Ulcerative ColitisPhase 2ORIGINNCT02337608
Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis
A Phase 2 study testing GLPG1205 in people with Ulcerative Colitis, run by Lakefront Biotherapeutics NV at 39 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- GLPG1205
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 39 sitesin 6 countries
- Study dates
- Dec 2014to Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
39 sites in 6 countries.
39 sites in 6 countries
Russia11 sites
Kazan State Medical University
Kazan'
Territorial Clinical Hospital
Krasnoyarsk
Central Research Institute of Gastroenterology
Moscow
Moscow Vladimirsky Regional Clinical Research Institute
Moscow
Semashko Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod
City Clinical Hospital #12
Novosibirsk
Penza Regional Clinical Hospital n.a. N. N. Burdenko
Penza
City Clinical Hospital #31
Saint Petersburg
City General Hospital #2
Saint Petersburg
St. Venerable Martyress Elizabeth Municipal Hospital
Saint Petersburg
Stavropol State Medical University
Stavropol
Germany7 sites
Gastroenterology Specialist Practice
Berlin
Asklepios West Hospital Hamburg, Clinic of Internal Medicine
Hamburg
Hannover Medical School
Hanover
University Hospital Jena
Jena
Gastroenterology Group Practice Minden
Minden
Gastroenterology Practice at Germania-Campus
Münster
Internal Medicine Group Practice Oldenburg
Oldenburg
Poland7 sites
Healthcare Center Orkan Med Stec Michalska Spolka Jawna
Ksawerów
Saint Family Hospital Medical Center
Lodz
Sopmed Llc
Sopot
H-T Medical Center
Tychy
Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
Warsaw
Vivamed
Warsaw
Active Health Center, Non-Public Healthcare Facility Zawidawie Center
Wroclaw
Hungary6 sites
Clinexpert Medical Center
Budapest
Hungarian Center for Obesity Ltd.
Budapest
Medical Centre, Hungarian Defence Forces
Budapest
Szent Margit Hospital
Budapest
Main Railway Outpatient Clinic Debrecen
Debrecen
Javorszky Odon Hospital
Vác
Czechia5 sites
Hepato-Gastroenterology HK Ltd.
Hradec Králové
Outpatient Clinic of Internal Medicine and Gastroenterology
Pilsen
Orlickoustecka Hospital, Inc.
Ústí nad Orlicí
Regional Hospital T. Bata, Clinic of Internal Medicine
Zlín
Hospital Znojmo
Znojmo
Belgium3 sites
St. Pierre University Hospital Center
Brussels
Leuven University Hospital
Leuven
Clinic Saint-Joseph
Liège
About this study
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
- 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.
- Conditions
- Ulcerative Colitis
- Being tested
- GLPG1205, Placebo
- Keywords
- moderate to severe ulcerative colitis, GLPG1205
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG1205Drug
GLPG1205 daily dosing in the morning for 12 weeks
PlaceboDrug
placebo daily dosing in the morning daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| GLPG1205 100mg QD | Experimental | GLPG1205 100mg daily dosing in the morning Receives: Drug: GLPG1205 |
| Placebo | Placebo comparator | Placebo daily dosing in the morning Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Screening and Week 8
Secondary outcomes (11)
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
Measured: From Screening 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
Measured: Screening and Week 8
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
Measured: From Screening to Week 16
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
Measured: From Screening to Week 16
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
Measured: From Screening to Week 16
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
Measured: From Screening to Week 16
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
Measured: From Screening to Week 16
The plasma levels of GLPG1205
To characterize the pharmacokinetics (PK) of GLPG1205 by measuring the amount in plasma at Week 4, 8 and 12
Measured: 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
Measured: From Screening to Week 16
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
Measured: From Screening 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
Measured: Screening and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric Vanhoutte, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337608
- Sponsor's protocol ID
- GLPG1205-CL-211
- Other IDs
- 2014-001893-32, 2014
- Acronym
- ORIGIN
- Status last verified
- Nov 2015
- First submitted
- 9 Jan 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02337608
- Acronym / sponsor ID
- ORIGIN / GLPG1205-CL-211
- Conditions
- Ulcerative Colitis
- Keywords
- moderate to severe ulcerative colitis, GLPG1205
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLPG1205 100mg QD | Experimental | Drug: GLPG1205GLPG1205 100mg daily dosing in the morning |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo daily dosing in the morning |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLPG1205GLPG1205 daily dosing in the morning for 12 weeks | Drug | GLPG1205 100mg QD |
| Placeboplacebo daily dosing in the morning daily for 12 weeks | Drug | Placebo |
Primary outcome
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
11 secondary outcomes
Changes in partial Mayo score
Time frame: From Screening to Week 12
Histological response rate
Time frame: Screening and Week 8
Number of subjects with adverse events
Time frame: From Screening to Week 16
Number of subjects with abnormal laboratory parameters
Time frame: From Screening to Week 16
Number of subjects with abnormal vital signs
Time frame: From Screening to Week 16
Number of subjects with abnormal electrocardiogram
Time frame: From Screening to Week 16
Number of subjects with abnormal physical examination
Time frame: From Screening to Week 16
The plasma levels of GLPG1205
Time frame: Week 4, 8 and 12
Changes in serum C-reactive protein (CRP) levels
Time frame: From Screening to Week 16
Changes in faecal calprotectin levels
Time frame: From Screening to Week 12
Changes in myeloperoxidase (MPO) levels in colonic biopsies
Time frame: Screening and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Vanhoutte, MD study director
Lakefront Biotherapeutics NV
39 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLPG1205 in people with Ulcerative Colitis, run by Lakefront Biotherapeutics NV at 39 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Russia, Germany, Poland, Hungary, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Mayo score at Week 8 (time frame: Screening and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.