Colitis, Ulcerative, Crohn Disease
Conditions
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.
Interventions
DRUGTEV-48574
Subcutaneous infusion
DRUGPlacebo
Matching Placebo
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS | Week 14 | 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". |
| Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD | Baseline to Week 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by the MMS | Baseline to Week 14 | 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. |
| Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES) | Week 14 | 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. |
| Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES | Week 14 | 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. |
| Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by 2-item Patient-reported Outcome (PRO2) Score | Baseline to Week 14 | 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. |
| Number of Participants With Moderate to Severe UC With a Clinical Remission as Defined by PRO2 Score | Week 14 | 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. |
| Number of Participants With Moderate to Severe CD With an Endoscopic Response as Defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) | Baseline to Week 14 | 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. |
| Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score | Baseline to Weeks 4, 8, 12 and 14 | 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. |
| Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by CDAI Score | Week 14 | 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. |
| Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by PRO2-CD Score | Baseline to Week 14 | 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. |
| Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by PRO2-CD Score | Week 14 | 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 |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Baseline (Day 1) up to Week 18 | 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. |
| Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs | Baseline (Day 1) up to Week 18 | 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. |
| Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Weeks 2, 4, 8, 14, and 18 | 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. |
| Number of ADA Positive Participants With the Presence of Neutralizing ADA | Weeks 2, 4, 8, 14, and 18 | 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. |
Countries
Austria, Belgium, Bulgaria, Canada, Czechia, France, Georgia, Germany, Hungary, Israel, Italy, Japan, Norway, Poland, Slovakia, Spain, Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORTeva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D, Inc.
Participant flow
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.
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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. | 47 |
| 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. | 46 |
| 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. | 7 |
| 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. | 46 |
| 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. | 46 |
| 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. | 47 |
| 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. | 3 |
| Total | 286 |
Baseline characteristics
| Characteristic | Placebo (UC) | TEV-48574 450 mg (UC) | TEV-48574 900 mg (UC) | TEV-48574 1800 mg (UC) | Placebo (CD) | TEV-48574 450 mg (CD) | TEV-48574 900 mg (CD) | TEV-48574 1800 mg (CD) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 42.2 years STANDARD_DEVIATION 13.08 | 38.7 years STANDARD_DEVIATION 12.99 | 42.1 years STANDARD_DEVIATION 13.19 | 40.9 years STANDARD_DEVIATION 16.24 | 38.3 years STANDARD_DEVIATION 15.13 | 42.5 years STANDARD_DEVIATION 15.08 | 38.1 years STANDARD_DEVIATION 13.58 | 43.7 years STANDARD_DEVIATION 23.54 | 40.4 years STANDARD_DEVIATION 13.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 46 Participants | 45 Participants | 7 Participants | 46 Participants | 43 Participants | 46 Participants | 3 Participants | 278 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Modified Mayo Score (MMS) | 6.8 units on a scale STANDARD_DEVIATION 1.16 | 6.6 units on a scale STANDARD_DEVIATION 1.15 | 6.8 units on a scale STANDARD_DEVIATION 1.11 | 6.6 units on a scale STANDARD_DEVIATION 1.13 | — | — | — | — | 6.7 units on a scale STANDARD_DEVIATION 1.14 |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 43 Participants | 44 Participants | 45 Participants | 7 Participants | 45 Participants | 45 Participants | 41 Participants | 3 Participants | 273 Participants |
| Sex: Female, Male Female | 14 Participants | 18 Participants | 19 Participants | 5 Participants | 24 Participants | 19 Participants | 16 Participants | 1 Participants | 116 Participants |
| Sex: Female, Male Male | 30 Participants | 29 Participants | 27 Participants | 2 Participants | 22 Participants | 27 Participants | 31 Participants | 2 Participants | 170 Participants |
| Simple Endoscopic Score for Crohn's Disease (SES-CD) | — | — | — | — | 12.0 units on a scale STANDARD_DEVIATION 5.7 | 12.7 units on a scale STANDARD_DEVIATION 6.64 | 12.1 units on a scale STANDARD_DEVIATION 5.81 | 7.7 units on a scale STANDARD_DEVIATION 2.89 | 12.1 units on a scale STANDARD_DEVIATION 6.01 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 47 | 0 / 46 | 0 / 7 | 0 / 46 | 0 / 46 | 0 / 46 | 0 / 3 |
| other Total, other adverse events | 6 / 44 | 10 / 47 | 6 / 46 | 2 / 7 | 9 / 46 | 9 / 46 | 5 / 46 | 2 / 3 |
| serious Total, serious adverse events | 1 / 44 | 0 / 47 | 1 / 46 | 0 / 7 | 5 / 46 | 6 / 46 | 1 / 46 | 0 / 3 |
Outcome results
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.
