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

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GLPG0974

Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 infectious colitis.

Key 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.

Sites / Locations

Imelda
UZ Gent
AZ Groeninge
UZ Leuven
Hepato-Gastroenterologie HK, s.r.o.
Fakulní nemocnice Olomouc
Homolka Hospitál
Nemocnice Slaný
Krajská zdravotní a.s., Masarykova nemocnice v Ústí nad Labem T. Bati a.s.
Krajská nemocnice Tomáše Bati - Zlin
Nemocnice Znojmo
Latvijas Jūras Medicīnas Centrs
Rīgas slimnīca Bikor Holim
SIA Gremošanas slimību centrs "Gastro"
Univerzitná nemocnica Bratislava
Fakultná Nemocnica Nitra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GLPG0974

Placebo

Arm Description

1 capsule of 200 mg GLPG0974 twice daily

1 capsule placebo twice daily

Outcomes

Primary Outcome Measures

Number of adverse events

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

Changes in physical exam measures

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

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

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

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

Changes in urine safety lab parameters

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

Secondary Outcome Measures

Changes in (partial) Mayo clinical disease activity score

To evaluate the efficacy of GLPG0974 in terms of changes in (partial) Mayo clinical disease activity score reported

Changes in histopathological clinical activity score in colon biopsies

To evaluate the efficacy of GLPG0974 in terms of changes in histopathological clinical activity score (Geboes score) in colon biopsies reported

The amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974

To evaluate the amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 - pharmacokinetics (PK) in ulcerative colitis patients

Changes in the levels of faecal calprotectin over time after multiple oral doses of GLPG0974

To evaluate the changes in the levels of calprotectin in faeces over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients

Changes in the levels of C-reactive protein in serum over time after multiple oral doses of GLPG0974

To evaluate the changes in the levels of C-reactive protein in serum over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients

Changes in the levels of myeloperoxidase (MPO) in colon biopsies over time after multiple oral doses of GLPG0974

To evaluate the changes in the levels of MPO in colon biopsies over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients

Changes in the levels of predominant microbiota in faeces over time after multiple oral doses of GLPG0974

To evaluate the changes in the levels of predominant microbiota in faeces over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients

Changes in the levels of predominant microbiota in colon biopsies over time after multiple oral doses of GLPG0974

To evaluate the changes in the levels of predominant microbiota in colon biopsies over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients

Full Information

NCT ID

NCT01829321

First Posted

April 9, 2013

Last Updated

April 24, 2014

Sponsor

Galapagos NV

1. Study Identification

Unique Protocol Identification Number

NCT01829321

Brief Title

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

Official Title

Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of GLPG0974 in Subjects With Mild to Moderate Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galapagos NV

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GLPG0974

Arm Type

Experimental

Arm Description

1 capsule of 200 mg GLPG0974 twice daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

1 capsule placebo twice daily

Intervention Type

Drug

Intervention Name(s)

GLPG0974

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of adverse events

Description

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

Time Frame