Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT02914600
• Date of registration: 22/09/2016
• Prospective Registration: Yes
• Primary sponsor: Galapagos NV
• Public title: Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease DIVERSITYLTE
• Scientific title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease
• Date of first enrolment: March 17, 2017
• Target sample size: 1188
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT02914600
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

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, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Galapagos Study Director
• Affiliation: Galapagos NV

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Must have the ability to understand and sign a written informed consent form (ICF),
which must be obtained prior to initiation of study procedures associated with this
trial

- Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or
GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for
CD

- Females of childbearing potential must have a negative pregnancy test at Day 1

- Female subjects of childbearing potential who engage in heterosexual intercourse must
agree to use protocol specified method(s) of contraception for the duration described
in the protocol

- Willingness to refrain from live or attenuated vaccines during the study and for 12
weeks after last dose of study drug

- Must have completed all required procedures or met protocol specified efficacy
discontinuation criteria in a prior filgotinib treatment study for CD

Key Exclusion Criteria:

- Known hypersensitivity to the study drug

- Any chronic medical condition (including, but not limited to, cardiac or pulmonary
disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor,
would make the individual unsuitable for the study or would prevent compliance with
the study protocol

- Females of reproductive potential who are unwilling to abide by protocol-specified
contraceptive methods as defined in the protocol

- Use of prohibited medications as outlined in the study protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Filgotinib

Drug: Placebo

Primary Outcome(s)

Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests [Time Frame: Up to 390 weeks plus 30 days]

Secondary Outcome(s)

Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores [Time Frame: Baseline and up to 390 weeks]

Change from Baseline in PRO2 Scores [Time Frame: Baseline and up to 390 weeks]

Secondary ID(s)

GS-US-419-3896

2016-002763-34

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gilead Sciences