) 2.680  (0.7778) 2.540  (0.4101)
Early Termination (n=4, 3) 3.018  (0.5803) 2.867  (0.4400)
4.Secondary Outcome
Title Forced Vital Capacity (FVC)
Hide Description The FVC was volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
Hide Arm/Group Description:
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 8 5
Mean (Standard Deviation)
Unit of Measure: liters
Day 0: Predose (n= 8, 5) 3.828  (0.8215) 3.666  (0.6068)
Day 0: 30 minutes postdose (n= 8, 5) 3.823  (0.6500) 3.722  (0.6752)
Day 0: 6 hours postdose (n= 8, 5) 3.808  (0.7718) 3.722  (0.7297)
Day 4 (n= 8, 5) 3.988  (0.6058) 3.824  (0.7415)
Day 14 (n=6, 5) 3.462  (0.5926) 3.710  (0.5220)
Day 28: Predose (n=5, 4) 3.908  (0.7670) 3.883  (0.6412)
Day 28: 30 minutes postdose (n=4, 4) 3.878  (0.7876) 3.980  (0.7951)
Day 28: 6 hours postdose (n=4, 4) 3.810  (0.7409) 3.790  (0.4830)
Day 35 (n=4, 4) 3.613  (0.6874) 3.920  (0.7777)
Day 56: Predose (n=2, 2) 3.700  (0.5233) 3.410  (0.3818)
Day 56: 30 minutes postdose (n=2, 2) 3.775  (0.5303) 3.540  (0.4667)
Day 56: 6 hours postdose (n=2, 2) 3.715  (0.6435) 3.545  (0.3748)
Day 63 (n=2, 2) 3.705  (0.5162) 3.575  (0.5020)
Day 84: (n=2, 2) 3.710  (0.6505) 3.415  (0.3323)
Early Termination (n=4, 3) 3.908  (0.8070) 4.193  (0.8364)
5.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
Hide Description Percentage of FEV1 was calculated as (FEV1/FVC)*100. It signified the percentage of the total amount of air exhaled from the lungs during the first second of forced exhalation. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, Day 63, 84 or early termination (any time before Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
Hide Arm/Group Description:
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 8 5
Mean (Standard Deviation)
Unit of Measure: percentage of FVC
Day 0: Predose (n=8, 5) 71.875  (10.3156) 72.600  (11.4149)
Day 0: 30 minutes postdose (n=8, 5) 70.250  (9.1613) 71.600  (13.1833)
Day 0: 6 hours postdose (n=8, 5) 69.125  (12.5178) 69.600  (12.1984)
Day 4 (n=8, 5) 71.000  (13.1909) 69.400  (8.7063)
Day 14 (n=6, 5) 66.667  (7.5011) 68.800  (8.1670)
Day 28: Predose (n=5, 4) 67.400  (13.1263) 74.500  (11.2694)
Day 28: 30 minutes postdose (n=4, 4) 66.500  (13.9881) 74.500  (9.6782)
Day 28: 6 hours postdose (n=4, 4) 63.750  (12.3390) 71.250  (13.8173)
Day 35 (n=4, 4) 62.500  (7.5498) 71.750  (7.8049)
Day 56: Predose (n=2, 2) 68.000  (8.4853) 80.000  (19.7990)
Day 56: 30 minutes postdose (n=2, 2) 71.000  (11.3137) 81.000  (15.5563)
Day 56: 6 hours postdose (n=2, 2) 67.000  (7.0711) 76.500  (14.8492)
Day 63 (n=2, 2) 66.500  (9.1924) 72.500  (9.1924)
Day 84 (n=2, 2) 71.500  (9.1924) 75.500  (19.0919)
Early Termination (n=4, 3) 77.750  (9.8107) 69.000  (5.5678)
6.Secondary Outcome
Title Asthma Control Questionnaire (ACQ) Total Score
Hide Description The ACQ is questionnaire that comprises of 7-questions evaluating participant’s asthma control. Six self-administered questions assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; using 7-point ordinal rating scale from 0 (good control) to 6 (poor control). Seventh question is completed by a health professional on forced expiratory volume in 1 second (FEV1) percentage (%) predicted; scale: 0 (greater than [>] 95% predicted) to 6 (less than [<] 50% predicted. Final score is the average score of the 7 questions, with a score range of 0 (well controlled) to 6 (extremely poor controlled). Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
Time Frame Baseline, Day 28, 56, 84 or early termination (any time before Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
Hide Arm/Group Description:
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 8 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=8, 5) 2.44  (0.737) 1.77  (0.861)
Day 28 (n=5, 4) 2.00  (0.416) 1.46  (0.914)
Day 56 (n=2, 2) 1.43  (0.808) 1.50  (1.111)
Day 84 (n=2, 2) 1.57  (1.010) 2.36  (0.101)
Early Termination (n=5, 3) 1.72  (1.304) 0.57  (0.378)
7.Secondary Outcome
Title Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Hide Description The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Time Frame Day 0 to 84
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.
Arm/Group Title Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
Hide Arm/Group Description:
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With Diary Data
Hide Description Participants recorded asthma symptoms, use of reliever inhalers (beta-agonist use for symptom relief and as prophylaxis), and morning and evening peak expiratory flow (PEF) measurements in a diary.
Time Frame Day 0, 4, 14, 28, 35, 56, 63 to Day and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.
Arm/Group Title Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
Hide Arm/Group Description:
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Participants With Exacerbations
Hide Description Exacerbation was defined as: Mild (determined from diary data) - 2 consecutive days satisfying the same or 1 of the following criteria: any night with awakening(s) due to asthma or morning PEF 20 % or more below baseline where baseline = average of the 10 days before randomization or as-needed medication use of 2 inhalations or more in 24 hours above baseline where baseline = average of the 10 days before randomization. Severe (determined by taking an exacerbation update and history): deterioration of asthma resulting in emergency treatment or hospitalization or need for oral steroids for 3 days or more (as judged by the Investigator).
Time Frame Day 0 to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.
Arm/Group Title Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
Hide Arm/Group Description:
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Morning Peak Flow and Peak Flow Variability
Hide Description Peak flow is a participant’s maximum speed of expiration.
Time Frame Day 0 to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.
Arm/Group Title Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
Hide Arm/Group Description:
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Adult Asthma Quality of Life (QoL) Questionnaire Final Score
Hide Description The AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants are asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. The 4 domain scores are the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).
Time Frame Day 0, 28, 84 or early termination (any time before Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.
Arm/Group Title Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg) Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)
Hide Arm/Group Description:
CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) for CAT-354
Hide Description [Not Specified]
Time Frame Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
Hide Arm/Group Description:
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 1 1 1
Mean (Standard Deviation)
Unit of Measure: microgram/milliliter (mcg/mL)
After first dose (Day 0) 27.7 [1]   (NA) 219 [1]   (NA) 163 [1]   (NA)
After second dose (Day 28) 34.5 [1]   (NA) 255 [1]   (NA) 235 [1]   (NA)
After third dose (Day 56) 33.4 [1]   (NA) 338 [1]   (NA) 251 [1]   (NA)
[1]
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
13.Secondary Outcome
Title Minimum Observed Serum Concentration (Cmin) for CAT-354
Hide Description [Not Specified]
Time Frame Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
Hide Arm/Group Description:
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 1 1 1
Mean (Standard Deviation)
Unit of Measure: mcg/mL
After first dose (Day 0) 4.84 [1]   (NA) 51.8 [1]   (NA) 52.8 [1]   (NA)
After second dose (Day 28) 7.91 [1]   (NA) 54.1 [1]   (NA) 64.4 [1]   (NA)
After third dose (Day 56) 9.70 [1]   (NA) 85.5 [1]   (NA) 68.4 [1]   (NA)
[1]
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
14.Secondary Outcome
Title Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354
Hide Description [Not Specified]
Time Frame Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
Hide Arm/Group Description:
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 1 1 1
Mean (Standard Deviation)
Unit of Measure: microgram*day/milliliter (mcg*day/mL)
After first dose (Day 0) 335 [1]   (NA) 2820 [1]   (NA) 2090 [1]   (NA)
After second dose (Day 28) 408 [1]   (NA) 4720 [1]   (NA) 3080 [1]   (NA)
After third dose (Day 56) 499 [1]   (NA) 3690 [1]   (NA) 3420 [1]   (NA)
[1]
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
15.Secondary Outcome
Title Accumulation Ratio for CAT-354 (RA)
Hide Description Accumulation ratio (RA) is calculated for Cmax, Cmin and AUC as RA for Cmax = Cmax (56 - 84)/Cmax (0 - 28); Similarily, RA for Cmin = Cmin (56 - 84)/Cmin (0 - 28) and RA for AUC= AUC (56 - 84)/AUC (0 - 28) where Cmax (0 - 28) and Cmax (56 - 84) are the maximum observed serum concentration after first dose (Day 0 to Day 28) and after third dose (Day 56 to Day 84), respectively; Cmin (0 - 28) and Cmin (56 - 84) are the minimum observed serum concentration after first and third dose, respectively; AUC (0 - 28) and AUC (56 - 84) are the area under the serum concentration time curve over a dosage interval determined after first and third dose, respectively.
Time Frame Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
Hide Arm/Group Description:
CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 1 1 1
Mean (Standard Deviation)
Unit of Measure: ratio
RA for Cmin 1.20 [1]   (NA) 1.54 [1]   (NA) 1.73 [1]   (NA)
RA for Cmax 2.00 [1]   (NA) 1.65 [1]   (NA) 1.30 [1]   (NA)
RA for AUC 1.49 [1]   (NA) 1.31 [1]   (NA) 1.64 [1]   (NA)
[1]
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
16.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame Day 0 to 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication.
Arm/Group Title Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
Hide Arm/Group Description:
Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Overall Number of Participants Analyzed 3 2 4 4
Measure Type: Number
Unit of Measure: participants
TEAEs 2 2 4 3
TESAEs 0 0 0 1
Time Frame Day 0 to 84
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
Hide Arm/Group Description Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56 CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
All-Cause Mortality
Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/2 (0.00%)      0/4 (0.00%)      1/4 (25.00%)    
Immune system disorders         
Hypersensitivity  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA. 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo CAT-354 1 mg/kg CAT-354 5 mg/kg CAT-354 10 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      2/2 (100.00%)      4/4 (100.00%)      2/4 (50.00%)    
Gastrointestinal disorders         
Abdominal pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Constipation  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Diarrhoea  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Nausea  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Vomiting  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  2 1/4 (25.00%)  1
General disorders         
Chest discomfort  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Inflammation  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Immune system disorders         
Seasonal allergy  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/4 (0.00%)  0 2/4 (50.00%)  3
Infections and infestations         
Nasopharyngitis  1  2/3 (66.67%)  2 2/2 (100.00%)  2 1/4 (25.00%)  1 1/4 (25.00%)  1
Urinary tract infection  1  1/3 (33.33%)  1 0/2 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Investigations         
Forced expiratory volume decreased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Musculoskeletal pain  1  0/3 (0.00%)  0 1/2 (50.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Nervous system disorders         
Headache  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Hypoaesthesia  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/3 (33.33%)  2 0/2 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Dyspnoea exertional  1  0/3 (0.00%)  0 1/2 (50.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA. 9.0
Study was prematurely terminated due to low recruitment rate, delay due to temporary halt and potential for expiry date of study drug. It was not considered possible to draw meaningful conclusions from the small dataset.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The Principal Investigator (PIs) also agree for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: Meena Jain, MB BChir/Associate Medical Director
Organization: MedImmune, LLC
Phone: 301-398-0000
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00640016     History of Changes
Other Study ID Numbers: CAT-354-0603
2007-002090-31 ( EudraCT Number )
First Submitted: March 13, 2008
First Posted: March 20, 2008
Results First Submitted: June 3, 2016
Results First Posted: January 31, 2017
Last Update Posted: January 31, 2017