Back to resultsEfficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GLPG0634
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Active Crohn's Disease, GLPG0634
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- St. Pierre University Hospital Center
- University Hospital Saint Luc
- University Hospital Ghent
- University Hospitals Leuven
- CHR de la Citadelle
- Clinic Saint Joseph
- Hepato-Gastroenterology HK Ltd.
- University Hospital Olomouc
- Outpatient Clinic of Internal Medicine and Gastroenterology
- Institute of Clinical and Experimental Medicine
- Masaryk's Hospital Usti Nad Labem
- Hospital Znojmo
- Hospital Gabriel Montpied
- Beaujon Hospital
- Dijon University Hospital Center
- Hospital Michallon
- Lille Regional University Hospital Center
- North Hospital
- Archet Hospital
- Saint Etienne University Hospital Center
- DRK Clinics Berlin Westend
- Interdisciplinary Crohn Colitis Center Rhein Main
- Asklepios West Hospital Hamburg
- University Hospital Jena
- University Hospital Schleswig-Holstein
- University Hospital Magdeburg
- Gastroenterology Group Practice Minden
- Internal Medicine Group Practice Oldenburg
- Drug Research Center Ltd.
- Clinexpert Medical Center
- Semmelweis University
- Szent Margit Hospital
- University of Debrecen, Medical and Health Science Center
- Bekes County Pandy Kalman Hospital
- Tolna County Balassa Janos Hospital
- Jan Biziel University Hospital #2
- Saint Family Hospital Medical Center
- H-T. Medical Center
- Clinical Hospital of Ministry of Internal Affairs and Administration
- Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
- Vivamed
- Active Health Center
- Colentina Clinical Hospital
- Fundeni Clinical Institute
- Medical Center for Gastroenterology
- Center for Gastroenterology, Ltd
- Territorial Clinical Hospital
- State Medical University
- Territorial Clinical Hospital
- A.N. Ryzhikh State Research Center for Coloproctology
- City Clinical Hospital #24
- Moscow Clinical Research Center
- Vladimirsky Regional Clinical Research Institute
- Semashko Nizhny Novgorod Regional Clinical Hospital
- City Clinical Hospital #12
- City Clinical Hospital #31
- First Pavlov State Medical University
- Mechnikov North-Western State Medical University
- St. Elizabeth City Hospital
- Queen Elizabeth Hospital
- Royal Bournemouth Hospital
- St Mark's Hospital
- Manchester Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
GLPG0634 200 mg QD
GLPG0634 100 mg QD
Placebo QD
Arm Description
2 tablets of 100 mg GLPG0634 in the morning
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
2 placebo tablets in the morning
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
Change from Baseline in Crohn's Disease Activity Index score
Change from Baseline in Crohn's Disease Activity Index score, assessed at every visit
Change from Screening in endoscopic score
Change from Screening in endoscopic Simplified Endoscopy Score for Crohn's Disease (SES-CD) score at Week 10
Change from Screening in histopathology biopsy score
Change from Screening in histopathology biopsy score at Week 10
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
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)
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
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
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)
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02048618
Brief Title
Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
February 2016 (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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Active Crohn's Disease, GLPG0634
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLPG0634 200 mg QD
Arm Type
Experimental
Arm Description
2 tablets of 100 mg GLPG0634 in the morning
Arm Title
GLPG0634 100 mg QD
Arm Type
Experimental
Arm Description
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
Arm Title
Placebo QD
Arm Type
Placebo Comparator
Arm Description
2 placebo tablets in the morning
Intervention Type
Drug
Intervention Name(s)
GLPG0634
Other Intervention Name(s)
GLPG0634 tablets
Intervention Description
100 mg oral tablet, intake once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo tablets
Intervention Description
placebo oral tablets, intake once daily for 20 weeks
Primary Outcome Measure Information:
Title
Percentage of subjects achieving clinical remission at Week 10
Description
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving clinical remission
Description
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points, assessed at every visit
Time Frame
Up to Week 20
Title
Percentage of subjects achieving clinical response
Description
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
Time Frame
Up to Week 20
Title
Percentage of subjects achieving endoscopic remission at Week 10
Description
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
Time Frame
Week 10
Title
Percentage of subjects achieving endoscopic response at Week 10
Description
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
Time Frame
Week 10
Title
Percentage of subjects achieving mucosal healing at Week 10
Description
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
Time Frame
Week 10
Title
Change from Baseline in Crohn's Disease Activity Index score
Description
Change from Baseline in Crohn's Disease Activity Index score, assessed at every visit
Time Frame
Up to Week 20
Title
Change from Screening in endoscopic score
Description
Change from Screening in endoscopic Simplified Endoscopy Score for Crohn's Disease (SES-CD) score at Week 10
Time Frame
Week 10
Title
Change from Screening in histopathology biopsy score
Description
Change from Screening in histopathology biopsy score at Week 10
Time Frame
Week 10
Title
Change from Baseline in Subjects' Quality of Life (based on the Inflammatory Bowel Disease Questionnaire (IBDQ) questionnaire score)
Description
Change from Baseline in Subjects' Quality of Life based on the IBDQ questionnaire score at Week 10 and Week 20
Time Frame
Up to Week 20
