Trial Outcomes & Findings for A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease (NCT NCT05499130)
NCT ID: NCT05499130
Last Updated: 2025-12-05
Results Overview
The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranging from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical remission was defined as MMS ≤2 points with Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and centrally read endoscopic score of 0 or 1, where a score of 1 did not include "friability".
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
290 participants
Primary outcome timeframe
Week 14
Results posted on
2025-12-05
Participant Flow
In this trial, 290 participants were randomized, and 286 participants were analyzed; 4 randomized participants (2 ulcerative colitis \[UC\] and 2 crohn's disease \[CD\]) were excluded from all analyses for non-compliance with Good Clinical Practice.
Participants were randomized to 1 of 4 treatment groups (TEV-48574 450 milligrams \[mg\], TEV-48574 900 mg, TEV-48574 1800 mg, or placebo to match TEV-48574) by indication UC and CD. The treatment arm TEV-48574 1800 mg was discontinued. Therefore, the participants randomized to TEV-48574 1800 mg arm were not included in the overall efficacy analysis for the trial (Modified Intent-to-treat \[mITT\] Analysis Set).
Participant milestones
| Measure |
Placebo (UC)
Participants with UC received placebo matched to TEV-48574 administered every 2 weeks (Q2W) (for a total of 7 doses) by subcutaneous (SC) injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
COMPLETED
|
39
|
47
|
45
|
7
|
37
|
37
|
43
|
3
|
|
Overall Study
STARTED
|
44
|
47
|
46
|
7
|
46
|
46
|
47
|
3
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
44
|
47
|
46
|
7
|
46
|
46
|
46
|
3
|
|
Overall Study
mITT Analysis Set
|
44
|
47
|
46
|
0
|
46
|
46
|
46
|
0
|
|
Overall Study
Immunogenicity Analysis Set
|
0
|
47
|
45
|
7
|
0
|
46
|
46
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
1
|
0
|
9
|
9
|
4
|
0
|
Reasons for withdrawal
| Measure |
Placebo (UC)
Participants with UC received placebo matched to TEV-48574 administered every 2 weeks (Q2W) (for a total of 7 doses) by subcutaneous (SC) injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
5
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
0
|
1
|
4
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Other Than Specified
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Number analyzed = participants with UC.
Baseline characteristics by cohort
| Measure |
Placebo (UC)
n=44 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=47 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
n=7 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
n=46 Participants
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
n=46 Participants
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
n=47 Participants
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
n=3 Participants
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 13.08 • n=44 Participants
|
38.7 years
STANDARD_DEVIATION 12.99 • n=47 Participants
|
42.1 years
STANDARD_DEVIATION 13.19 • n=46 Participants
|
40.9 years
STANDARD_DEVIATION 16.24 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 15.13 • n=46 Participants
|
42.5 years
STANDARD_DEVIATION 15.08 • n=46 Participants
|
38.1 years
STANDARD_DEVIATION 13.58 • n=47 Participants
|
43.7 years
STANDARD_DEVIATION 23.54 • n=3 Participants
|
40.4 years
STANDARD_DEVIATION 13.99 • n=286 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=44 Participants
|
18 Participants
n=47 Participants
|
19 Participants
n=46 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=46 Participants
|
19 Participants
n=46 Participants
|
16 Participants
n=47 Participants
|
1 Participants
n=3 Participants
|
116 Participants
n=286 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=44 Participants
|
29 Participants
n=47 Participants
|
27 Participants
n=46 Participants
|
2 Participants
n=7 Participants
|
22 Participants
n=46 Participants
|
27 Participants
n=46 Participants
|
31 Participants
n=47 Participants
|
2 Participants
n=3 Participants
|
170 Participants
n=286 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=44 Participants
|
1 Participants
n=47 Participants
|
1 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=46 Participants
|
2 Participants
n=46 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=286 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=44 Participants
|
46 Participants
n=47 Participants
|
45 Participants
n=46 Participants
|
7 Participants
n=7 Participants
|
46 Participants
n=46 Participants
|
43 Participants
n=46 Participants
|
46 Participants
n=47 Participants
|
3 Participants
n=3 Participants
|
278 Participants
n=286 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=47 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=286 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=44 Participants
|
1 Participants
n=47 Participants
|
1 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=46 Participants
|
2 Participants
n=47 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=286 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=44 Participants
|
1 Participants
n=47 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=46 Participants
|
0 Participants
n=46 Participants
|
2 Participants
n=47 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=286 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
43 Participants
n=44 Participants
|
44 Participants
n=47 Participants
|
45 Participants
n=46 Participants
|
7 Participants
n=7 Participants
|
45 Participants
n=46 Participants
|
45 Participants
n=46 Participants
|
41 Participants
n=47 Participants
|
3 Participants
n=3 Participants
|
273 Participants
n=286 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=44 Participants
|
1 Participants
n=47 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=47 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=286 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=47 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=286 Participants
|
|
Modified Mayo Score (MMS)
|
6.8 units on a scale
STANDARD_DEVIATION 1.16 • n=44 Participants • Number analyzed = participants with UC.
