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

Phase 2Active Not RecruitingNCT05668013

Teva Branded Pharmaceutical Products R&D LLC247 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

247

Conditions

Crohn Disease Colitis, Ulcerative

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (93)

Teva Investigational Site 15556

San Diego, California, United States

Teva Investigational Site 15357

Kissimmee, Florida, United States

Teva Investigational Site 15375

Orlando, Florida, United States

Teva Investigational Site 15359

Pinellas Park, Florida, United States

Teva Investigational Site 15567

Gurnee, Illinois, United States

Outcomes

Primary Outcomes

Number of participants with moderate to severe ulcerative colitis (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"

Time frame: Week 44

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

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

Time frame: Week 44

Secondary Outcomes

Number of participants with moderate to severe UC with a clinical response as defined by Mayo score

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

Time frame: Week 44

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

Time frame: Week 44

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

Time frame: Week 44

Number of participants with moderate to severe UC with Corticosteroid-free clinical remission based on the modified Mayo score

Defined by clinical remission and corticosteroid-free for ≥12 weeks preceding week 44

Time frame: Week 44

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

Time frame: Week 44

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

Time frame: Week 44

Number of participants with moderate to severe CD with Corticosteroid-free endoscopic response based on SES-CD

Defined by endoscopic response and corticosteroid-free for ≥12 weeks preceding week 44

Time frame: Week 44

Number of participants with moderate to severe CD with Corticosteroid-free clinical remission based on CDAI

Defined by a CDAI score of \<150 points and corticosteroid-free for ≥12 weeks preceding week 44

Time frame: Week 44

Number of participants who experience adverse events in the double-blind 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.

Time frame: Up to Week 48

Number of participants who experience adverse events in the open-label (OL) period

Time frame: Up to 5 years after start of OL period

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

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

Number of participants with treatment emergent Anti-Drug Antibodies (ADA)

Time frame: Weeks 0, 4, 8, 16, 28, 44, and 48

Number of ADA positive participants with the presence of neutralizing ADA

Time frame: Weeks 0, 4, 8, 16, 28, 44, and 48