Trial Outcomes & Findings for Long-Term Safety Of PF-00547659 In Ulcerative Colitis (NCT NCT01771809)
NCT ID: NCT01771809
Last Updated: 2021-06-03
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
330 participants
Primary outcome timeframe
From start of study drug administration up to 168 weeks
Results posted on
2021-06-03
Participant Flow
The study was conducted at 101 centers in 21 countries between 18 Mar 2013 (first participant first visit) and 13 Dec 2017 (last participant last visit).
A total of 331 participants were randomized and 330 participants received treatment in the study. One participant discontinued due to adverse event prior to receiving treatment.
Participant milestones
| Measure |
SHP647 75 mg
Participants received 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
SHP647 225 mg
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
166
|
|
Overall Study
COMPLETED
|
93
|
83
|
|
Overall Study
NOT COMPLETED
|
71
|
83
|
Reasons for withdrawal
| Measure |
SHP647 75 mg
Participants received 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
SHP647 225 mg
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
12
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
34
|
42
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Other (Insufficient clinical response)
|
22
|
20
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Other (other)
|
9
|
5
|
Baseline Characteristics
Long-Term Safety Of PF-00547659 In Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
SHP647 75 mg
n=164 Participants
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
SHP647 225 mg
n=166 Participants
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.5 Years
STANDARD_DEVIATION 12.75 • n=5 Participants
|
41.1 Years
STANDARD_DEVIATION 13.68 • n=7 Participants
|
40.8 Years
STANDARD_DEVIATION 13.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
160 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
148 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 168 weeksPopulation: SAS consisted of all enrolled participants who had received at least 1 dose of SHP647.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.
Outcome measures
| Measure |
SHP647 75 mg
n=164 Participants
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
SHP647 225 mg
n=166 Participants
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
Participants with any TEAE
|
146 Participants
|
147 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
Participants with any TESAE
|
34 Participants
|
40 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
Participants who withdrew treatment due to TEAE
|
12 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: SAS consisted of all enrolled participants who had received at least 1 dose of SHP647.
Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment \[PGA\]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.
Outcome measures
| Measure |
SHP647 75 mg
n=164 Participants
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
SHP647 225 mg
n=166 Participants
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
|---|---|---|
|
Percentage of Participants With Mucosal Healing at Week 16
|
27.4 Percentage of participants
|
29.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156Population: The pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of SHP647 and for whom at least 1 postdose PK sample was collected. Here 'Number of Participants Analyzed' refers to the number of participants evaluable for specific timepoint.
Serum trough concentrations of SHP647 versus time was reported.
Outcome measures
| Measure |
SHP647 75 mg
n=163 Participants
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
SHP647 225 mg
n=164 Participants
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
|---|---|---|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 156
|
983.49 Micrograms/liter (ug/L)
Standard Deviation 1485.708
|
1893.88 Micrograms/liter (ug/L)
Standard Deviation 4530.680
|
|
Serum Trough Concentrations of SHP647 Versus Time
Baseline
|
6398.62 Micrograms/liter (ug/L)
Standard Deviation 8584.412
|
8064.41 Micrograms/liter (ug/L)
Standard Deviation 10629.768
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 4
|
5496.56 Micrograms/liter (ug/L)
Standard Deviation 4026.759
|
16787.31 Micrograms/liter (ug/L)
Standard Deviation 7807.292
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 8
|
6245.79 Micrograms/liter (ug/L)
Standard Deviation 3371.708
|
20345.29 Micrograms/liter (ug/L)
Standard Deviation 9286.956
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 12
|
9038.72 Micrograms/liter (ug/L)
Standard Deviation 5540.836
|
23915.87 Micrograms/liter (ug/L)
Standard Deviation 10434.073
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 16
|
10445.24 Micrograms/liter (ug/L)
Standard Deviation 6387.004
|
24772.35 Micrograms/liter (ug/L)
Standard Deviation 11970.153
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 20
|
10928.76 Micrograms/liter (ug/L)
Standard Deviation 7900.859
|
25582.98 Micrograms/liter (ug/L)
Standard Deviation 11767.775
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 24
|
11145.54 Micrograms/liter (ug/L)
Standard Deviation 8019.864
|
27832.20 Micrograms/liter (ug/L)
Standard Deviation 12469.086
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 28
|
12978.11 Micrograms/liter (ug/L)
Standard Deviation 8772.285
|
27797.77 Micrograms/liter (ug/L)
Standard Deviation 13070.361
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 32
|
12926.04 Micrograms/liter (ug/L)
Standard Deviation 8798.671
|
28381.93 Micrograms/liter (ug/L)
Standard Deviation 11748.573
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 36
|
12785.55 Micrograms/liter (ug/L)
Standard Deviation 9182.501
|
29666.64 Micrograms/liter (ug/L)
Standard Deviation 13997.231
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 40
|
13004.90 Micrograms/liter (ug/L)
Standard Deviation 9544.675
|
28947.34 Micrograms/liter (ug/L)
Standard Deviation 12151.971
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 44
|
13337.50 Micrograms/liter (ug/L)
Standard Deviation 8620.549
|
29855.69 Micrograms/liter (ug/L)
Standard Deviation 13605.897
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 48
|
14061.44 Micrograms/liter (ug/L)
Standard Deviation 9257.991
|
30010.61 Micrograms/liter (ug/L)
Standard Deviation 14014.183
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 52
|
14192.83 Micrograms/liter (ug/L)
Standard Deviation 9326.176
|
28917.76 Micrograms/liter (ug/L)
Standard Deviation 14545.617
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 56
|
15179.77 Micrograms/liter (ug/L)
Standard Deviation 10405.996
|
29985.88 Micrograms/liter (ug/L)
Standard Deviation 14122.172
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 60
|
15133.54 Micrograms/liter (ug/L)
Standard Deviation 9673.602
|
29086.78 Micrograms/liter (ug/L)
Standard Deviation 12606.888
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 64
|
15354.29 Micrograms/liter (ug/L)
Standard Deviation 10112.098
|
31613.08 Micrograms/liter (ug/L)
Standard Deviation 13712.478
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 68
|
15584.38 Micrograms/liter (ug/L)
Standard Deviation 10407.781
|
30609.08 Micrograms/liter (ug/L)
Standard Deviation 14331.857
|
|
Serum Trough Concentrations of SHP647 Versus Time
Week 72
|
15006.48 Micrograms/liter (ug/L)
Standard Deviation 9390.020
|
31342.89 Micrograms/liter (ug/L)
Standard Deviation 14012.311
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 16, 24, 40, 48, 64 and 156Population: The SAS consisted of all enrolled participants who had received at least 1 dose of SHP647. Here, "number of participants analyzed" refers to the number of participants evaluable for this outcome at specific time points.
The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64. The number of participants with positive ADA was reported.
Outcome measures
| Measure |
SHP647 75 mg
n=164 Participants
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
SHP647 225 mg
n=166 Participants
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
|---|---|---|
|
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Week 64
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Baseline
|
9 Participants
|
10 Participants
|
|
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Week 8
|
3 Participants
|
1 Participants
|
|
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Week 16
|
1 Participants
|
1 Participants
|
|
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Week 24
|
1 Participants
|
1 Participants
|
|
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Week 40
|
1 Participants
|
2 Participants
|
|
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Week 48
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Week 156
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 16, 24, 40, 48, 64 and 156Population: Here, "number of participants analyzed" refers to the number of participants evaluable for this outcome at specific time points with non-missing ADA sample.
The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (\>=) 0.903. The number of participants with NAb was reported. Here "inconclusive" refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64.
Outcome measures
| Measure |
SHP647 75 mg
n=148 Participants
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
SHP647 225 mg
n=153 Participants
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
|---|---|---|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Baseline: With +ADA, missing NAb
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 8: With +ADA, without +NAb
|
2 Participants
|
0 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 16: With +ADA, with +NAb
|
0 Participants
|
1 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 16: With +ADA, without +NAb
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 24: Without +ADA
|
105 Participants
|
118 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 24: With +ADA, with +NAb
|
0 Participants
|
1 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 24: With +ADA, without +NAb
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 40: Without +ADA
|
93 Participants
|
102 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 40: With +ADA, with +NAb
|
1 Participants
|
2 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 40: With +ADA, without +NAb
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 48: Without +ADA
|
96 Participants
|
92 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 48: With +ADA, with +NAb
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 48: With +ADA, without +NAb
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 64: Without +ADA
|
82 Participants
|
86 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 64: With +ADA, with +NAb
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 64: With +ADA, without +NAb
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 156: Without +ADA
|
73 Participants
|
80 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 156: With +ADA, with +NAb
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Baseline: Without +ADA
|
139 Participants
|
143 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Baseline: With +ADA, with +NAb
|
0 Participants
|
4 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Baseline: With +ADA, without +NAb
|
0 Participants
|
1 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Baseline: With +ADA, with inconclusive NAb
|
8 Participants
|
5 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 8: Without +ADA
|
140 Participants
|
150 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 8: With +ADA, with +NAb
|
1 Participants
|
1 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 16: Without +ADA
|
139 Participants
|
143 Participants
|
|
Number of Participants With Positive Neutralizing Antibodies (NAb)
Week 156: With +ADA, without +NAb
|
0 Participants
|
1 Participants
|
Adverse Events
SHP647 75 mg
Serious events: 34 serious events
Other events: 116 other events
Deaths: 1 deaths
SHP647 225 mg
Serious events: 40 serious events
Other events: 119 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SHP647 75 mg
n=164 participants at risk
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
SHP647 225 mg
n=166 participants at risk
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
2/164 • Number of events 2 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 3 • From start of study drug administration up to 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serous cystadenocarcinoma ovary
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Eye disorders
Retinal detachment
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Colitis ulcerative
|
9.1%
15/164 • Number of events 19 • From start of study drug administration up to 168 weeks
|
10.8%
18/166 • Number of events 19 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Enteritis
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
General disorders
Non-Cardiac chest pain
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
General disorders
Pyrexia
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Congenital, familial and genetic disorders
Arrhythmogenic right ventricular dysplasia
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Immune system disorders
Drug hypersensitivity
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Immune system disorders
Serum sickness
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Anal abscess
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Cellulitis
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Chronic sinusitis
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Clostridium difficile infection
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Gastroenteritis
|
1.2%
2/164 • Number of events 2 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Meningitis listeria
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Meningitis viral
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Pelvic abscess
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Pneumonia
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Viral infection
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Injury, poisoning and procedural complications
Anastomotic fistula
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Injury, poisoning and procedural complications
Stoma complication
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Investigations
Blood iron decreased
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
1.2%
2/166 • Number of events 2 • From start of study drug administration up to 168 weeks
|
|
Nervous system disorders
Basilar migraine
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
1.2%
2/166 • Number of events 2 • From start of study drug administration up to 168 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Nervous system disorders
Typical aura without headache
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/164 • From start of study drug administration up to 168 weeks
|
0.60%
1/166 • Number of events 1 • From start of study drug administration up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.61%
1/164 • Number of events 1 • From start of study drug administration up to 168 weeks
|
0.00%
0/166 • From start of study drug administration up to 168 weeks
|
Other adverse events
| Measure |
SHP647 75 mg
n=164 participants at risk
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
SHP647 225 mg
n=166 participants at risk
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.5%
27/164 • Number of events 41 • From start of study drug administration up to 168 weeks
|
17.5%
29/166 • Number of events 42 • From start of study drug administration up to 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
12/164 • Number of events 15 • From start of study drug administration up to 168 weeks
|
10.8%
18/166 • Number of events 20 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
9/164 • Number of events 14 • From start of study drug administration up to 168 weeks
|
12.0%
20/166 • Number of events 33 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Colitis ulcerative
|
25.0%
41/164 • Number of events 52 • From start of study drug administration up to 168 weeks
|
21.7%
36/166 • Number of events 50 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
11/164 • Number of events 13 • From start of study drug administration up to 168 weeks
|
4.2%
7/166 • Number of events 11 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.9%
8/164 • Number of events 10 • From start of study drug administration up to 168 weeks
|
11.4%
19/166 • Number of events 20 • From start of study drug administration up to 168 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
10/164 • Number of events 10 • From start of study drug administration up to 168 weeks
|
4.2%
7/166 • Number of events 7 • From start of study drug administration up to 168 weeks
|
|
General disorders
Influenza like illness
|
4.9%
8/164 • Number of events 11 • From start of study drug administration up to 168 weeks
|
5.4%
9/166 • Number of events 10 • From start of study drug administration up to 168 weeks
|
|
General disorders
Pyrexia
|
8.5%
14/164 • Number of events 20 • From start of study drug administration up to 168 weeks
|
4.2%
7/166 • Number of events 10 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Bronchitis
|
6.1%
10/164 • Number of events 12 • From start of study drug administration up to 168 weeks
|
4.8%
8/166 • Number of events 12 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Clostridium difficile infection
|
6.7%
11/164 • Number of events 12 • From start of study drug administration up to 168 weeks
|
2.4%
4/166 • Number of events 4 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Gastroenteritis
|
11.0%
18/164 • Number of events 25 • From start of study drug administration up to 168 weeks
|
7.8%
13/166 • Number of events 17 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Influenza
|
4.9%
8/164 • Number of events 9 • From start of study drug administration up to 168 weeks
|
9.0%
15/166 • Number of events 19 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Nasopharyngitis
|
12.2%
20/164 • Number of events 27 • From start of study drug administration up to 168 weeks
|
16.9%
28/166 • Number of events 44 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Pharyngitis
|
1.2%
2/164 • Number of events 2 • From start of study drug administration up to 168 weeks
|
10.2%
17/166 • Number of events 20 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Sinusitis
|
4.3%
7/164 • Number of events 11 • From start of study drug administration up to 168 weeks
|
6.0%
10/166 • Number of events 14 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
14.0%
23/164 • Number of events 34 • From start of study drug administration up to 168 weeks
|
12.0%
20/166 • Number of events 35 • From start of study drug administration up to 168 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.7%
11/164 • Number of events 15 • From start of study drug administration up to 168 weeks
|
6.0%
10/166 • Number of events 12 • From start of study drug administration up to 168 weeks
|
|
Nervous system disorders
Headache
|
10.4%
17/164 • Number of events 23 • From start of study drug administration up to 168 weeks
|
12.7%
21/166 • Number of events 56 • From start of study drug administration up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
20/164 • Number of events 20 • From start of study drug administration up to 168 weeks
|
6.6%
11/166 • Number of events 12 • From start of study drug administration up to 168 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
8/164 • Number of events 9 • From start of study drug administration up to 168 weeks
|
7.8%
13/166 • Number of events 13 • From start of study drug administration up to 168 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER