Back to resultsEfficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis (ORIGIN)
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GLPG1205
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring moderate to severe ulcerative colitis, GLPG1205
Eligibility 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
Sites / Locations
- St. Pierre University Hospital Center
- Leuven University Hospital
- Clinic Saint-Joseph
- Hepato-Gastroenterology HK Ltd.
- Outpatient Clinic of Internal Medicine and Gastroenterology
- Orlickoustecka Hospital, Inc.
- Regional Hospital T. Bata, Clinic of Internal Medicine
- Hospital Znojmo
- Gastroenterology Specialist Practice
- Asklepios West Hospital Hamburg, Clinic of Internal Medicine
- Hannover Medical School
- University Hospital Jena
- Gastroenterology Group Practice Minden
- Gastroenterology Practice at Germania-Campus
- Internal Medicine Group Practice Oldenburg
- Clinexpert Medical Center
- Hungarian Center for Obesity Ltd.
- Medical Centre, Hungarian Defence Forces
- Szent Margit Hospital
- Main Railway Outpatient Clinic Debrecen
- Javorszky Odon Hospital
- Healthcare Center Orkan Med Stec Michalska Spolka Jawna
- Saint Family Hospital Medical Center
- Sopmed Llc
- H-T Medical Center
- Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
- Vivamed
- Active Health Center, Non-Public Healthcare Facility Zawidawie Center
- Kazan State Medical University
- Territorial Clinical Hospital
- Central Research Institute of Gastroenterology
- Moscow Vladimirsky Regional Clinical Research Institute
- Semashko Nizhny Novgorod Regional Clinical Hospital
- City Clinical Hospital #12
- Penza Regional Clinical Hospital n.a. N. N. Burdenko
- City Clinical Hospital #31
- City General Hospital #2
- St. Venerable Martyress Elizabeth Municipal Hospital
- Stavropol State Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GLPG1205 100mg QD
Placebo
Arm Description
GLPG1205 100mg daily dosing in the morning
Placebo daily dosing in the morning
Outcomes
Primary Outcome Measures
Changes in Mayo score at 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
Changes in partial Mayo score
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
Histological response rate
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
Number of subjects with adverse events
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of adverse events at every visit
Number of subjects with abnormal laboratory parameters
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal laboratory parameters at every visit
Number of subjects with abnormal vital signs
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal vital signs at every visit
Number of subjects with abnormal electrocardiogram
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal electrocardiograms at every visit
Number of subjects with abnormal physical examination
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal physical examination at every visit
The plasma levels of GLPG1205
To characterize the pharmacokinetics (PK) of GLPG1205 by measuring the amount in plasma at Week 4, 8 and 12
Changes in serum C-reactive protein (CRP) levels
To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of C-reactive protein in serum at every visit
Changes in faecal calprotectin levels
To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of faecal calprotectin in stool at every visit up to Week 12
Changes in myeloperoxidase (MPO) levels in colonic biopsies
To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of myeloperoxidase (MPO) in colonic biopsies at Screening and Week 8
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02337608
Brief Title
Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis
Acronym
ORIGIN
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
moderate to severe ulcerative colitis, GLPG1205
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLPG1205 100mg QD
Arm Type
Experimental
Arm Description
GLPG1205 100mg daily dosing in the morning
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily dosing in the morning
Intervention Type
Drug
Intervention Name(s)
GLPG1205
Intervention Description
GLPG1205 daily dosing in the morning for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo daily dosing in the morning daily for 12 weeks
Primary Outcome Measure Information:
Title
Changes in Mayo score at Week 8
Description
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
Time Frame
Screening and Week 8
Secondary Outcome Measure Information:
Title
Changes in partial Mayo score
Description
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
Time Frame
From Screening to Week 12
Title
Histological response rate
Description
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
Time Frame
Screening and Week 8
Title
Number of subjects with adverse events
Description
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of adverse events at every visit
Time Frame
From Screening to Week 16
Title
Number of subjects with abnormal laboratory parameters
Description
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal laboratory parameters at every visit
Time Frame
From Screening to Week 16
Title
Number of subjects with abnormal vital signs
Description
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal vital signs at every visit
Time Frame
From Screening to Week 16
Title
Number of subjects with abnormal electrocardiogram
Description
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal electrocardiograms at every visit
Time Frame
From Screening to Week 16
Title
Number of subjects with abnormal physical examination
Description
To evaluate the safety and tolerability of GLPG1205 between GLPG1205 treated subjects and placebo subjects in terms of abnormal physical examination at every visit
Time Frame
From Screening to Week 16
Title
The plasma levels of GLPG1205
Description
To characterize the pharmacokinetics (PK) of GLPG1205 by measuring the amount in plasma at Week 4, 8 and 12
Time Frame
Week 4, 8 and 12
Title
Changes in serum C-reactive protein (CRP) levels
Description
To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of C-reactive protein in serum at every visit
Time Frame
From Screening to Week 16
Title
Changes in faecal calprotectin levels
Description
To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of faecal calprotectin in stool at every visit up to Week 12
Time Frame
From Screening to Week 12
Title
Changes in myeloperoxidase (MPO) levels in colonic biopsies
Description
To characterize the pharmacodynamics (PD) of GLPG1205 by measuring the levels of myeloperoxidase (MPO) in colonic biopsies at Screening and Week 8
Time Frame
Screening and Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Vanhoutte, MD
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
St. Pierre University Hospital Center
City
Brussels
Country
Belgium
Facility Name
Leuven University Hospital
City
Leuven
Country
Belgium
Facility Name
Clinic Saint-Joseph
City
Liege
Country
Belgium
Facility Name
Hepato-Gastroenterology HK Ltd.
