Back to resultsA Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
Primary Purpose
Crohn Disease, Colitis, Ulcerative
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TEV-48574 Dose Regimen A
TEV-48574 Dose Regiment B
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
Inclusion Criteria: Participants achieved clinical response and/or clinical remission in the 14-week TV48574-IMM-20036 DRF study Participants who are women of childbearing potential (WOCBP) should have a negative β-human chorionic gonadotropin test result and practice a highly effective method of birth control Male participants (including vasectomized) with WOCBP partners should use condoms after the first IMP administration and throughout the study NOTE- Additional criteria may apply, please contact the investigator for more information Exclusion Criteria: Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons) and participants who didn't meet the definition of clinical response or clinical remission based on their DRF week 14 assessment 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. Participant anticipates requiring major surgery during this study. Participants with clinical symptoms that may indicate coronavirus disease 2019 (COVID-19) infection 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 Any woman becoming pregnant during the study will be withdrawn from the study. NOTE- Additional criteria apply, please contact the investigator for more information
Sites / Locations
- Teva Investigational Site 15357Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)
TEV-48574 Dose Regimen A for Crohn's Disease (CD)
TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)
TEV-48574 Dose Regimen B for Crohn's Disease (CD)
Arm Description
Administered by subcutaneous infusion for participants with UC
Administered by subcutaneous infusion for participants with CD
Administered by subcutaneous infusion for participants with UC
Administered by subcutaneous infusion for participants with CD
Outcomes
Primary Outcome Measures
Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score
Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by:
stool frequency subscore of 0 or 1,
rectal bleeding subscore of 0, and
endoscopic subscore of 0 or 1, where a score of 1 does not include "friability"
Number of participants with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease
Endoscopic response is defined as at week 24 in participants with moderate to severe CD, defined as a reduction from the dose range finding (DRF) study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) of >50%
Secondary Outcome Measures
Number of participants with moderate to severe UC with a clinical response as defined by Mayo score
Clinical response at week 24, defined as a decrease from baseline in the modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from DRF baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1
Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score
Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1
Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score
Endoscopic remission defined as a Mayo endoscopic subscore of 0
Number of participants with moderate to severe UC with a clinical response based on patient-reported outcome (PRO2)
Clinical response defined as decrease from DRF study baseline of at least 50% in 2-item patient-reported outcome (PRO2; rectal bleeding and stool frequency)
Number of participants with moderate to severe UC in Clinical remission based on PRO2 score
Clinical remission defined as score of rectal bleeding = 0 and stool frequency = 0 on the PRO2 scale
Number of participants with moderate to severe UC with Histological remission defined as a Robarts Histopathology Index of ≤5
Number of participants with moderate to severe UC with Histological remission defined as Geboes index score ≤3.1
Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index
Clinical response defined as a ≥100-point decrease from DRF baseline Crohn's Disease Activity Index (CDAI) score
Number of participants with moderate to severe CD in clinical remission as defined by CDAI score
Clinical remission defined as a CDAI score less than 150
Number of participants with moderate to severe CD with Endoscopic remission as defined by SES-CD score
Endoscopic remission defined as SES-CD score of 0-2, or SES-CD score of 0-4, with no individual sub score >1
Number of participants with moderate to severe CD with a clinical response as defined by PRO2 score
Clinical response defined as a decrease from DRF baseline of at least 50% in PRO2 (PRO2 is defined as having 2 components, abdominal pain and stool frequency)
Number of participants with moderate to severe CD in clinical remission as defined by PRO2 score
Clinical remission defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2 scale
Number of participants with moderate to severe CD with an Endoscopic response as defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD)
Endoscopic response defined as a decrease from DRF baseline in Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) of >50%.
Number of participants with moderate to severe CD with a Histologic response as defined by Global Histologic Activity score
Histologic response defined as a ≥50% decrease from DRF baseline in Global Histologic Activity score
Number of Participants Who Experience Adverse Events
Adverse events include clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions.
