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
Overview
- Phase
- Phase 1
- Intervention
- Golimumab
- Conditions
- Colitis, Ulcerative
- Sponsor
- Janssen Research & Development, LLC
- Enrollment
- 35
- Primary Endpoint
- Serum golimumab concentrations at Week 6
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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).
Detailed 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 Participants who are not in clinical response at Week 6 will be withdrawn from further treatment with golimumab.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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Golimumab
Intervention: Golimumab
Outcomes
Primary Outcomes
Serum golimumab concentrations at Week 6
Time Frame: Week 6
Sample will be collected prior to the administration of study medication.
Secondary Outcomes
- Number of participants who will achieve clinical response at Week 6(Week 6)
- Number of participants who will achieve clinical remission at Week 6 measured by the Mayo score(Week 6)
- Number of participants who will achieve clinical remission at Week 6 measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) score(Week 6)
- Number of participants with mucosal healing at Week 6(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(Week 54 and Week 110)