| Primary | Fold Change From Baseline in Fecal Calprotectin at Week 14 | The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14. | Modified Intent to Treat (mITT: all randomized participants who received greater than or equal to [>=] 1 dose study drug); Data as Observed (DAO: all mITT participants with all data needed for calculation of specified endpoint). "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint. | Posted | | Least Squares Mean | 95% Confidence Interval | fold change | | Baseline, Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG003 | Anrukinzumab 600 mg | Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
| | Units | Counts |
|---|
| Participants | - OG0007
- OG00114
- OG00215
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.41(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.
- OG0010.29(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.
- OG002
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Least squares (LS) mean | 0.41 | | | 2-Sided | 80 | 0.225 | 0.766 | | | LS mean and confidence interval (CI) were based on back log-transformation of those from the analysis of covariance (ANCOVA) model. | No | Superiority or Other | | | | | | |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab | Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12). | All participants with evaluable pharmacokinetic (PK) results were included in PK population. PK samples with time deviation greater than (>) 20 percent (%) from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" = participants in PK population; "n" = evaluable participants at specified time point. | Posted | | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | | Pre-dose to end of the dosing interval after Day 1, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 600 mg | Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
| |
| Secondary | Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab | Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12). | All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" signifies participants in PK population; "n" signifies evaluable participants at specified time point. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose to end of the dosing interval after Day 1, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 600 mg | Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
| |
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab | Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported. | All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | nanogram*hour/milliliter (ng*hr/mL) | | Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 600 mg | Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
| |
| Secondary | Plasma Decay Half-Life (t1/2) for Anrukinzumab | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | hours | | Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 | | | | ID | Title | Description |
|---|
| OG000 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 600 mg | Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
| |
| Secondary | Systemic Clearance (CL) for Anrukinzumab | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | liters/day | | Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 | | | | ID | Title | Description |
|---|
| OG000 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 600 mg | Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
| |
| Secondary | Volume of Distribution (Vz) for Anrukinzumab | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | liters | | Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 | | | | ID | Title | Description |
|---|
| OG000 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 600 mg | Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
| |
| Secondary | Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12 | The fold change from baseline in fecal calprotectin at post-baseline visit, is the ratio of the measurement of fecal calprotectin at post-baseline visit to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at post-baseline visit. | mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in mITT population; "n" signifies participants in mITT DAO population for specified time point. | Posted | | Least Squares Mean | 95% Confidence Interval | fold change | | Baseline, Week 2, 4, 8, 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
|
| Secondary | Total Interleukin-13 (IL-13) Level | | mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in mITT population; "n" signifies participants in mITT DAO population for specified time point. | Posted | | Mean | Standard Deviation | picogram/milliliter | | Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG003 | Anrukinzumab 600 mg | Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 Week 32 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial. | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | Posted | | Number | | participants | | Baseline up to Week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg |
|
| Secondary | Number of Participants Who Discontinued From the Study Due to Adverse Events | | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | Posted | | Number | | participants | | Baseline up to Week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG003 | Anrukinzumab 600 mg | Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
| |
| Secondary | Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody | Neutralizing antibody was not analyzed as no participant had positive ADA samples. | mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in mITT population; "n" signifies participants in mITT DAO population for specified time point. | Posted | | Number | | participants | | Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG003 | Anrukinzumab 600 mg | |
|
| Other Pre-specified | Clinical Response Rate at Week 14 | Clinical response rate is defined as percentage of participants with at least 3 point decrease from baseline in total Mayo score with at least 30% change along with 1 point decrease from baseline or absolute score of 0 or 1 in rectal bleeding. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity. | mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg |
|
| Other Pre-specified | Clinical Remission Rate at Week 14 | Clinical remission rate is defined as percentage of participants with a total Mayo score less than or equal to 2, with no individual subscore greater than 1 at post baseline visit. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity. | mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg | |
|
| Other Pre-specified | Change From Baseline in Total Mayo Score at Week 14 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity. | mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint. | Posted | | Least Squares Mean | 95% Confidence Interval | unit on a scale | | Baseline, Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
|
| Other Pre-specified | Number of Participants With Change From Baseline in Stool Frequency at Week 14 | Stool frequency is a sub score of Mayo score used to measure the disease activity of ulcerative colitis. The score for stool frequency ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for stool frequency at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score. | mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint. | Posted | | Number | | participants | | Baseline, Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
|
| Other Pre-specified | Number of Participants With Change From Baseline in Rectal Bleeding at Week 14 | Mayo score is used to measure the disease activity of ulcerative colitis. Rectal bleeding is a sub score of Mayo score. The score for rectal bleeding ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for rectal bleeding at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score. | mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint. | Posted | | Number | | participants | | Baseline, Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
|
| Secondary | Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14 | Mayo score is used to measure the disease activity of ulcerative colitis. Endoscopy or flexible sigmoidoscopy is a sub score of Mayo score. The score for endoscopic subscore ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for endoscopy or flexible sigmoidoscopy at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score. | mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint. | Posted | | Number | | participants | | Baseline, Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG001 | Anrukinzumab 200 mg | Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. | | OG002 | Anrukinzumab 400 mg | Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12. |
|