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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 247
- Locations
- 93
- Primary Endpoint
- Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
TEV-48574 Dose Regimen A for Crohn's Disease (CD)
Administered by subcutaneous infusion for participants with CD
Intervention: TEV-48574 Dose Regimen A (Drug)
TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)
Administered by subcutaneous infusion for participants with UC
Intervention: TEV-48574 Dose Regimen A (Drug)
TEV-48574 Dose Regimen B for Crohn's Disease (CD)
Administered by subcutaneous infusion for participants with CD
Intervention: TEV-48574 Dose Regiment B (Drug)
TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)
Administered by subcutaneous infusion for participants with UC
Intervention: TEV-48574 Dose Regiment B (Drug)
Outcomes
Primary Outcomes
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"
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 Outcomes
- Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index(Week 44)
- Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score(Week 44)
- Number of participants with moderate to severe CD in clinical remission as defined by CDAI score(Week 44)
- Number of participants who experience adverse events in the double-blind period(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(Up to 5 years after start of OL period)
- Number of participants with moderate to severe UC with Corticosteroid-free clinical remission based on the modified Mayo score(Week 44)
- Number of participants with moderate to severe CD with Corticosteroid-free endoscopic response based on SES-CD(Week 44)
- Number of participants with treatment emergent Anti-Drug Antibodies (ADA)(Weeks 0, 4, 8, 16, 28, 44, and 48)
- Number of participants with moderate to severe UC with a clinical response as defined by Mayo score(Week 44)
- Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score(Week 44)
- Number of participants who experience adverse events in the open-label (OL) period(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(Up to Week 48)
- Number of participants with moderate to severe CD with Corticosteroid-free clinical remission based on CDAI(Week 44)
- Number of ADA positive participants with the presence of neutralizing ADA(Weeks 0, 4, 8, 16, 28, 44, and 48)