For Healthcare Professionals

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

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About the study

The primary objective is to characterize the efficacy 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) at week 14. Secondary objectives: * To evaluate the efficacy and dose response of the 2 different dose regimens as assessed by multiple standard measures * To evaluate the safety and tolerability of the 2 different dose regimens * To evaluate the immunogenicity of the 2 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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months
  2. The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study
  3. The participant 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 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

Exclusion Criteria:

  1. 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
  2. Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic coliti
  3. 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
  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. Participant anticipates requiring major surgery during this study.
  6. 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.
  7. A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis)
  8. A history of more than 2 herpes zoster episode 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)
  10. 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.
  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 cance
  13. Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse
  14. Participants with incurable diseases, persons in nursing homes, and participants incapable of giving written informed consent

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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-483-8279Email iconEmail Study Center

Study Details


Contition

Crohn Disease,Colitis, Ulcerative

Age

18 - 75

Phase

PHASE2

Participants Needed

240

Est. Completion Date

Nov 8, 2024

Treatment Type

INTERVENTIONAL


Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

ClinicalTrials.gov NCT Identifier

NCT05499130

Study Number

TV48574-IMM-20036

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