Ignite Creation Date:
2024-05-06 @ 9:41 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03041025
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2017-01-31
Brief Title:
Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multi-center Randomized Double-blind Sponsor Open Placebo-controlled Repeat-dose Proof of Mechanism Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Explore Efficacy of GSK2330811 in Participants With Diffuse Cutaneous Systemic Sclerosis
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GSK2330811 is a humanized monoclonal antibody which is in development for systemic sclerosis SSc a rare autoimmune disease with high morbidity and mortality Currently there are no approved disease modifying therapies and it is an area of high unmet medical need GSK2330811 has been shown to bind and neutralize Oncostatin M OSM that has been associated with fibrosis vasculopathy and inflammation in a number of diseases This multi-center randomized double-blind sponsor open placebo controlled proof of mechanism study will be the first study to evaluate the safety tolerability pharmacokinetics PK and pharmacodynamics PD of repeat subcutaneous SC doses of GSK2330811 in male and female participants with diffuse cutaneous SSc dcSSc Participants with active disease and a disease duration of 60 months will be enrolled Approximately 24 to 40 participants will be randomized across two sequential cohorts Cohort 1 will evaluate a repeat-dose predicted to provide sub-maximal inhibition of OSM leading to a dose escalation decision Cohort 1 is planned to consist of at least 4 participants randomized such that 3 participants will receive GSK2330811 100 milligram mg and 1 will receive placebo Cohort 2 is planned to consist of at least 20 participants randomized such that participants will receive GSK2330811 300 mg and placebo in a 31 ratio respectively The duration of the study is up to 34 weeks including a screening period of up to 6 weeks treatment period of 12 weeks and follow-up period of 16 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-003417-95 | EUDRACT_NUMBER | None | None |