Status:
COMPLETED
Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis
Lead Sponsor:
Galapagos NV
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
* Approximately 45 patients suffering from mild to moderate ulcerative colitis will be examined for any side effects (safety and tolerability) that may occur when taking GLPG0974 or matching placebo (...
Eligibility Criteria
Inclusion
- Key
- 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 infectious colitis.
- Key
Exclusion
- History of sensitivity to any component of the study drug
- Any concurrent illness, condition, disability or clinically significant abnormality (including lab tests) that represents a safety risk , may affect the interpretation of data, or may prevent the subject to safely complete the assessments
- Positive serology for HIV 1 or 2 or hepatitis B or C, or any history of HIV or hepatitis.
- History of active infections requiring intravenous antibiotics within the past four weeks prior to randomization.
- History of bowel surgery, or presence or history of intestinal malignancy.
- Suspicion of Crohn's disease, indeterminate colitis, microscopic colitis, ischaemic colitis or radiation-induced colitis.
- History of lower GI bleeding disorder, other than UC.
- A history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal (other than UC), pulmonary or metabolic disease.
- History of tuberculosis (TB) infection.
- Treatment with systemic corticosteroids within 1 week prior to randomization.
- Treatment with TNF-α inhibitors or other biologics within 2 months prior to randomization.
- Treatment with immunosuppressants, initiated or changed within 3 months prior to randomization .
- Current use of probiotic or prebiotic preparations
- Regular daily use of NSAIDs, within 7 days prior to randomization.
- Administration of any experimental therapy within 90 days or 5x the half-life.
- History of drug or alcohol abuse.
- Pregnant or lactating women.
- Medical, psychiatric, cognitive, or other conditions that compromise the subject's ability to complete the study.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01829321
Start Date
April 1 2013
End Date
April 1 2014
Last Update
April 25 2014
Active Locations (16)
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1
Imelda
Bonheiden, Belgium
2
UZ Gent
Ghent, Belgium
3
AZ Groeninge
Kortrijk, Belgium
4
UZ Leuven
Leuven, Belgium