Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis
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|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Recruitment Status : Withdrawn (Sponsor withdrew study for business reasons)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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434576
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|