Trial Outcomes & Findings for Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients (NCT NCT01284062)

Last Updated: 2014-11-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

Baseline, Week 14

Results posted on

2014-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Overall Study STARTED	21	21	21	21
Overall Study COMPLETED	10	13	15	7
Overall Study NOT COMPLETED	11	8	6	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Overall Study Adverse Event	4	5	0	5
Overall Study Lack of Efficacy	3	2	2	1
Overall Study Medication error without adverse event	0	0	1	0
Overall Study Protocol Violation	1	0	0	2
Overall Study Withdrawal by Subject	3	1	2	5
Overall Study Other	0	0	0	1
Overall Study Site Closed	0	0	1	0

Baseline Characteristics

Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=21 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=21 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=21 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=21 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Total n=84 Participants Total of all reporting groups
Age, Continuous	36.6 years STANDARD_DEVIATION 14.5 • n=93 Participants	37.5 years STANDARD_DEVIATION 10.4 • n=4 Participants	46.3 years STANDARD_DEVIATION 12.9 • n=27 Participants	37.0 years STANDARD_DEVIATION 11.5 • n=483 Participants	39.4 years STANDARD_DEVIATION 12.8 • n=36 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	10 Participants n=4 Participants	7 Participants n=27 Participants	10 Participants n=483 Participants	35 Participants n=36 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	11 Participants n=4 Participants	14 Participants n=27 Participants	11 Participants n=483 Participants	49 Participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline, Week 14

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=14 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=15 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=13 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Fold Change From Baseline in Fecal Calprotectin at Week 14	0.41 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.29 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.79 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	1.24 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.

SECONDARY outcome

Timeframe: Pre-dose to end of the dosing interval after Day 1, Week 12

Population: 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.

Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=20 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=21 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab Day 1 (n=19, 20, 20)	54480 nanogram/milliliter (ng/mL) Standard Deviation 15027	101200 nanogram/milliliter (ng/mL) Standard Deviation 36239	182200 nanogram/milliliter (ng/mL) Standard Deviation 64817	—
Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab Week 12 (n=15, 16, 13)	68270 nanogram/milliliter (ng/mL) Standard Deviation 34360	121400 nanogram/milliliter (ng/mL) Standard Deviation 43461	197600 nanogram/milliliter (ng/mL) Standard Deviation 80647	—

SECONDARY outcome

Timeframe: Pre-dose to end of the dosing interval after Day 1, Week 12

Population: 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.

Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=20 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=21 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab Day 1 (n=19, 20, 20)	0.0000 ng/mL Standard Deviation 0.00000	42.45 ng/mL Standard Deviation 165.38	51.19 ng/mL Standard Deviation 201.57	—
Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab Week 12 (n=15, 16, 13)	13310 ng/mL Standard Deviation 8314.0	22350 ng/mL Standard Deviation 14281	31120 ng/mL Standard Deviation 16821	—

SECONDARY outcome

Timeframe: Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2

Population: 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.

Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=20 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=20 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab	8346000 nanogramhour/milliliter (nghr/mL) Standard Deviation 3622500	14670000 nanogramhour/milliliter (nghr/mL) Standard Deviation 6055800	24430000 nanogramhour/milliliter (nghr/mL) Standard Deviation 7657300	—

SECONDARY outcome

Timeframe: Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

Population: 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.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=16 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=7 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Plasma Decay Half-Life (t1/2) for Anrukinzumab	392.4 hours Standard Deviation 99.107	470.5 hours Standard Deviation 361.46	362.4 hours Standard Deviation 111.18	—

SECONDARY outcome

Timeframe: Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

Population: 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.

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=16 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=13 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Systemic Clearance (CL) for Anrukinzumab	0.2844 liters/day Standard Deviation 0.15918	0.3090 liters/day Standard Deviation 0.14268	0.3789 liters/day Standard Deviation 0.23249	—

SECONDARY outcome

Timeframe: Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=16 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=7 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Volume of Distribution (Vz) for Anrukinzumab	5.726 liters Standard Deviation 2.5057	9.704 liters Standard Deviation 13.186	6.143 liters Standard Deviation 2.1013	—

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=21 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=21 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=21 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12 Fold Change at Week 2 (n=15, 17, 18, 13)	0.70 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.81 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.71 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.77 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.
Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12 Fold change at Week 4 (n=14, 18, 19, 16)	0.92 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.47 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.92 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.55 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.
Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12 Fold change at Week 8 (n=10, 16, 17, 16)	0.78 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.36 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	1.14 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.52 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.
Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12 Fold change at Week 12 (n=9, 13, 14, 11)	0.64 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.19 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.96 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.67 fold change Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.

SECONDARY outcome

Timeframe: Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=21 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=21 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=21 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Total Interleukin-13 (IL-13) Level Week 20 (n=8, 15, 15, 8)	1.5140 picogram/milliliter Standard Deviation 1.82370	9.8396 picogram/milliliter Standard Deviation 25.99516	7.4261 picogram/milliliter Standard Deviation 8.00205	4.1745 picogram/milliliter Standard Deviation 2.84220
Total Interleukin-13 (IL-13) Level Baseline (n=15, 21, 20, 19)	0.6247 picogram/milliliter Standard Deviation 0.97041	1.6231 picogram/milliliter Standard Deviation 2.95190	1.2900 picogram/milliliter Standard Deviation 2.07219	0.7525 picogram/milliliter Standard Deviation 1.59494
Total Interleukin-13 (IL-13) Level Day 2 (n=21, 19, 17, 18)	0.5980 picogram/milliliter Standard Deviation 0.81335	3.6373 picogram/milliliter Standard Deviation 4.69500	6.6673 picogram/milliliter Standard Deviation 7.29515	5.0474 picogram/milliliter Standard Deviation 4.97368
Total Interleukin-13 (IL-13) Level Day 4 (n=16, 16, 20, 15)	0.7056 picogram/milliliter Standard Deviation 1.29166	7.7698 picogram/milliliter Standard Deviation 9.02951	12.3410 picogram/milliliter Standard Deviation 11.84611	10.1349 picogram/milliliter Standard Deviation 10.24068
Total Interleukin-13 (IL-13) Level Day 7 (n=7, 12, 9, 13)	0.8991 picogram/milliliter Standard Deviation 1.15883	15.6742 picogram/milliliter Standard Deviation 34.90836	16.6700 picogram/milliliter Standard Deviation 16.73533	11.3600 picogram/milliliter Standard Deviation 16.79136
Total Interleukin-13 (IL-13) Level Week 2 (n=20, 21, 19, 19)	0.7177 picogram/milliliter Standard Deviation 0.98373	16.6373 picogram/milliliter Standard Deviation 54.71391	17.7895 picogram/milliliter Standard Deviation 18.53571	21.5021 picogram/milliliter Standard Deviation 27.03784
Total Interleukin-13 (IL-13) Level Week 4 (n=18, 21, 19, 17)	0.8949 picogram/milliliter Standard Deviation 1.47538	15.1244 picogram/milliliter Standard Deviation 43.76893	17.1853 picogram/milliliter Standard Deviation 15.00105	8.7807 picogram/milliliter Standard Deviation 5.39145
Total Interleukin-13 (IL-13) Level Week 8 (n=16, 18, 18, 15)	0.7310 picogram/milliliter Standard Deviation 1.09524	21.4964 picogram/milliliter Standard Deviation 72.31269	16.8200 picogram/milliliter Standard Deviation 15.47020	6.8027 picogram/milliliter Standard Deviation 3.44810
Total Interleukin-13 (IL-13) Level Week 12 (n=12, 14, 17, 11)	0.8925 picogram/milliliter Standard Deviation 1.38386	19.3543 picogram/milliliter Standard Deviation 52.00880	22.4335 picogram/milliliter Standard Deviation 27.04635	6.8461 picogram/milliliter Standard Deviation 4.19321
Total Interleukin-13 (IL-13) Level Week 14 (n=12, 14, 16, 13)	1.0545 picogram/milliliter Standard Deviation 1.15526	33.6697 picogram/milliliter Standard Deviation 110.9546	20.0044 picogram/milliliter Standard Deviation 37.36283	8.9492 picogram/milliliter Standard Deviation 6.33317
Total Interleukin-13 (IL-13) Level Week 16 (n=10, 12, 12, 7)	0.5054 picogram/milliliter Standard Deviation 0.29982	15.0002 picogram/milliliter Standard Deviation 40.41488	16.4423 picogram/milliliter Standard Deviation 24.54910	3.7570 picogram/milliliter Standard Deviation 2.91709
Total Interleukin-13 (IL-13) Level Week 24 (n=10, 12, 12, 8)	1.3300 picogram/milliliter Standard Deviation 1.41349	3.0140 picogram/milliliter Standard Deviation 3.23912	6.3665 picogram/milliliter Standard Deviation 7.85116	3.0913 picogram/milliliter Standard Deviation 1.99098
Total Interleukin-13 (IL-13) Level Week 28 (n=10, 12, 13, 8)	1.2151 picogram/milliliter Standard Deviation 2.23797	0.9936 picogram/milliliter Standard Deviation 0.75719	2.8005 picogram/milliliter Standard Deviation 2.67967	3.1724 picogram/milliliter Standard Deviation 2.15647
Total Interleukin-13 (IL-13) Level Week 32 (n=9, 12, 13, 8)	0.4727 picogram/milliliter Standard Deviation 0.37875	1.0548 picogram/milliliter Standard Deviation 0.80675	1.9379 picogram/milliliter Standard Deviation 1.99196	2.4725 picogram/milliliter Standard Deviation 2.54141

SECONDARY outcome

Timeframe: Baseline up to Week 32

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=21 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=21 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=21 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	15 participants	19 participants	17 participants	17 participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	4 participants	4 participants	2 participants	4 participants

SECONDARY outcome

Timeframe: Baseline up to Week 32

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=21 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=21 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=21 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Number of Participants Who Discontinued From the Study Due to Adverse Events	4 participants	5 participants	1 participants	5 participants

SECONDARY outcome

Timeframe: Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32

Neutralizing antibody was not analyzed as no participant had positive ADA samples.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=21 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=21 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=21 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody Week 14 (n=13, 14, 15, 13)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody Day 1 (n=18, 20, 19, 21)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody Week 4 (n=17, 18, 20, 18)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody Week 8 (n=15, 17, 18, 13)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody Week 12 (n=14, 15, 17, 13)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody Week 16 (n=10, 15, 14, 7)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody Week 20 (n=11, 14, 15, 7)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody Week 24 (n=10, 12, 14, 7)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody Week 28 (n=8, 12, 13, 7)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody Week 32 (n=10, 13, 15, 6)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=15 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=16 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=13 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14 Worsening	3 participants	2 participants	0 participants	0 participants
Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14 Improvement	6 participants	8 participants	11 participants	2 participants
Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14 No Change	3 participants	5 participants	5 participants	11 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=15 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=16 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=13 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Clinical Response Rate at Week 14	41.67 percentage of participants Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	60.00 percentage of participants Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	50.00 percentage of participants Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	15.38 percentage of participants Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=15 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=16 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=13 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Clinical Remission Rate at Week 14	16.67 percentage of participants Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	33.33 percentage of participants Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	18.75 percentage of participants Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	0.00 percentage of participants Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=15 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=16 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=13 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Change From Baseline in Total Mayo Score at Week 14	-1.32 unit on a scale Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	-2.28 unit on a scale Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	-2.30 unit on a scale Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.	-0.79 unit on a scale Data is reported in the statistical analysis section because only 80% CI was calculated for this outcome measure as per planned analysis.

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=15 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=16 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=13 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Number of Participants With Change From Baseline in Stool Frequency at Week 14 Improvement	4 participants	7 participants	7 participants	3 participants
Number of Participants With Change From Baseline in Stool Frequency at Week 14 No Change	8 participants	4 participants	8 participants	6 participants
Number of Participants With Change From Baseline in Stool Frequency at Week 14 Worsening	0 participants	4 participants	1 participants	4 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=15 Participants Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=16 Participants Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=13 Participants Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Number of Participants With Change From Baseline in Rectal Bleeding at Week 14 Improvement	4 participants	8 participants	7 participants	5 participants
Number of Participants With Change From Baseline in Rectal Bleeding at Week 14 No Change	6 participants	6 participants	6 participants	7 participants
Number of Participants With Change From Baseline in Rectal Bleeding at Week 14 Worsening	2 participants	1 participants	3 participants	1 participants

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Anrukinzumab 200 mg

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Anrukinzumab 400 mg

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Anrukinzumab 600 mg

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=21 participants at risk Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 200 mg n=21 participants at risk Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 400 mg n=21 participants at risk Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab 600 mg n=21 participants at risk Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Blood and lymphatic system disorders Anaemia	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Colitis ulcerative	14.3% 3/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 3/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholangitis sclerosing	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Clostridium difficile infection	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

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.
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Restriction type: OTHER