Title
The number of subjects with adverse events
Description
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs)
Time Frame
From screening up to 2 weeks after last dose
Title
The number of subjects with abnormal lab tests
Description
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms laboratory test abnormalities
Time Frame
From screening up to 2 weeks after last dose
Title
The number of subjects with abnormal vital signs
Description
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in vital signs
Time Frame
From screening up to 2 weeks after last dose
Title
The number of subjects with abnormal ECG
Description
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in electrocardiogram (ECG)
Time Frame
From screening up to 2 weeks after last dose
Title
The plasma levels of GLPG0634 and its metabolite
Description
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
Time Frame
Up to Week 20
Title
The change versus Baseline in levels of immune- and inflammation-related parameters in whole blood and serum
Description
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
Time Frame
Up to Week 20
Title
The change versus Baseline in levels of faecal calprotectin
Description
To characterize the pharmacodynamics (PD) of GLPG0634 and its metabolite by measuring the levels of faecal calprotectin
Time Frame
Up to Week 20
Title
The change versus Baseline in microbial communities in stool samples
Description
To characterize the effects of GLPG0634 and its metabolite on the microbial communities by measuring the levels of predominant microbiota in stool samples
Time Frame
Up to Week 10
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 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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pille Harrison, 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
University Hospital Saint Luc
City
Brussels
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liege
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
University Hospital Olomouc
City
Olomouc
Country
Czech Republic
Facility Name
Outpatient Clinic of Internal Medicine and Gastroenterology
City
Pilsen
Country
Czech Republic
Facility Name
Institute of Clinical and Experimental Medicine
City
Prague
Country
Czech Republic
Facility Name
Masaryk's Hospital Usti Nad Labem
City
Usti nad Labem
Country
Czech Republic
Facility Name
Hospital Znojmo
City
Znojmo
Country
Czech Republic
Facility Name
Hospital Gabriel Montpied
City
Clermont-Ferrand
Country
France
Facility Name
Beaujon Hospital
City
Clichy
Country
France
Facility Name
Dijon University Hospital Center
City
Dijon
Country
France
Facility Name
Hospital Michallon
City
Grenoble
Country
France
Facility Name
Lille Regional University Hospital Center
City
Lille
Country
France
Facility Name
North Hospital
City
Marseille
Country
France
Facility Name
Archet Hospital
City
Nice
Country
France
Facility Name
Saint Etienne University Hospital Center
City
Saint Etienne
Country
France
Facility Name
DRK Clinics Berlin Westend
City
Berlin
Country
Germany
Facility Name
Interdisciplinary Crohn Colitis Center Rhein Main
City
Frankfurt-am-Main
Country
Germany
Facility Name
Asklepios West Hospital Hamburg
City
Hamburg
Country
Germany
Facility Name
University Hospital Jena
City
Jena
Country
Germany
Facility Name
University Hospital Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
University Hospital Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Gastroenterology Group Practice Minden
City
Minden
Country
Germany
Facility Name
Internal Medicine Group Practice Oldenburg
City
Oldenburg
Country
Germany
Facility Name
Drug Research Center Ltd.
City
Balatonfured
Country
Hungary
Facility Name
Clinexpert Medical Center
City
Budapest
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
Country
Hungary
Facility Name
Szent Margit Hospital
City
Budapest
Country
Hungary
Facility Name
University of Debrecen, Medical and Health Science Center
City
Debrecen
Country
Hungary
Facility Name
Bekes County Pandy Kalman Hospital
City
Gyula
Country
Hungary
Facility Name
Tolna County Balassa Janos Hospital
City
Szekszard
Country
Hungary
Facility Name
Jan Biziel University Hospital #2
City
Bydgoszcz
Country
Poland
Facility Name
Saint Family Hospital Medical Center
City
Lodz
Country
Poland
Facility Name
H-T. Medical Center
City
Tychy
Country
Poland
Facility Name
Clinical Hospital of Ministry of Internal Affairs and Administration
City
Warsaw
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
City
Wroclaw
Country
Poland
Facility Name
Colentina Clinical Hospital
City
Bucharest
Country
Romania
Facility Name
Fundeni Clinical Institute
City
Bucharest
Country
Romania
Facility Name
Medical Center for Gastroenterology
City
Cluj-Napoca
Country
Romania
Facility Name
Center for Gastroenterology, Ltd
City
Timisoara
Country
Romania
Facility Name
Territorial Clinical Hospital
City
Barnaul
Country
Russian Federation
Facility Name
State Medical University
City
Kazan
Country
Russian Federation
Facility Name
Territorial Clinical Hospital
City
Krasnoyarsk
Country
Russian Federation
Facility Name
A.N. Ryzhikh State Research Center for Coloproctology
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital #24
City
Moscow
Country
Russian Federation
Facility Name
Moscow Clinical Research Center
City
Moscow
Country
Russian Federation
Facility Name
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
City Clinical Hospital #31
City
Saint Petersburg
Country
Russian Federation
Facility Name
First Pavlov State Medical University
City
Saint Petersburg
Country
Russian Federation
Facility Name
Mechnikov North-Western State Medical University
City
Saint Petersburg
Country
Russian Federation
Facility Name
St. Elizabeth City Hospital
City
Saint Petersburg
Country
Russian Federation
Facility Name
Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
St Mark's Hospital
City
Harrow
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27988142
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease
We'll reach out to this number within 24 hrs