Colitis, Ulcerative, Crohn Disease
Conditions
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.
Interventions
DRUGTEV-48574 Dose Regimen A
Subcutaneous (sc) administration using a commercial sc infusion system
DRUGTEV-48574 Dose Regiment B
Subcutaneous (sc) administration using a commercial sc infusion system
Sponsors
Teva Branded Pharmaceutical Products R&D LLC
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with moderate to severe UC with a clinical response as defined by Mayo score | Week 44 | 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 |
| Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score | Week 44 | 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 44 | Endoscopic remission defined as a Mayo endoscopic subscore of 0 |
| Number of participants with moderate to severe UC with Corticosteroid-free clinical remission based on the modified Mayo score | Week 44 | Defined by clinical remission and corticosteroid-free for ≥12 weeks preceding week 44 |
| Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index | Week 44 | Clinical response defined as a ≥100-point decrease from DRF baseline Crohn's Disease Activity Index (CDAI) score |
| Number of participants with moderate to severe CD in clinical remission as defined by CDAI score | Week 44 | Clinical remission defined as a CDAI score less than 150 |
| Number of participants with moderate to severe CD with Corticosteroid-free endoscopic response based on SES-CD | Week 44 | Defined by endoscopic response and corticosteroid-free for ≥12 weeks preceding week 44 |
| Number of participants with moderate to severe CD with Corticosteroid-free clinical remission based on CDAI | Week 44 | Defined by a CDAI score of \<150 points and corticosteroid-free for ≥12 weeks preceding week 44 |
| Number of participants who experience adverse events in the double-blind period | Up to Week 48 | 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. |
| Number of participants who experience adverse events in the open-label (OL) period | Up to 5 years after start of OL 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. |
| 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 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 treatment emergent Anti-Drug Antibodies (ADA) | Weeks 0, 4, 8, 16, 28, 44, and 48 | — |
| Number of ADA positive participants with the presence of neutralizing ADA | Weeks 0, 4, 8, 16, 28, 44, and 48 | — |
Countries
Austria, Bulgaria, Czechia, Georgia, Germany, Hungary, Israel, Italy, Japan, Norway, Poland, Slovakia, Spain, Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORTeva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D LLC
Outcome results
None listed