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GLPG0974

Phase 2

Ulcerative Colitis | Small molecule | Gastrointestinal |Lakefront Biotherapeutics|Last Updated: Apr 25, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

GLPG0974 · 3 trials · 2 indications

Phase 2 1Phase 1 2
NCT01829321Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative ColitisUlcerative Colitis
COMPLETED45 Analytics
PHASE2COMPLETED
Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events
Screening up to Follow up (14 days after last dosing)

To evaluate the safety and tolerability of GLPG0974 in terms of the number of adverse events reported

Changes in physical exam measures
Screening up to Follow up (14 days after last dosing)

To evaluate the safety and tolerability of GLPG0974 in terms of the changes in physical exam measures reported

Changes in vital signs as measured by heart rate, blood pressure and oral temperature
Screening up to Follow up (14 days after last dosing)

To evaluate the safety and tolerability of GLPG0974 in terms of the changes in vital signs as measured by heart rate, blood pressure and oral temperature reported

Changes in 12-lead ECG measures
Screening up to Follow up (14 days after last dosing)

To evaluate the safety and tolerability of GLPG0974 in terms of the changes in 12-lead ECG measures reported

Changes in blood safety lab parameters
Screening up to Follow up (14 days after last dosing)

To evaluate the safety and tolerability of GLPG0974 in terms of changes in blood safety lab parameters reported

Changes in urine safety lab parameters
Screening up to Follow up (14 days after last dosing)

To evaluate the safety and tolerability of GLPG0974 in terms of changes in urine safety lab parameters reported

Safety and tolerability
Between screening and 7-10 days after the last dose

To evaluate the safety and tolerability of GLPG0974 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments

The amount of GLPG0974 in plasma over time after a single oral dose

To characterize the amount of GLPG0974 in plasma over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects

Secondary Endpoints

Changes in (partial) Mayo clinical disease activity score
From Day 1 to Day 29
Changes in histopathological clinical activity score in colon biopsies
Day 1 and Day 29
The amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974
Day 8, Day 15 and Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GLPG0974EXPERIMENTAL1 capsule of 200 mg GLPG0974 twice daily
PlaceboPLACEBO_COMPARATOR1 capsule placebo twice daily
50 mg GLPG0974 or placeboOTHER50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
100 mg GLPG0974 or placeboOTHER100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days
200 mg GLPG0974 or placeboOTHER200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
400 mg GLPG0974 or placeboOTHER400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
GLPG0974 oral solutionEXPERIMENTALGLPG0974 oral solution
Placebo oral solutionPLACEBO_COMPARATORPlacebo oral solution

Interventions

NameTypeDescription
GLPG0974DRUG1 capsule in the morning and 1 capsule in the evening with food during 28 days
PlaceboDRUG1 capsule in the morning and 1 capsule in the evening with food during 28 days
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites16

Key Inclusion Criteria: * Men or women between 18 to 75 years of age inclusive, on the day of signing the informed consent with a documented history of UC. * Presence of mild-to-moderately active ulcerative colitis as evidenced by clinical signs and endoscopy. * Medication: 5-ASA. * Absence of infe...

Countries:BelgiumCzechiaLatviaSlovakia
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