Time frame: Baseline to Week 14
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD | 6 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD | 12 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD | 22 Participants |
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.
Time frame: Week 14
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS | 9 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS | 17 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS | 22 Participants |
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.
Time frame: Weeks 2, 4, 8, 14, and 18
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 18 | 1 Participants |
| Placebo (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 14 | 0 Participants |
| Placebo (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 4 | 0 Participants |
| Placebo (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 8 | 0 Participants |
| Placebo (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 2 | 0 Participants |
| TEV-48574 450 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 2 | 0 Participants |
| TEV-48574 450 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 14 | 0 Participants |
| TEV-48574 450 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 18 | 0 Participants |
| TEV-48574 450 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 4 | 0 Participants |
| TEV-48574 450 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 8 | 0 Participants |
| TEV-48574 900 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 18 | 0 Participants |
| TEV-48574 900 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 14 | 0 Participants |
| TEV-48574 900 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 2 | 0 Participants |
| TEV-48574 900 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 8 | 0 Participants |
| TEV-48574 900 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 4 | 0 Participants |
| TEV-48574 1800 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 4 | 0 Participants |
| TEV-48574 1800 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 2 | 0 Participants |
| TEV-48574 1800 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 8 | 0 Participants |
| TEV-48574 1800 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 14 | 0 Participants |
| TEV-48574 1800 mg (UC) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 18 | 0 Participants |
| Placebo (CD) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 14 | 0 Participants |
| Placebo (CD) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 2 | 0 Participants |
| Placebo (CD) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 18 | 0 Participants |
| Placebo (CD) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 4 | 0 Participants |
| Placebo (CD) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 8 | 0 Participants |
| TEV-48574 450 mg (CD) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 2 | 0 Participants |
| TEV-48574 450 mg (CD) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 14 | 0 Participants |
| TEV-48574 450 mg (CD) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 4 | 0 Participants |
| TEV-48574 450 mg (CD) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 18 | 0 Participants |
| TEV-48574 450 mg (CD) | Number of ADA Positive Participants With the Presence of Neutralizing ADA | Week 8 | 0 Participants |
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.
Time frame: Baseline (Day 1) up to Week 18
Population: The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 23 Participants |
| TEV-48574 450 mg (UC) | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 23 Participants |
| TEV-48574 900 mg (UC) | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 20 Participants |
| TEV-48574 1800 mg (UC) | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 2 Participants |
| Placebo (CD) | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 22 Participants |
| TEV-48574 450 mg (CD) | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 31 Participants |
| TEV-48574 900 mg (CD) | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 20 Participants |
| TEV-48574 1800 mg (CD) | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 2 Participants |
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.
Time frame: Baseline (Day 1) up to Week 18
Population: The safety analysis set for each indication (UC or CD) included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs | 2 Participants |
| TEV-48574 450 mg (UC) | Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs | 0 Participants |
| TEV-48574 900 mg (UC) | Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs | 1 Participants |
| TEV-48574 1800 mg (UC) | Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs | 0 Participants |
| Placebo (CD) | Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs | 1 Participants |
| TEV-48574 450 mg (CD) | Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs | 4 Participants |
| TEV-48574 900 mg (CD) | Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs | 1 Participants |
| TEV-48574 1800 mg (CD) | Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs | 0 Participants |
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.
Time frame: Week 14
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by CDAI Score | 19 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by CDAI Score | 23 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by CDAI Score | 25 Participants |
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
Time frame: Week 14
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by PRO2-CD Score | 12 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by PRO2-CD Score | 17 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by PRO2-CD Score | 17 Participants |
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.
Time frame: Baseline to Weeks 4, 8, 12 and 14
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score | Week 4 | 15 Participants |
| Placebo (UC) | Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score | Week 8 | 19 Participants |
| Placebo (UC) | Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score | Week 12 | 22 Participants |
| Placebo (UC) | Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score | Week 14 | 24 Participants |
| TEV-48574 450 mg (UC) | 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 |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score | Week 4 | 24 Participants |
| TEV-48574 450 mg (UC) | 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 |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score | Week 8 | 30 Participants |
| TEV-48574 900 mg (UC) | 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 |
| TEV-48574 900 mg (UC) | 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 |
| TEV-48574 900 mg (UC) | 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 |
| TEV-48574 900 mg (UC) | 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 |
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.
Time frame: Baseline to Week 14
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by PRO2-CD Score | 8 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by PRO2-CD Score | 16 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by PRO2-CD Score | 14 Participants |
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.
Time frame: Baseline to Week 14
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe CD With an Endoscopic Response as Defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) | 6 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe CD With an Endoscopic Response as Defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) | 16 Participants |
| TEV-48574 900 mg (UC) | 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 |
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.
Time frame: Week 14
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe UC With a Clinical Remission as Defined by PRO2 Score | 4 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe UC With a Clinical Remission as Defined by PRO2 Score | 14 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Moderate to Severe UC With a Clinical Remission as Defined by PRO2 Score | 11 Participants |
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.
Time frame: Baseline to Week 14
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by 2-item Patient-reported Outcome (PRO2) Score | 22 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by 2-item Patient-reported Outcome (PRO2) Score | 39 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by 2-item Patient-reported Outcome (PRO2) Score | 34 Participants |
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.
Time frame: Baseline to Week 14
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by the MMS | 23 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by the MMS | 38 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by the MMS | 32 Participants |
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.
Time frame: Week 14
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES) | 10 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES) | 21 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES) | 23 Participants |
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.
Time frame: Week 14
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (UC) | Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES | 3 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES | 8 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES | 8 Participants |
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.
Time frame: Weeks 2, 4, 8, 14, and 18
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 14 | 0 Participants |
| Placebo (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 4 | 0 Participants |
| Placebo (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 2 | 0 Participants |
| Placebo (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 18 | 1 Participants |
| Placebo (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 8 | 0 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 4 | 2 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 14 | 0 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 2 | 0 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 18 | 0 Participants |
| TEV-48574 450 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 8 | 0 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 4 | 0 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 14 | 0 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 18 | 0 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 8 | 0 Participants |
| TEV-48574 900 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 2 | 0 Participants |
| TEV-48574 1800 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 8 | 0 Participants |
| TEV-48574 1800 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 2 | 4 Participants |
| TEV-48574 1800 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 4 | 2 Participants |
| TEV-48574 1800 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 14 | 0 Participants |
| TEV-48574 1800 mg (UC) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 18 | 0 Participants |
| Placebo (CD) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 14 | 0 Participants |
| Placebo (CD) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 2 | 1 Participants |
| Placebo (CD) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 18 | 0 Participants |
| Placebo (CD) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 4 | 0 Participants |
| Placebo (CD) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 8 | 0 Participants |
| TEV-48574 450 mg (CD) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 2 | 0 Participants |
| TEV-48574 450 mg (CD) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 14 | 0 Participants |
| TEV-48574 450 mg (CD) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 4 | 0 Participants |
| TEV-48574 450 mg (CD) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 18 | 0 Participants |
| TEV-48574 450 mg (CD) | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) | Week 8 | 0 Participants |