Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GLPG0974 · 1 trial · 1 indication
To evaluate the safety and tolerability of GLPG0974 in terms of the number of adverse events reported
To evaluate the safety and tolerability of GLPG0974 in terms of the changes in physical exam measures reported
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
To evaluate the safety and tolerability of GLPG0974 in terms of the changes in 12-lead ECG measures reported
To evaluate the safety and tolerability of GLPG0974 in terms of changes in blood safety lab parameters reported
To evaluate the safety and tolerability of GLPG0974 in terms of changes in urine safety lab parameters reported
| Arm | Type | Description |
|---|---|---|
| GLPG0974 | EXPERIMENTAL | 1 capsule of 200 mg GLPG0974 twice daily |
| Placebo | PLACEBO_COMPARATOR | 1 capsule placebo twice daily |
| Name | Type | Description |
|---|---|---|
| GLPG0974 | DRUG | 1 capsule in the morning and 1 capsule in the evening with food during 28 days |
| Placebo | DRUG | 1 capsule in the morning and 1 capsule in the evening with food during 28 days |
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...
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GLPG0974 is an investigational small molecule being developed for the treatment of ulcerative colitis, a form of inflammatory bowel disease. It is in Phase 2 clinical development and has not been approved for any indication. Lakefront Biotherapeutics is the developer.
GLPG0974 targets FFAR2, also known as free fatty acid receptor 2. It acts as an antagonist at this receptor. By blocking FFAR2 signaling, the drug is designed to modulate inflammatory pathways relevant to ulcerative colitis.
GLPG0974 is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company is responsible for the clinical program evaluating the drug in ulcerative colitis.
GLPG0974 is in Phase 2 clinical development for ulcerative colitis. It is an investigational drug and has not received FDA approval. The Phase 2 trial has been completed.
GLPG0974 has been studied in one completed Phase 2 trial, NCT01829321, titled a safety, efficacy, pharmacokinetic and pharmacodynamic study in subjects with ulcerative colitis. The trial enrolled 45 participants across Belgium, Czechia, Latvia, and Slovakia.
Yes, the Phase 2 trial NCT01829321 was randomized, double-blind, and placebo-controlled. It enrolled 45 adults with ulcerative colitis and has been completed. No biomarker selection was used in the trial design.