Trial Outcomes & Findings for Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease (NCT NCT02914600)

Last Updated: 2024-07-10

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1188 participants

Primary outcome timeframe

From the First Dose to Week 312

Results posted on

2024-07-10

Participant Flow

Participants were enrolled at study sites in 37 countries: Australia, Austria, Belgium, Canada, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, the Netherlands, New-Zealand, Poland, Portugal, Republic of Korea, Romania, Russia, Serbia, Singapore, Slovakia, South-Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, the United Kingdom, and the United States (US).

Participants with Crohn's disease (CD), who had completed or met protocol-specified efficacy discontinuation criteria from previous parent studies (GS-US-419-4015 \[NCT03046056\], GS-US-419-4016 \[NCT03077412\] or GS-US-419-3895 \[GLPG0634-CL-309\] \[NCT02914561\]) were rolled-over to this long-term extension study. Sponsor decided not to pursue extension of filgotinib indication for CD, as GS-US-419-3895 did not meet the co-primary endpoint and decided to terminate this study prematurely.

Participant milestones

Participant milestones
Measure	Filgotinib 200 mg 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).	Filgotinib 100 mg 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).	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).
Overall Study STARTED	945	119	124
Overall Study Treated	944	119	124
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	945	119	124

Reasons for withdrawal

Reasons for withdrawal
Measure	Filgotinib 200 mg 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).	Filgotinib 100 mg 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).	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).
Overall Study Adverse Event	298	35	25
Overall Study Sponsors decision	287	41	12
Overall Study Withdrawal by Subject	158	20	18
Overall Study Investigators discretion	169	14	13
Overall Study Lost to Follow-up	10	4	0
Overall Study Pregnancy	8	0	0
Overall Study Protocol Violation	5	3	0
Overall Study Non-compliance with study drug	6	1	0
Overall Study Death	3	1	1
Overall Study Current Study Unblinded and participant confirmed on Placebo	0	0	55
Overall Study Enrolled but not treated	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Filgotinib 200 mg n=944 Participants 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).	Filgotinib 100 mg n=119 Participants 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).	Placebo n=124 Participants 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).	Total n=1187 Participants Total of all reporting groups
Age, Continuous	39 years STANDARD_DEVIATION 13.60 • n=5 Participants	47 years STANDARD_DEVIATION 13.28 • n=7 Participants	42 years STANDARD_DEVIATION 12.42 • n=5 Participants	40 years STANDARD_DEVIATION 13.6 • n=4 Participants
Sex: Female, Male Female	514 Participants n=5 Participants	33 Participants n=7 Participants	56 Participants n=5 Participants	603 Participants n=4 Participants
Sex: Female, Male Male	430 Participants n=5 Participants	86 Participants n=7 Participants	68 Participants n=5 Participants	584 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	904 Participants n=5 Participants	112 Participants n=7 Participants	123 Participants n=5 Participants	1139 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	25 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	137 Participants n=5 Participants	18 Participants n=7 Participants	23 Participants n=5 Participants	178 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	31 Participants n=4 Participants
Race (NIH/OMB) White	739 Participants n=5 Participants	89 Participants n=7 Participants	96 Participants n=5 Participants	924 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	47 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	51 Participants n=4 Participants

PRIMARY outcome

Timeframe: From the First Dose to Week 312

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=944 Participants 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).	Filgotinib 100 mg n=119 Participants 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).	Placebo n=124 Participants 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).
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	820 Participants	103 Participants	96 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300

Population: Participants from safety analysis set with available data were analyzed.

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.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=911 Participants 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).	Filgotinib 100 mg n=113 Participants 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).	Placebo n=113 Participants 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).
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools Baseline	5.6 Number of liquid/very soft stools/day Standard Deviation 3.26	4.0 Number of liquid/very soft stools/day Standard Deviation 3.12	2.2 Number of liquid/very soft stools/day Standard Deviation 1.92
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools Change at Week 12	-1.6 Number of liquid/very soft stools/day Standard Deviation 2.71	-0.7 Number of liquid/very soft stools/day Standard Deviation 2.01	0.2 Number of liquid/very soft stools/day Standard Deviation 1.44
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools Change at Week 24	-1.8 Number of liquid/very soft stools/day Standard Deviation 2.89	-0.7 Number of liquid/very soft stools/day Standard Deviation 2.59	0.1 Number of liquid/very soft stools/day Standard Deviation 1.15
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools Change at Week 48	-2.0 Number of liquid/very soft stools/day Standard Deviation 3.14	-0.8 Number of liquid/very soft stools/day Standard Deviation 2.49	0.0 Number of liquid/very soft stools/day Standard Deviation 1.21
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools Change at Week 96	-2.2 Number of liquid/very soft stools/day Standard Deviation 3.11	-0.7 Number of liquid/very soft stools/day Standard Deviation 2.70	0.4 Number of liquid/very soft stools/day Standard Deviation 2.79
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools Change at Week 156	-2.4 Number of liquid/very soft stools/day Standard Deviation 3.14	-0.7 Number of liquid/very soft stools/day Standard Deviation 3.19	-0.2 Number of liquid/very soft stools/day Standard Deviation 1.63
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools Change at Week 216	-2.8 Number of liquid/very soft stools/day Standard Deviation 3.17	-1.2 Number of liquid/very soft stools/day Standard Deviation 4.10	1.0 Number of liquid/very soft stools/day Standard Deviation 1.41
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools Change at Week 264	-2.0 Number of liquid/very soft stools/day Standard Deviation 2.86	-4.8 Number of liquid/very soft stools/day Standard Deviation 6.18	—
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools Change at Week 300	0.0 Number of liquid/very soft stools/day Standard Deviation 2.71	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300

Population: Participants from safety analysis set with available data were analyzed.

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.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=911 Participants 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).	Filgotinib 100 mg n=113 Participants 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).	Placebo n=113 Participants 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).
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain Change at Week 24	-0.7 units on a scale Standard Deviation 0.92	-0.2 units on a scale Standard Deviation 0.75	0.0 units on a scale Standard Deviation 0.51
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain Baseline	1.6 units on a scale Standard Deviation 0.91	1.0 units on a scale Standard Deviation 0.89	0.7 units on a scale Standard Deviation 0.75
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain Change at Week 12	-0.6 units on a scale Standard Deviation 0.91	-0.2 units on a scale Standard Deviation 0.65	0.0 units on a scale Standard Deviation 0.52
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain Change at Week 48	-0.8 units on a scale Standard Deviation 0.97	-0.3 units on a scale Standard Deviation 0.70	-0.1 units on a scale Standard Deviation 0.54
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain Change at Week 96	-0.8 units on a scale Standard Deviation 1.00	-0.2 units on a scale Standard Deviation 0.73	0.0 units on a scale Standard Deviation 0.55
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain Change at Week 156	-0.8 units on a scale Standard Deviation 0.98	-0.2 units on a scale Standard Deviation 0.77	0.0 units on a scale Standard Deviation 0.57
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain Change at Week 216	-0.9 units on a scale Standard Deviation 1.05	-0.5 units on a scale Standard Deviation 0.88	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain Change at Week 264	-0.8 units on a scale Standard Deviation 0.64	-1.3 units on a scale Standard Deviation 0.50	—
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain Change at Week 300	-0.3 units on a scale Standard Deviation 0.50	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300

Population: Participants from safety analysis set with available data were analyzed.

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.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=897 Participants 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).	Filgotinib 100 mg n=110 Participants 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).	Placebo n=110 Participants 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).
Change From Baseline in CDAI Scores Baseline	280.5 units on a scale Standard Deviation 116.58	189.9 units on a scale Standard Deviation 112.73	120.4 units on a scale Standard Deviation 81.33
Change From Baseline in CDAI Scores Change at Week 12	-86.8 units on a scale Standard Deviation 114.02	-29.1 units on a scale Standard Deviation 79.84	4.2 units on a scale Standard Deviation 53.42
Change From Baseline in CDAI Scores Change at Week 24	-98.5 units on a scale Standard Deviation 122.68	-30.8 units on a scale Standard Deviation 92.92	5.7 units on a scale Standard Deviation 51.30
Change From Baseline in CDAI Scores Change at Week 48	-110.2 units on a scale Standard Deviation 125.08	-40.9 units on a scale Standard Deviation 91.47	0.6 units on a scale Standard Deviation 49.32
Change From Baseline in CDAI Scores Change at Week 96	-118.6 units on a scale Standard Deviation 131.49	-23.3 units on a scale Standard Deviation 91.94	11.0 units on a scale Standard Deviation 69.29
Change From Baseline in CDAI Scores Change at Week 156	-121.4 units on a scale Standard Deviation 132.33	-33.5 units on a scale Standard Deviation 99.15	0.3 units on a scale Standard Deviation 59.27
Change From Baseline in CDAI Scores Change at Week 216	-137.0 units on a scale Standard Deviation 147.14	-57.5 units on a scale Standard Deviation 121.12	2.5 units on a scale Standard Deviation 37.76
Change From Baseline in CDAI Scores Change at Week 264	-134.8 units on a scale Standard Deviation 128.86	-171.5 units on a scale Standard Deviation 141.81	—
Change From Baseline in CDAI Scores Change at Week 300	-32.5 units on a scale Standard Deviation 92.99	—	—

Adverse Events

Filgotinib 200 mg

Serious events: 284 serious events

Other events: 697 other events

Deaths: 6 deaths

Filgotinib 100 mg

Serious events: 34 serious events

Other events: 89 other events

Deaths: 2 deaths

Placebo

Serious events: 20 serious events

Other events: 78 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Galapagos Medical Information

Galapagos NV

Phone: +3215342900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
Publication restrictions are in place

