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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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ClinicalTrials.gov Identifier: NCT05668013
Recruitment Status : Recruiting
First Posted : December 29, 2022
Last Update Posted : May 2, 2024
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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Brief Summary:

The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD).

Secondary objectives of the study are to:

  • evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
  • evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
  • evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD

The total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.


Condition or disease Intervention/treatment Phase
Crohn Disease Colitis, Ulcerative Drug: TEV-48574 Dose Regimen A Drug: TEV-48574 Dose Regiment B Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Treatment Phase of the Dose-Ranging Study (RELIEVE UCCD LTE)
Actual Study Start Date : January 11, 2023
Estimated Primary Completion Date : July 5, 2031
Estimated Study Completion Date : August 2, 2031

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)
Administered by subcutaneous infusion for participants with UC
 Drug: TEV-48574 Dose Regimen A
Subcutaneous (sc) administration using a commercial sc infusion system
Experimental: TEV-48574 Dose Regimen A for Crohn's Disease (CD)
Administered by subcutaneous infusion for participants with CD
 Drug: TEV-48574 Dose Regimen A
Subcutaneous (sc) administration using a commercial sc infusion system
Experimental: TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)
Administered by subcutaneous infusion for participants with UC
 Drug: TEV-48574 Dose Regiment B
Subcutaneous (sc) administration using a commercial sc infusion system
Experimental: TEV-48574 Dose Regimen B for Crohn's Disease (CD)
Administered by subcutaneous infusion for participants with CD
 Drug: TEV-48574 Dose Regiment B
Subcutaneous (sc) administration using a commercial sc infusion system


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score [ Time Frame: Week 44 ]

    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"

  2. Number of participants with moderate to severe Crohn's disease (CD) who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease [ Time Frame: Week 44 ]
    Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from DRF study baseline at week 44 in participants with CD


Secondary Outcome Measures :
  1. Number of participants with moderate to severe UC with a clinical response as defined by Mayo score [ Time Frame: Week 44 ]
    Clinical response at week 44, 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

  2. Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score [ Time Frame: Week 44 ]
    Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1

  3. Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score [ Time Frame: Week 44 ]
    Endoscopic remission defined as a Mayo endoscopic subscore of 0

  4. Number of participants with moderate to severe UC with Corticosteroid-free clinical remission based on the modified Mayo score [ Time Frame: Week 44 ]
    Defined by clinical remission and corticosteroid-free for ≥12 weeks preceding week 44

  5. Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index [ Time Frame: Week 44 ]
    Clinical response defined as a ≥100-point decrease from DRF baseline Crohn's Disease Activity Index (CDAI) score

  6. Number of participants with moderate to severe CD in clinical remission as defined by CDAI score [ Time Frame: Week 44 ]
    Clinical remission defined as a CDAI score less than 150

  7. Number of participants with moderate to severe CD with Corticosteroid-free endoscopic response based on SES-CD [ Time Frame: Week 44 ]
    Defined by endoscopic response and corticosteroid-free for ≥12 weeks preceding week 44

  8. Number of participants with moderate to severe CD with Corticosteroid-free clinical remission based on CDAI [ Time Frame: Week 44 ]
    Defined by a CDAI score of <150 points and corticosteroid-free for ≥12 weeks preceding week 44

  9. Number of participants who experience adverse events in the double-blind period [ Time Frame: Up to Week 48 ]
    Adverse events can include any of the following 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.

  10. Number of participants who experience adverse events in the open-label (OL) period [ Time Frame: Up to 5 years after start of OL period ]
    Adverse events can include any of the following 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.

  11. Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events in the double-blind period [ Time Frame: Up to Week 48 ]
  12. Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events in the open-label (OL) period [ Time Frame: Up to 5 years after start of OL period ]
  13. Number of participants with treatment emergent Anti-Drug Antibodies (ADA) [ Time Frame: Weeks 0, 4, 8, 16, 28, 44, and 48 ]
  14. Number of ADA positive participants with the presence of neutralizing ADA [ Time Frame: Weeks 0, 4, 8, 16, 28, 44, and 48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study.
  • Re-induction- Participants who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF 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)
  • 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.
  • 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05668013


Contacts
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Contact: Teva U.S. Medical Information 1-888-483-8279 USMedInfo@tevapharm.com

Locations
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Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Branded Pharmaceutical Products R&D, Inc.
More Information
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT05668013    
Other Study ID Numbers: TV48574-IMM-20038
2022-002593-89 ( EudraCT Number )
First Posted: December 29, 2022    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Ulcer
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes