A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
- Conditions
- Moderate to severe Ulcerative colitis or moderate to severe Crohn'sdiseaseMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.0Level: LLTClassification code 10011400Term: Crohn's colitisSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2022-002593-89-BG
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 218
1.Maintenance Period: a. Adults of male and female sex (without restrictions on gender) who at the time of informed consent achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week of DRF study) or in the re-induction period of this study.
OLE Period: Adults of male and female sex (without restrictions based on gender) who have clinical response and/or clinical remission at week 44 of the maintenance period of this study.
- Clinical response assessed by decrease from DRF study baseline in
modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score by =2 points and at least 30%, with a decrease in rectal bleeding subscore of =1 point or an absolute subscore of 0 or 1 at week 14 of the of the DRF study/re-induction period or week 44 of the maintenance period in patients with moderate to severe UC .
- Clinical remission at week 14 of the DRF study/re-induction period or week 44 of the maintenance period in patients with moderate to severe UC. 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
- Clinical response assessed by =100-point decrease CDAI score from
DRF study baseline week 14 of the TV48574-IMM-20036 DRF study/reinduction period or week 44 of the maintenance period in patients with moderate to severe CD
- Clinical remission defined as a CDAI score <150 at week 14 of the DRF study/re-induction period or week 44 of the maintenance period in patients with moderate to severe CD
2. Re-induction period: Adults of male and female sex (without restrictions
based on gender) who did not achieve clinical response and/or clinical remission at week 14 of the TV48574 IMM 20036 DRF study
b. Patients who are women of childbearing potential (WOCBP) should have a negative ß- human chorionic gonadotropin test result and practice a highly effective method of birth control.
• Male patients (including vasectomized) with WOCBP partners should use condoms after the first IMP administration and throughout the study
c. The patient must be willing and able to comply with study restrictions and to remain at the investigational center for the required duration during the study period, and willing to return to the investigational center for further visits, as applicable, and the follow-up procedures and assessments as specified in this protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 156
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62
a. Patients who discontinued the TV48574-IMM-20036 DRF study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons) and patients who didn’t meet the definition of clinical response or clinical remission based on their DRF week 14 assessment b. The patient has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator and/or the clinical study physician. c. Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis. d. Patient has colonic dysplasia or neoplasia with exception of dysplasia on a completely excised adenomatous polyp [not a sessile one]), 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. e. 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 study visit. f. Patient anticipates requiring major surgery during this study. g. A history of an opportunistic infection (eg, CMV, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis). h. A history of more than 2 herpes zoster episodes in the last 5 years or multimetameric herpes zoster. i. A history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis). j. Current or history of chronic liver or biliary disease (with the exception of Gilbert' syndrome, asymptomatic gallstones or uncomplicated fatty liver disease) at screening or (baseline ALT) (or AST >2× ULN) or bilirubin >1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at week 14 of the DRF study or the re-induction period. k. Absolute neutrophil count <1.5x109/L or Hemoglobin <8 g/dL or
lymphocyte count <0.8x109/L or platelet count <75,000/mL at week
14 of the DRF study or the re-induction period. If a subject fails to meet an exclusion laboratory criterion due to an isolated laboratory test falling outside of the normal acceptable range, a single retest will be permitted once, with the retest value determining subject eligibility for the study. l. The patient has QTcF>480 ms at week 14 of the DRF study or the reinduction period. If a subject fails to meet an exclusion criterion due to an isolated electrocardiogram (ECG) reading falling outside of the normal acceptable range, a single retest will be permitted once, with the retest determining subject eligibility for the study. m. Any acute infection that in the opinion of the investigator compromises the safety of the patients . n. The patient 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. o. The patient has a known hypersensitivity to the IMP and/or
excipients. p. Presence of a transplanted organ. q. A history of malignancy within the last 5 years(exception: basal cell carcinoma or in situ ca
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method