|
6.6 units on a scale
STANDARD_DEVIATION 1.15 • n=47 Participants • Number analyzed = participants with UC.
|
6.8 units on a scale
STANDARD_DEVIATION 1.11 • n=46 Participants • Number analyzed = participants with UC.
|
6.6 units on a scale
STANDARD_DEVIATION 1.13 • n=7 Participants • Number analyzed = participants with UC.
|
—
|
—
|
—
|
—
|
6.7 units on a scale
STANDARD_DEVIATION 1.14 • n=144 Participants • Number analyzed = participants with UC.
|
|
Simple Endoscopic Score for Crohn's Disease (SES-CD)
|
—
|
—
|
—
|
—
|
12.0 units on a scale
STANDARD_DEVIATION 5.70 • n=46 Participants • Number analyzed = participants with CD.
|
12.7 units on a scale
STANDARD_DEVIATION 6.64 • n=46 Participants • Number analyzed = participants with CD.
|
12.1 units on a scale
STANDARD_DEVIATION 5.81 • n=47 Participants • Number analyzed = participants with CD.
|
7.7 units on a scale
STANDARD_DEVIATION 2.89 • n=3 Participants • Number analyzed = participants with CD.
|
12.1 units on a scale
STANDARD_DEVIATION 6.01 • n=142 Participants • Number analyzed = participants with CD.
|
PRIMARY outcome
Timeframe: Week 14Population: The mITT analysis set for UC included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg.
The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranging from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical remission was defined as MMS ≤2 points with Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and centrally read endoscopic score of 0 or 1, where a score of 1 did not include "friability".
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=44 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=47 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS
|
22 Participants
|
9 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 14Population: The mITT analysis set for CD included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg.
The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components was assessed in the 5 segments: the rectum, sigmoid and left colon, transverse colon, right colon, and ileum. The SES-CD was the sum of the individual scores of each of the components across the 5 segments. The range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Endoscopic response at Week 14 in participants with moderate to severe CD was defined as a reduction in SES-CD of at least 50% from baseline.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=46 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD
|
22 Participants
|
6 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 14Population: The mITT analysis set for UC included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg.
The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranged from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical response was defined as a decrease from baseline in the MMS of at least 2 points and at least a 30% reduction from baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of ≤1.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=44 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=47 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by the MMS
|
32 Participants
|
23 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 14Population: The mITT analysis set for UC included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg.
The endoscopic subscore evaluation for the MMS consisted of independent, blinded, central review of a high-resolution recorded video. The endoscopic subscore assessed disease activity from 0 (normal or inactive disease) to 3 (severe activity). Higher scores indicated more severe disease activity. Endoscopic improvement was defined as a MES of 0 or 1 at Week 14.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=44 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=47 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES)
|
23 Participants
|
10 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 14Population: The mITT analysis set for UC included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg.
The endoscopic subscore evaluation for the MMS consisted of independent, blinded, central review of a high-resolution recorded video. The endoscopic subscore assessed disease activity from 0 (normal or inactive disease) to 3 (severe activity). Higher scores indicated more severe disease activity. Endoscopic remission was defined as a MES of 0 at Week 14.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=44 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=47 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES
|
8 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 14Population: The mITT analysis set for UC included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg.
The PRO2-UC score was derived from 2 parameters from the MMS: stool frequency and rectal bleeding, recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Each parameter ranged from 0 (normal) to 3 (severe) with each subscore representing an average over the preceding 7 days. The total score was the summation of the subscores and therefore ranged from 0 (normal or inactive disease) to 6 (severe activity), where higher scores indicated more severe disease activity. Clinical response was defined as decrease from baseline of at least 50% in PRO2 (stool frequency and rectal bleeding) at Week 14.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=44 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=47 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by 2-item Patient-reported Outcome (PRO2) Score
|
34 Participants
|
22 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 14Population: The mITT analysis set for UC included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg.
