A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)
Published: 12/16/2022
General Information:
The primary objective of the study is to evaluate the efficacy and dose response of 3 different dose regimens of TEV‑48574 subcutaneous (sc) administered every 2 weeks (Q2W) in adult patients with IBD (moderate to severe UC or CD) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14.
Eligibility:
You may be able to participate in the MAESTRO study if you meet key inclusion criteria*:
- 18-75 years of age
- Diagnosis of ulcerative colitis (UC) or Crohn's Disease (CD) for ≥ 3 months
- 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.
You will not be able to participate in the MAESTRO study if you meet key exclusion criteria*:
- Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
- You have 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.
- You have 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.
- You anticipate requiring major surgery during this study.
- You have 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.
- You have a history of an infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis).
- You have a history of an opportunistic infection.
- You have a history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis).
*NOTE - other inclusion and exclusion criteria apply, please contact the investigator for more information
Study Details:
Study description/explanation of participation:
The purpose of this clinical research study is to evaluate if 3 different doses of TEV-48574, herein referred to as the “study drug”, works in adults who have moderate to severe UC. The study will also evaluate how safe the study drug is and how well it can be tolerated at each dose. If you choose to take part, you will be asked to come to the study center for up to 11 visits. This will take about 6 months.
Description of treatment or intervention (mechanism of action):
There are 3 different dosing regimens and treatment is a subcutaneous injection – a shot given under the skin in the abdomen, every 2 weeks for 14 weeks.
Patient participation requirements:
You will visit the study center 8 times for study assessments, and to be given the study medication (investigational medication or placebo). You will receive study medication once every 2 weeks.
Electronic "evening" diary answering questions related to your symptoms.
You will be willing to sign a consent form after review of study details with the physician to participate in the study.
Possible risks and side effects:
Risks can be related to the injection site reaction, an allergic reaction, immunosuppression (not seen in previous studies) and immunogenicity.
Benefits: There is no guarantee that you will receive a medical benefit from taking part in this study. Your condition could get better, get worse, or stay the same. The information we get from this study may help us to treat people with UC and Crohn’s disease better in the future.
The study team will explain the possible benefits and risks of the research study.