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See termination reason in detailed description.
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The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care therapies.
The trial was terminated prematurely on Mar 24, 2014 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD 0360324 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD 0360324 | Biological | 100 mg Q2W or 150 mg Q2W via intravenous infusion based on protocol determined dose escalation/de-escalation criteria; 12 weeks Active Therapy; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16 | 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. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Chest X-ray Global Assessment Score (5-point ) | 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. | Baseline, Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai School Of Medicine/Mount Sinai Medical Center | New York | New York | 10029 | United States | ||
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16 | 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. | No subjects were analyzed due to early termination of the study and the small enrollment number. | Posted | Baseline, Week 16 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye swelling | Eye disorders | MedDRA 17.1 | Non-systematic Assessment |
Due to early termination of the study and the small enrollment number, analysis of primary and secondary pharmacodynamic endpoints could not be performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D017565 | Sarcoidosis, Pulmonary |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012507 | Sarcoidosis |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline for injection | Other | normal saline Q2W via intravenous infusion for 12 weeks |
|
| Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20 | 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. | Baseline, Weeks 2, 4, 8, 12, 14, and 20 |
| Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20 | 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. | Baseline, Weeks 2, 4, 8, 12, 14, and 20 |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20 | 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. | Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20 |
| Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20 | 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. | Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20 |
| Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20 | 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. | Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20 |
| Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks | 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. | Baseline, Weeks 0, 2, 4, 8, 12, 14, 16 |
| Medical Arts Building |
| Cincinnati |
| Ohio |
| 45219 |
| United States |
| The Barrett Cancer Center at UC Health | Cincinnati | Ohio | 45219 | United States |
| University Hospital | Cincinnati | Ohio | 45219 | United States |
| Iinterstitial Lung Disease & Sarcoidosis Clinic | Cincinnati | Ohio | 45267 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Change From Baseline in Chest X-ray Global Assessment Score (5-point ) | 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. | No subjects were analyzed due to early termination of the study and the small enrollment number. | Posted | Baseline, Week 16 |
|
|
| Secondary | Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20 | 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. | No subjects were analyzed due to early termination of the study and the small enrollment number. | Posted | Baseline, Weeks 2, 4, 8, 12, 14, and 20 |
|
|
| Secondary | Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20 | 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. | No subjects were analyzed due to early termination of the study and the small enrollment number. | Posted | Baseline, Weeks 2, 4, 8, 12, 14, and 20 |
|
|
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20 | 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. | No subjects were analyzed due to early termination of the study and the small enrollment number. | Posted | Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20 |
|
|
| Secondary | Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20 | 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. | No subjects were analyzed due to early termination of the study and the small enrollment number. | Posted | Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20 |
|
|
| Secondary | Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20 | 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. | No subjects were analyzed due to early termination of the study and the small enrollment number. | Posted | Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20 |
|
|
| Secondary | Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks | 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. | No subjects were analyzed due to early termination of the study and the small enrollment number. | Posted | Baseline, Weeks 0, 2, 4, 8, 12, 14, 16 |
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
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.
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004333 |
| Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |