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Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis (ORIGIN)

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ClinicalTrials.gov Identifier: NCT02337608
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:
  • Approximately 60 patients suffering from moderate to severe ulcerative colitis will be evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or matching placebo once daily for 12 weeks in addition to their stable background treatment.
  • During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG1205 present in the blood (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism of action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies will be determined.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: GLPG1205 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate to Severe Ulcerative Colitis
Study Start Date : December 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GLPG1205 100mg QD
GLPG1205 100mg daily dosing in the morning
Drug: GLPG1205
GLPG1205 daily dosing in the morning for 12 weeks

Placebo Comparator: Placebo
Placebo daily dosing in the morning
Drug: Placebo
placebo daily dosing in the morning daily for 12 weeks




Primary Outcome Measures :
  1. Changes in Mayo score at Week 8 [ Time Frame: Screening and Week 8 ]
    To evaluate the efficacy of GLPG1205 in terms of changes in Mayo score comparing results at Week 8 with baseline between GLPG1205 treated subjects and placebo subjects


Secondary Outcome Measures :
  1. Changes in partial Mayo score [ Time Frame: From Screening to Week 12 ]
    To evaluate the efficacy of GLPG1205 in terms of changes in partial Mayo score comparing results with baseline between GLPG1205 treated subjects and placebo subjects at every visit up to Week 12

  2. Histological response rate [ Time Frame: Screening and Week 8 ]
    To evaluate the efficacy of GLPG1205 in terms of histological response rate by use of the histopathological Geboes index comparing results at Week 8 with baseline between GLPG1205 treated subjects and placebo subjects

  3. Number of subjects with adverse events [ Time Frame: From Screening to Week 16 ]
    To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of adverse events at every visit

  4. Number of subjects with abnormal laboratory parameters [ Time Frame: From Screening to Week 16 ]
    To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal laboratory parameters at every visit

  5. Number of subjects with abnormal vital signs [ Time Frame: From Screening to Week 16 ]
    To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal vital signs at every visit

  6. Number of subjects with abnormal electrocardiogram [ Time Frame: From Screening to Week 16 ]
    To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal electrocardiograms at every visit

  7. Number of subjects with abnormal physical examination [ Time Frame: From Screening to Week 16 ]
    To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal physical examination at every visit

  8. The plasma levels of GLPG1205 [ Time Frame: Week 4, 8 and 12 ]
    To characterize the pharmacokinetics (PK) of GLPG1205 by measuring the amount in plasma at Week 4, 8 and 12

  9. Changes in serum C-reactive protein (CRP) levels [ Time Frame: From Screening to Week 16 ]
    To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of C-reactive protein in serum at every visit

  10. Changes in faecal calprotectin levels [ Time Frame: From Screening to Week 12 ]
    To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of faecal calprotectin in stool at every visit up to Week 12

  11. Changes in myeloperoxidase (MPO) levels in colonic biopsies [ Time Frame: Screening and Week 8 ]
    To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of myeloperoxidase (MPO) in colonic biopsies at Screening and Week 8



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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

Inclusion Criteria:

  • Male or female subjects between 18 and 75 years
  • Documented history of UC
  • Presence of active UC for a minimum period of 14 days prior to screening and spread beyond the rectum, Mayo score ≥ 6 with rectal bleeding score ≥ 1 and endoscopy score ≥ 2
  • Absence of infectious colitis
  • Tumor necrosis factor alpha (TNFα) inhibitor-naive subjects should have failed at least 1 prior conventional therapy
  • Continuation of concurrent treatment with oral steroids (≤30 mg prednisolone eq/day), immunosuppressants and 5-aminosalicylates at stable dose is allowed
  • Female subjects must have a negative blood pregnancy test, unless they are surgically sterile, had a hysterectomy, or have been postmenopausal for at least 1 year
  • Subjects will have to use highly effective contraceptive methods

Exclusion Criteria:

  • History of sensitivity to any component of the study drug, or a history of drug or other allergy
  • Any concurrent illness, condition, disability, or clinically significant abnormality that, in the investigator's opinion, represents a safety risk for the subject's participation, may affect the interpretation of data, or may prevent the subject from safely completing the assessments
  • History of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, GI (other than UC), pulmonary, or metabolic disease
  • History of active infections requiring intravenous antibiotics within the past 4 weeks prior to screening.
  • History of malignancy within the past 5 years; presence or history of intestinal malignancy
  • History of bowel surgery within 6 months prior to screening; history of colon resection with < 30 cm of the colon remaining
  • Suspicion of Crohn's disease, indeterminate colitis, microscopic colitis, ischemic colitis, diverticular disease-associated colitis, or radiation-induced colitis
  • Subject who has received non-permitted UC therapies within specified timeframes, depending on the medication, as stated in the protocol
  • Subject who is pregnant or lactating

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): NCT02337608


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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: NCT02337608     History of Changes
Other Study ID Numbers: GLPG1205-CL-211
2014-001893-32 ( EudraCT Number )
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Keywords provided by Galapagos NV:
moderate to severe ulcerative colitis
GLPG1205

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