Restriction type: OTHER

Measure	Filgotinib 200 mg n=944 participants at risk 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).	Filgotinib 100 mg n=119 participants at risk 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).	Placebo n=124 participants at risk 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	1.5% 14/944 • Number of events 16 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
Vascular disorders Hypertension	4.2% 40/944 • Number of events 41 • From the First Dose to Week 312 Safety Analysis Set	6.7% 8/119 • Number of events 8 • From the First Dose to Week 312 Safety Analysis Set	2.4% 3/124 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set
General disorders Pyrexia	6.9% 65/944 • Number of events 94 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 4 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
General disorders Fatigue	3.7% 35/944 • Number of events 40 • From the First Dose to Week 312 Safety Analysis Set	4.2% 5/119 • Number of events 6 • From the First Dose to Week 312 Safety Analysis Set	3.2% 4/124 • Number of events 6 • From the First Dose to Week 312 Safety Analysis Set
General disorders Asthenia	2.1% 20/944 • Number of events 24 • From the First Dose to Week 312 Safety Analysis Set	0.84% 1/119 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Respiratory, thoracic and mediastinal disorders Cough	2.2% 21/944 • Number of events 23 • From the First Dose to Week 312 Safety Analysis Set	1.7% 2/119 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.2% 21/944 • Number of events 23 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/119 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Psychiatric disorders Anxiety	2.5% 24/944 • Number of events 26 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	2.4% 3/124 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set
Psychiatric disorders Insomnia	2.4% 23/944 • Number of events 24 • From the First Dose to Week 312 Safety Analysis Set	1.7% 2/119 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
Psychiatric disorders Depression	2.1% 20/944 • Number of events 20 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Investigations Mycobacterium tuberculosis complex test positive	1.3% 12/944 • Number of events 12 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/119 • From the First Dose to Week 312 Safety Analysis Set	4.0% 5/124 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set
Investigations Weight decreased	2.3% 22/944 • Number of events 22 • From the First Dose to Week 312 Safety Analysis Set	0.84% 1/119 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set	1.6% 2/124 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set
Injury, poisoning and procedural complications Procedural pain	0.32% 3/944 • Number of events 4 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
Injury, poisoning and procedural complications Meniscus injury	0.21% 2/944 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Injury, poisoning and procedural complications Arthropod bite	0.53% 5/944 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
Nervous system disorders Headache	8.4% 79/944 • Number of events 95 • From the First Dose to Week 312 Safety Analysis Set	3.4% 4/119 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set	8.9% 11/124 • Number of events 12 • From the First Dose to Week 312 Safety Analysis Set
Nervous system disorders Dizziness	2.8% 26/944 • Number of events 28 • From the First Dose to Week 312 Safety Analysis Set	0.84% 1/119 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Blood and lymphatic system disorders Lymphopenia	2.9% 27/944 • Number of events 34 • From the First Dose to Week 312 Safety Analysis Set	1.7% 2/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Blood and lymphatic system disorders Iron deficiency anaemia	2.3% 22/944 • Number of events 23 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/119 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
Blood and lymphatic system disorders Anaemia	6.5% 61/944 • Number of events 73 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	4.0% 5/124 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Constipation	2.2% 21/944 • Number of events 27 • From the First Dose to Week 312 Safety Analysis Set	4.2% 5/119 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set	4.0% 5/124 • Number of events 6 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Anal fistula	2.5% 24/944 • Number of events 31 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	4.0% 5/124 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Abdominal pain upper	2.5% 24/944 • Number of events 27 • From the First Dose to Week 312 Safety Analysis Set	1.7% 2/119 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Abdominal pain	9.9% 93/944 • Number of events 126 • From the First Dose to Week 312 Safety Analysis Set	12.6% 15/119 • Number of events 19 • From the First Dose to Week 312 Safety Analysis Set	12.1% 15/124 • Number of events 18 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Abdominal distension	1.8% 17/944 • Number of events 19 • From the First Dose to Week 312 Safety Analysis Set	4.2% 5/119 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Vomiting	7.1% 67/944 • Number of events 86 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	2.4% 3/124 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Rectal haemorrhage	1.1% 10/944 • Number of events 12 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Nausea	7.8% 74/944 • Number of events 83 • From the First Dose to Week 312 Safety Analysis Set	6.7% 8/119 • Number of events 8 • From the First Dose to Week 312 Safety Analysis Set	3.2% 4/124 • Number of events 6 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Gastrooesophageal reflux disease	2.3% 22/944 • Number of events 24 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Gastritis	1.7% 16/944 • Number of events 16 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Dyspepsia	3.1% 29/944 • Number of events 31 • From the First Dose to Week 312 Safety Analysis Set	1.7% 2/119 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set	2.4% 3/124 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Diarrhoea	5.7% 54/944 • Number of events 66 • From the First Dose to Week 312 Safety Analysis Set	8.4% 10/119 • Number of events 13 • From the First Dose to Week 312 Safety Analysis Set	8.9% 11/124 • Number of events 12 • From the First Dose to Week 312 Safety Analysis Set
