Overview

This trial is active, not recruiting.

Condition colitis, ulcerative
Treatment golimumab
Phase phase 1
Target TNF-alpha
Sponsor Janssen Research & Development, LLC
Start date August 2013
End date February 2015
Trial size 35 participants
Trial identifier NCT01900574, 2012-004366-18, CNTO148UCO1001, CR101676

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
golimumab Simponi
Golimumab will be administered subcutaneously. For participants weighing less than 45 kg, the dose of golimumab at Week 0 will be 90 mg/m2 (up to 200 mg) and 45 mg/m2 (up to 100 mg) at Weeks 2, 6, and 10. For participants weighing 45 kg or more, the dose of golimumab at Week 0 will be 200 mg and 100 mg at Weeks 2, 6, and 10. From Week 14, the dose of golimumab will be 45 mg/m2 and 100 mg, every 4 weeks for participants weighing less than 45 kg and 45 kg or more, respectively. From Week 18, participants weighing 45 kg or more have the option to administer golimumab at home after being properly trained. At Week 14 or at any time after, the participants have the option to decrease their dose of golimumab to 50 mg (weighing 45 kg or more) or 22.5 mg/square meter (less than 45 kg) at the discretion of the investigator. A single dose increase back to 100 mg or 45 mg/m2 is permitted based on the investigator's assessment of an increase in a participant's ulcerative colitis disease activity.

Primary Outcomes

Measure
Serum golimumab concentrations at Week 6
time frame: Week 6
Area under the curve for serum golimumab concentration from Week 0 through Week 6
time frame: Week 0 to Week 6

Secondary Outcomes

Measure
Number of participants with adverse events as a measure of safety
time frame: Up to Week 126
Number of participants who will achieve clinical response at Week 6
time frame: Week 6
Number of participants who will achieve clinical remission at Week 6 measured by the Mayo score
time frame: Week 6
Number of participants who will achieve clinical remission at Week 6 measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) score
time frame: Week 6
Number of participants with mucosal healing at Week 6
time frame: Week 6
Number of participants who will achieve clinical remission at Week 54 and Week 110 measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) score
time frame: Week 54 and Week 110

Eligibility Criteria

Male or female participants from 2 years up to 17 years old.

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

Additional Information

Official title A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis
Description This is an open-label (both [participants and investigator] know what treatment participants will receive) and multicenter study. The study is divided into 2 parts: Part 1: pharmacokinetics portion (Week 0 to Week 14); Part 2: study extension (Week 14 to Week 114). The focus of this study is to evaluate the pharmacokinetics and safety of golimumab. Additionally the efficacy of short-term therapy with golimumab will be evaluated. Participants in clinical response at Week 6 will continue to receive open label golimumab maintenance therapy and will enter the study extension at Week 14. Participants who are not in clinical response at Week 6 will be withdrawn from further treatment with golimumab. At Week 114, participants who, in the opinion of the investigator, may benefit from continued treatment will be eligible to continue to receive golimumab every 4 weeks until marketing authorization is obtained in the treatment of pediatric UC in that country, or until a decision has been made not to pursue an indication in pediatric UC. Approximately 30 participants will be enrolled in this study. The total duration of study participation for a participant will be approximately 126 weeks or longer.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.