Recent Updates
Recently added Catalysts

GSK3152314A

Phase 2

Arthritis, Rheumatoid | Small molecule | Immunology |GSK plc|Last Updated: Dec 1, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment135

FDA Designations

No designations recorded

Clinical trial landscape

GSK3152314A · 1 trial · 1 indication

Phase 2 1
NCT00674635Phase II Study Evaluating the Safety and Efficacy of GSK315234A in Patients With Rheumatoid ArthritisArthritis, Rheumatoid
COMPLETED135 Analytics
PHASE2COMPLETED
Phase II Study Evaluating the Safety and Efficacy of GSK315234A in Patients With Rheumatoid Arthritis
Arthritis, RheumatoidUnlock trial analytics

Study Endpoints

Primary Endpoints

• To assess the safety and tolerability of GSK315234A after single and repeat intravenous infusions in subjects with active rheumatoid arthritis on a background of methotrexate.
Part A total of 150Days; Part B total of 236 days and Part C total of 180 days

safety assessment includes AEs, vital signs, ECG, clinical laboratory tests.

• To assess the effect of GSK315234A on disease activity [as defined by Disease Activity Score (DAS) 28 score] on Day 28 after a single intravenous infusion
Part A total of 150 days

DAS28 at Day 28 and DAS28 at Day 56

• To assess the effect of GSK315234A on disease activity [as defined by Disease Activity Score (DAS) 28 score] on Day 56 in subjects with active rheumatoid arthritis on a background of methotrexate (Part B and Part C).
Part B total of 236 days and Part C total of 180 days

DAS28 scores on Day 56 (Part B and C)

Secondary Endpoints

Weighted mean DAS28 after single and repeat intravenous doses
Part A total of 150Days; Part B total of 236 days and Part C total of 180 days
Plasma PK parameters of GSK315234A after single and repeat intravenous doses including free, and bound GSK315234A (serum) concentrations, AUC(0-¥), Cmax, clearance, volume of distribution and accumulation ratio
Part A total of 150Days; Part B total of 236 days and Part C total of 180 days
DAS28 and EULAR response criteria after single and repeat intravenous doses
Part A total of 150Days; Part B total of 236 days and Part C total of 180 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORmatching placebo
GSK315234AACTIVE_COMPARATORPart A single IV dose; Part B 3 repeat IV dose at Day 1, Day 28 and Day 56; Part C single SC dose

Interventions

NameTypeDescription
GSK3152314ADRUGPart A single IV dose; Part B 3 repeat IV dose at Day 1, Day 28 and Day 56; Part C single SC dose
PlaceboDRUGmatching placebo
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Males or females between 18 and 75 years of age, inclusive. * All subjects must use acceptable contraception (as defined in the study restriction section) to ensure that no pregnancies occur during the course of the study and for at least 12 weeks after dosing for males and fo...

Countries:AustraliaNew ZealandRussiaSerbiaUkraine
Unlock Eligibility Criteria

Frequently asked questions about GSK3152314A

What is GSK3152314A used for?

GSK3152314A is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 2 clinical development. The drug has been studied in a completed Phase 2 trial that evaluated its safety and efficacy in patients with rheumatoid arthritis.

What does GSK3152314A target?

The molecular target of GSK3152314A has not been disclosed in available information. The drug is a small molecule being developed by GSK plc for rheumatoid arthritis, and its specific mechanism of action has not been publicly detailed.

Who makes GSK3152314A?

GSK3152314A is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research on this investigational drug for the treatment of rheumatoid arthritis.

What phase is GSK3152314A in?

GSK3152314A is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 2 clinical trial has been completed, and the drug remains under investigation for rheumatoid arthritis.

What clinical trials is GSK3152314A in?

GSK3152314A has been studied in one clinical trial, identified as NCT00674635. This was a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of GSK315234A in patients with rheumatoid arthritis. The trial enrolled 135 participants and has been completed.

Is GSK3152314A the same as GSK315234A?

Yes, GSK3152314A is the same as GSK315234A. The clinical trial NCT00674635 refers to the drug as GSK315234A, while the drug name is also listed as GSK3152314A. Both names refer to the same investigational drug being developed for rheumatoid arthritis.