City
Hradec Kralove
Country
Czech Republic
Facility Name
Outpatient Clinic of Internal Medicine and Gastroenterology
City
Pilsen
Country
Czech Republic
Facility Name
Orlickoustecka Hospital, Inc.
City
Usti nad Orlici
Country
Czech Republic
Facility Name
Regional Hospital T. Bata, Clinic of Internal Medicine
City
Zlin
Country
Czech Republic
Facility Name
Hospital Znojmo
City
Znojmo
Country
Czech Republic
Facility Name
Gastroenterology Specialist Practice
City
Berlin
Country
Germany
Facility Name
Asklepios West Hospital Hamburg, Clinic of Internal Medicine
City
Hamburg
Country
Germany
Facility Name
Hannover Medical School
City
Hannover
Country
Germany
Facility Name
University Hospital Jena
City
Jena
Country
Germany
Facility Name
Gastroenterology Group Practice Minden
City
Minden
Country
Germany
Facility Name
Gastroenterology Practice at Germania-Campus
City
Muenster
Country
Germany
Facility Name
Internal Medicine Group Practice Oldenburg
City
Oldenburg
Country
Germany
Facility Name
Clinexpert Medical Center
City
Budapest
Country
Hungary
Facility Name
Hungarian Center for Obesity Ltd.
City
Budapest
Country
Hungary
Facility Name
Medical Centre, Hungarian Defence Forces
City
Budapest
Country
Hungary
Facility Name
Szent Margit Hospital
City
Budapest
Country
Hungary
Facility Name
Main Railway Outpatient Clinic Debrecen
City
Debrecen
Country
Hungary
Facility Name
Javorszky Odon Hospital
City
Vac
Country
Hungary
Facility Name
Healthcare Center Orkan Med Stec Michalska Spolka Jawna
City
Ksawerow
Country
Poland
Facility Name
Saint Family Hospital Medical Center
City
Lodz
Country
Poland
Facility Name
Sopmed Llc
City
Sopot
Country
Poland
Facility Name
H-T Medical Center
City
Tychy
Country
Poland
Facility Name
Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
City
Warsaw
Country
Poland
Facility Name
Vivamed
City
Warsaw
Country
Poland
Facility Name
Active Health Center, Non-Public Healthcare Facility Zawidawie Center
City
Wroclaw
Country
Poland
Facility Name
Kazan State Medical University
City
Kazan
Country
Russian Federation
Facility Name
Territorial Clinical Hospital
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Central Research Institute of Gastroenterology
City
Moscow
Country
Russian Federation
Facility Name
Moscow Vladimirsky Regional Clinical Research Institute
City
Moscow
Country
Russian Federation
Facility Name
Semashko Nizhny Novgorod Regional Clinical Hospital
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
City Clinical Hospital #12
City
Novosibirsk
Country
Russian Federation
Facility Name
Penza Regional Clinical Hospital n.a. N. N. Burdenko
City
Penza
Country
Russian Federation
Facility Name
City Clinical Hospital #31
City
Saint Petersburg
Country
Russian Federation
Facility Name
City General Hospital #2
City
Saint Petersburg
Country
Russian Federation
Facility Name
St. Venerable Martyress Elizabeth Municipal Hospital
City
Saint Petersburg
Country
Russian Federation
Facility Name
Stavropol State Medical University
City
Stavropol
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis
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