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

• Register: EUCTR
• Last refreshed on: 5 January 2021
• Main ID: EUCTR2016-001367-36-GB
• Date of registration: 19/12/2016
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences, Inc.
• Public title: A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease
• Scientific title: 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: 04/01/2017
• Target sample size: 1320
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001367-36
• Study type: Interventional clinical trial of medicinal product
• Study design: 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: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical Trials Mailbox
• Affiliation: Gilead Sciences International Ltd.

• Name: Clinical Trials Mailbox
• Affiliation: Gilead Sciences International Ltd.

Key inclusion & exclusion criteria

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 must 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 participation in Cohort A 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):
- 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
Exclusion criteria:
Due to exceeding the character limit, please see the protocol for a full list of principal exclusion criteria.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856

Intervention(s)

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

Primary Outcome(s)

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

Primary end point(s): The EU-specific primary endpoints for the Cohort A Induction Study
• 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
• 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
• The proportion of subjects achieving clinical remission by PRO2 at Week 58
• The proportion of subjects achieving 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 Week 10
• To evaluate the efficacy of filgotinib as compared to placebo in establishing both clinical remission by PRO2 score & endoscopic response at Week 10

EU-specific objectives of the Maintenance Study are:
• 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

Timepoint(s) of evaluation of this end point: Week 10 and Week 58

Secondary Outcome(s)

Secondary end point(s): The EU-specific key secondary endpoints for the Cohort A Induction Study
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 Cohort B Induction Study
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
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

Timepoint(s) of evaluation of this end point: Week 10 and Week 58

Secondary ID(s)

2016-001367-36-HU

GS-US-419-3895

Source(s) of Monetary Support

Gilead Sciences, Inc.

Ethics review

Status: Approved
Approval date: 04/01/2017
Contact: