Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis
|ClinicalTrials.gov Identifier: NCT01434576|
Recruitment Status : Withdrawn (Sponsor withdrew study for business reasons)
First Posted : September 15, 2011
Last Update Posted : August 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Biological: HGS1025 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics and Safety of HGS1025, a Human Monoclonal Anti-CCR5 Antibody, in Subjects With Ulcerative Colitis|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2012|
|Experimental: HGS1025 2 mg/kg||
2 mg/kg of HGS1025 administered by IV infusion on Day 0, 14, 28 and 56, and then every 28 days thereafter if patient achieves clinical response
|Experimental: HGS1025 10 mg/kg||
10 mg/kg of HGS1025 administered by IV infusion on Day 0, 14, 28 and 56, and then every 28 days thereafter if patient achieves clinical response
|Placebo Comparator: Placebo||
Placebo administered by IV infusion on Day 0, 14, 28 and 56. Subjects receiving placebo during the first 8 weeks of treatment will be given the option to receive HGS1025 10 mg/kg in the continuation phase of the study.
- Pharmacodynamics (serum & tissue biological markers; CCR5 receptor occupancy) [ Time Frame: 8 weeks ]Change in CCR5 properties; change in inflammatory markers in blood and colon.
- Clinical Response [ Time Frame: 8 weeks ]Decrease in Mayo Score and rectal bleeding.
- Type, frequency, and severity of adverse events [ Time Frame: Through 8 weeks after the last dose of study agent ]
- Clinical response [ Time Frame: 4 weeks ]Decrease in Mayo Score and rectal bleeding.
- Clinical remission [ Time Frame: 4 weeks & 8 weeks ]Decrease in Mayo Score and no rectal bleeding or colon friability.
- Mucosal healing [ Time Frame: 4 weeks & 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434576
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|