A Study to Test the Effect of TEV-48574 in Moderate to Se... | NCT05499130 | Trialant
NCT05499130
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Status
Completed
Last Update Posted
Mar 27, 2026Actual
Enrollment
290Actual
Phase
Phase 2
Conditions
Crohn Disease
Colitis, Ulcerative
Interventions
TEV-48574
Placebo
Countries
United States
Austria
Belgium
Bulgaria
Canada
Czechia
France
Georgia
Germany
Hungary
Israel
Italy
Japan
Norway
Poland
Slovakia
Spain
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT05499130
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TV48574-IMM-20036
Secondary IDs
ID
Type
Description
Link
2021-006881-19
EudraCT Number
2024-511089-36-00
Registry Identifier
Clinical Trials Information System
Brief Title
A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
Official Title
A 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14.
Secondary objectives:
To evaluate the efficacy of 2 different doses of TEV-48574 as assessed by multiple standard measures
To evaluate the safety and tolerability of 2 different doses of TEV-48574
To evaluate the immunogenicity of 2 different dioses of TEV-48574
The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.
Detailed Description
Not provided
Conditions Module
Conditions
Crohn Disease
Colitis, Ulcerative
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
290Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
TEV-48574, 450 mg (UC)
Experimental
Administered by subcutaneous infusion for participants with UC
Drug: TEV-48574
TEV-48574, 900 mg (UC)
Experimental
Administered by subcutaneous infusion for participants with UC
Drug: TEV-48574
TEV-48574, 1800 mg (UC)
Experimental
Administered by subcutaneous infusion for participants with UC. This arm was discontinued with Amend 03.
Drug: TEV-48574
TEV-48574, 450 mg (CD)
Experimental
Administered by subcutaneous infusion for participants with CD
Drug: TEV-48574
TEV-48574, 900 mg (CD)
Experimental
Administered by subcutaneous infusion for participants with CD
Drug: TEV-48574
TEV-48574, 1800 mg (CD)
Experimental
Administered by subcutaneous infusion for participants with CD. This arm was discontinued with Amend 03.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TEV-48574
Drug
Subcutaneous infusion
TEV-48574, 1800 mg (CD)
TEV-48574, 1800 mg (UC)
TEV-48574, 450 mg (CD)
TEV-48574, 450 mg (UC)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS
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".
Week 14
Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD
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.
Baseline to Week 14
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by the MMS
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months
The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study
The participant is able to understand the nature of the study and any potential hazards associated with participating in the study
Women of non-childbearing potential who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile as assessed by a physician, or 1-year postmenopausal
Male participants (including vasectomized) with women of childbearing potential (WOCBP) partners (whether pregnant or not) must use condoms after the first investigational medicinal product (IMP) administration and throughout the study or until 50 days after the last IMP dose, whichever is longer
NOTE- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
The participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician
Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic coliti
Participant has colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known non-passable colonic stricture, presence of colonic or small bowel stoma, presence of non-passable colonic or small bowel obstruction or resection preventing the endoscopy procedure, or fulminant colitis
Presence of active enteric infections (positive stool culture) or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks prior to the first screening visit
Participant anticipates requiring major surgery during this study.
A participant is Hepatitis B core antibody or surface antigen positive and/or Hepatitis C antibody positive with detectable ribonucleic acids, or positive human immunodeficiency virus types 1 or 2 at screening.
A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis)
A history of more than 2 herpes zoster episode in the last 5 years or multimetameric herpes zoster
A history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis)
The participant is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.
Presence of a transplanted organ
A history of malignancy within the last 5 years (exception: basal cell carcinoma or in situ carcinoma of the cervix if successful curative therapy occurred at least 12 months prior to screening) or curatively resected papillary thyroid cance
Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse
Participants with incurable diseases, persons in nursing homes, and participants incapable of giving written informed consent
NOTE- Additional criteria apply, please contact the investigator for more information
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Teva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Teva Investigational Site 15568
Sun City
Arizona
85351
United States
Teva Investigational Site 15556
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
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).