The PRO2-UC score was derived from 2 parameters from the MMS: stool frequency and rectal bleeding, recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Each parameter ranged from 0 (normal) to 3 (severe) with each subscore representing an average over the preceding 7 days. The total score was the summation of the subscores and therefore ranged from 0 (normal or inactive disease) to 6 (severe activity), where higher scores indicated more severe disease activity. Clinical remission was defined as score of stool frequency = 0 and rectal bleeding = 0 on the PRO2 scale at Week 14.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=44 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=47 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe UC With a Clinical Remission as Defined by PRO2 Score
|
11 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 14Population: The mITT analysis set for CD included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg.
The MM-SES-CD is an endoscopic scoring tool that considers each individual parameter's prognostic value for achieving endoscopic remission while on active therapy. The SES-CD assesses the following 4 components: presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components was assessed in the 5 segments: the rectum, sigmoid and left colon, transverse colon, right colon, and ileum. The SES-CD was the sum of the individual scores of each of the components across the 5 segments. The range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for the overall SES-CD score, with higher scores indicating a greater degree of inflammation. Endoscopic response was defined as a decrease in MM-SES-CD of ≥50% from baseline at Week 14.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=46 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe CD With an Endoscopic Response as Defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD)
|
18 Participants
|
6 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Weeks 4, 8, 12 and 14Population: The mITT analysis set for CD included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg. Here, 'number analyzed' = participants evaluable at specified timepoint.
The CDAI score consisted of an adjusted composite sum of 8 parameters, including daily diary evaluation for severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight, and hematocrit. The subscores of abdominal pain (0 \[no pain\] to 3 \[worst pain\]), general well-being (0 \[well\] to 4 \[terrible\]), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score that ranged from 0 (none) to 600 (severe) with a higher score indicating a worse outcome. Clinical response was defined as a ≥100-point decrease in CDAI score from baseline.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=46 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score
Week 8
|
25 Participants
|
19 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score
Week 14
|
30 Participants
|
24 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score
Week 4
|
18 Participants
|
15 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score
Week 12
|
31 Participants
|
22 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 14Population: The mITT analysis set for CD included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg.
The CDAI score consisted of an adjusted composite sum of 8 parameters, including daily diary evaluation for severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight, and hematocrit. The subscores of abdominal pain (0 \[no pain\] to 3 \[worst pain\]), general well-being (0 \[well\] to 4 \[terrible\]), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score that ranged from 0 (none) to 600 (severe) with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI score \<150 at Week 14.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=46 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by CDAI Score
|
25 Participants
|
19 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 14Population: The mITT analysis set for CD included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg.
The PRO2-CD score was the sum of the daily stool frequency subscore (0 \[normal\] to 3 \[severe\]) and abdominal pain subscore (0 \[no pain\] to 3 \[worst pain\]) from the CDAI. Total PRO2-CD score ranged from 0 (normal) - 6 (severe), with higher scores indicating more severe disease. These were recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Clinical response was defined as a decrease from baseline of at least 50% in PRO2-CD (abdominal pain and stool frequency) at Week 14.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=46 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by PRO2-CD Score
|
14 Participants
|
8 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 14Population: The mITT analysis set for CD included only those participants who received at least 1 dose of placebo, TEV-48574 450 mg, or TEV-48574 900 mg.
The PRO2-CD score was the sum of the daily stool frequency subscore (0 \[normal\] to 3 \[severe\]) and abdominal pain subscore (0 \[no pain\] to 3 \[worst pain\]) from the CDAI. Total PRO2-CD score ranged from 0 (normal) - 6 (severe), with higher scores indicating more severe disease. These were recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Clinical remission was defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2-CD scale at Week 14
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=46 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by PRO2-CD Score
|
17 Participants
|
12 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 18Population: The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=44 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=47 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
n=7 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
n=46 Participants
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
n=46 Participants
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
n=46 Participants
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
n=3 Participants
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
|
20 Participants
|
23 Participants
|
23 Participants
|
2 Participants
|
22 Participants
|
31 Participants
|
20 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 18Population: The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=44 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=47 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
n=7 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
n=46 Participants
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
n=46 Participants
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
n=46 Participants
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
n=3 Participants
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 14, and 18Population: The immunogenicity analysis set included all randomized participants who received at least 1 dose of TEV-48574 and who had at least 1 reportable immunogenicity result.
