A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05668013
Collaborator
(none)
128
4
29.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TEV-48574 Dose Regimen A
  • Drug: TEV-48574 Dose Regiment B
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Jan 6, 2023
Anticipated Primary Completion Date :
Jan 12, 2025
Anticipated Study Completion Date :
Jun 22, 2025

Arms and Interventions

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

Primary Outcome Measures

  1. Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score [Week 24]

    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 CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease [Week 24]

    Endoscopic response is defined as at week 24 in patients 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 at least 50%

Secondary Outcome Measures

  1. Number of participants with moderate to severe UC with a clinical response as defined by Mayo score [Week 24]

    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

  2. Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score [Week 24]

    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 [Week 24]

    Endoscopic remission defined as a Mayo endoscopic subscore of 0

  4. Number of participants with moderate to severe UC with a clinical response based on patient-reported outcome (PRO2) [Weeks 0, 4, 8, 10, 12, 16, 20, and 24]

    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)

  5. Number of participants with moderate to severe UC in Clinical remission based on PRO2 score [Weeks 0, 4, 8, 10, 12, 16, 20 and 24]

    Clinical remission defined as score of rectal bleeding = 0 and stool frequency = 0 on the PRO2 scale

  6. Number of participants with moderate to severe UC with Histological remission defined as a Robarts Histopathology Index of ≤5 [Week 24]

  7. Number of participants with moderate to severe UC with Histological remission defined as Geboes index score ≤3.1 [Week 24]

  8. Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index [Weeks 0, 4, 8, 10, 12, 16, 20 and 24]

    Clinical response defined as a ≥100-point decrease from DRF baseline Crohn's Disease Activity Index (CDAI) score

  9. Number of participants with moderate to severe CD in clinical remission as defined by CDAI score [Weeks 0, 4, 8, 10, 12, 16, 20 and 24]

    Clinical remission defined as a CDAI score less than 150

  10. Number of participants with moderate to severe CD with Endoscopic remission as defined by SES-CD score [Week 24]

    Endoscopic remission defined as SES-CD score of 0-2, or SES-CD score of 0-4, with no individual sub score >1

  11. Number of participants with moderate to severe CD with a clinical response as defined by PRO2 score [Weeks 0, 4, 8, 10, 12, 16, 20 and 24]

    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)

  12. Number of participants with moderate to severe CD in clinical remission as defined by PRO2 score [Weeks 0, 4, 8, 10, 12, 16, 20 and 24]

    Clinical remission defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2 scale

  13. Number of participants with moderate to severe CD with an Endoscopic response as defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) [Week 24]

    Endoscopic response defined as a decrease from DRF baseline in Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) of >50%.

  14. Number of participants with moderate to severe CD with a Histologic response as defined by Global Histologic Activity score [Week 24]

    Histologic response defined as a ≥50% decrease from DRF baseline in Global Histologic Activity score

  15. Number of Participants Who Experience Adverse Events [Up to Week 26]

    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.

  16. Number of participants who report the use of concomitant medications [Up to Week 26]

  17. Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events [Up to Week 24]

  18. Number of participants with infusion device-related adverse events and malfunctions [Up to Week 26]

  19. Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA) [Weeks 0, 4, 8, 10, 12, 16, 20, 24 and 26]

  20. Number of ADA positive participants with the presence of neutralizing ADA [Weeks 0, 4, 8, 10, 12, 16, 20, 24 and 26]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participants who at the time of informed consent 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier:
NCT05668013
Other Study ID Numbers:
  • TV48574-IMM-20038
  • 2022-002593-89
First Posted:
Dec 29, 2022
Last Update Posted:
Jan 12, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2023