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

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ClinicalTrials.gov Identifier: NCT01829321
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: GLPG0974 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GLPG0974
1 capsule of 200 mg GLPG0974 twice daily
Drug: GLPG0974
1 capsule in the morning and 1 capsule in the evening with food during 28 days

Placebo Comparator: Placebo
1 capsule placebo twice daily
Drug: Placebo
1 capsule in the morning and 1 capsule in the evening with food during 28 days




Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: Screening up to Follow up (14 days after last dosing) ]
    To evaluate the safety and tolerability of GLPG0974 in terms of the number of adverse events reported

  2. Changes in physical exam measures [ Time Frame: Screening up to Follow up (14 days after last dosing) ]
    To evaluate the safety and tolerability of GLPG0974 in terms of the changes in physical exam measures reported

  3. Changes in vital signs as measured by heart rate, blood pressure and oral temperature [ Time Frame: Screening up to Follow up (14 days after last dosing) ]
    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

  4. Changes in 12-lead ECG measures [ Time Frame: Screening up to Follow up (14 days after last dosing) ]
    To evaluate the safety and tolerability of GLPG0974 in terms of the changes in 12-lead ECG measures reported

  5. Changes in blood safety lab parameters [ Time Frame: Screening up to Follow up (14 days after last dosing) ]
    To evaluate the safety and tolerability of GLPG0974 in terms of changes in blood safety lab parameters reported

  6. Changes in urine safety lab parameters [ Time Frame: Screening up to Follow up (14 days after last dosing) ]
    To evaluate the safety and tolerability of GLPG0974 in terms of changes in urine safety lab parameters reported


Secondary Outcome Measures :
  1. Changes in (partial) Mayo clinical disease activity score [ Time Frame: From Day 1 to Day 29 ]
    To evaluate the efficacy of GLPG0974 in terms of changes in (partial) Mayo clinical disease activity score reported

  2. Changes in histopathological clinical activity score in colon biopsies [ Time Frame: Day 1 and Day 29 ]
    To evaluate the efficacy of GLPG0974 in terms of changes in histopathological clinical activity score (Geboes score) in colon biopsies reported

  3. The amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 [ Time Frame: Day 8, Day 15 and Day 29 ]
    To evaluate the amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 - pharmacokinetics (PK) in ulcerative colitis patients

  4. Changes in the levels of faecal calprotectin over time after multiple oral doses of GLPG0974 [ Time Frame: Screening up to Day 29 ]
    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

  5. Changes in the levels of C-reactive protein in serum over time after multiple oral doses of GLPG0974 [ Time Frame: Screening up to Day 29 ]
    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

  6. Changes in the levels of myeloperoxidase (MPO) in colon biopsies over time after multiple oral doses of GLPG0974 [ Time Frame: Day 1 and Day 29 ]
    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

  7. Changes in the levels of predominant microbiota in faeces over time after multiple oral doses of GLPG0974 [ Time Frame: Day 1 and Day 29 ]
    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

  8. Changes in the levels of predominant microbiota in colon biopsies over time after multiple oral doses of GLPG0974 [ Time Frame: Day 1 and Day 29 ]
    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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829321


Locations
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Belgium
Imelda
Bonheiden, Belgium
UZ Gent
Gent, Belgium
AZ Groeninge
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
Czech Republic
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czech Republic
Fakulní nemocnice Olomouc
Olomouc, Czech Republic
Homolka Hospitál
Prague, Czech Republic
Nemocnice Slaný
Slany, Czech Republic
Krajská zdravotní a.s., Masarykova nemocnice v Ústí nad Labem T. Bati a.s.
Usti nad Labem, Czech Republic
Krajská nemocnice Tomáše Bati - Zlin
Zlin, Czech Republic
Nemocnice Znojmo
Znojmo, Czech Republic
Latvia
Latvijas Jūras Medicīnas Centrs
Riga, Latvia
Rīgas slimnīca Bikor Holim
Riga, Latvia
SIA Gremošanas slimību centrs "Gastro"
Riga, Latvia
Slovakia
Univerzitná nemocnica Bratislava
Bratislava, Slovakia
Fakultná Nemocnica Nitra
Nitra, Slovakia
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Frédéric Vanhoutte, MD Galapagos NV

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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01829321     History of Changes
Other Study ID Numbers: GLPG0974-CL-201
2012-005521-73 ( EudraCT Number )
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases