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

NCT01829321 | Completed Phase 2 DMC

• 2 other identifiers: GLPG0974-CL-2012012-005521-73
• Study Type: interventional
• Target: 45
• Locations: 4 countries
• Sites: 16

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

Outcome Measures

Primary Outcomes (6)

• Number of adverse events

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

  Screening up to Follow up (14 days after last dosing)

• Changes in physical exam measures

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

  Screening up to Follow up (14 days after last dosing)

• 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

  Screening up to Follow up (14 days after last dosing)

• 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

  Screening up to Follow up (14 days after last dosing)

• Changes in blood safety lab parameters

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

  Screening up to Follow up (14 days after last dosing)

• Changes in urine safety lab parameters

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

  Screening up to Follow up (14 days after last dosing)

Secondary Outcomes (8)

• 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

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

  Screening up to Day 29

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

  Screening up to Day 29

Study Arms (2)

GLPG0974

EXPERIMENTAL

1 capsule of 200 mg GLPG0974 twice daily

Drug: GLPG0974

Placebo

PLACEBO COMPARATOR

1 capsule placebo twice daily

Drug: Placebo

Interventions

GLPG0974 DRUG

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

GLPG0974

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (16)

Imelda

Bonheiden, Belgium

Location

UZ Gent

Ghent, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, Czechia

Location

Fakulní nemocnice Olomouc

Olomouc, Czechia

Location

Homolka Hospitál

Prague, Czechia

Location

Nemocnice Slaný

Slaný, Czechia

Location

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

Ústí nad Labem, Czechia

Location

Krajská nemocnice Tomáše Bati - Zlin

Zlín, Czechia

Location

Nemocnice Znojmo

Znojmo, Czechia

Location

Latvijas Jūras Medicīnas Centrs

Riga, Latvia

Location

Rīgas slimnīca Bikor Holim

Riga, Latvia

Location

SIA Gremošanas slimību centrs "Gastro"

Riga, Latvia

Location

Univerzitná nemocnica Bratislava

Bratislava, Slovakia

Location

Fakultná Nemocnica Nitra

Nitra, Slovakia

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

4-(((R)-1-(benzo(b)thiophene-3-carbonyl)-2-methyl-azetidine-2-carbonyl)-(3-chloro-benzyl)-amino)-butyric acid

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Frédéric Vanhoutte, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 11, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

BE (4); CZ (7); LA (3); SL (2)