Trial Outcomes & Findings for A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis (NCT NCT01732211)
NCT ID: NCT01732211
Last Updated: 2020-01-06
Results Overview
The percent predicted FVC was calculated by observed FVC/predicted FVC \* 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
TERMINATED
PHASE2
1 participants
Baseline, Week 16
2020-01-06
Participant Flow
In Part A, approximately 22 subjects were to be enrolled to receive PD 0360324 100 mg once every 2 weeks (Q2W)/150 mg Q2W. In Part B, approximately 66 subjects were planned to be enrolled to receive PD 0360324 (either 100 or 150 mg Q2W defined in Part A) B.
Participant milestones
| Measure |
PD 0360324 100 mg Q2W / 150 mg Q2W
PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.
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|---|---|
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Overall Study
STARTED
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1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
Baseline characteristics by cohort
| Measure |
PD 0360324 100 mg Q2W / 150 mg Q2W
n=1 Participants
PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.
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|---|---|
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Age, Continuous
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58 years
STANDARD_DEVIATION NA • n=99 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=99 Participants
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|
Sex: Female, Male
Male
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1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: No subjects were analyzed due to early termination of the study and the small enrollment number.
The percent predicted FVC was calculated by observed FVC/predicted FVC \* 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 16Population: No subjects were analyzed due to early termination of the study and the small enrollment number.
Digital copies of Chest x-rays performed during the study were graded according to a 5 point Likert scale: 1 = markedly worsened; 2 = worsened; 3 = unchanged; 4 = improved; and 5 = markedly improved. Baseline will be defined as the last available x-ray prior to first dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 14, and 20Population: No subjects were analyzed due to early termination of the study and the small enrollment number.
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 14, and 20Population: No subjects were analyzed due to early termination of the study and the small enrollment number.
The percent predicted FVC was calculated by observed FVC/predicted FVC \* 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20Population: No subjects were analyzed due to early termination of the study and the small enrollment number.
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20Population: No subjects were analyzed due to early termination of the study and the small enrollment number.
The percent predicted FEV1 was calculated by observed FEV1/predicted FEV1 \* 100. The predicted FEV1 values was calculated according to age, height, race and gender. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20Population: No subjects were analyzed due to early termination of the study and the small enrollment number.
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 0, 2, 4, 8, 12, 14, 16Population: No subjects were analyzed due to early termination of the study and the small enrollment number.
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Through FVC was obtained from spirometry, performed before study treatment administration.
Outcome measures
Outcome data not reported
Adverse Events
PD 0360324 100 mg Q2W / 150 mg Q2W
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PD 0360324 100 mg Q2W / 150 mg Q2W
n=1 participants at risk
PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.
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|---|---|
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Eye disorders
Eye swelling
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100.0%
1/1
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Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
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100.0%
1/1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER