Trial Outcomes & Findings for An Imaging Study Using PET/CT to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation (NCT NCT02937168)
NCT ID: NCT02937168
Last Updated: 2021-11-09
Results Overview
GLG is the total FDG uptake in the whole lung. A region of interest (ROI) was drawn around lung boundary in each axial slice. Standardized uptake value (SUV) mean and area of each ROI was recorded. Using the formula: area\*slice thickness the volume of each slice was calculated. Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice. This number for each slice was summed together to provide GLG of that lung. Average between GLG of right lung and GLG of left lung was reported.
TERMINATED
PHASE4
5 participants
Baseline (Day 1) of Part 1
2021-11-09
Participant Flow
This study consisted of 2 parts: Part 1, a 21-day positron emission tomography (PET)/computed tomography (CT) screening period, and Part 2 (only participants with asthma), a 6-week double blind treatment/assessment period.
Participants with eosinophilic asthma were to be randomly assigned 1:1 in a double-blind fashion in Part 2 of the study to receive either placebo or reslizumab. Study was terminated prior to administration of reslizumab.
Participant milestones
| Measure |
Part 1: PET/CT Scan
Healthy participants had 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants received Fluorodeoxyglucose F-18 (FDG) as part of the PET/CT procedures and provided sputum/blood samples.
|
Part 2: Reslizumab
Reslizumab 3.0 milligrams/kilogram (mg/kg) was planned to be administered by intravenous (IV) infusion, over 20 to 50 minutes, at Baseline (Day 1) of Part 2. PET/CT scan was to be done on Weeks 2, 4 and 6.
|
Part 2: Placebo
Matching placebo was planned to be administered by IV infusion at Baseline. (Day 1) of Part 2. PET/CT scan was to be done on Weeks 2, 4 and 6.
|
|---|---|---|---|
|
PET/CT Screening Period (21 Days)
STARTED
|
5
|
0
|
0
|
|
PET/CT Screening Period (21 Days)
COMPLETED
|
5
|
0
|
0
|
|
PET/CT Screening Period (21 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (6 Weeks)
STARTED
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (6 Weeks)
COMPLETED
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (6 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Imaging Study Using PET/CT to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation
Baseline characteristics by cohort
| Measure |
Part 1: PET/CT Scan
n=5 Participants
Healthy participants had 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants received FDG as part of the PET/CT procedures and provided sputum/blood samples.
|
|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) of Part 1Population: All recruited healthy participants.
GLG is the total FDG uptake in the whole lung. A region of interest (ROI) was drawn around lung boundary in each axial slice. Standardized uptake value (SUV) mean and area of each ROI was recorded. Using the formula: area\*slice thickness the volume of each slice was calculated. Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice. This number for each slice was summed together to provide GLG of that lung. Average between GLG of right lung and GLG of left lung was reported.
Outcome measures
| Measure |
Part 1: PET/CT Scan
n=5 Participants
Healthy participants had 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants received FDG as part of the PET/CT procedures and provided sputum/blood samples.
|
Part 2: Placebo
Matching placebo was planned to be administered by IV infusion at Baseline. (Day 1) of Part 2. PET/CT scan was to be done on Weeks 2, 4 and 6.
|
|---|---|---|
|
Part 1: Average Global Lung Glycolysis (GLG) at Baseline (Day 1)
|
668.08 cubic centimeters (cm^3)
Standard Deviation 191.83
|
—
|
PRIMARY outcome
Timeframe: Day 8Population: All recruited healthy participants.
GLG is the total FDG uptake in the whole lung. ROI was drawn around lung boundary in each axial slice. SUV mean and area of each ROI was recorded. Using the formula: area\*slice thickness the volume of each slice was calculated. Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice. This number for each slice was summed together to provide GLG of that lung. Average between GLG of right lung and GLG of left lung was reported.
Outcome measures
| Measure |
Part 1: PET/CT Scan
n=5 Participants
Healthy participants had 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants received FDG as part of the PET/CT procedures and provided sputum/blood samples.
|
Part 2: Placebo
Matching placebo was planned to be administered by IV infusion at Baseline. (Day 1) of Part 2. PET/CT scan was to be done on Weeks 2, 4 and 6.
|
|---|---|---|
|
Part 1: Average Global Lung Glycolysis (GLG) at Day 8
|
621.71 cm^3
Standard Deviation 208.74
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Part 2 of the study was not conducted, hence this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Part 2 of the study was not conducted, hence this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Part 2 of the study was not conducted, hence this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Part 2 of the study was not conducted, hence this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Part 2 of the study was not conducted, hence this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Part 2 of the study was not conducted, hence this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 21 daysPopulation: All recruited healthy participants.
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Outcome measures
| Measure |
Part 1: PET/CT Scan
n=5 Participants
Healthy participants had 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants received FDG as part of the PET/CT procedures and provided sputum/blood samples.
|
Part 2: Placebo
Matching placebo was planned to be administered by IV infusion at Baseline. (Day 1) of Part 2. PET/CT scan was to be done on Weeks 2, 4 and 6.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any AEs
|
1 Participants
|
—
|
|
Number of Participants With Adverse Events (AEs)
SAEs
|
0 Participants
|
—
|
Adverse Events
Part 1: PET/CT Scan
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: PET/CT Scan
n=5 participants at risk
Healthy participants had 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan. Participants received FDG as part of the PET/CT procedures and provided sputum/blood samples.
|
|---|---|
|
General disorders
Right-hand injury
|
20.0%
1/5 • AEs were collected in Part 1 (21 days).
All recruited healthy participants were analyzed.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER