Ulcerative ColitisPhase 2NCT01829321
Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis
A Phase 2 study testing GLPG0974 in people with Ulcerative Colitis, run by Lakefront Biotherapeutics NV at 16 sites in 4 countries.
Trial 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. 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?
- GLPG0974
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Apr 2013to Apr 2014
- 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
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Czechia7 sites
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové
Fakulní nemocnice Olomouc
Olomouc
Homolka Hospitál
Prague
Nemocnice Slaný
Slaný
Krajská zdravotní a.s., Masarykova nemocnice v Ústí nad Labem T. Bati a.s.
Ústí nad Labem
Krajská nemocnice Tomáše Bati - Zlin
Zlín
Nemocnice Znojmo
Znojmo
Belgium4 sites
Imelda
Bonheiden
UZ Gent
Ghent
AZ Groeninge
Kortrijk
UZ Leuven
Leuven
Latvia3 sites
Latvijas Jūras Medicīnas Centrs
Riga
Rīgas slimnīca Bikor Holim
Riga
SIA Gremošanas slimību centrs "Gastro"
Riga
Slovakia2 sites
Univerzitná nemocnica Bratislava
Bratislava
Fakultná Nemocnica Nitra
Nitra
About this study
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
- 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
- Being tested
- GLPG0974, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0974Drug
1 capsule in the morning and 1 capsule in the evening with food during 28 days
PlaceboDrug
1 capsule in the morning and 1 capsule in the evening with food during 28 days
| Study group | Role | What they receive |
|---|---|---|
| GLPG0974 | Experimental | 1 capsule of 200 mg GLPG0974 twice daily Receives: Drug: GLPG0974 |
| Placebo | Placebo comparator | 1 capsule placebo twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
To evaluate the safety and tolerability of GLPG0974 in terms of the number of adverse events reported
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Screening up to Follow up (14 days after last dosing)
Secondary outcomes (8)
Changes in (partial) Mayo clinical disease activity score
To evaluate the efficacy of GLPG0974 in terms of changes in (partial) Mayo clinical disease activity score reported
Measured: From Day 1 to Day 29
Changes in histopathological clinical activity score in colon biopsies
To evaluate the efficacy of GLPG0974 in terms of changes in histopathological clinical activity score (Geboes score) in colon biopsies reported
Measured: Day 1 and Day 29
The amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974
To evaluate the amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 - pharmacokinetics (PK) in ulcerative colitis patients
Measured: Day 8, Day 15 and Day 29
Changes in the levels of faecal calprotectin over time after multiple oral doses of GLPG0974
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
Measured: Screening up to Day 29
Changes in the levels of C-reactive protein in serum over time after multiple oral doses of GLPG0974
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
Measured: Screening up to Day 29
Changes in the levels of myeloperoxidase (MPO) in colon biopsies over time after multiple oral doses of GLPG0974
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
Measured: Day 1 and Day 29
Changes in the levels of predominant microbiota in faeces over time after multiple oral doses of GLPG0974
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
Measured: Day 1 and Day 29
Changes in the levels of predominant microbiota in colon biopsies over time after multiple oral doses of GLPG0974
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
Measured: Day 1 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
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
- 45 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
- NCT01829321
- Sponsor's protocol ID
- GLPG0974-CL-201
- Other IDs
- 2012-005521-73
- Status last verified
- Apr 2014
- First submitted
- 9 Apr 2013
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01829321
- Acronym / sponsor ID
- GLPG0974-CL-201
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Apr 2013 (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 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.
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 |
|---|---|---|
| GLPG0974 | Experimental | Drug: GLPG09741 capsule of 200 mg GLPG0974 twice daily |
| Placebo | Placebo comparator | Drug: Placebo1 capsule placebo twice daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (18 listed)
- 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.
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 |
|---|---|---|
| GLPG09741 capsule in the morning and 1 capsule in the evening with food during 28 days | Drug | GLPG0974 |
| Placebo1 capsule in the morning and 1 capsule in the evening with food during 28 days | Drug | Placebo |
Primary outcome
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
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
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
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
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
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
8 secondary outcomes
Changes in (partial) Mayo clinical disease activity score
Time frame: From Day 1 to Day 29
Changes in histopathological clinical activity score in colon biopsies
Time frame: Day 1 and Day 29
The amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974
Time frame: Day 8, Day 15 and Day 29
Changes in the levels of faecal calprotectin over time after multiple oral doses of GLPG0974
Time frame: Screening up to Day 29
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
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
Changes in the levels of predominant microbiota in faeces over time after multiple oral doses of GLPG0974
Time frame: Day 1 and Day 29
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
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 25 Apr 2014.
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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
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLPG0974 in people with Ulcerative Colitis, run by Lakefront Biotherapeutics NV at 16 sites in 4 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 4 inclusion and 18 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 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Czechia, Belgium, Latvia, Slovakia. 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?
Number of adverse events (time frame: Screening up to Follow up (14 days after last dosing)). The study lists 6 primary outcomes in all. 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 25 Apr 2014.