Recruitment Details
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES)
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.
Week 14
Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES
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.
Week 14
Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by 2-item Patient-reported Outcome (PRO2) Score
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.
Baseline to Week 14
Number of Participants With Moderate to Severe UC With a Clinical Remission as Defined by PRO2 Score
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.
Week 14
Number of Participants With Moderate to Severe CD With an Endoscopic Response as Defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD)
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.
Baseline to Week 14
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score
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.
Baseline to Weeks 4, 8, 12 and 14
Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by CDAI Score
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.
Week 14
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by PRO2-CD Score
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.
Baseline to Week 14
Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by PRO2-CD Score
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
Week 14
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
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.
Baseline (Day 1) up to Week 18
Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs
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.
Baseline (Day 1) up to Week 18
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs)
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.
Weeks 2, 4, 8, 14, and 18
Number of ADA Positive Participants With the Presence of Neutralizing ADA
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.
Weeks 2, 4, 8, 14, and 18
San Diego
California
92103
United States
Teva Investigational Site 15747
San Diego
California
92103
United States
Teva Investigational Site 15357
Kissimmee
Florida
34741
United States
Teva Investigational Site 15563
Miami
Florida
33032
United States
Teva Investigational Site 15365
Miami
Florida
33136
United States
Teva Investigational Site 15748
Miami
Florida
33176
United States
Teva Investigational Site 15375
Orlando
Florida
32803
United States
Teva Investigational Site 15359
Pinellas Park
Florida
33781
United States
Teva Investigational Site 15566
Glenview
Illinois
60026
United States
Teva Investigational Site 15567
Gurnee
Illinois
60031
United States
Teva Investigational Site 15574
New Albany
Indiana
47150
United States
Teva Investigational Site 15362
Iowa City
Iowa
52242
United States
Teva Investigational Site 15367
Kansas City
Kansas
66160
United States
Teva Investigational Site 15368
Louisville
Kentucky
40202
United States
Teva Investigational Site 15575
Louisville
Kentucky
40218
United States
Teva Investigational Site 15363
Columbia
Maryland
21045
United States
Teva Investigational Site 15358
Liberty
Missouri
64068
United States
Teva Investigational Site 15373
St Louis
Missouri
63110
United States
Teva Investigational Site 15369
Las Vegas
Nevada
89128.
United States
Teva Investigational Site 15558
North Massapequa
New York
11758
United States
Teva Investigational Site 15370
Chapel Hill
North Carolina
27514
United States
Teva Investigational Site 15750
Beavercreek
Ohio
45440
United States
Teva Investigational Site 15557
Greenville
South Carolina
29607
United States
Teva Investigational Site 15573
Cordova
Tennessee
38018
United States
Teva Investigational Site 15360
Austin
Texas
78748
United States
Teva Investigational Site 15371
Dallas
Texas
75246
United States
Teva Investigational Site 15569
Garland
Texas
75044
United States
Teva Investigational Site 15559
Harlingen
Texas
78550
United States
Teva Investigational Site 15366
Katy
Texas
77494
United States
Teva Investigational Site 15743
Lubbock
Texas
79424
United States
Teva Investigational Site 15372
Pearland
Texas
77584
United States
Teva Investigational Site 15374
San Antonio
Texas
78229
United States
Teva Investigational Site 15565
Southlake
Texas
76092
United States
Teva Investigational Site 15361
Tyler
Texas
75701
United States
Teva Investigational Site 15364
Salt Lake City
Utah
84124
United States
Teva Investigational Site 33055
Innsbruck
6020
Austria
Teva Investigational Site 33056
Vienna
1090
Austria
Teva Investigational Site 37134
Edegem
2650
Belgium
Teva Investigational Site 37133
Liège
4000
Belgium
Teva Investigational Site 59243
Gorna Oryahovitsa
5100
Bulgaria
Teva Investigational Site 59198
Pleven
5803
Bulgaria
Teva Investigational Site 59197
Sofia
1618
Bulgaria
Teva Investigational Site 59199
Sofia
1680
Bulgaria
Teva Investigational Site 59196
Sofia
1784
Bulgaria
Teva Investigational Site 11257
Winnipeg
Manitoba
R3A 1R9
Canada
Teva Investigational Site 54221
Brno
615 00
Czechia
Teva Investigational Site 54222
Klatovy
339 01
Czechia
Teva Investigational Site 54241
Prague
140 00
Czechia
Teva Investigational Site 54220
Slaný
274 01
Czechia
Teva Investigational Site 54242
Zábřeh
78901
Czechia
Teva Investigational Site 35280
Caen
14000
France
Teva Investigational Site 35295
Nantes
44300
France
Teva Investigational Site 35277
Nice
06200
France
Teva Investigational Site 35279
Saint-Priest-en-Jarez
42270
France
Teva Investigational Site 81057
Tbilisi
0102
Georgia
Teva Investigational Site 81052
Tbilisi
0119
Georgia
Teva Investigational Site 81054
Tbilisi
0160
Georgia
Teva Investigational Site 81056
Tbilisi
0178
Georgia
Teva Investigational Site 81053
Tbilisi
0180
Georgia
Teva Investigational Site 81055
Tbilisi
0180
Georgia
Teva Investigational Site 32796
Berlin
10318
Germany
Teva Investigational Site 32872
Berlin
12559
Germany
Teva Investigational Site 32873
Duisburg
47055
Germany
Teva Investigational Site 32793
Kiel
24105
Germany
Teva Investigational Site 32797
Leipzig
04103
Germany
Teva Investigational Site 32795
Tübingen
72076
Germany
Teva Investigational Site 32794
Ulm
89081
Germany
Teva Investigational Site 32874
Wipperfürth
51688
Germany
Teva Investigational Site 51334
Budapest
1085
Hungary
Teva Investigational Site 51335
Budapest
H-1033
Hungary
Teva Investigational Site 51336
Gyöngyös
3200
Hungary
Teva Investigational Site 51333
Székesfehérvár
H-8000
Hungary
Teva Investigational Site 51338
Vác
H-2600
Hungary
Teva Investigational Site 80179
Afula
1834111
Israel
Teva Investigational Site 80191
Beersheba
8410101
Israel
Teva Investigational Site 80184
Holon
58100
Israel
Teva Investigational Site 80182
Kfar Saba
4428164
Israel
Teva Investigational Site 80180
Rehovot
7661041
Israel
Teva Investigational Site 30304
Brescia
25123
Italy
Teva Investigational Site 30285
Milan
20132
Italy
Teva Investigational Site 30286
Milan
20157
Italy
Teva Investigational Site 30284
Rozzano
20089
Italy
Teva Investigational Site 30303
San Donato Milanese
20097
Italy
Teva Investigational Site 30300
San Giovanni Rotondo
71013
Italy
Teva Investigational Site 30301
Turin
10128
Italy
Teva Investigational Site 84112
Fukuoka
814-0180
Japan
Teva Investigational Site 84110
Kashiwa
277-0871
Japan
Teva Investigational Site 84117
Minato
108-8642
Japan
Teva Investigational Site 84115
Mitaka
181-8611
Japan
Teva Investigational Site 84118
Nagoya
457-8511
Japan
Teva Investigational Site 84113
Osaka
530-0011
Japan
Teva Investigational Site 84114
Sakura
285-8741
Japan
Teva Investigational Site 84116
Shinjuku
169-0073
Japan
Teva Investigational Site 84111
Toyama
930-8550
Japan
Teva Investigational Site 41015
Lorenskog
1478
