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Crohn's DiseasePhase 2NCT02048618

Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease

A Phase 2 study testing GLPG0634 in people with Crohn's Disease, run by Lakefront Biotherapeutics NV at 63 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 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
Crohn's Disease
What is being tested?
GLPG0634
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
175 participants
Where
63 sitesin 9 countries
Study dates
Feb 2014to Feb 2016
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 ileal, colonic, or ileocolonic CD
  • CDAI score ≥ 220 to ≤ 450
  • Evidence of active inflammation as demonstrated by endoscopic confirmation of active disease
  • Subjects previously not exposed to anti-TNF treatment (TNF-naïve) or subjects previously exposed to anti-TNF therapy at a registered dose, that has been discontinued at least 8 weeks prior to Screening and deemed by the treating physician as a primary or secondary non-responder or intolerant (TNF-experienced)
  • Continuation of concurrent treatment with oral steroids (≤30 mg prednisolone eq/day), mesalazine, olsalazine, CD-related antibiotics and probiotics at stable dose is allowed
  • Previous exposure to immunomodulators is permitted, but must be discontinued
  • Haematology and biochemistry lab parameters within predefined ranges as stated in the protocol

Who cannot join

  • Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC
  • Stoma, gastric or ileoanal pouch, procto- or total colectomy, symptomatic stenosis or obstructive strictures, history of bowel perforation, (suspected) abscess; actively draining fistulae
  • Subject who has had surgical bowel resections within the past 6 months, short bowel syndrome or is receiving tube feeding, defined formula diets, or parenteral alimentation
  • Subject with positive Clostridium difficile toxin stool assay or evidence of any other gastrointestinal infection
  • Subject who has received non-permitted IBD therapies within specified timeframes, depending on the medication, as stated in the protocol
  • Subject with a (previous history of) dysplasia of the gastrointestinal tract
Show all 10Show fewer
  • Concurrent gastro-intestinal malignancy or a history of cancer elsewhere
  • History of lymphoproliferative disease
  • Known active infection of any kind, current therapy for chronic infection or history of specific infections as stated in the protocol
  • Subject who is pregnant, lactating or not willing to maintain highly effective birth control methods during the course of the study and 12 weeks thereafter

Trial locations and contacts

63 sites in 9 countries.

63 sites in 9 countries

Russia13 sites

  • Territorial Clinical Hospital

    Barnaul

  • State Medical University

    Kazan'

  • Territorial Clinical Hospital

    Krasnoyarsk

  • A.N. Ryzhikh State Research Center for Coloproctology

    Moscow

  • City Clinical Hospital #24

    Moscow

  • Moscow Clinical Research Center

    Moscow

  • Vladimirsky Regional Clinical Research Institute

    Moscow

  • Semashko Nizhny Novgorod Regional Clinical Hospital

    Nizhny Novgorod

  • City Clinical Hospital #12

    Novosibirsk

  • City Clinical Hospital #31

    Saint Petersburg

  • First Pavlov State Medical University

    Saint Petersburg

  • Mechnikov North-Western State Medical University

    Saint Petersburg

  • St. Elizabeth City Hospital

    Saint Petersburg

Other trials in Russia

France8 sites

  • Hospital Gabriel Montpied

    Clermont-Ferrand

  • Beaujon Hospital

    Clichy

  • Dijon University Hospital Center

    Dijon

  • Hospital Michallon

    Grenoble

  • Lille Regional University Hospital Center

    Lille

  • North Hospital

    Marseille

  • Archet Hospital

    Nice

  • Saint Etienne University Hospital Center

    Saint-Etienne

Other trials in France

Germany8 sites

  • DRK Clinics Berlin Westend

    Berlin

  • Interdisciplinary Crohn Colitis Center Rhein Main

    Frankfurt am Main

  • Asklepios West Hospital Hamburg

    Hamburg

  • University Hospital Jena

    Jena

  • University Hospital Schleswig-Holstein

    Kiel

  • University Hospital Magdeburg

    Magdeburg

  • Gastroenterology Group Practice Minden

    Minden

  • Internal Medicine Group Practice Oldenburg

    Oldenburg

Other trials in Germany

Hungary7 sites

  • Drug Research Center Ltd.