Treatment-emergent ADA positive: - the participant had a positive ADA sample (after first dose of study drug) but not at baseline (prior to first dose of study drug), or - the participant had a positive ADA sample at baseline (prior to first dose of study drug) and at the visit (after first dose of study drug), with at least a 4-fold increase in titer level.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
n=7 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=47 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=45 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
n=46 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
n=46 Participants
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
n=3 Participants
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs)
Week 2
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs)
Week 4
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs)
Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs)
Week 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs)
Week 18
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 14, and 18Population: The immunogenicity analysis set included all randomized participants who received at least 1 dose of TEV-48574 and who had at least 1 reportable immunogenicity result. 'Overall number of participants analyzed' = ADA positive participants. 'Number analyzed' = ADA positive participants at specified timepoint.
Treatment-emergent ADA positive: - the participant had a positive ADA sample (after first dose of study drug) but not at baseline (prior to first dose of study drug), or - the participant had a positive ADA sample at baseline (prior to first dose of study drug) and at the visit (after first dose of study drug), with at least a 4-fold increase in titer level.
Outcome measures
| Measure |
TEV-48574 900 mg (UC)
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=1 Participants
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=2 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
n=4 Participants
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
n=1 Participants
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of ADA Positive Participants With the Presence of Neutralizing ADA
Week 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of ADA Positive Participants With the Presence of Neutralizing ADA
Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of ADA Positive Participants With the Presence of Neutralizing ADA
Week 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of ADA Positive Participants With the Presence of Neutralizing ADA
Week 18
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of ADA Positive Participants With the Presence of Neutralizing ADA
Week 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
TEV-48574 900 mg (UC)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo (UC)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
TEV-48574 450 mg (UC)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
TEV-48574 1800 mg (UC)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (CD)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
TEV-48574 450 mg (CD)
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
TEV-48574 900 mg (CD)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
TEV-48574 1800 mg (CD)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TEV-48574 900 mg (UC)
n=46 participants at risk
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=44 participants at risk
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=47 participants at risk
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
n=7 participants at risk
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
n=46 participants at risk
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
n=46 participants at risk
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
n=46 participants at risk
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
n=3 participants at risk
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 2 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pelvic mass
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood pressure orthostatic decreased
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.3%
1/44 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Noninfective oophoritis
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
TEV-48574 900 mg (UC)
n=46 participants at risk
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (UC)
n=44 participants at risk
Participants with UC received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (UC)
n=47 participants at risk
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (UC)
n=7 participants at risk
Participants with UC received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
Placebo (CD)
n=46 participants at risk
Participants with CD received placebo matched to TEV-48574 administered Q2W (for a total of 7 doses) by SC injection during the 14-week treatment period.
|
TEV-48574 450 mg (CD)
n=46 participants at risk
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (450 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 900 mg (CD)
n=46 participants at risk
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (900 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
TEV-48574 1800 mg (CD)
n=3 participants at risk
Participants with CD received a single loading dose (2250 mg) of TEV-48574 by SC injection, followed by 6 induction doses (1800 mg) of TEV-48574 Q2W by SC injection during the 14-week treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
6.8%
3/44 • Number of events 3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.1%
1/47 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
6.5%
3/46 • Number of events 3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
6.4%
3/47 • Number of events 3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
4.3%
2/46 • Number of events 3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
4.3%
2/46 • Number of events 2 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.3%
1/44 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.3%
1/44 • Number of events 2 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
6.4%
3/47 • Number of events 3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
6.5%
3/46 • Number of events 4 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
4.3%
2/46 • Number of events 2 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
6.5%
3/46 • Number of events 3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.3%
1/44 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
6.4%
3/47 • Number of events 3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
4.3%
2/46 • Number of events 3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
4.3%
2/46 • Number of events 2 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
4.5%
2/44 • Number of events 2 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
8.7%
4/46 • Number of events 5 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
2.2%
1/46 • Number of events 2 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/46 • Number of events 2 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
2.2%
1/46 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/44 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/46 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Baseline (Day 1) up to Week 18
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER