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A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)

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ClinicalTrials.gov Identifier: NCT05499130
Recruitment Status : Recruiting
First Posted : August 12, 2022
Last Update Posted : December 29, 2022
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary:

The primary objective is to evaluate the efficacy and dose response of 3 different dose regimens of 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 and dose response of the 3 different dose regimens as assessed by multiple standard measures at week 14.
  • To evaluate the safety and tolerability of the 3 different dose regimens.
  • To evaluate the immunogenicity of the 3 different dose regimens.

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.


Condition or disease Intervention/treatment Phase
Crohn Disease Colitis, Ulcerative Drug: TEV-48574 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)
Actual Study Start Date : August 25, 2022
Estimated Primary Completion Date : August 27, 2024
Estimated Study Completion Date : October 10, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TEV-48574 Dose A (UC)
Dose regimen A administered by subcutaneous infusion for participants with UC
Drug: TEV-48574
Subcutaneous infusion Dose regimen A/B/C

Experimental: TEV-48574 Dose B (UC)
Dose regimen B administered by Subcutaneous infusion for participants with UC
Drug: TEV-48574
Subcutaneous infusion Dose regimen A/B/C

Experimental: TEV-48574 Dose C (UC)
Dose regimen C administered by subcutaneous infusion for participants with UC
Drug: TEV-48574
Subcutaneous infusion Dose regimen A/B/C

Experimental: TEV-48574 Dose A (CD)
Dose regimen A administered by subcutaneous infusion for participants with CD
Drug: TEV-48574
Subcutaneous infusion Dose regimen A/B/C

Experimental: TEV-48574 Dose B (CD)
Dose regimen B administered by subcutaneous infusion for participants with CD
Drug: TEV-48574
Subcutaneous infusion Dose regimen A/B/C

Experimental: TEV-48574 Dose C (CD)
Dose regimen C administered by subcutaneous infusion for participants with CD
Drug: TEV-48574
Subcutaneous infusion Dose regimen A/B/C

Placebo Comparator: Placebo UC
Matching Placebo
Drug: Placebo
Matching Placebo

Placebo Comparator: Placebo CD
Matching Placebo
Drug: Placebo
Matching Placebo




Primary Outcome Measures :
  1. Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score [ Time Frame: Week 14 ]

    Clinical remission is a 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" Each parameter of the score ranges from 0 (normal or inactive disease) to 3 (severe activity) and the total score from 0 to 9, respectively

  2. Number of participants with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease [ Time Frame: Week 14 ]
    Endoscopic response defined as a reduction from 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 a decrease from baseline in Mayo score [ Time Frame: Baseline and Week 14 ]
    Clinical response at week 14, 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 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 14 ]
    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 14 ]
    Endoscopic remission defined as a Mayo endoscopic subscore of 0

  4. Number of participants with moderate to severe UC with a clinical response as defined as a decrease from baseline in 2-item patient-reported outcome (PRO2) [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14 ]
    Clinical response defined as decrease from 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 as defined by PRO2 score [ Time Frame: Weeks 2, 4, 6, 8, 10, 12 and 14 ]
    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 [ Time Frame: Week 14 ]
  7. Number of participants with moderate to severe UC with Histological remission defined as Geboes index score ≤3.1 [ Time Frame: Week 14 ]
  8. Number of participants with moderate to severe CD with a clinical response with a decrease from baseline in Crohn's Disease Activity Index [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14 ]
    Clinical response defined as a ≥100-point decrease in Crohn's Disease Activity Index (CDAI) score

  9. Number of participants with moderate to severe CD in clinical remission as defined by CDAI score [ Time Frame: Week 14 ]
    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 [ Time Frame: Week 14 ]
    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 [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14 ]
    Clinical response defined as a decrease from 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 [ Time Frame: Weeks 2, 4, 6, 8, 10, 12 and 14 ]
    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) [ Time Frame: Baseline and Week 14 ]
    Endoscopic response defined as a decrease from baseline in Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) of >50%. The MM-SES-CD takes into account the chances of each parameter (presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures) achieving endoscopic remission.

  14. Number of participants with moderate to severe CD with a Histologic response as defined by Global Histologic Activity score [ Time Frame: Baseline and Week 14 ]
    Histologic response defined as a ≥50% decrease from baseline in Global Histologic Activity score

  15. Number of Participants Who Experience Adverse Events [ Time Frame: Baseline up to Week 18 ]
    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 [ Time Frame: Up to Week 18 ]
  17. Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events [ Time Frame: Up to Week 18 ]
  18. Number of participants with infusion device-related adverse events and malfunctions [ Time Frame: Up to Week 18 ]
  19. Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA) [ Time Frame: Baseline, Weeks 2, 4, 8, 14, and 18 ]
  20. Number of ADA positive participants with the presence of neutralizing ADA [ Time Frame: Weeks 2, 4, 8, 14, and 18 ]


Information from the National Library of Medicine

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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:

  • 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 colitis.
  • 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 1 herpes zoster episode 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).
  • 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 informed consent.

NOTE- Additional criteria apply, please contact the investigator for more information


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): NCT05499130


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

Locations
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United States, Florida
Teva Investigational Site 15357 Recruiting
Kissimmee, Florida, United States, 34741
Teva Investigational Site 15359 Recruiting
Pinellas Park, Florida, United States, 33781
United States, Maryland
Teva Investigational Site 15363 Recruiting
Columbia, Maryland, United States, 21045
United States, Missouri
Teva Investigational Site 15358 Recruiting
Liberty, Missouri, United States, 64068
United States, Texas
Teva Investigational Site 15360 Recruiting
Austin, Texas, United States, 78748
Teva Investigational Site 15361 Recruiting
Tyler, Texas, United States, 75701
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.
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT05499130    
Other Study ID Numbers: TV48574-IMM-20036
2021-006881-19 ( EudraCT Number )
First Posted: August 12, 2022    Key Record Dates
Last Update Posted: December 29, 2022
Last Verified: December 2022
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