Trial Outcomes & Findings for Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis (NCT NCT03926195)

NCT ID: NCT03926195

Last Updated: 2024-04-30

Results Overview

Baseline for sperm/semen parameters was the mean of 2 evaluable semen samples at screening. The normal range for sperm concentration is ≥15 million sperms/mL. Percentage change = (\[mean at Week 13 - baseline\] / baseline) × 100; value at Week 13 was the mean of 2 evaluable samples collected at Week 13.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 109 participants
• Primary outcome timeframe: Baseline to Week 13
• Results posted on: 2024-04-30

Participant Flow

Participants were enrolled at study sites in Bulgaria, Czech Republic, Estonia, Georgia, Latvia, Poland, Spain, and Ukraine. The first participant was screened on 28 May 2019. A total of 308 participants were screened of which 109 participants were randomized into the study.

There were 3 distinct parts to the study: 1) Double-Blind Treatment Phase (DB Phase; Day 1 through the Week 13 study visit); 2) Extension Phase (EXT Phase; after the Week 13 study visit and up to Week 156); and 3) Monitoring Phase (up to 52 weeks).

Participant milestones

Measure	Filgonitib Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.
DB Treatment Phase (Through Week 13) STARTED	54	55
DB Treatment Phase (Through Week 13) COMPLETED	54	53
DB Treatment Phase (Through Week 13) NOT COMPLETED	0	2
EXT Phase (Through Week 156) STARTED	46	49
EXT Phase (Through Week 156) COMPLETED	24	26
EXT Phase (Through Week 156) NOT COMPLETED	22	23
Monitoring Phase (52 Weeks) STARTED	27	21
Monitoring Phase (52 Weeks) COMPLETED	27	20
Monitoring Phase (52 Weeks) NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Filgonitib Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.
DB Treatment Phase (Through Week 13) Withdrawal by Subject	0	2
EXT Phase (Through Week 156) Adverse Event	5	1
EXT Phase (Through Week 156) Pre-Specified Decrease In Sperm Parameters	16	17
EXT Phase (Through Week 156) Withdrawal by Subject	1	3
EXT Phase (Through Week 156) Physician Decision	0	2
Monitoring Phase (52 Weeks) Withdrawal by Subject	0	1

Baseline Characteristics

Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis

Baseline characteristics by cohort

Measure	Filgonitib n=54 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=55 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Total n=109 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 8.5 • n=5 Participants	39 years STANDARD_DEVIATION 7.8 • n=7 Participants	40 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	55 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sperm Concentration	71.2 million sperms/milliliter (mL) STANDARD_DEVIATION 41.00 • n=5 Participants	66.9 million sperms/milliliter (mL) STANDARD_DEVIATION 38.72 • n=7 Participants	69.0 million sperms/milliliter (mL) STANDARD_DEVIATION 39.74 • n=5 Participants
Total Sperm Count	208.4 million sperms/ejaculate STANDARD_DEVIATION 136.94 • n=5 Participants	225.2 million sperms/ejaculate STANDARD_DEVIATION 137.39 • n=7 Participants	216.9 million sperms/ejaculate STANDARD_DEVIATION 136.79 • n=5 Participants
Sperm Total Motility	55.9 percentage of motile sperm STANDARD_DEVIATION 8.99 • n=5 Participants	58.2 percentage of motile sperm STANDARD_DEVIATION 8.48 • n=7 Participants	57.1 percentage of motile sperm STANDARD_DEVIATION 8.77 • n=5 Participants
Ejaculate Volume	3.1 mL STANDARD_DEVIATION 1.26 • n=5 Participants	3.5 mL STANDARD_DEVIATION 1.29 • n=7 Participants	3.3 mL STANDARD_DEVIATION 1.29 • n=5 Participants
Percent Normal Sperm Morphology	43 percentage of normal sperm STANDARD_DEVIATION 6.2 • n=5 Participants	43 percentage of normal sperm STANDARD_DEVIATION 6.0 • n=7 Participants	43 percentage of normal sperm STANDARD_DEVIATION 6.0 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 13

Population: The Semen Analysis Set included all randomized and treated (≥ 1 dose of double-blind study drug) participants who had 2 semen samples that were eligible for mean calculation at baseline and at the Week 13 analysis visit with the date of the first chronologic semen sample used for purposes of assigning analysis visit windows.

Baseline for sperm/semen parameters was the mean of 2 evaluable semen samples at screening. The normal range for sperm concentration is ≥15 million sperms/mL.

Percentage change = ([mean at Week 13 - baseline] / baseline) × 100; value at Week 13 was the mean of 2 evaluable samples collected at Week 13.

Outcome measures

Measure	Filgonitib n=54 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=53 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13	13.0 percentage of participants	7.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The Week 26 Semen Analysis Set included all participants treated (≥ 1 dose of open-label filgotinib or SOC in the extension phase) who had 2 evaluable samples at baseline and at Week 26.

Arthritis responder: For rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nrAxSpA), a participant with an improvement in the Physician's Global Assessment of Disease Activity (PhGADA) of at least 20% compared with baseline (Day 1) at the specified assessment time.

Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.

PhGADA: Physician measured the participant's disease severity on a visual analogue scale (VAS) ranged from 0 (no disease)-100 (worst disease) millimeters (mm).

Baseline value for sperm/semen parameters was the mean of 2 evaluable semen collections at the screening visit. The normal range for sperm concentration is ≥15 million sperms/mL.

Percentage change = ([mean at Week 26 - baseline] / baseline) × 100; value at Week 26 was the mean of 2 evaluable samples collected at Week 26.

Outcome measures

Measure	Filgonitib n=39 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=25 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) n=7 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) n=23 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26	10.3 percentage of participants	8.0 percentage of participants	14.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 13

Population: Participants in the Semen Analysis Set with available data were analyzed.

The normal range for sperm total motility is ≥40%.

Outcome measures

Measure	Filgonitib n=54 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=52 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Change From Baseline in Sperm Total Motility at Week 13	-2.3 percentage of motile sperms Interval -8.1 to 1.4	-1.7 percentage of motile sperms Interval -5.8 to 0.7	—	—

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Participants in the Week 26 Semen Analysis Set with available data were analyzed.

Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.

Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.

PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.

The normal range for sperm total motility is ≥40%.

Outcome measures

Measure	Filgonitib n=38 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=25 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) n=7 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) n=23 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Change From Baseline in Sperm Total Motility at Week 26	-2.4 percentage of motile sperms Interval -9.3 to 1.0	0.9 percentage of motile sperms Interval -5.2 to 6.3	-1.4 percentage of motile sperms Interval -13.3 to 13.0	-2.8 percentage of motile sperms Interval -8.5 to 2.9

SECONDARY outcome

Timeframe: Baseline, Week 13

Population: Participants in the Semen Analysis Set were analyzed.

The normal range for total sperm count is ≥ 39 million sperms/ejaculate.

Outcome measures

Measure	Filgonitib n=54 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=53 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Change From Baseline in Total Sperm Count at Week 13	-2.1 million sperms/ejaculate Interval -41.7 to 31.0	-9.6 million sperms/ejaculate Interval -36.2 to 18.0	—	—

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Participants in the Week 26 Semen Analysis Set were analyzed.

Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.

Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.

PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.

The normal range for total sperm count is ≥ 39 million sperms/ejaculate.

Outcome measures

Measure	Filgonitib n=39 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=25 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) n=7 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) n=23 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Change From Baseline in Total Sperm Count at Week 26	-0.2 million sperms/ejaculate Interval -39.5 to 44.5	16.8 million sperms/ejaculate Interval -49.3 to 60.6	32.2 million sperms/ejaculate Interval -60.8 to 121.3	-29.9 million sperms/ejaculate Interval -79.8 to 36.6

SECONDARY outcome

Timeframe: Baseline, Week 13

Population: Participants in the Semen Analysis Set were analyzed.

The normal range for sperm concentration is ≥15 million sperms/mL.

Outcome measures

Measure	Filgonitib n=54 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=53 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Change From Baseline in Sperm Concentration at Week 13	3.7 million sperms/mL Interval -7.2 to 13.1	-0.4 million sperms/mL Interval -6.1 to 7.8	—	—

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Participants in the Week 26 Semen Analysis Set were analyzed.

Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.

Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.

PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.

The normal range for sperm concentration is ≥15 million sperms/mL.

Outcome measures

Measure	Filgonitib n=39 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=25 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) n=7 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) n=23 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Change From Baseline in Sperm Concentration at Week 26	1.7 million sperms/mL Interval -8.9 to 21.2	9.6 million sperms/mL Interval -3.7 to 29.0	10.3 million sperms/mL Interval -43.5 to 36.3	-5.8 million sperms/mL Interval -12.9 to 4.6

SECONDARY outcome

Timeframe: Baseline, Week 13

Population: Participants in the Semen Analysis Set were analyzed.

The normal range for ejaculate volume is ≥1.5 mL.

Outcome measures

Measure	Filgonitib n=54 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=53 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Change From Baseline in Ejaculate Volume at Week 13	-0.3 mL Interval -0.6 to 0.1	-0.2 mL Interval -0.4 to 0.1	—	—

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Participants in the Week 26 Semen Analysis Set were analyzed.

Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.

Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.

PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.

The normal range for ejaculate volume is ≥1.5 mL.

Outcome measures

Measure	Filgonitib n=39 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=25 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) n=7 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) n=23 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Change From Baseline in Ejaculate Volume at Week 26	-0.2 mL Interval -0.7 to 0.4	-0.6 mL Interval -0.7 to -0.2	0.2 mL Interval -1.0 to 1.1	-0.3 mL Interval -0.6 to 0.2

SECONDARY outcome

Timeframe: Baseline, Week 13

Population: Participants in the Semen Analysis Set were analyzed.

The normal range for percent normal sperm morphology is ≥30% normal sperms.

Outcome measures

Measure	Filgonitib n=54 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=53 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Change From Baseline in Percent Normal Sperm Morphology at Week 13	1 percentage of normal sperms Interval -1.0 to 2.0	1 percentage of normal sperms Interval -1.0 to 3.0	—	—

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Participants in the Week 26 Semen Analysis Set were analyzed.

Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.

Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.

PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.

The normal range for percent normal sperm morphology is ≥30% normal sperms.

Outcome measures

Measure	Filgonitib n=39 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.	Placebo n=25 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.	Filgotinib/SOC (Nonresponder) n=7 Participants Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).	Placebo/SOC (Nonresponder) n=23 Participants Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).
Change From Baseline in Percent Normal Sperm Morphology at Week 26	1 percentage of normal sperms Interval -2.0 to 5.0	3 percentage of normal sperms Interval -2.0 to 8.0	3 percentage of normal sperms Interval -15.0 to 6.0	4 percentage of normal sperms Interval 1.0 to 8.0

Adverse Events

Double-Blind Phase: Filgotinib 200 mg

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Double-Blind Phase: Placebo

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Extension Phase: Placebo - SOC

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Extension Phase: Filgotinib 200 mg - SOC

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Extension Phase: Filgotinib 200 mg - OL Filgotinib 200 mg

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Double-Blind Phase: Filgotinib 200 mg n=54 participants at risk Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase.	Double-Blind Phase: Placebo n=55 participants at risk Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase.	Extension Phase: Placebo - SOC n=49 participants at risk At Week 13, participants were unblinded and started SOC treatment in the EXT phase, for up to approximately 143 weeks (until Week 156).	Extension Phase: Filgotinib 200 mg - SOC n=7 participants at risk At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase, for up to approximately 143 weeks (until Week 156).	Extension Phase: Filgotinib 200 mg - OL Filgotinib 200 mg n=39 participants at risk At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily in the EXT phase, for up to approximately 143 weeks (until Week 156).
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.0% 1/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.6% 1/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	4.1% 2/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Injury, poisoning and procedural complications Wound	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	1.8% 1/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Nervous system disorders Radiculopathy	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.6% 1/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Eye disorders Uveitis	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.6% 1/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.9% 1/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.6% 1/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.6% 1/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Musculoskeletal and connective tissue disorders Tenosynovitis	1.9% 1/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations Appendicitis	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations COVID-19 pneumonia	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.6% 1/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.

Other adverse events

Measure	Double-Blind Phase: Filgotinib 200 mg n=54 participants at risk Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase.	Double-Blind Phase: Placebo n=55 participants at risk Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase.	Extension Phase: Placebo - SOC n=49 participants at risk At Week 13, participants were unblinded and started SOC treatment in the EXT phase, for up to approximately 143 weeks (until Week 156).	Extension Phase: Filgotinib 200 mg - SOC n=7 participants at risk At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase, for up to approximately 143 weeks (until Week 156).	Extension Phase: Filgotinib 200 mg - OL Filgotinib 200 mg n=39 participants at risk At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily in the EXT phase, for up to approximately 143 weeks (until Week 156).
Gastrointestinal disorders Diarrhoea	1.9% 1/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.0% 1/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	5.1% 2/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Gastrointestinal disorders Splenic artery aneurysm	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Gastrointestinal disorders Toothache	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Renal and urinary disorders Renal aneurysm	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Immune system disorders Drug hypersensitivity	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Vascular disorders Hypertension	3.7% 2/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	3.6% 2/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.0% 1/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	5.1% 2/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Immune system disorders Seasonal allergy	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.6% 1/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Investigations Alanine aminotransferase increased	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	4.1% 2/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.6% 1/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Investigations Aspartate aminotransferase increased	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	4.1% 2/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	5.1% 2/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Nervous system disorders Headache	3.7% 2/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	1.8% 1/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	4.1% 2/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	5.1% 2/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Nervous system disorders Sciatica	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.0% 1/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Ear and labyrinth disorders External ear pain	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	1.9% 1/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.0% 1/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	7.7% 3/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	6.1% 3/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations COVID-19	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	20.4% 10/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	42.9% 3/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	15.4% 6/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations Herpes zoster disseminated	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations Latent tuberculosis	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.0% 1/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	7.7% 3/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations Nasopharyngitis	7.4% 4/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	7.3% 4/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	6.1% 3/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	57.1% 4/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	5.1% 2/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations Pharyngitis	3.7% 2/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	3.6% 2/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	4.1% 2/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	5.1% 2/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations Pyospermia	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations Respiratory tract infection	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	6.1% 3/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.6% 1/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations Rhinitis	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	6.1% 3/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations Upper respiratory tract infection	1.9% 1/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	6.1% 3/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	5.1% 2/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	1.8% 1/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	2.0% 1/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Metabolism and nutrition disorders Dyslipidaemia	3.7% 2/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	5.1% 2/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.
Metabolism and nutrition disorders Obesity	0.00% 0/54 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/55 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/49 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	14.3% 1/7 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.	0.00% 0/39 • From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE. The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.

Additional Information

Galapagos Medical Information

Galapagos NV

Phone: +32 15 342 900

Email: medicalinfo@glpg.com

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