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

• Status: Not yet recruiting
• Trial end date: 2024-10-10
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to evaluate the efficacy and dose response of 3 different dose regimens of TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD).

Secondary objectives:

• To evaluate the efficacy and dose response of the 3 different dose regimens as assessed by multiple standard measures.

• To evaluate the safety and tolerability of the 3 different dose regimens.

• To evaluate the immunogenicity of the 3 different dose regimens.

The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Criteria

Inclusion Criteria:

• Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months.

• The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study.

• The participant is able to understand the nature of the study and any potential hazards associated with participating in the study.

• 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.

• Male participants (including vasectomized) with women of childbearing potential (WOCBP) partners (whether pregnant or not) must use condoms after the first investigational medicinal product (IMP) administration and throughout the study or until 50 days after the last IMP dose, whichever is longer.

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

• The 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.

• Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.

• Participant has colonic dysplasia or neoplasia, 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.

• 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.

• Participant anticipates requiring major surgery during this study.

• A participant is Hepatitis B core antibody or surface antigen positive and/or Hepatitis C antibody positive with detectable ribonucleic acids, or positive human immunodeficiency virus types 1 or 2 at screening.

• A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis).

• A history of more than 1 herpes zoster episode or multimetameric herpes zoster.

• A history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis).

• The 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.

• Presence of a transplanted organ.

• 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).

• Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse.

• Participants with incurable diseases, persons in nursing homes, and participants incapable of giving informed consent.

NOTE- Additional criteria apply, please contact the investigator for more information