Norway
Teva Investigational Site 41014
Tromsø
9038
Norway
Teva Investigational Site 53565
Bydgoszcz
85-794
Poland
Teva Investigational Site 53542
Częstochowa
42-202
Poland
Teva Investigational Site 53543
Elblag
82-300
Poland
Teva Investigational Site 53544
Gdansk
80-382
Poland
Teva Investigational Site 53545
Gdynia
81-537
Poland
Teva Investigational Site 53571
Jelenia Góra
58-500
Poland
Teva Investigational Site 53546
Katowice
40-040
Poland
Teva Investigational Site 53560
Krakow
30-363
Poland
Teva Investigational Site 53548
Krakow
31-156
Poland
Teva Investigational Site 53512
Krakow
31-506
Poland
Teva Investigational Site 53547
Kłodzko
57-300
Poland
Teva Investigational Site 53515
Lodz
90-752
Poland
Teva Investigational Site 53514
Lodz
91-495
Poland
Teva Investigational Site 53518
Nowy Targ
34-400
Poland
Teva Investigational Site 53559
Opole
45-819
Poland
Teva Investigational Site 53572
Piotrkow Trybunalski
97-300
Poland
Teva Investigational Site 53549
Poznan
54-144
Poland
Teva Investigational Site 53563
Poznan
54-144
Poland
Teva Investigational Site 53517
Poznan
60-324
Poland
Teva Investigational Site 53516
Poznan
60-529
Poland
Teva Investigational Site 53566
Poznan
60-702
Poland
Teva Investigational Site 53513
Rzeszów
35-326
Poland
Teva Investigational Site 53550
Sopot
81-756
Poland
Teva Investigational Site 53551
Staszów
28-200
Poland
Teva Investigational Site 53508
Szczecin
71-434
Poland
Teva Investigational Site 53519
Szczecin
71-685
Poland
Teva Investigational Site 53552
Tarnów
33-100
Poland
Teva Investigational Site 53573
Tarnów
33-100
Poland
Teva Investigational Site 53553
Torun
87-100
Poland
Teva Investigational Site 53554
Wadowice
34-100
Poland
Teva Investigational Site 53557
Warsaw
00-189
Poland
Teva Investigational Site 53570
Warsaw
02-672
Poland
Teva Investigational Site 53556
Warsaw
02-786
Poland
Teva Investigational Site 53555
Warsaw
04-501
Poland
Teva Investigational Site 53558
Wroclaw
50-381
Poland
Teva Investigational Site 53510
Wroclaw
52-416
Poland
Teva Investigational Site 53567
Wroclaw
53-149
Poland
Teva Investigational Site 53562
Wroclaw
53-611
Poland
Teva Investigational Site 53520
Wroclaw
53-673
Poland
Teva Investigational Site 53509
Zamość
22-400
Poland
Teva Investigational Site 53511
Łęczna
21-010
Poland
Teva Investigational Site 62098
Banská Bystrica
975 17
Slovakia
Teva Investigational Site 62074
Bardejov
085 01
Slovakia
Teva Investigational Site 62073
Bratislava
811 09
Slovakia
Teva Investigational Site 62071
Košice
040 13
Slovakia
Teva Investigational Site 62076
Prešov
080 01
Slovakia
Teva Investigational Site 62097
Prešov
080 01
Slovakia
Teva Investigational Site 62099
Rimavská Sobota
979 01
Slovakia
Teva Investigational Site 62072
Šahy
936 01
Slovakia
Teva Investigational Site 31325
Alicante
03010
Spain
Teva Investigational Site 31302
Córdoba
14004
Spain
Teva Investigational Site 31293
Huelva
21005
Spain
Teva Investigational Site 31301
Las Palmas de Gran Canaria
35010
Spain
Teva Investigational Site 31318
Santiago de Compostela
15702
Spain
Teva Investigational Site 31291
Seville
41009
Spain
Teva Investigational Site 31292
Valencia
46026
Spain
Teva Investigational Site 58327
Chernivtsi
58002
Ukraine
Teva Investigational Site 58324
Ivano-Frankivsk
76008
Ukraine
Teva Investigational Site 58329
Lviv
79000
Ukraine
Teva Investigational Site 58325
Lviv
79010
Ukraine
Teva Investigational Site 58332
Lviv
79010
Ukraine
Teva Investigational Site 58328
Ternopil
46002
Ukraine
Teva Investigational Site 58322
Uzhhorod
88000
Ukraine
Teva Investigational Site 58323
Uzhhorod
88000
Ukraine
Teva Investigational Site 58330
Vinnytsia
21018
Ukraine
Teva Investigational Site 58331
Vinnytsia
21018
Ukraine
Teva Investigational Site 34305
London
SE1 9RT
United Kingdom
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.
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG006
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.
FG007
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.
FG00044 subjects
FG00147 subjects
FG00246 subjects
FG0037 subjects
FG00446 subjects
FG00546 subjects
FG00647 subjects
FG0073 subjects
Received at Least 1 Dose of Study Drug
FG00044 subjects
FG00147 subjects
FG00246 subjects
FG0037 subjects
FG00446 subjects
FG00546 subjects
FG00646 subjects
FG0073 subjects
mITT Analysis Set
The mITT analysis set for each indication (UC or CD) included only those participants who received at least 1 dose of placebo, TEV-48574 low dose, or TEV-48574 medium dose.
FG00044 subjects
FG00147 subjects
FG00246 subjects
FG0030 subjects
FG00446 subjects
FG00546 subjects
FG00646 subjects
FG0070 subjects
Immunogenicity Analysis Set
The immunogenicity analysis set included all participants in all randomized participants who received at least 1 dose of TEV-48574 and who had at least 1 reportable immunogenicity result.
FG0000 subjects
FG00147 subjects
FG00245 subjects
FG0037 subjects
FG0040 subjects
FG00546 subjects
FG00646 subjects
FG0073 subjects
COMPLETED
FG00039 subjects
FG00147 subjects
FG00245 subjects
FG0037 subjects
FG00437 subjects
FG00537 subjects
FG00643 subjects
FG0073 subjects
NOT COMPLETED
FG0005 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0049 subjects
FG0059 subjects
FG0064 subjects
FG0070 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0054 subjects
FG0061 subjects
FG0070 subjects
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other Than Specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The intent-to-treat (ITT) analysis set for each indication (UC or CD) included all randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (UC)
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
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.
BG007
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.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00044
BG00147
BG00246
BG0037
BG00446
BG00546
BG00647
BG0073
BG008286
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00044
ParticipantsBG00147
ParticipantsBG00246
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00044
ParticipantsBG00147
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00044
ParticipantsBG00147
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
ParticipantsBG00044
ParticipantsBG00147
ParticipantsBG002
Modified Mayo Score (MMS)
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.
Number analyzed = participants with UC.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG00044
ParticipantsBG001
Simple Endoscopic Score for Crohn's Disease (SES-CD)
SES-CD assesses following 4 components: presence of ulcers and strictures, percentage of ulcerated surfaces and affected surface. Each of these components scored on a scale of 0 (none/unaffected) to 3 (worst). Each of these 4 components was assessed in 5 segments: rectum, sigmoid and left colon, transverse colon, right colon, and ileum. SES-CD was the sum of individual scores of each components across 5 segments. Range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for overall SES-CD score, with larger scores indicating greater degree of inflammation.
Number analyzed = participants with CD.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS
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".
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.
Posted
Count of Participants
Participants
Week 14
ID
Title
Description
OG000
Placebo (UC)
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.
OG001
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.
OG002
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.
Units
Counts
Participants
OG00044
OG00147
OG00246
Title
Denominators
Categories
Title
Measurements
OG0009
OG00117
OG00222
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in Response Rate
15.7
Other
OG000
OG001
Posterior Probability
Primary
Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD
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.
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.
Posted
Count of Participants
Participants
Baseline to Week 14
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by the MMS
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.
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.
