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EUCTR2016-001367-36

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn?s Disease

Datenbasis: WHO (Import vom 29.03.2024)
Geändert: 25.08.2023, 01:00
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Moderately to Severely Active Crohn?s Disease (CD)
MedDRA version: 20.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Interventions (Datenquelle: WHO)


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

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Gender:
Female: yes
Male: yes

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-Na?ve 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
? Must not have used any TNFa antagonist or vedolizumab = 8 weeks prior to screening, ustekinumab IV or SC = 12 weeks prior to screening, or any other biologic agent = 8 weeks prior to screening or within 5 times the half-life of the biologic agent prior to screening, whichever is longer

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
? Must not have used any TNFa antagonist or vedolizumab = 8 weeks prior to screening, ustekinumab IV or SC = 12 weeks prior to screening, or any other biologic agent = 8 weeks prior to screening or within 5 times the half-life of the biologic agent prior to screening, whichever is longer

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 eithe
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 for the purpose of current or future fertilization during the course of the study and up to 35 days after the last dose of the study drug
?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
?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
?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, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic
zoster or central nervous system zoster

Biologic-Na?ve subjects who meet any of the following exclusion criteria are not eligible for Cohort A.
?Prior or current use of:
-TNFa antagonist including infliximab, adalimumab, golimumab, certolizumab or biosimilar agent
-Vedolizumab
-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, ustekinumab IV or SC = 12 weeks prior to screening, or any other biologic agent = 8 weeks prior to screening or within

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2016-001367-36
Weitere Informationen zur Studie

Datum der Studienregistrierung

27.12.2016

Einschluss der ersten teilnehmenden Person

27.03.2017

Rekrutierungsstatus

Not Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

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

Studientyp (Datenquelle: WHO)

Interventional clinical trial of medicinal product

Design der Studie (Datenquelle: WHO)

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

Phase (Datenquelle: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primäre Endpunkte (Datenquelle: WHO)

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;Secondary Objective: EU- specific key secondary objectives of both Cohort A Induction Study & Cohort B Induction Study are:
? 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 are:
? To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical remission by CDAI at Wk58
? To evaluate the efficacy of filgotinib as compared to placebo in establishing sustained clinical remission by PRO2 at Wks 10&58
? To evaluate the efficacy of filgotinib as compared to placebo in establishing both clinical remission by PRO2 & endoscopic response at Wk58
? To evaluate the efficacy of filgotinib as compared to placebo in establishing 6-month corticosteroid-free remission by PRO2 at Wk58;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;Timepoint(s) of evaluation of this end point: Week 10 and Week 58

Sekundäre Endpunkte (Datenquelle: WHO)

Secondary end point(s): 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 Cohort B 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 Maintenance Study 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;Timepoint(s) of evaluation of this end point: Week 10 and Week 58

Kontakt für Auskünfte (Datenquelle: WHO)

Galapagos NV

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

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

Link zu den Ergebnissen im Primärregister

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Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Czechia, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Clinical Trials Information Desk
Generaal De Wittelaan L11 A3
Galapagos NV
+3215342900
medicalinfo@glpg.com

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Clinical Trials Information Desk
Generaal De Wittelaan L11 A3
Galapagos NV
+3215342900
medicalinfo@glpg.com

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

GS-US-419-3895
2016-001367-36-HU
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