Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis

NCT ID: NCT01829321

Last Updated: 2014-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-04-30

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 (2:1 ratio) for 28 days.
• During the course of the study, patients will also be evaluated for improvement of disease activity by different efficacy measures, the amount of GLPG0974 present in the blood determined (PK) and the effects of GLPG0974 on selected biomarkers (PD) in the blood, colon biopsies and faeces will be explored.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GLPG0974

1 capsule of 200 mg GLPG0974 twice daily

Group Type: EXPERIMENTAL

GLPG0974

Intervention Type: DRUG

1 capsule in the morning and 1 capsule in the evening with food during 28 days

Placebo

1 capsule placebo twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 capsule in the morning and 1 capsule in the evening with food during 28 days

Interventions

GLPG0974

1 capsule in the morning and 1 capsule in the evening with food during 28 days

Intervention Type: DRUG

Placebo

1 capsule in the morning and 1 capsule in the evening with food during 28 days

Intervention Type: DRUG

Eligibility Criteria

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 infectious colitis.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Vanhoutte, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Imelda

Bonheiden, , Belgium

UZ Gent

Ghent, , Belgium

AZ Groeninge

Kortrijk, , Belgium

UZ Leuven

Leuven, , Belgium

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, , Czechia

Fakulní nemocnice Olomouc

Olomouc, , Czechia

Homolka Hospitál

Prague, , Czechia

Nemocnice Slaný

Slaný, , Czechia

Krajská zdravotní a.s., Masarykova nemocnice v Ústí nad Labem T. Bati a.s.

Ústí nad Labem, , Czechia

Krajská nemocnice Tomáše Bati - Zlin

Zlín, , Czechia

Nemocnice Znojmo

Znojmo, , Czechia

Latvijas Jūras Medicīnas Centrs

Riga, , Latvia

Rīgas slimnīca Bikor Holim

Riga, , Latvia

SIA Gremošanas slimību centrs "Gastro"

Riga, , Latvia

Univerzitná nemocnica Bratislava

Bratislava, , Slovakia

Fakultná Nemocnica Nitra

Nitra, , Slovakia

Countries

Belgium; Czechia; Latvia; Slovakia

Other Identifiers

2012-005521-73

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG0974-CL-201

Identifier Type: -

Identifier Source: org_study_id