Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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14 March 2022 |
Main ID: |
EUCTR2016-001367-36-BG |
Date of registration:
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12/12/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease
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Scientific title:
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Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease |
Date of first enrolment:
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23/03/2017 |
Target sample size:
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1320 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001367-36 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Combined induction and maintenance phase study design If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belarus
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Belgium
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Brazil
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Bulgaria
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Canada
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Croatia
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Czech Republic
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Czechia
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France
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Georgia
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Germany
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Greece
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Hong Kong
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Hungary
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Iceland
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India
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Ireland
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Israel
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Italy
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Japan
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Korea, Republic of
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Malaysia
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Mexico
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Netherlands
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New Zealand
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Norway
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Singapore
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Slovakia
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South Africa
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Spain
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Sri Lanka
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Sweden
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Switzerland
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Taiwan
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials Information Desk
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Address:
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Generaal De Wittelaan L11 A3
2800
Mechelen
Belgium |
Telephone:
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+3215342900 |
Email:
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medicalinfo@glpg.com |
Affiliation:
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Galapagos NV |
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Name:
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Clinical Trials Information Desk
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Address:
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Generaal De Wittelaan L11 A3
2800
Mechelen
Belgium |
Telephone:
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+3215342900 |
Email:
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medicalinfo@glpg.com |
Affiliation:
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Galapagos NV |
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Key inclusion & exclusion criteria
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Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in either the Cohort A or B Induction Study.
• Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures
• Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
• Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline
• Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
• Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum
• Moderately or severely active CD
• Meet one of the protocol specified tuberculosis (TB) screening criteria
• May be receiving the following drugs (subjects on these therapies should be willing to remain on stable doses for the times noted in the protocol)
- Oral 5-aminosalicylate (5-ASA) compounds
- Azathioprine or 6-mercaptopurine (6-MP) or methotrexate (MTX)
- Oral corticosteroid therapy
- Antibiotics for the treatment of CD
• Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose
• Must be up to date on colorectal cancer screening and surveillance as standard of care according to local guidelines
Biologic-Naïve subjects must meet all of the additional inclusion criteria to be eligible for Cohort A
• Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least one of the following agents (depending on current country treatment recommendations/guidelines):
- Corticosteroids
- Immunomodulators
Biologic-Experienced subjects must meet all of the additional inclusion criteria to be eligible for Cohort A.
• Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least one of the following agents (depending on current country treatment recommendations/guidelines) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response, or intolerance:
- TNFa Antagonists
- Vedolizumab
- Ustekinumab
Subjects must meet all of the additional inclusion criteria to be eligible for participation in Cohort B induction study.
• Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least one of the following agents (depending on current country treatment recommendations/guidelines):
- TNFa Antagonists
- Vedolizumab
- Ustekinumab
Subjects must meet all of the following inclusion criteria to be eligible for participation in the Maintenance Study.
• Completion of Cohort A or B induction study with either clinical remission by PRO2 or endoscopic response at Week 10
• Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose
• May be on oral corticosteroid therapy (prednisone prescribed at a stable dose = 30 mg/day or budesonide at a dose of = 9 mg/day); dose must remain stable to Week 14 longer Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1214 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 106
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in either the Cohort A or B induction study
•Pregnant or lactating females
•Males and females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods
•Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting
•Male subjects unwilling to refrain from sperm donation during the study and for at least 90 days after the last dose of study drug
•Known hypersensitivity to filgotinib its metabolites, or formulation excipients
•Currently have complications of CD
•Have any current or prior abscesses
•History of major surgery or trauma within 30 days prior to screening
•Presence of UC, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
•History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
•Dependence on parenteral nutrition
•History or evidence of incompletely resected colonic mucosal dysplasia
•Stool sample positive for C. diff toxin, pathogenic E. coli, Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp
•Stool sample positive for O&P unless approved by the medical monitor
•Active clinically significant infection or any infection requiring hospitalization or treatment with intravenous anti-infectives within 30 days of screening (or 8 weeks of Day 1); or any infection requiring oral anti-infective therapy within 2 weeks of screening (or 6 weeks of Day 1)
•Infection with HIV, HBV or HCV
•Presence of Child-Pugh Class C hepatic impairment
•Active TB or history of latent TB that has not been treated
•History of malignancy within the last 5 years except for subjects who have been treated or resected for non-melanoma skin cancer or cervical carcinoma in situ
•History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder or multiple myeloma
•History of treatment with lymphocyte-depleting therapies, including but not limited to alemtuzumab, cyclophosphamide, total lymphoid radiation and rituximab
•History of cytapheresis = 2 months prior to screening
•Use of any prohibited concomitant medications as described in the protocol
•Any chronic medical condition or psychiatric problem that, in the opinion of the Investigator or Sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol
•Administration of a live or attenuated vaccine within 30 days of randomization
•History of opportunistic infection or immunodeficiency syndrome
•Currently on any chronic systemic anti-infective therapy for chronic infection
•History of disseminated Staphylococcus aureus
•History of symptomatic herpes zoster or herpes simplex within 12 weeks of screening, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster or central nervous system zoster
Biologic-Naïve subjects who meet any of the following exclusion criteria are not eligible for Cohort A
•Prior or current use of TNFa antagonist, including (but not limited to) infliximab, adalimumab, golimumab, certolizumab or biosimilar agent
•Prior or current use of vedolizumab
•Prior or current use of ustekinumab
Biologic-Experienced subjects who meet the following exclusion criterion are not eligible for Cohort A
•Have used any TNFa antagonist or vedolizumab = 8 weeks prior to screening, ustekinum
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0
Level: LLT
Classification code 10013099
Term: Disease Crohns
System Organ Class: 100000004856
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Intervention(s)
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Product Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: The EU-specific primary objectives of Cohort A Induction Study are: • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by Patient Reported Outcomes (PRO2) at Week 10 • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 10
The EU-specific primary objectives of Cohort B Induction Study are: • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by PRO2 at Week 10 • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 10
The EU-specific primary objectives of the Maintenance Study are: • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by PRO2 at Week 58 • To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response at Week 58
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Timepoint(s) of evaluation of this end point: Week 10 and Week 58
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Primary end point(s): The EU-specific primary endpoints for the Cohort A Induction Study are: • The proportion of subjects achieving clinical remission by PRO2 at Week 10 • The proportion of subjects achieving endoscopic response at Week 10
The EU-specific primary endpoints for the Cohort B Induction Study are: • The proportion of subjects achieving clinical remission by PRO2 at Week 10 • The proportion of subjects achieving endoscopic response at Week 10
The EU-specific primary endpoints for the Maintenance Study are: • The proportion of subjects achieving clinical remission by PRO2 at Week 58 • The proportion of subjects achieving endoscopic response at Week 58
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Secondary Objective: EU-specific key secondary objectives of both Cohort A Induction Study & Cohort B Induction Study: • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by Crohn's Disease Activity Index (CDAI) at Wk10 • To evaluate the efficacy of filgotinib as compared to placebo in establishing both clinical remission by PRO2 score & endoscopic response at Wk10 EU-specific key secondary objectives of the Maintenance Study: • To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by CDAI at Week 58 • To evaluate the efficacy of filgotinib as compared to placebo in establishing sustained clinical remission by PRO2 at Weeks 10 & 58 • To evaluate the efficacy of filgotinib as compared to placebo in establishing both clinical remission by PRO2 & endoscopic response at Week 58 • To evaluate the efficacy of filgotinib as compared to placebo in establishing 6-month corticosteroid-free remission by PRO2 at Week 58
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Secondary Outcome(s)
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Secondary end point(s): Cohort A Induction Study
The EU-specific key secondary endpoints for the Cohort A Induction Study are:
• The proportion of subjects achieving clinical remission by CDAI at Week 10
• The proportion of subjects achieving both clinical remission by PRO2 and endoscopic response (combined into a single endpoint on a patient level) at Week 10
The EU-specific key secondary endpoints for the Cohort B Induction Study are:
The key secondary endpoints are:
• The proportion of subjects achieving clinical remission by CDAI at Week 10
• The proportion of subjects achieving both clinical remission by PRO2 and endoscopic response (combined into a single endpoint on a patient level) at Week 10
The EU-specific key secondary endpoints for the Maintenance Study are:
The key secondary endpoints are:
• The proportion of subjects achieving clinical remission by CDAI at Week 58
• The proportion of subjects achieving sustained clinical remission by PRO2 at Weeks 10 and 58
• The proportion of subjects achieving both clinical remission by PRO2 and endoscopic response (combined into a single endpoint on a patient level) at Week 58
• The proportion of subjects achieving 6 month corticosteroid-free remission by PRO2 at Week 58
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Timepoint(s) of evaluation of this end point: Week 10 and Week 58
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Secondary ID(s)
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2016-001367-36-HU
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GS-US-419-3895
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Source(s) of Monetary Support
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Galapagos NV
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Ethics review
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Status: Approved
Approval date: 24/02/2017
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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