Trial Outcomes & Findings for Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis. (NCT NCT02840721)
NCT ID: NCT02840721
Last Updated: 2023-10-23
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious AE (SAE) was any untoward medical occurrence at any dose that (1) resulted in death; (2) was life-threatening (immediate risk of death); (3) required inpatient hospitalization or prolongation of existing hospitalization; (4) resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); (5) resulted in congenital anomaly/birth defect. A treatment-emergent AE (TEAE) was defined as an event that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state. Causality to study treatment was determined by the investigator.
COMPLETED
PHASE2
50 participants
Day 1 up to final onsite visit (Week 26)
2023-10-23
Participant Flow
Participant milestones
| Measure |
PF-06480605 500 mg IV
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Treatment Period
STARTED
|
50
|
|
Treatment Period
COMPLETED
|
49
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|
Treatment Period
NOT COMPLETED
|
1
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|
Follow-Up
STARTED
|
49
|
|
Follow-Up
COMPLETED
|
42
|
|
Follow-Up
NOT COMPLETED
|
7
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Reasons for withdrawal
| Measure |
PF-06480605 500 mg IV
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Treatment Period
Adverse Event
|
1
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|
Follow-Up
Lack of Efficacy
|
1
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Follow-Up
Withdrawal by Subject
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4
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Follow-Up
Withdrawal of Consent
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2
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Baseline Characteristics
Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.
Baseline characteristics by cohort
| Measure |
PF-06480605 500 mg IV
n=50 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Age, Continuous
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40.0 years
STANDARD_DEVIATION 14.52 • n=5 Participants
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Sex: Female, Male
Female
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22 Participants
n=5 Participants
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Sex: Female, Male
Male
|
28 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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48 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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2 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1 up to final onsite visit (Week 26)Population: The analysis population included all participants who received at least 1 dose of PF-06480605.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious AE (SAE) was any untoward medical occurrence at any dose that (1) resulted in death; (2) was life-threatening (immediate risk of death); (3) required inpatient hospitalization or prolongation of existing hospitalization; (4) resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); (5) resulted in congenital anomaly/birth defect. A treatment-emergent AE (TEAE) was defined as an event that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state. Causality to study treatment was determined by the investigator.
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=50 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Who Withdrew Due to Adverse Events
All-causality AEs
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33 Participants
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|
Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Who Withdrew Due to Adverse Events
All-causality SAEs
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3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Who Withdrew Due to Adverse Events
Treatment-related AEs
|
8 Participants
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Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Who Withdrew Due to Adverse Events
Treatment-related SAEs
|
1 Participants
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Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Who Withdrew Due to Adverse Events
Withdrew due to AEs
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1 Participants
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PRIMARY outcome
Timeframe: Day 1 up to final onsite visit (Week 26)Population: The analysis population included all participants who received at least 1 dose of PF-06480605.
The following parameters were evaluated: hematology (hemoglobin, hematocrit, erythrocytes, erythrocyte mean corpuscular volume, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, and prothrombin time), clinical chemistry (bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, glucose, and creatine kinase), and urinalysis (urine glucose, ketones, urine protein, urine hemoglobin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, and bacteria).
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=50 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Number of Participants With Laboratory Abnormalities
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38 Participants
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PRIMARY outcome
Timeframe: Baseline up to final onsite visit (Week 26)Population: The analysis population included all participants who received at least 1 dose of PF-06480605.
Vital signs evaluation included sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), and pulse rate. Sitting blood pressure was measured with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mm Hg). The same size BP cuff which had been properly sized and calibrated was used to measure BP each time. Number of participants with vital signs data meeting pre-specified criteria is presented.
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=50 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Sitting DBP <50 mm Hg
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1 Participants
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Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Sitting SBP <90 mm Hg
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4 Participants
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|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Sitting pulse rate <40 beats per minute (bpm)
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0 Participants
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Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Sitting pulse rate >120 bpm
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1 Participants
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Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Sitting DBP increase from baseline >=20 mm Hg
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2 Participants
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Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Sitting SBP increase from baseline >=30 mm Hg
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5 Participants
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|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Sitting DBP decrease from baseline >=20 mm Hg
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7 Participants
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|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Sitting SBP decrease from baseline >=30 mm Hg
|
1 Participants
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PRIMARY outcome
Timeframe: Baseline up to final onsite visit (Week 26)Population: The analysis population included all participants who received at least 1 dose of PF-06480605 and had both baseline and at least 1 post-baseline ECG evaluation performed.
All scheduled 12-lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Number of participants with ECG data meeting pre-specified criteria is presented.
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=49 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
PR interval >=300 milliseconds (msec)
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0 Participants
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Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
QRS duration >=140 msec
|
0 Participants
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|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
QT interval >=500 msec
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0 Participants
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|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
QTcF interval: 450 to <480 msec
|
5 Participants
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Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
QTcF interval: 480 to <500 msec
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0 Participants
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Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
QTcF interval: >=500 msec
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0 Participants
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|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
PR interval increase from baseline >=25%/50%
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0 Participants
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|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
QRS duration increase from baseline >=50%
|
0 Participants
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|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
QTcF increase from baseline: 30 to <60 msec
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9 Participants
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Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
QTcF increase from baseline: >=60 msec
|
1 Participants
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PRIMARY outcome
Timeframe: Week 14Population: The analysis population included all participants who were eligible for enrollment, not a major protocol violator, with at least 6 out of 7 planned doses received and a final colonoscopy at Week 14.
Endoscopic improvement at Week 14 was defined as Mayo endoscopic sub-score of 0 or 1, and without friability. The Mayo scoring system was used to assess ulcerative colitis activity, and it ranges from 0 to 12, calculated as sum of 4 sub-scores, with higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2=3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, mild friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=45 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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Percentage of Participants Achieving Endoscopic Improvement at Week 14, Based on Uniformly Minimum-Variance Unbiased Estimator (UMVUE) - Per Protocol Analysis Set
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38.20 percentage of participants
Interval 23.82 to 53.68
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SECONDARY outcome
Timeframe: Week 14Population: The analysis population included all participants who received at least 1 dose of PF-06480605.
Remission: total Mayo score \<=2 with no individual subscore \>1. Mayo scoring system was used to assess ulcerative colitis activity (range: 0 to 12, calculated as sum of 4 subscores, higher scores indicating more severe disease). The 4 subscores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on modified endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, no friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=50 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Percentage of Participants Achieving Remission at Week 14 - Full Analysis Set
|
24.00 percentage of participants
Interval 13.06 to 38.17
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SECONDARY outcome
Timeframe: Week 14Population: The analysis population included all participants who were eligible for enrollment, not a major protocol violator, with at least 6 out of 7 planned doses received and a final colonoscopy at Week 14.
Remission: total Mayo score \<=2 with no individual subscore \>1. Mayo scoring system was used to assess ulcerative colitis activity (range: 0 to 12, calculated as sum of 4 subscores, higher scores indicating more severe disease). The 4 subscores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on modified endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, no friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=45 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Percentage of Participants Achieving Remission at Week 14 - Per Protocol Analysis Set
|
26.67 percentage of participants
Interval 14.6 to 41.94
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SECONDARY outcome
Timeframe: Week 14Population: The analysis population included all participants who received at least 1 dose of PF-06480605.
Endoscopic remission at Week 14 was defined as Mayo endoscopic sub-score of 0. The Mayo scoring system was used to assess ulcerative colitis activity, and it ranges from 0 to 12, calculated as sum of 4 sub-scores, with higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, mild friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=50 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Percentage of Participants Achieving Endoscopic Remission at Week 14 - Full Analysis Set
|
10.00 percentage of participants
Interval 3.33 to 21.81
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SECONDARY outcome
Timeframe: 30 minutes pre-dose and 1 hour post-dose on Day 85Population: The analysis population included all enrolled participants who received at least 1 dose of PF-06480605 and in whom at least 1 concentration value was reported.
Maximum serum concentration (Cmax) of PF-06480605 was observed directly from data.
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=44 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Maximum Serum Concentration (Cmax) of PF-06480605
|
263400 nanograms (ng)/milliliters (mL)
Geometric Coefficient of Variation 54
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SECONDARY outcome
Timeframe: 30 minutes pre-dose and 1 hour post-dose on Day 85Population: The analysis population included all enrolled participants who received at least 1 dose of PF-06480605 and had at least 1 derived value of a specific pharmacokinetic (PK) parameter.
Average serum concentration (Cav) of PF-06480605 was calculated as AUCtau/tau, where tau was the dosing interval (tau=14 days), and AUCtau was the area under the concentration-time profile from time 0 to time tau.
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=44 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Average Serum Concentration (Cav) of PF-06480605
|
171400 nanograms (ng)/milliliters (mL)
Geometric Coefficient of Variation 45
|
SECONDARY outcome
Timeframe: 30 minutes pre-dose and 1 hour post-dose on Day 85Population: The analysis population included all enrolled participants who received at least 1 dose of PF-06480605 and in whom at least 1 concentration value was reported.
Lowest serum concentration (Cmin) of PF-06480605 was observed directly from data.
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=44 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Lowest Serum Concentration (Cmin) of PF-06480605
|
87650 ng/mL
Geometric Coefficient of Variation 50
|
SECONDARY outcome
Timeframe: 30 minutes pre-dose and 1 hour post-dose on Day 85Population: The analysis population included all enrolled participants who received at least 1 dose of PF-06480605 and had at least 1 derived value of a specific pharmacokinetic (PK) parameter.
AUCtau of PF-06480605 was calculated using linear/log trapezoidal method; tau was the dosing interval (=14 days).
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=44 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Area Under the Concentration-time Profile From Time Zero to Time Tau (AUCtau) of PF-06480605
|
57610000 ng.hr/mL
Geometric Coefficient of Variation 45
|
SECONDARY outcome
Timeframe: Day 1 up to final onsite visit (Week 26)Population: The analysis population included all enrolled participants who received at least 1 dose of PF 06480605 with at least 1 post-treatment ADA determination.
Serum samples were analyzed using a new ADA assay with acid pre-treatment followed by a more drug-tolerant cell-based NAb assay. For ADA assay with acid pre-treatment, the sample was deemed positive if log titer \>=1.30; for cell-based NAb assay, the sample was deemed positive if log titer \>=0.699.
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=50 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Percentage of Participants Who Developed Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
ADA
|
82.0 percentage of participants
|
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Percentage of Participants Who Developed Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
NAb
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 8, 12 and 26Population: The analysis population included all participants who received at least 1 dose of PF 06480605 with at least 1 fecal calprotectin measurement.
Fecal calprotectin has been used to detect intestinal inflammation (colitis or enteritis) and can serve as a biomarker for inflammatory bowel diseases. Elevated fecal calprotectin levels indicate migration of neutrophils into the intestinal mucosa, which occurs during intestinal inflammation.
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=48 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Change From Baseline in Fecal Calprotectin
Baseline
|
3662.25 micrograms/grams
Standard Deviation 3556.331
|
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Change From Baseline in Fecal Calprotectin
Week 2 change from baseline
|
-1861.38 micrograms/grams
Standard Deviation 3565.861
|
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Change From Baseline in Fecal Calprotectin
Week 8 change from baseline
|
-2509.43 micrograms/grams
Standard Deviation 3751.843
|
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Change From Baseline in Fecal Calprotectin
Week 12 change from baseline
|
-2844.26 micrograms/grams
Standard Deviation 3623.922
|
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Change From Baseline in Fecal Calprotectin
Week 26 change from baseline
|
-2726.97 micrograms/grams
Standard Deviation 3673.063
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, and 26Population: The analysis population included all participants who received at least 1 dose of PF 06480605 with 1 hsCRP measurement.
HsCRP is used mainly as a marker of inflammation.
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=48 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
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Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Baseline
|
0.9316 micrograms/deciliter
Standard Deviation 1.15545
|
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Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Week 2 change from baseline
|
-0.2136 micrograms/deciliter
Standard Deviation 1.43785
|
|
Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Week 4 change from baseline
|
-0.4883 micrograms/deciliter
Standard Deviation 1.10820
|
|
Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Week 6 change from baseline
|
-0.3314 micrograms/deciliter
Standard Deviation 1.39605
|
|
Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Week 8 change from baseline
|
-0.4875 micrograms/deciliter
Standard Deviation 1.00870
|
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Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Week 10 change from baseline
|
-0.5738 micrograms/deciliter
Standard Deviation 0.97608
|
|
Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Week 12 change from baseline
|
-0.4242 micrograms/deciliter
Standard Deviation 1.18416
|
|
Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Week 14 change from baseline
|
-0.3983 micrograms/deciliter
Standard Deviation 1.21181
|
|
Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Week 16 change from baseline
|
-0.5070 micrograms/deciliter
Standard Deviation 1.37798
|
|
Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Week 20 change from baseline
|
-0.4728 micrograms/deciliter
Standard Deviation 1.11950
|
|
Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Week 24 change from baseline
|
-0.5334 micrograms/deciliter
Standard Deviation 1.03224
|
|
Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)
Week 26 change from baseline
|
-0.3453 micrograms/deciliter
Standard Deviation 1.37576
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, and 26Population: The analysis population included all participants who received at least 1 dose of PF 06480605 with 1 sTL1A measurement.
TL1A is a member of the tumor necrosis factor (TNF) family of cytokines. The investigational product of this study PF-06480605 is a fully human neutralizing antibody against TL1A.
Outcome measures
| Measure |
PF-06480605 500 mg IV
n=50 Participants
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
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|---|---|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Week 8 change from baseline
|
7319.3 picograms/mL
Standard Deviation 3587.14
|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Baseline
|
103.9 picograms/mL
Standard Deviation 32.05
|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Week 2 change from baseline
|
3390.4 picograms/mL
Standard Deviation 1349.87
|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Week 4 change from baseline
|
5308.9 picograms/mL
Standard Deviation 2073.59
|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Week 6 change from baseline
|
6908.7 picograms/mL
Standard Deviation 3278.23
|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Week 10 change from baseline
|
7175.7 picograms/mL
Standard Deviation 4095.36
|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Week 12 change from baseline
|
6446.3 picograms/mL
Standard Deviation 4422.46
|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Week 14 change from baseline
|
6539.1 picograms/mL
Standard Deviation 4836.21
|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Week 16 change from baseline
|
5316.6 picograms/mL
Standard Deviation 4941.13
|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Week 20 change from baseline
|
3903.3 picograms/mL
Standard Deviation 4092.26
|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Week 24 change from baseline
|
3190.2 picograms/mL
Standard Deviation 3172.22
|
|
Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)
Week 26 change from baseline
|
3084.3 picograms/mL
Standard Deviation 2964.75
|
Adverse Events
PF-06480605 500 mg IV
Serious adverse events
| Measure |
PF-06480605 500 mg IV
n=50 participants at risk
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
|
|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
4.0%
2/50 • Number of events 2 • Day 1 up to final onsite visit (Week 26)
The same event may appear as both a non-serious adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Peritonitis
|
2.0%
1/50 • Number of events 1 • Day 1 up to final onsite visit (Week 26)
The same event may appear as both a non-serious adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/50 • Number of events 1 • Day 1 up to final onsite visit (Week 26)
The same event may appear as both a non-serious adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
PF-06480605 500 mg IV
n=50 participants at risk
Participants received PF-06480605 500 mg intravenously once every 2 weeks (Q2W) for a total of 7 doses (i.e., 12-week treatment period), and then were followed up for additional 14 weeks after the last dose of PF-06480605.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
3/50 • Number of events 3 • Day 1 up to final onsite visit (Week 26)
The same event may appear as both a non-serious adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
10.0%
5/50 • Number of events 5 • Day 1 up to final onsite visit (Week 26)
The same event may appear as both a non-serious adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
6.0%
3/50 • Number of events 7 • Day 1 up to final onsite visit (Week 26)
The same event may appear as both a non-serious adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
3/50 • Number of events 3 • Day 1 up to final onsite visit (Week 26)
The same event may appear as both a non-serious adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pharyngitis
|
6.0%
3/50 • Number of events 3 • Day 1 up to final onsite visit (Week 26)
The same event may appear as both a non-serious adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
6/50 • Number of events 6 • Day 1 up to final onsite visit (Week 26)
The same event may appear as both a non-serious adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
3/50 • Number of events 3 • Day 1 up to final onsite visit (Week 26)
The same event may appear as both a non-serious adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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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