A Phase 2 interventional study of TEV-48574 and Placebo in Crohn Disease and Colitis, Ulcerative, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 164 sites in 19 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 2, Interventional, and Treatment
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:
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.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's enrollment of 290 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 206 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
NOTE- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
NOTE- Additional criteria apply, please contact the investigator for more information
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administered by subcutaneous infusion for participants with UC
Drug: TEV-48574
Administered by subcutaneous infusion for participants with UC
Drug: TEV-48574
Administered by subcutaneous infusion for participants with UC. This arm was discontinued with Amend 03.
Drug: TEV-48574
Administered by subcutaneous infusion for participants with CD
Drug: TEV-48574
Administered by subcutaneous infusion for participants with CD
Drug: TEV-48574
Administered by subcutaneous infusion for participants with CD. This arm was discontinued with Amend 03.
Drug: TEV-48574
Matching Placebo
Drug: Placebo
Matching Placebo
Drug: Placebo
Subcutaneous infusion
Also known as: duvakitug
Matching Placebo
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
| Milestone | 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) |
|---|---|---|---|---|---|---|---|---|
| Started | 44 | 47 | 46 | 7 | 46 | 46 | 47 | 3 |
| Received at least 1 dose of study drug | 44 | 47 | 46 | 7 | 46 | 46 | 46 | 3 |
| Mitt analysis set | 44 | 47 | 46 | 0 | 46 | 46 | 46 | 0 |
| Immunogenicity analysis set | 0 | 47 | 45 | 7 | 0 | 46 | 46 | 3 |
| Completed | 39 | 47 | 45 | 7 | 37 | 37 | 43 | 3 |
| Not completed | 5 | 0 | 1 | 0 | 9 | 9 | 4 | 0 |
| Withdrew: Adverse event | 2 | 0 | 1 | 0 | 1 | 4 | 1 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 | 0 | 5 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 | 0 | 1 | 2 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Other than specified | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
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".
| Participants | Placebo (UC) | TEV-48574 450 mg (UC) | TEV-48574 900 mg (UC) |
|---|---|---|---|
| Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS | 9 | 17 | 22 |
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.
| Participants | Placebo (CD) | TEV-48574 450 mg (CD) | TEV-48574 900 mg (CD) |
|---|---|---|---|
| Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD | 6 | 12 | 22 |
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.
| Participants | Placebo (UC) | TEV-48574 450 mg (UC) | TEV-48574 900 mg (UC) |
|---|---|---|---|
| Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by the MMS | 23 | 38 | 32 |
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.
| Participants | Placebo (UC) | TEV-48574 450 mg (UC) | TEV-48574 900 mg (UC) |
|---|---|---|---|
| Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES) | 10 | 21 | 23 |
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.
| Participants | Placebo (UC) | TEV-48574 450 mg (UC) | TEV-48574 900 mg (UC) |
|---|---|---|---|
| Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES | 3 | 8 | 8 |
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.
| Participants | Placebo (UC) | TEV-48574 450 mg (UC) | 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 | 22 | 39 | 34 |
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.
| Participants | Placebo (UC) | TEV-48574 450 mg (UC) | TEV-48574 900 mg (UC) |
|---|---|---|---|
| Number of Participants With Moderate to Severe UC With a Clinical Remission as Defined by PRO2 Score | 4 | 14 | 11 |
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.
| Participants | Placebo (CD) | TEV-48574 450 mg (CD) | TEV-48574 900 mg (CD) |
|---|---|---|---|
| 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 | 16 | 18 |
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.
| Participants | Placebo (CD) | TEV-48574 450 mg (CD) | TEV-48574 900 mg (CD) |
|---|---|---|---|
| Week 4 | 15 | 24 | 18 |
| Week 8 | 19 | 30 | 25 |
| Week 12 | 22 | 31 | 31 |
| Week 14 | 24 | 30 | 30 |
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.
| Participants | Placebo (CD) | TEV-48574 450 mg (CD) | TEV-48574 900 mg (CD) |
|---|---|---|---|
| Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by CDAI Score | 19 | 23 | 25 |
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.
