Trial Outcomes & Findings for An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis (NCT NCT03290781)
NCT ID: NCT03290781
Last Updated: 2022-01-14
Results Overview
Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood \& 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
366 participants
Primary outcome timeframe
At Week 52
Results posted on
2022-01-14
Participant Flow
This study was conducted at 400 sites from 4 April 2018 (first participant first visit) to 1 July 2021 (last participant last visit). A total of 366 participants were enrolled, randomized and received study treatment.
Participant with moderate to severe Ulcerative Colitis (UC) who achieved a clinical response and completed their treatment period in the induction studies (either SHP647-301 \[NCT03259334\] or SHP647-302 \[NCT03259308\]) were randomized into this study as ontamalimab and placebo responders to receive placebo or ONTA 25 milligrams (mg) or 75 mg.
Participant milestones
| Measure |
ONTA 25mg/ Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
|
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
73
|
71
|
86
|
82
|
11
|
22
|
21
|
|
Overall Study
COMPLETED
|
24
|
53
|
30
|
59
|
6
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
49
|
18
|
56
|
23
|
5
|
3
|
4
|
Reasons for withdrawal
| Measure |
ONTA 25mg/ Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
|
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Disease Relapse
|
32
|
5
|
38
|
7
|
3
|
1
|
4
|
|
Overall Study
Other
|
3
|
0
|
2
|
2
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
5
|
7
|
4
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
9
|
10
|
1
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Site Terminated by Sponsor
|
1
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
ONTA 25mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25mg/ONTA 25mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75mg/ONTA 75mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
n=11 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
n=22 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
n=21 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Total
n=366 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.3 Years
STANDARD_DEVIATION 15.40 • n=5 Participants
|
41.2 Years
STANDARD_DEVIATION 13.17 • n=7 Participants
|
42.0 Years
STANDARD_DEVIATION 13.81 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 14.21 • n=4 Participants
|
44.7 Years
STANDARD_DEVIATION 14.16 • n=21 Participants
|
40.9 Years
STANDARD_DEVIATION 9.42 • n=10 Participants
|
39.9 Years
STANDARD_DEVIATION 12.10 • n=115 Participants
|
42.1 Years
STANDARD_DEVIATION 13.75 • n=6 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
150 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
216 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
27 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
337 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
28 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
312 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: At Week 52Population: The ontamalimab responder full analysis set (FAS) consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood \& 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Remission Based on Composite Score at Week 52
|
6 Participants
|
38 Participants
|
11 Participants
|
33 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder FAS only (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg).
Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Endoscopic Remission at Week 52
|
7 Participants
|
40 Participants
|
13 Participants
|
40 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Remission at Week 52
|
13 Participants
|
48 Participants
|
19 Participants
|
42 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood \& 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Sustained Remission at Week 52
|
4 Participants
|
23 Participants
|
7 Participants
|
22 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding \>=1 point or a sub-score for rectal bleeding \<= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood \& 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Response Based on Composite Score at Week 52
|
15 Participants
|
49 Participants
|
20 Participants
|
47 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of \<=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52
|
6 Participants
|
37 Participants
|
11 Participants
|
29 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood \& 3=blood alone passes).
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
|
1 Participants
|
12 Participants
|
3 Participants
|
12 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Glucocorticoid-free Remission at Week 52
|
0 Participants
|
8 Participants
|
2 Participants
|
10 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Remission defined as a total mayo score of less than or equal to (\<=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy \[modified, excludes friability\], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease \[spontaneous bleeding, ulceration\].