    Balatonfüred

  • Clinexpert Medical Center

    Budapest

  • Semmelweis University

    Budapest

  • Szent Margit Hospital

    Budapest

  • University of Debrecen, Medical and Health Science Center

    Debrecen

  • Bekes County Pandy Kalman Hospital

    Gyula

  • Tolna County Balassa Janos Hospital

    Szekszárd

Other trials in Hungary

Poland7 sites

  • Jan Biziel University Hospital #2

    Bydgoszcz

  • Saint Family Hospital Medical Center

    Lodz

  • H-T. Medical Center

    Tychy

  • Clinical Hospital of Ministry of Internal Affairs and Administration

    Warsaw

  • Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults

    Warsaw

  • Vivamed

    Warsaw

  • Active Health Center

    Wroclaw

Other trials in Poland

Belgium6 sites

  • St. Pierre University Hospital Center

    Brussels

  • University Hospital Saint Luc

    Brussels

  • University Hospital Ghent

    Ghent

  • University Hospitals Leuven

    Leuven

  • CHR de la Citadelle

    Liège

  • Clinic Saint Joseph

    Liège

Other trials in Belgium

Czechia6 sites

  • Hepato-Gastroenterology HK Ltd.

    Hradec Králové

  • University Hospital Olomouc

    Olomouc

  • Outpatient Clinic of Internal Medicine and Gastroenterology

    Pilsen

  • Institute of Clinical and Experimental Medicine

    Prague

  • Masaryk's Hospital Usti Nad Labem

    Ústí nad Labem

  • Hospital Znojmo

    Znojmo

Other trials in Czechia

Romania4 sites

  • Colentina Clinical Hospital

    Bucharest

  • Fundeni Clinical Institute

    Bucharest

  • Medical Center for Gastroenterology

    Cluj-Napoca

  • Center for Gastroenterology, Ltd

    Timișoara

Other trials in Romania

United Kingdom4 sites

  • Queen Elizabeth Hospital

    Birmingham

  • Royal Bournemouth Hospital

    Bournemouth

  • St Mark's Hospital

    Harrow

  • Manchester Royal Infirmary

    Manchester

Other trials in United Kingdom

About this study

Official title: Double-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal Ulceration

  • 180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 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 GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects GLPG0634 administration on subjects' quality of life will be evaluated.
Read the detailed description
  • 180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated when taking GLPG0634 or matching placebo once daily in addition to their stable background treatment. The population will include 50% anti-TNF naïve patients and 50% of subjects previously exposed to anti-TNF.
  • The study will consist of 2 parts, with total treatment duration of 20 weeks. Randomisation in Part 1 will be stratified according to subject's previous anti-TNF exposure, C-reactive protein (CRP) level at Screening and oral corticosteroid use at Day -1. However, at Week 10, subjects will be re-randomized automatically and stratified according to the subject's clinical response (reduction of Crohn's Disease Activity Index (CDAI) of 100 points), previous anti-TNF exposure and corticosteroid use at Day -1 to receive GLPG0634 200 mg q.d., 100 mg q.d. doses, or matching placebo q.d. in a blinded fashion. In Part 2, all will continue the study until Week 20.
  • As efficacy parameters, the ability to achieve clinical response or remission, endoscopic response \& remission as well as mucosal healing with GLPG0634 given once daily compared to placebo will be evaluated after 10 weeks of treatment. In subjects who achieved clinical remission at Week 10, maintenance of the remission will be assessed during Part 2 of the study.
  • 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 GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects of different doses and dose regimens of GLPG0634 administration on subjects' quality of life will be evaluated.
Conditions
Crohn's Disease
Being tested
GLPG0634, Placebo
Keywords
Active Crohn's Disease, GLPG0634
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLPG0634Drug

    Also called GLPG0634 tablets

    100 mg oral tablet, intake once daily for 20 weeks

  • PlaceboDrug

    Also called Placebo tablets

    placebo oral tablets, intake once daily for 20 weeks

Study groups in NCT02048618
Study groupRoleWhat they receive
GLPG0634 200 mg QDExperimental2 tablets of 100 mg GLPG0634 in the morning
Receives: Drug: GLPG0634
GLPG0634 100 mg QDExperimental1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
Receives: Drug: GLPG0634; Drug: Placebo
Placebo QDPlacebo comparator2 placebo tablets in the morning
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects achieving clinical remission at Week 10

    Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points

    Measured: Week 10

Secondary outcomes (17)

  1. Percentage of subjects achieving clinical remission

    Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points, assessed at every visit

    Measured: Up to Week 20

  2. Percentage of subjects achieving clinical response

    Percentage of subjects achieving clinical response as defined by a decrease in Crohn's Disease Activity Index score of at least 100 points, assessed at every visit

    Measured: Up to Week 20

  3. Percentage of subjects achieving endoscopic remission at Week 10

    Percentage of subjects achieving endoscopic remission as defined by a reduction of Simplified Endoscopy Score for Crohn's Disease (SES-CD) score ≤ 4, with ulcerated surface subscore no greater than 1 in any segment at Week 10

    Measured: Week 10

  4. Percentage of subjects achieving endoscopic response at Week 10

    Percentage of subjects achieving endoscopic response as defined by a reduction of Simplified Endoscopy Score for Crohn's Disease (SES-CD) score by at least 50% from Screening at Week 10

    Measured: Week 10

  5. Percentage of subjects achieving mucosal healing at Week 10

    Percentage of subjects achieving mucosal healing as defined by a Simplified Endoscopy Score for Crohn's Disease (SES-CD) score equal to 0 at Week 10

    Measured: Week 10

  6. Change from Baseline in Crohn's Disease Activity Index score

    Change from Baseline in Crohn's Disease Activity Index score, assessed at every visit

    Measured: Up to Week 20

  7. Change from Screening in endoscopic score

    Change from Screening in endoscopic Simplified Endoscopy Score for Crohn's Disease (SES-CD) score at Week 10

    Measured: Week 10

  8. Change from Screening in histopathology biopsy score

    Change from Screening in histopathology biopsy score at Week 10

    Measured: Week 10

  9. Change from Baseline in Subjects' Quality of Life (based on the Inflammatory Bowel Disease Questionnaire (IBDQ) questionnaire score)

    Change from Baseline in Subjects' Quality of Life based on the IBDQ questionnaire score at Week 10 and Week 20

    Measured: Up to Week 20

  10. The number of subjects with adverse events

    To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs)

    Measured: From screening up to 2 weeks after last dose

  11. The number of subjects with abnormal lab tests

    To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms laboratory test abnormalities

    Measured: From screening up to 2 weeks after last dose

  12. The number of subjects with abnormal vital signs

    To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in vital signs

    Measured: From screening up to 2 weeks after last dose

  13. The number of subjects with abnormal ECG

    To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in electrocardiogram (ECG)

    Measured: From screening up to 2 weeks after last dose

  14. The plasma levels of GLPG0634 and its metabolite

    To characterize the pharmacokinetics (PK) of GLPG0634 and its metabolite by measuring the amount in plasma from Week 2 up to Week 20 at every visit

    Measured: Up to Week 20

  15. The change versus Baseline in levels of immune- and inflammation-related parameters in whole blood and serum

    To characterize the pharmacodynamics (PD) of GLPG0634 and its metabolite by measuring the levels of immune- and inflammation-related parameters in whole blood and serum

    Measured: Up to Week 20

  16. The change versus Baseline in levels of faecal calprotectin

    To characterize the pharmacodynamics (PD) of GLPG0634 and its metabolite by measuring the levels of faecal calprotectin

    Measured: Up to Week 20

  17. The change versus Baseline in microbial communities in stool samples

    To characterize the effects of GLPG0634 and its metabolite on the microbial communities by measuring the levels of predominant microbiota in stool samples

    Measured: Up to Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionNov 2015
  4. Study completionFeb 2016

Resources

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
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02048618
Sponsor's protocol ID
GLPG0634-CL-211
Other IDs
2013-002857-32
Status last verified
Feb 2016
First submitted
27 Jan 2014
Last updated
23 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Reinisch W, Serone A, Hebuterne X, Kuhbacher T, Klopocka M, Roblin X, Brodbeck J, Etchevers K, Galien R, Grant E, Tasset C, Yoon OK, Zaboli S, Vermeire S. Mucosal p-STAT1/3 correlates with histologic disease activity in Crohn's disease and is responsive to filgotinib. Tissue Barriers. 2023 Apr 3;11(2):2088961. doi: 10.1080/21688370.2022.2088961. Epub 2022 Jun 28.

    PubMed 35762272

  • Vermeire S, Schreiber S, Petryka R, Kuehbacher T, Hebuterne X, Roblin X, Klopocka M, Goldis A, Wisniewska-Jarosinska M, Baranovsky A, Sike R, Stoyanova K, Tasset C, Van der Aa A, Harrison P. Clinical remission in patients with moderate-to-severe Crohn's disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial. Lancet. 2017 Jan 21;389(10066):266-275. doi: 10.1016/S0140-6736(16)32537-5. Epub 2016 Dec 15.

    PubMed 27988142

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GLPG0634 in people with Crohn's Disease, run by Lakefront Biotherapeutics NV at 63 sites in 9 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 10 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 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Russia, France, Germany, Hungary, Poland and 4 more countries. 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?

Percentage of subjects achieving clinical remission at Week 10 (time frame: Week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02048618, which also lists 2 linked publications.

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 23 Feb 2016.

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