RELIEVE UCCD: A Study to Test the 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

NCT05499130

Collaborator

(none)

280

Enrollment

Arms

25.5

Anticipated Duration (Months)

Study Details

Study Description

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).

Secondary objectives:

To evaluate the efficacy and dose response of the 3 different dose regimens as assessed by multiple standard measures.
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

Study Design

Study Type:

Interventional

Anticipated 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)

Anticipated Study Start Date :

Aug 25, 2022

Anticipated Primary Completion Date :

Aug 27, 2024

Anticipated Study Completion Date :

Oct 10, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score [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
Number of participants with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease [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

Number of participants with moderate to severe UC with a clinical response as defined by a decrease from baseline in Mayo score [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
Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score [Week 14]
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 [Week 14]
Endoscopic remission defined as a Mayo endoscopic subscore of 0
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) [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)
Number of participants with moderate to severe UC in Clinical remission as defined by PRO2 score [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
Number of participants with moderate to severe UC with Histological remission defined as a Robarts Histopathology Index of ≤5 [Week 14]
Number of participants with moderate to severe UC with Histological remission defined as Geboes index score ≤3.1 [Week 14]
Number of participants with moderate to severe CD with a clinical response with a decrease from baseline in Crohn's Disease Activity Index [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
Number of participants with moderate to severe CD in clinical remission as defined by CDAI score [Week 14]
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 [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
Number of participants with moderate to severe CD with a clinical response as defined by PRO2 score [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)
Number of participants with moderate to severe CD in clinical remission as defined by PRO2 score [Weeks 2, 4, 6, 8, 10, 12 and 14]
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) [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.
Number of participants with moderate to severe CD with a Histologic response as defined by Global Histologic Activity score [Baseline and Week 14]
Histologic response defined as a ≥50% decrease from baseline in Global Histologic Activity score
Number of Participants Who Experience Adverse Events [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.
Number of participants who report the use of concomitant medications [Up to Week 18]
Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events [Up to Week 18]
Number of participants with infusion device-related adverse events and malfunctions [Up to Week 18]
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA) [Baseline, Weeks 2, 4, 8, 14, and 18]
Number of ADA positive participants with the presence of neutralizing ADA [Weeks 2, 4, 8, 14, and 18]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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:

NCT05499130

Other Study ID Numbers:

TV48574-IMM-20036
2021-006881-19

First Posted:

Aug 12, 2022

Last Update Posted:

Aug 12, 2022

Last Verified:

Aug 1, 2022

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:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022