Gastrointestinal disorders Crohn's disease	22.2% 210/944 • Number of events 269 • From the First Dose to Week 312 Safety Analysis Set	21.8% 26/119 • Number of events 36 • From the First Dose to Week 312 Safety Analysis Set	16.1% 20/124 • Number of events 22 • From the First Dose to Week 312 Safety Analysis Set
Hepatobiliary disorders Cholelithiasis	0.53% 5/944 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Skin and subcutaneous tissue disorders Rash	2.9% 27/944 • Number of events 29 • From the First Dose to Week 312 Safety Analysis Set	5.9% 7/119 • Number of events 7 • From the First Dose to Week 312 Safety Analysis Set	1.6% 2/124 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set
Skin and subcutaneous tissue disorders Dermatitis contact	0.21% 2/944 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Renal and urinary disorders Nephrolithiasis	1.2% 11/944 • Number of events 11 • From the First Dose to Week 312 Safety Analysis Set	5.9% 7/119 • Number of events 9 • From the First Dose to Week 312 Safety Analysis Set	1.6% 2/124 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set
Musculoskeletal and connective tissue disorders Muscle spasms	1.6% 15/944 • Number of events 18 • From the First Dose to Week 312 Safety Analysis Set	3.4% 4/119 • Number of events 4 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.42% 4/944 • Number of events 4 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
Musculoskeletal and connective tissue disorders Back pain	4.6% 43/944 • Number of events 53 • From the First Dose to Week 312 Safety Analysis Set	3.4% 4/119 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 82/944 • Number of events 103 • From the First Dose to Week 312 Safety Analysis Set	12.6% 15/119 • Number of events 24 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Urinary tract infection	6.0% 57/944 • Number of events 82 • From the First Dose to Week 312 Safety Analysis Set	6.7% 8/119 • Number of events 14 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Upper respiratory tract infection	6.0% 57/944 • Number of events 84 • From the First Dose to Week 312 Safety Analysis Set	6.7% 8/119 • Number of events 9 • From the First Dose to Week 312 Safety Analysis Set	2.4% 3/124 • Number of events 4 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Sinusitis	3.2% 30/944 • Number of events 35 • From the First Dose to Week 312 Safety Analysis Set	5.9% 7/119 • Number of events 9 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Pharyngitis	1.9% 18/944 • Number of events 22 • From the First Dose to Week 312 Safety Analysis Set	0.84% 1/119 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set	2.4% 3/124 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Oral herpes	1.5% 14/944 • Number of events 19 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 4 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Anal abscess	1.7% 16/944 • Number of events 22 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	1.6% 2/124 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Bronchitis	3.2% 30/944 • Number of events 37 • From the First Dose to Week 312 Safety Analysis Set	4.2% 5/119 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set	1.6% 2/124 • Number of events 4 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations COVID-19	13.5% 127/944 • Number of events 139 • From the First Dose to Week 312 Safety Analysis Set	14.3% 17/119 • Number of events 17 • From the First Dose to Week 312 Safety Analysis Set	7.3% 9/124 • Number of events 10 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Gastroenteritis	2.8% 26/944 • Number of events 29 • From the First Dose to Week 312 Safety Analysis Set	3.4% 4/119 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Herpes zoster	2.3% 22/944 • Number of events 22 • From the First Dose to Week 312 Safety Analysis Set	0.84% 1/119 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Influenza	2.9% 27/944 • Number of events 31 • From the First Dose to Week 312 Safety Analysis Set	3.4% 4/119 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set	3.2% 4/124 • Number of events 6 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Latent tuberculosis	1.5% 14/944 • Number of events 14 • From the First Dose to Week 312 Safety Analysis Set	1.7% 2/119 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set	3.2% 4/124 • Number of events 4 • From the First Dose to Week 312 Safety Analysis Set
Infections and infestations Nasopharyngitis	8.6% 81/944 • Number of events 101 • From the First Dose to Week 312 Safety Analysis Set	10.9% 13/119 • Number of events 21 • From the First Dose to Week 312 Safety Analysis Set	4.8% 6/124 • Number of events 6 • From the First Dose to Week 312 Safety Analysis Set
Metabolism and nutrition disorders Folate deficiency	1.4% 13/944 • Number of events 14 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 5 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
Metabolism and nutrition disorders Hyperlipidaemia	0.32% 3/944 • Number of events 3 • From the First Dose to Week 312 Safety Analysis Set	3.4% 4/119 • Number of events 4 • From the First Dose to Week 312 Safety Analysis Set	0.00% 0/124 • From the First Dose to Week 312 Safety Analysis Set
Metabolism and nutrition disorders Hypokalaemia	2.3% 22/944 • Number of events 24 • From the First Dose to Week 312 Safety Analysis Set	2.5% 3/119 • Number of events 4 • From the First Dose to Week 312 Safety Analysis Set	1.6% 2/124 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set
Metabolism and nutrition disorders Hypophosphataemia	3.2% 30/944 • Number of events 35 • From the First Dose to Week 312 Safety Analysis Set	0.84% 1/119 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set	0.81% 1/124 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set
Metabolism and nutrition disorders Iron deficiency	2.2% 21/944 • Number of events 23 • From the First Dose to Week 312 Safety Analysis Set	0.84% 1/119 • Number of events 1 • From the First Dose to Week 312 Safety Analysis Set	1.6% 2/124 • Number of events 2 • From the First Dose to Week 312 Safety Analysis Set