| Participants | Placebo (CD) | TEV-48574 450 mg (CD) | TEV-48574 900 mg (CD) |
|---|---|---|---|
| Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by PRO2-CD Score | 8 | 16 | 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
| Participants | Placebo (CD) | TEV-48574 450 mg (CD) | TEV-48574 900 mg (CD) |
|---|---|---|---|
| Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by PRO2-CD Score | 12 | 17 | 17 |
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.
| Participants | 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) |
|---|---|---|---|---|---|---|---|---|
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 23 | 23 | 20 | 2 | 22 | 31 | 20 | 2 |
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.
| Participants | 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) |
|---|---|---|---|---|---|---|---|---|
| Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs | 2 | 0 | 1 | 0 | 1 | 4 | 1 | 0 |
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.
| Participants | TEV-48574 450 mg (UC) | TEV-48574 900 mg (UC) | TEV-48574 1800 mg (UC) | TEV-48574 450 mg (CD) | TEV-48574 900 mg (CD) | TEV-48574 1800 mg (CD) |
|---|---|---|---|---|---|---|
| Week 2 | 0 | 0 | 0 | 4 | 1 | 0 |
| Week 4 | 0 | 2 | 0 | 2 | 0 | 0 |
| Week 8 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 14 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 18 | 1 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | TEV-48574 450 mg (UC) | TEV-48574 900 mg (UC) | TEV-48574 1800 mg (UC) | TEV-48574 450 mg (CD) | TEV-48574 900 mg (CD) | TEV-48574 1800 mg (CD) |
|---|---|---|---|---|---|---|
| Week 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 8 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 14 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 18 | 1 | 0 | 0 | 0 | 0 | 0 |
Collected over Baseline (Day 1) up to Week 18. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo (UC) | 0/44 (0%) | 1/44 (2.3%) | 6/44 (13.6%) |
| TEV-48574 450 mg (UC) | 0/47 (0%) | 0/47 (0%) | 10/47 (21.3%) |
| TEV-48574 900 mg (UC) | 0/46 (0%) | 1/46 (2.2%) | 6/46 (13%) |
| TEV-48574 1800 mg (UC) | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Placebo (CD) | 0/46 (0%) | 5/46 (10.9%) | 9/46 (19.6%) |
| TEV-48574 450 mg (CD) | 0/46 (0%) | 6/46 (13%) | 9/46 (19.6%) |
| TEV-48574 900 mg (CD) | 0/46 (0%) | 1/46 (2.2%) | 5/46 (10.9%) |
| TEV-48574 1800 mg (CD) | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Event | 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) |
|---|---|---|---|---|---|---|---|---|
| Haemorrhage intracranialNervous system disorders | 1/44 | 0/47 | 0/46 | 0/7 | 0/46 | 0/46 | 0/46 | 0/3 |
| LeukocytosisBlood and lymphatic system disorders | 0/44 | 0/47 | 0/46 | 0/7 | 0/46 | 1/46 | 0/46 | 0/3 |
| Atrial fibrillationCardiac disorders | 0/44 | 0/47 | 0/46 | 0/7 | 0/46 | 1/46 | 0/46 | 0/3 |
| Coronary artery diseaseCardiac disorders | 0/44 | 0/47 | 0/46 | 0/7 | 0/46 | 1/46 | 0/46 | 0/3 |
| Abdominal painGastrointestinal disorders | 0/44 | 0/47 | 0/46 | 0/7 | 0/46 | 0/46 | 1/46 | 0/3 |
| Crohn's diseaseGastrointestinal disorders | 0/44 | 0/47 | 0/46 | 0/7 | 1/46 | 0/46 | 0/46 | 0/3 |
| Food poisoningGastrointestinal disorders | 0/44 | 0/47 | 0/46 | 0/7 | 0/46 | 1/46 | 0/46 | 0/3 |
| Intestinal perforationGastrointestinal disorders | 0/44 | 0/47 | 0/46 | 0/7 | 1/46 | 0/46 | 0/46 | 0/3 |
| NauseaGastrointestinal disorders | 0/44 | 0/47 | 0/46 | 0/7 | 1/46 | 0/46 | 0/46 | 0/3 |
| Rectal haemorrhageGastrointestinal disorders | 0/44 | 0/47 | 0/46 | 0/7 | 1/46 | 0/46 | 0/46 | 0/3 |
| Event | 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) |
|---|---|---|---|---|---|---|---|---|
| InfluenzaInfections and infestations | 1/44 | 0/47 | 2/46 | 0/7 | 1/46 | 1/46 | 0/46 | 1/3 |
| ProteinuriaRenal and urinary disorders | 0/44 | 0/47 | 1/46 | 0/7 | 0/46 | 0/46 | 0/46 | 1/3 |
| EczemaSkin and subcutaneous tissue disorders | 0/44 | 0/47 | 0/46 | 0/7 | 0/46 | 0/46 | 0/46 | 1/3 |
| InsomniaPsychiatric disorders | 0/44 | 0/47 | 1/46 | 1/7 | 0/46 | 0/46 | 0/46 | 0/3 |
| Abnormal uterine bleedingReproductive system and breast disorders | 0/44 | 0/47 | 0/46 | 1/7 | 0/46 | 0/46 | 0/46 | 0/3 |
| HeadacheNervous system disorders | 2/44 | 0/47 | 2/46 | 0/7 | 1/46 | 4/46 | 1/46 | 0/3 |
| AnaemiaBlood and lymphatic system disorders | 3/44 | 1/47 | 1/46 | 0/7 | 1/46 | 3/46 | 0/46 | 0/3 |
| NasopharyngitisInfections and infestations | 1/44 | 3/47 | 0/46 | 0/7 | 3/46 | 2/46 | 3/46 | 0/3 |
| VomitingGastrointestinal disorders | 0/44 | 3/47 | 0/46 | 0/7 | 2/46 | 0/46 | 1/46 | 0/3 |
| Upper respiratory tract infectionInfections and infestations | 1/44 | 3/47 | 1/46 | 0/7 | 2/46 | 0/46 | 0/46 | 0/3 |
The intent-to-treat (ITT) analysis set for each indication (UC or CD) included all randomized participants.
| Age, Continuous(years) | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 42.2 ± 13.08 | 38.7 ± 12.99 | 42.1 ± 13.19 | 40.9 ± 16.24 | 38.3 ± 15.13 | 42.5 ± 15.08 | 38.1 ± 13.58 | 43.7 ± 23.54 | 40.4 ± 13.99 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Female | 14 | 18 | 19 | 5 | 24 | 19 | 16 | 1 | 116 |
| Male | 30 | 29 | 27 | 2 | 22 | 27 | 31 | 2 | 170 |
| Ethnicity (NIH/OMB)(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 6 |
| Not Hispanic or Latino | 42 | 46 | 45 | 7 | 46 | 43 | 46 | 3 | 278 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Race — Asian | 1 | 1 | 1 | 0 | 0 | 1 | 2 | 0 | 6 |
| Race — Black or African American | 0 | 1 | 0 | 0 | 1 | 0 | 2 | 0 | 4 |
| Race — White | 43 | 44 | 45 | 7 | 45 | 45 | 41 | 3 | 273 |
| Race — Other | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 2 |
| Race — Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Modified Mayo Score (MMS)(units on a scale) | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 6.8 ± 1.16 | 6.6 ± 1.15 | 6.8 ± 1.11 | 6.6 ± 1.13 | — | — | — | — | 6.7 ± 1.14 |
| Simple Endoscopic Score for Crohn's Disease (SES-CD)(units on a scale) | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Mean | — | — | — | — | 12.0 ± 5.70 | 12.7 ± 6.64 | 12.1 ± 5.81 | 7.7 ± 2.89 | 12.1 ± 6.01 |
Showing the first 100 of 164 sites across 19 countries. Choose a country and city above to see the rest.
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Studies of the drug tested here: Duvakitug
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