A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s Disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

1.Adults of male and female sex (without restrictions on gender) between 18 and 75 years of age, inclusive, at the time of informed consent., 2.The patient is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study., 3.The patient is able to understand the nature of the study and any potential hazards associated with participating in the study, 4.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, 5. Male patients (including vasectomized) with WOCBP partners (whether pregnant or not) must use condoms after the first IMP administration and throughout the study or until 50 days after the last IMP dose, whichever is longer

Exclusion Criteria

1.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., 10.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 Any woman becoming pregnant during the study will be withdrawn from the study., 11.Presence of a transplanted organ., 12.A history of malignancy within the last 5 years (exception: basal cell carcinoma or in situ carcinoma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 or curatively resected papillary thyroid cancer)., 13.Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse., 14.Patients with incurable diseases, persons in nursing homes, and patients incapable of giving written informed consent., 2.Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis., 3. 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., 4. 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., 5.Patient anticipates requiring major surgery during this study., 6. Hepatitis B core antibody (HBcAb) or surface antigen (HBsAg) positive. If HBcAb is positive and HBsAg negative, Hepatitis B viral deoxyribonucleic acid (DNA) will be done as reflective test, and, if undetectable, then not exclusionary. Hepatitis C antibody positive with detectable RNAs. Positive human immunodeficiency virus types 1 or 2 at screening., 7.A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis)., 8.A history of more than 2 herpes zoster episodes in the last 5 years or multimetameric herpes zoster, 9.A history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis).

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

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