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

Phase 3

Terminated

Conditions: Crohn's Disease

Interventions: Drug: Filgotinib
Drug: Placebo

Registration Number: NCT02914600

Lead Sponsor: Galapagos NV

Brief Summary: The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1188

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 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
Female participants 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 concomitant medications as outlined in the study protocol

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Filgotinib 100 mg	Filgotinib	Participants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg. Male participants from the US \& Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).
Filgotinib 200 mg	Filgotinib	Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg. Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).
Placebo	Placebo	Participants who received placebo and completed the parent study, continued to receive placebo in this extension study. After unblinding of the parent study, participants on placebo treatment discontinued study drug and study participation. Treatment was administered orally once a day until unblinding of the parent study (up to 308 weeks).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	From the First Dose to Week 312	An AE was defined as any untoward medical occurrence in a participant administered a study drug, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug * Any AEs leading to premature discontinuation of study drug.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools	Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300	The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of liquid or very soft stools were summed over the 7 days prior to each visit. The remaining predictors were also weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Change from baseline for number of liquid or very soft stool per day was reported.
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain	Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300	The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Change from baseline in abdominal pain was reported.
Change From Baseline in CDAI Scores	Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300	The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

Trial Locations

Locations (484): Digestive Health Specialists Of The Southeast
🇺🇸
Dothan, Alabama, United States
Arizona Digestive Health - Sun City
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Sun City, Arizona, United States
Southern California Research Center, Inc.
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Coronado, California, United States
Cedars Sinai Medical Center
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Los Angeles, California, United States
Inland Empire Clinical Trials, LLC
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Rialto, California, United States
UC San Diego Health Systems
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San Diego, California, United States
Kaiser Permanente
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San Francisco, California, United States
Clearview Medical Research, LLC
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Santa Clarita, California, United States
University of Colorado Denver and Hospital
🇺🇸
Aurora, Colorado, United States
South Denver Gastroenterology, PC
🇺🇸
Lone Tree, Colorado, United States
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Digestive Health Specialists Of The Southeast
🇺🇸Dothan, Alabama, United States