A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis

• Status: Active, not recruiting
• Trial end date: 2024-01-08
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative Colitis (UC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies; Antibodies, Monoclonal; Golimumab; Immunoglobulins

Criteria

Inclusion criteria:

• Moderate to severe Ulcerative Colitis (UC) defined by a Mayo score (a score used to assess the treatment for UC) of 6 to 12 inclusive, including an endoscopic subscore of 2 or more.

• Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine and azathioprine OR must either have or have had a history of corticosteroid dependency (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC) OR required more than 3 courses of corticosteroids in the past year

• No history of latent or active tuberculosis prior to screening

• Positive protective antibody titers to varicella and measles prior to the first administration of study agent

Exclusion criteria:

• Have severe extensive UC that is likely to require a colectomy (surgical removal of the colon) within 12 weeks of study entry

• Have UC limited to the rectum only or to less than 20 cm of the colon

• Presence of a stoma

• Presence or history of a fistula

• Have evidence of Crohn's disease (an inflammatory large intestine disease)

• Previous exposure to anti-tumor necrosis factor therapy