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Remission Based on Total Mayo Score at Week 52
|
5 Participants
|
38 Participants
|
10 Participants
|
33 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 4
|
28 Participants
|
25 Participants
|
25 Participants
|
24 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 8
|
22 Participants
|
25 Participants
|
29 Participants
|
31 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 12
|
18 Participants
|
26 Participants
|
22 Participants
|
30 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 16
|
16 Participants
|
32 Participants
|
17 Participants
|
35 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 20
|
20 Participants
|
25 Participants
|
16 Participants
|
31 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 24
|
12 Participants
|
31 Participants
|
12 Participants
|
31 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 28
|
13 Participants
|
31 Participants
|
19 Participants
|
32 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 32
|
17 Participants
|
35 Participants
|
13 Participants
|
30 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 36
|
13 Participants
|
37 Participants
|
13 Participants
|
32 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 40
|
15 Participants
|
34 Participants
|
12 Participants
|
25 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 44
|
11 Participants
|
27 Participants
|
12 Participants
|
33 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 48
|
13 Participants
|
32 Participants
|
16 Participants
|
27 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
At Week 52
|
9 Participants
|
33 Participants
|
10 Participants
|
30 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Sustained Endoscopic Remission at Week 52
|
4 Participants
|
27 Participants
|
8 Participants
|
29 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (Week 64)Population: The safety set consisted of all participants who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]).
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=71 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=86 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=82 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
n=11 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
n=22 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
n=21 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
46 Participants
|
41 Participants
|
54 Participants
|
51 Participants
|
8 Participants
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: At Week 12, 24, 36 and 52Population: The safety set consisted of all participants who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and "number analyzed" refer to the participants evaluable at specific time points.
Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.
Outcome measures
| Measure |
ONTA 25 mg/ Placebo
n=72 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 25 mg/ONTA 25 mg
n=70 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/Placebo
n=81 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75 mg/ONTA 75 mg
n=73 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
n=11 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
n=22 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
n=21 Participants
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab
At Week 36
|
5 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab
At Week 12
|
7 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab
At Week 24
|
6 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab
At Week 52
|
1 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
ONTA 25mg/ Placebo
Serious events: 6 serious events
Other events: 41 other events
Deaths: 0 deaths
ONTA 25mg/ONTA 25mg
Serious events: 9 serious events
Other events: 27 other events
Deaths: 0 deaths
ONTA 75mg/Placebo
Serious events: 9 serious events
Other events: 52 other events
Deaths: 1 deaths
ONTA 75mg/ONTA 75mg
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo/Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 1 deaths
Placebo/ONTA 25mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo/ONTA 75mg
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ONTA 25mg/ Placebo
n=73 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 milligram (mg) of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
|
ONTA 25mg/ONTA 25mg
n=71 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75mg/Placebo
n=86 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75mg/ONTA 75mg
n=82 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
n=11 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
n=22 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
n=21 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.7%
2/73 • Number of events 2 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
General disorders
Chest discomfort
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
General disorders
Sudden cardiac death
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Appendicitis
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
1.2%
1/82 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Peritonitis
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Pneumonia
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Sepsis
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
4.8%
1/21 • Number of events 1 • From start of study drug administration up to Week 64
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Investigations
Clostridium test positive
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Investigations
International normalised ratio increased
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 2 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
1.2%
1/82 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Nervous system disorders
Headache
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Renal and urinary disorders
Bladder metaplasia
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
4.8%
1/21 • Number of events 1 • From start of study drug administration up to Week 64
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis hypertrophic
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
Other adverse events
| Measure |
ONTA 25mg/ Placebo
n=73 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 milligram (mg) of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
|
ONTA 25mg/ONTA 25mg
n=71 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75mg/Placebo
n=86 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
ONTA 75mg/ONTA 75mg
n=82 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/Placebo
n=11 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 25mg
n=22 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
Placebo/ONTA 75mg
n=21 participants at risk
Participants who achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
2/73 • Number of events 2 • From start of study drug administration up to Week 64
|
5.6%
4/71 • Number of events 4 • From start of study drug administration up to Week 64
|
3.5%
3/86 • Number of events 3 • From start of study drug administration up to Week 64
|
1.2%
1/82 • Number of events 1 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
1.2%
1/82 • Number of events 1 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Gastrointestinal disorders
Abdominal pain
|
4.1%
3/73 • Number of events 3 • From start of study drug administration up to Week 64
|
2.8%
2/71 • Number of events 4 • From start of study drug administration up to Week 64
|
4.7%
4/86 • Number of events 4 • From start of study drug administration up to Week 64
|
3.7%
3/82 • Number of events 3 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Gastrointestinal disorders
Colitis ulcerative
|
23.3%
17/73 • Number of events 17 • From start of study drug administration up to Week 64
|
4.2%
3/71 • Number of events 3 • From start of study drug administration up to Week 64
|
33.7%
29/86 • Number of events 34 • From start of study drug administration up to Week 64
|
7.3%
6/82 • Number of events 7 • From start of study drug administration up to Week 64
|
36.4%
4/11 • Number of events 4 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
4.8%
1/21 • Number of events 1 • From start of study drug administration up to Week 64
|
|
General disorders
Oedema peripheral
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
2.8%
2/71 • Number of events 2 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
4.5%
1/22 • Number of events 1 • From start of study drug administration up to Week 64
|
9.5%
2/21 • Number of events 2 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
4/73 • Number of events 4 • From start of study drug administration up to Week 64
|
4.2%
3/71 • Number of events 4 • From start of study drug administration up to Week 64
|
3.5%
3/86 • Number of events 3 • From start of study drug administration up to Week 64
|
7.3%
6/82 • Number of events 7 • From start of study drug administration up to Week 64
|
18.2%
2/11 • Number of events 2 • From start of study drug administration up to Week 64
|
4.5%
1/22 • Number of events 1 • From start of study drug administration up to Week 64
|
4.8%
1/21 • Number of events 1 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
2.3%
2/86 • Number of events 2 • From start of study drug administration up to Week 64
|
2.4%
2/82 • Number of events 2 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
4.5%
1/22 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
4.7%
4/86 • Number of events 4 • From start of study drug administration up to Week 64
|
3.7%
3/82 • Number of events 5 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
9.1%
2/22 • Number of events 2 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Infections and infestations
Viral infection
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
1.2%
1/86 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Investigations
Weight increased
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
4.5%
1/22 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Investigations
White blood cell count decreased
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
0.00%
0/71 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
9.1%
2/22 • Number of events 4 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/73 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
4/73 • Number of events 5 • From start of study drug administration up to Week 64
|
5.6%
4/71 • Number of events 5 • From start of study drug administration up to Week 64
|
3.5%
3/86 • Number of events 3 • From start of study drug administration up to Week 64
|
3.7%
3/82 • Number of events 3 • From start of study drug administration up to Week 64
|
0.00%
0/11 • From start of study drug administration up to Week 64
|
4.5%
1/22 • Number of events 1 • From start of study drug administration up to Week 64
|
14.3%
3/21 • Number of events 4 • From start of study drug administration up to Week 64
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
1/73 • Number of events 1 • From start of study drug administration up to Week 64
|
1.4%
1/71 • Number of events 2 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
0.00%
0/82 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
0.00%
0/21 • From start of study drug administration up to Week 64
|
|
Nervous system disorders
Headache
|
5.5%
4/73 • Number of events 5 • From start of study drug administration up to Week 64
|
4.2%
3/71 • Number of events 4 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
3.7%
3/82 • Number of events 3 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
13.6%
3/22 • Number of events 7 • From start of study drug administration up to Week 64
|
4.8%
1/21 • Number of events 1 • From start of study drug administration up to Week 64
|
|
Vascular disorders
Hypertension
|
4.1%
3/73 • Number of events 3 • From start of study drug administration up to Week 64
|
4.2%
3/71 • Number of events 3 • From start of study drug administration up to Week 64
|
0.00%
0/86 • From start of study drug administration up to Week 64
|
2.4%
2/82 • Number of events 2 • From start of study drug administration up to Week 64
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to Week 64
|
0.00%
0/22 • From start of study drug administration up to Week 64
|
4.8%
1/21 • Number of events 1 • From start of study drug administration up to Week 64
|
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