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GW274150

Phase 2

Arthritis, Rheumatoid | Small molecule | Immunology |GSK plc|Last Updated: Oct 18, 2017

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

GW274150 · 5 trials · 4 indications

Phase 2 4Phase 1 1
NCT00379990A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.Arthritis, Rheumatoid
COMPLETED48 Analytics
NCT00319137An Adaptive Design Trial Of GW274150 In The Treatment Of Acute MigraineMigraine Disorders
COMPLETED126 Analytics
NCT00242866Use Of GW274150 In The Prophylactic Treatment Of MigraineMigraine Disorders
COMPLETED430 Analytics
NCT00370435Study Of 90mg Of GW274150 In Subjects Over 50 Years, Who Have Rheumatoid Arthritis (RA)Arthritis, Rheumatoid
COMPLETED6 Analytics
PHASE2COMPLETED
A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.
Arthritis, RheumatoidUnlock trial analytics
PHASE2COMPLETED
An Adaptive Design Trial Of GW274150 In The Treatment Of Acute Migraine
Migraine DisordersUnlock trial analytics
PHASE2COMPLETED
Use Of GW274150 In The Prophylactic Treatment Of Migraine
Migraine DisordersUnlock trial analytics
PHASE2COMPLETED
Study Of 90mg Of GW274150 In Subjects Over 50 Years, Who Have Rheumatoid Arthritis (RA)
Arthritis, RheumatoidUnlock trial analytics

Study Endpoints

Primary Endpoints

Measurment of synovial vascularity
Day 1, Day 15 and Day 28

Power Doppler ultrasonographic measurement of synovial vascularity

Dose of GW274150 that results in 50% of subjects reporting cessation of migraine pain by 2 hours and to study the relationship between dose and therapeutic response.
Occurrence of a migraine headache day on each day during the 4-week baseline period and the 12-week treatment period.
12 Weeks
Liver function and creatinine clearance after single 90mg dose of GW274150
Effect on the late asthmatic reaction following an inhaled allergen challenge
Up to Day 115

Secondary Endpoints

Synovial thickness
Day 1, 15 and 28
Safety: ECG
Day 1, 15 and 28
Safety: Vital Signs
Day 1, 15 and 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GW274150 60 mg once daily for 28 daysEXPERIMENTAL60 mg GW274150 taken once daily for 28 days
Prednisolone 7.5 mg once daily for 28 daysACTIVE_COMPARATOR7.5 mg prednisolone taken once daily for 28 days
Placebo once daily for 28 daysPLACEBO_COMPARATORPlacebo taken once daily for 28 days
Arm 1EXPERIMENTALGW274150 - 5mg or 30mg
Arm 2PLACEBO_COMPARATORPlacebo to match GW274150
Sequence 1EXPERIMENTALSubjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3.
Sequence 2EXPERIMENTALSubjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3.
Sequence 3EXPERIMENTALSubjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3.
Sequence 4EXPERIMENTALSubjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3.
Sequence 5EXPERIMENTALSubjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3.
Sequence 6EXPERIMENTALSubjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3.

Interventions

NameTypeDescription
GW274150DRUG60 mg /day
PrednisoloneDRUG7.5 mg/day
PlaceboOTHERPlacebo
SingulairDRUGSingulair will be available as over encapsulated 10 mg orange tablets.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: * Diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology * Female subjects who are not capable of becoming pregnant * Active disease defined as Disease Activity Score (DAS) 28 = 4.0 and at least one metacarpal-phalangeal ...

Countries:SerbiaUnited KingdomAustraliaNew ZealandBelgiumDenmarkFinlandFranceGermanyItalyNetherlandsNorwaySpain
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Frequently asked questions about GW274150

What is GW274150 used for?

GW274150 is an investigational small molecule being studied for the prophylactic treatment of migraine, the treatment of acute migraine, mild asthma, and rheumatoid arthritis. It is being developed by GSK plc (GSK). The drug is currently in Phase 2 clinical development for migraine and rheumatoid arthritis.

What does GW274150 target?

GW274150 is a small molecule that targets inducible nitric oxide synthase (iNOS). By inhibiting this enzyme, it may reduce the production of nitric oxide, which is thought to play a role in inflammation and pain pathways relevant to migraine, asthma, and rheumatoid arthritis.

Who makes GW274150?

GW274150 is being developed by GSK plc, a global biopharmaceutical company listed on the New York Stock Exchange under the ticker GSK. GSK has sponsored multiple clinical trials of GW274150 across different indications.

What phase is GW274150 in?

GW274150 is in Phase 2 clinical development. It has completed Phase 2 trials for the prophylactic treatment of migraine and for acute migraine, as well as a Phase 2 trial in rheumatoid arthritis. A Phase 1 trial in mild asthma has also been completed.

What clinical trials is GW274150 in?

GW274150 has been studied in four completed clinical trials. These include NCT00242866 for migraine prophylaxis, NCT00319137 for acute migraine, NCT00273013 for mild asthma, and NCT00370435 for rheumatoid arthritis. All trials have been completed, with no active trials currently ongoing.

Is GW274150 the same as other migraine drugs?

GW274150 is a distinct investigational compound developed by GSK. It is not known to be the same as any other marketed migraine medication. Its mechanism of action, targeting inducible nitric oxide synthase, differs from common migraine treatments such as triptans or gepants.