Number of participants who report the use of concomitant medications
Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events
Number of participants with infusion device-related adverse events and malfunctions
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)
Number of ADA positive participants with the presence of neutralizing ADA
Full Information
NCT ID
NCT05668013
First Posted
December 12, 2022
Last Updated
May 12, 2023
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05668013
Brief Title
A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
Official Title
A 24-Week Phase 2b Long-Term Extension, RandomizEd, Double-BLind, Study to Determine the Long-Term PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Main Phase of the Dose-Ranging Study (RELIEVE UCCD LTE)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
January 13, 2025 (Anticipated)
Study Completion Date
January 27, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of the study is to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 2 weeks (Q2W) in adult participants with inflammatory bowel disease (IBD)
Secondary objectives of the study are to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD to evaluate the safety and tolerability of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD, and to evaluate the immunogenicity of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD
The total duration of participant participation in the study is planned to be 26 weeks for each individual participant. The study duration is approximately 30 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Colitis, Ulcerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)
Arm Type
Experimental
Arm Description
Administered by subcutaneous infusion for participants with UC
Arm Title
TEV-48574 Dose Regimen A for Crohn's Disease (CD)
Arm Type
Experimental
Arm Description
Administered by subcutaneous infusion for participants with CD
Arm Title
TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)
Arm Type
Experimental
Arm Description
Administered by subcutaneous infusion for participants with UC
Arm Title
TEV-48574 Dose Regimen B for Crohn's Disease (CD)
Arm Type
Experimental
Arm Description
Administered by subcutaneous infusion for participants with CD
Intervention Type
Drug
Intervention Name(s)
TEV-48574 Dose Regimen A
Intervention Description
Subcutaneous (sc) administration using a commercial sc infusion system
Intervention Type
Drug
Intervention Name(s)
TEV-48574 Dose Regiment B
Intervention Description
Subcutaneous (sc) administration using a commercial sc infusion system
Primary Outcome Measure Information:
Title
Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score
Description
Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by:
stool frequency subscore of 0 or 1,
rectal bleeding subscore of 0, and
endoscopic subscore of 0 or 1, where a score of 1 does not include "friability"
Time Frame
Week 24
Title
Number of participants with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease
Description
Endoscopic response is defined as at week 24 in participants with moderate to severe CD, defined as a reduction from the dose range finding (DRF) study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) of >50%
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Number of participants with moderate to severe UC with a clinical response as defined by Mayo score
Description
Clinical response at week 24, defined as a decrease from baseline in the modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from DRF baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1
Time Frame
Week 24
Title
Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score
Description
Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1
Time Frame
Week 24
Title
Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score
Description
Endoscopic remission defined as a Mayo endoscopic subscore of 0
Time Frame
Week 24
Title
Number of participants with moderate to severe UC with a clinical response based on patient-reported outcome (PRO2)
Description
Clinical response defined as decrease from DRF study baseline of at least 50% in 2-item patient-reported outcome (PRO2; rectal bleeding and stool frequency)
Time Frame
Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24
Title
Number of participants with moderate to severe UC in Clinical remission based on PRO2 score
Description
Clinical remission defined as score of rectal bleeding = 0 and stool frequency = 0 on the PRO2 scale
Time Frame
Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24
Title
Number of participants with moderate to severe UC with Histological remission defined as a Robarts Histopathology Index of ≤5
Time Frame
Week 24
Title
Number of participants with moderate to severe UC with Histological remission defined as Geboes index score ≤3.1
Time Frame
Week 24
Title
Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index
Description
Clinical response defined as a ≥100-point decrease from DRF baseline Crohn's Disease Activity Index (CDAI) score
Time Frame
Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24
Title
Number of participants with moderate to severe CD in clinical remission as defined by CDAI score
Description
Clinical remission defined as a CDAI score less than 150
Time Frame
Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24
Title
Number of participants with moderate to severe CD with Endoscopic remission as defined by SES-CD score
Description
Endoscopic remission defined as SES-CD score of 0-2, or SES-CD score of 0-4, with no individual sub score >1
Time Frame
Week 24
Title
Number of participants with moderate to severe CD with a clinical response as defined by PRO2 score
Description
Clinical response defined as a decrease from DRF baseline of at least 50% in PRO2 (PRO2 is defined as having 2 components, abdominal pain and stool frequency)
Time Frame
Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24
Title
Number of participants with moderate to severe CD in clinical remission as defined by PRO2 score
Description
Clinical remission defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2 scale
Time Frame
Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24
Title
Number of participants with moderate to severe CD with an Endoscopic response as defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD)
Description
Endoscopic response defined as a decrease from DRF baseline in Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) of >50%.
Time Frame
Week 24
Title
Number of participants with moderate to severe CD with a Histologic response as defined by Global Histologic Activity score
Description
Histologic response defined as a ≥50% decrease from DRF baseline in Global Histologic Activity score
Time Frame
Week 24
Title
Number of Participants Who Experience Adverse Events
Description
Adverse events include clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions.
Time Frame
Up to Week 26
Title
Number of participants who report the use of concomitant medications
Time Frame
Up to Week 26
Title
Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events
Time Frame
Up to Week 24
Title
Number of participants with infusion device-related adverse events and malfunctions
Time Frame
Up to Week 26
Title
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)
Time Frame
Weeks 0, 4, 8, 14, 20, 24, and 26
Title
Number of ADA positive participants with the presence of neutralizing ADA
Time Frame
Weeks 0, 4, 8, 14, 20, 24, and 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants achieved clinical response and/or clinical remission in the 14-week TV48574-IMM-20036 DRF study
Participants who are women of childbearing potential (WOCBP) should have a negative β-human chorionic gonadotropin test result and practice a highly effective method of birth control
Male participants (including vasectomized) with WOCBP partners should use condoms after the first IMP administration and throughout the study
NOTE- Additional criteria may apply, please contact the investigator for more information
Exclusion Criteria:
Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons) and participants who didn't meet the definition of clinical response or clinical remission based on their DRF week 14 assessment
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.
Participant anticipates requiring major surgery during this study.
Participants with clinical symptoms that may indicate coronavirus disease 2019 (COVID-19) infection
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.
NOTE- Additional criteria apply, please contact the investigator for more information
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teva U.S. Medical Information
Phone
1-888-483-8279
Email
USMedInfo@tevapharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 15357
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit www.clinicalstudydatarequest.com to make your request.
Learn more about this trial
A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
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