Posted
Count of Participants
Participants
Baseline to Week 14
ID
Title
Description
OG000
Placebo (UC)
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.
OG001
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.
Secondary
Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES)
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.
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.
Posted
Count of Participants
Participants
Week 14
ID
Title
Description
OG000
Placebo (UC)
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.
OG001
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.
OG002
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.
Secondary
Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES
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.
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.
Posted
Count of Participants
Participants
Week 14
ID
Title
Description
OG000
Placebo (UC)
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.
OG001
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.
OG002
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.
Secondary
Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by 2-item Patient-reported Outcome (PRO2) Score
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.
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.
Posted
Count of Participants
Participants
Baseline to Week 14
ID
Title
Description
OG000
Placebo (UC)
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.
OG001
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.
Secondary
Number of Participants With Moderate to Severe UC With a Clinical Remission as Defined by PRO2 Score
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.
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.
Posted
Count of Participants
Participants
Week 14
ID
Title
Description
OG000
Placebo (UC)
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.
OG001
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.
Secondary
Number of Participants With Moderate to Severe CD With an Endoscopic Response as Defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD)
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.
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.
Posted
Count of Participants
Participants
Baseline to Week 14
ID
Title
Description
OG000
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.
OG001
TEV-48574 450 mg (CD)
Secondary
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score
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.
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.
Posted
Count of Participants
Participants
Baseline to Weeks 4, 8, 12 and 14
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by CDAI Score
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.
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.
Posted
Count of Participants
Participants
Week 14
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by PRO2-CD Score
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.
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.
Posted
Count of Participants
Participants
Baseline to Week 14
ID
Title
Description
OG000
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.
OG001
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.
OG002
TEV-48574 900 mg (CD)
Secondary
Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by PRO2-CD Score
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
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.
Posted
Count of Participants
Participants
Week 14
ID
Title
Description
OG000
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.
OG001
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.
OG002
TEV-48574 900 mg (CD)
Secondary
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
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.
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
Baseline (Day 1) up to Week 18
ID
Title
Description
OG000
Placebo (UC)
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.
OG001
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.
OG002
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.
Secondary
Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs
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.
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
Baseline (Day 1) up to Week 18
ID
Title
Description
OG000
Placebo (UC)
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.
OG001
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.
OG002
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.
Secondary
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs)
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.
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.
Posted
Count of Participants
Participants
Weeks 2, 4, 8, 14, and 18
ID
Title
Description
OG000
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.
OG001
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.
OG002
TEV-48574 1800 mg (UC)
Secondary
Number of ADA Positive Participants With the Presence of Neutralizing ADA
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.
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.
Posted
Count of Participants
Participants
Weeks 2, 4, 8, 14, and 18
ID
Title
Description
OG000
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.
OG001
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.
OG002
Time Frame
Baseline (Day 1) up to Week 18
Description
The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (UC)
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.
0
44
1
44
6
44
EG001
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.
0
47
0
47
10
47
EG002
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.
0
46
1
46
6
46
EG003
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.
0
7
0
7
2
7
EG004
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.
0
46
5
46
9
46
EG005
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.
0
46
6
46
9
46
EG006
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.
0
46
1
46
5
46
EG007
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.
0
3
0
3
2
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukocytosis
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected46 at risk
EG0060 events0 affected46 at risk
EG0070 events0 affected3 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Pelvic mass
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Blood pressure orthostatic decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Noninfective oophoritis
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected46 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected44 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected46 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected46 at risk
EG0053 events3 affected46 at risk
EG0060 events0 affected46 at risk
EG0070 events0 affected3 at risk
Vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected47 at risk
EG0022 events2 affected46 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected44 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0013 events3 affected47 at risk
EG0021 events1 affected46 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected44 at risk
EG0010 events0 affected47 at risk
EG0022 events2 affected46 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0022 events1 affected46 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected46 at risk
EG003
Abnormal uterine bleeding
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected46 at risk
EG003
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 (mITT Analysis Set).
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
A beta-binomial model was employed to obtain this posterior probability using a non-informative prior to assess superior efficacy compared to placebo.
Other
OG000
OG002
Difference in Response Rate
27.4
Other
OG000
OG002
Posterior Probability
0.997
A beta-binomial model was employed to obtain this posterior probability using a non-informative prior to assess superior efficacy compared to placebo.
Other
OG002
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.
Units
Counts
Participants
OG00046
OG00146
OG00246
Title
Denominators
Categories
Title
Measurements
OG0006
OG00112
OG00222
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in Response Rate
13.0
Other
OG000
OG001
Posterior Probability
0.939
A beta-binomial model was employed to obtain this posterior probability using a non-informative prior to assess superior efficacy compared to placebo.
Other
OG000
OG002
Difference in Response Rate
34.8
Other
OG000
OG002
Posterior Probability
1.000
A beta-binomial model was employed to obtain this posterior probability using a non-informative prior to assess superior efficacy compared to placebo.
Other
OG002
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.
Units
Counts
Participants
OG00044
OG00147
OG00246
Title
Denominators
Categories
Title
Measurements
OG00023
OG00138
OG00232
Units
Counts
Participants
OG00044
OG00147
OG00246
Title
Denominators
Categories
Title
Measurements
OG00010
OG00121
OG00223
Units
Counts
Participants
OG00044
OG00147
OG00246
Title
Denominators
Categories
Title
Measurements
OG0003
OG0018
OG0028
OG002
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.
Units
Counts
Participants
OG00044
OG00147
OG00246
Title
Denominators
Categories
Title
Measurements
OG00022
OG00139
OG00234
OG002
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.
Units
Counts
Participants
OG00044
OG00147
OG00246
Title
Denominators
Categories
Title
Measurements
OG0004
OG00114
OG00211
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.
OG002
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.
Units
Counts
Participants
OG00046
OG00146
OG00246
Title
Denominators
Categories
Title
Measurements
OG0006
OG00116
OG00218
OG002
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.
Units
Counts
Participants
OG00046
OG00146
OG00246
Title
Denominators
Categories
Week 4
ParticipantsOG00040
ParticipantsOG00145
ParticipantsOG00244
Title
Measurements
OG00015
OG00124
OG00218
Week 8
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00246
Title
Measurements
OG000
Week 12
ParticipantsOG00045
ParticipantsOG00146
ParticipantsOG00245
Title
Measurements
OG000
Week 14
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00246
Title
Measurements
OG000
OG002
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.
Units
Counts
Participants
OG00046
OG00146
OG00246
Title
Denominators
Categories
Title
Measurements
OG00019
OG00123
OG00225
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.
Units
Counts
Participants
OG00046
OG00146
OG00246
Title
Denominators
Categories
Title
Measurements
OG0008
OG00116
OG00214
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.
Units
Counts
Participants
OG00046
OG00146
OG00246
Title
Denominators
Categories
Title
Measurements
OG00012
OG00117
OG00217
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00044
OG00147
OG00246
OG0037
OG00446
OG00546
OG00646
OG0073
Title
Denominators
Categories
Title
Measurements
OG00023
OG00123
OG00220
OG0032
OG00422
OG00531
OG00620
OG0072
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00044
OG00147
OG00246
OG0037
OG00446
OG00546
OG00646
OG0073
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0021
OG0030
OG0041
OG0054
OG0061
OG0070
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00047
OG00145
OG0027
OG00346
OG00446
OG0053
Title
Denominators
Categories
Week 2
Title
Measurements
OG0000
OG0010
OG0020
OG0034
OG0041
OG0050
Week 4
Title
Measurements
OG0000
OG0012
OG0020
OG003
Week 8
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 14
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 18
Title
Measurements
OG0001
OG0010
OG0020
OG003
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.
OG003
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.
OG004
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.
OG005
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.