Trial Outcomes & Findings for A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care (NCT NCT03733444)

NCT ID: NCT03733444

Last Updated: 2022-07-29

Results Overview

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 781 participants
• Primary outcome timeframe: Baseline up to week 52
• Results posted on: 2022-07-29

Participant Flow

Participants with a centrally confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) were enrolled at 121 sites.

A total of 1431 participants were screened for the study, and 781 were randomized and 777 were treated.

Participant milestones

Measure	GLPG1690, 600 mg Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
Overall Study STARTED	260	262	259
Overall Study Treated	259	260	258
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	260	262	259

Reasons for withdrawal

Measure	GLPG1690, 600 mg Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
Overall Study Adverse Event	8	10	5
Overall Study Death	20	19	11
Overall Study Lost to Follow-up	3	0	1
Overall Study Lack of Efficacy	0	1	1
Overall Study Physician Decision	2	1	0
Overall Study Protocol Violation	2	1	0
Overall Study Protocol Specified Withdrawal Criteria Met	1	1	2
Overall Study Study Terminated by Sponsor	203	209	221
Overall Study Withdrawal by Subject	19	18	16
Overall Study Miscellaneous	1	0	1
Overall Study Not Treated	1	2	1

Baseline Characteristics

FAS population with available data.

Baseline characteristics by cohort

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Total n=777 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 7.2 • n=259 Participants	69.7 years STANDARD_DEVIATION 7.3 • n=260 Participants	70.6 years STANDARD_DEVIATION 6.6 • n=258 Participants	69.8 years STANDARD_DEVIATION 7.1 • n=777 Participants
Sex: Female, Male Female	50 Participants n=259 Participants	47 Participants n=260 Participants	49 Participants n=258 Participants	146 Participants n=777 Participants
Sex: Female, Male Male	209 Participants n=259 Participants	213 Participants n=260 Participants	209 Participants n=258 Participants	631 Participants n=777 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=259 Participants	34 Participants n=260 Participants	28 Participants n=258 Participants	94 Participants n=777 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	217 Participants n=259 Participants	215 Participants n=260 Participants	218 Participants n=258 Participants	650 Participants n=777 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=259 Participants	11 Participants n=260 Participants	12 Participants n=258 Participants	33 Participants n=777 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=259 Participants	1 Participants n=260 Participants	2 Participants n=258 Participants	5 Participants n=777 Participants
Race (NIH/OMB) Asian	72 Participants n=259 Participants	72 Participants n=260 Participants	68 Participants n=258 Participants	212 Participants n=777 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=259 Participants	0 Participants n=260 Participants	1 Participants n=258 Participants	2 Participants n=777 Participants
Race (NIH/OMB) Black or African American	2 Participants n=259 Participants	0 Participants n=260 Participants	1 Participants n=258 Participants	3 Participants n=777 Participants
Race (NIH/OMB) White	174 Participants n=259 Participants	178 Participants n=260 Participants	178 Participants n=258 Participants	530 Participants n=777 Participants
Race (NIH/OMB) More than one race	0 Participants n=259 Participants	1 Participants n=260 Participants	2 Participants n=258 Participants	3 Participants n=777 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=259 Participants	8 Participants n=260 Participants	6 Participants n=258 Participants	22 Participants n=777 Participants
Forced Vital Capacity	2775.66 Milliliter (mL) STANDARD_DEVIATION 823.17 • n=259 Participants • FAS population with available data.	2768.63 Milliliter (mL) STANDARD_DEVIATION 701.90 • n=260 Participants • FAS population with available data.	2749.54 Milliliter (mL) STANDARD_DEVIATION 785.10 • n=256 Participants • FAS population with available data.	2764.67 Milliliter (mL) STANDARD_DEVIATION 770.66 • n=775 Participants • FAS population with available data.

PRIMARY outcome

Timeframe: Baseline up to week 52

Population: Full Analysis Set

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Annual Rate of Decline in Forced Vital Capacity (FVC) up to Week 52	-173.8 mL/year Standard Error 18.04	-174.9 mL/year Standard Error 17.65	-176.6 mL/year Standard Error 17.74	—	—	—

SECONDARY outcome

Timeframe: Up to week 52

Population: Full Analysis Set

Disease progression was defined as the composite occurrence of more than or equal to (>=)10 percent (%) absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality. FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With Disease Progression Up to 52 Weeks	23.9 Percentage of participants	23.1 Percentage of participants	22.1 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 125)

Population: Full Analysis Set

Percentage of participants with respiratory related to hospitalization were reported in this measure.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS)	13.5 Percentage of participants	10.8 Percentage of participants	6.6 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52

Population: Full Analysis Set

SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight.

Domain scores = 100 * summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component

Total score = 100 * summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire

Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52	4.6 Score on a scale Standard Error 1.13	4.3 Score on a scale Standard Error 1.08	4.7 Score on a scale Standard Error 1.10	—	—	—

SECONDARY outcome

Timeframe: Baseline up to EoS (week 125)

Population: Full Analysis Set

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Annual Rate of Decline of FVC Until EoS	-179.5 mL/year Standard Error 15.96	-174.4 mL/year Standard Error 15.63	-182.4 mL/year Standard Error 15.72	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 125)

Population: Full Analysis Set

Disease progression was defined as the composite occurrence of >=10% absolute decline in percent predicted %FVC or all-cause mortality. FVC (in mL]) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With Disease Progression Until EoS	31.7 Percentage of participants	27.7 Percentage of participants	26.7 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 100

Population: Full Analysis Set

SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight.

Domain scores = 100 * summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component

Total score = 100 * summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire

Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 100	12.1 Score on a scale Interval 3.0 to 21.2	14.8 Score on a scale Interval 4.6 to 25.1	11.2 Score on a scale Interval 1.6 to 20.8	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 125)

Population: Full Analysis Set

Percentage of participants with all cause hospitalization was reported for this measure.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With All Cause Hospitalization Until EoS	20.8 Percentage of participants	18.8 Percentage of participants	14.0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 125)

Population: Full Analysis Set

Percentage of participants with respiratory related mortality until end of study were reported for this study.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With Respiratory Related Mortality Until EoS	5.8 Percentage of participants	4.2 Percentage of participants	1.6 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 125)

Population: Full Analysis Set

Percentage of Participants who were hospitalized for lung transplant were reported for this measure.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants Hospitalized for Non-Elective Lung Transplant Until EoS	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 125)

Population: Full Analysis Set

Percentage of participants with acute IPF exacerbation until end of study were reported for this measure.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation Until EoS	5.4 Percentage of participants	3.1 Percentage of participants	1.9 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 125)

Population: Full Analysis Set

Percentage of participants with all-cause mortality or hospitalization for non-elective lung transplant were reported for this measure.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With All Cause Mortality or Hospitalization for Non-elective Lung Transplant Until EoS	8.1 Percentage of participants	6.9 Percentage of participants	3.9 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 125)

Population: Full Analysis Set

Percentage of participants with all-cause mortality or hospitalization for qualifying for lung transplant were reported for this measure.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With All Cause Mortality, Hospitalization for Non-elective Lung Transplant or Hospitalization for Qualifying for Lung Transplant Until EoS	8.1 Percentage of participants	6.9 Percentage of participants	3.9 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 125)

Population: Full Analysis Set

Percentage of participants with all-cause mortality or respiratory related hospitalization that meets >=10% absolute decline in %FVC or respiratory-related hospitalization were reported for this measure.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With All-Cause Mortality or Hospitalization That Meets >=10% Absolute Decline in %FVC or Respiratory-Related Hospitalization Until EoS	16.6 Percentage of participants	12.7 Percentage of participants	8.9 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 125)

Population: Full Analysis Set

Percentage of participants with all-cause mortality or respiratory related hospitalization were reported for this measure.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With All-Cause Mortality or Respiratory-Related Hospitalizations Until EoS	16.6 Percentage of participants	12.7 Percentage of participants	8.9 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Week 52

Population: FAS with available data at specified time point.

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=127 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=137 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=131 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
FVC at Week 52	2707.73 mL Standard Error 66.096	2652.20 mL Standard Error 61.173	2654.66 mL Standard Error 73.437	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52

Population: FAS with available data at specified time point.

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=127 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=137 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=131 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Change From Baseline in FVC at Week 52	-153.78 mL Standard Error 21.291	-156.34 mL Standard Error 17.410	-177.39 mL Standard Error 21.349	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52

Population: FAS with available data at specified time point.

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=127 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=137 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=131 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percent Change From Baseline in FVC at Week 52	-5.71 Percent change Standard Error 0.770	-5.85 Percent change Standard Error 0.690	-6.42 Percent change Standard Error 0.807	—	—	—

SECONDARY outcome

Timeframe: Week 100

Population: FAS with available data at specified time point.

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=4 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=2 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=3 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
FVC at Week 100	2474.0 mL Standard Error 210.660	2897.50 mL Standard Error 613.500	2937.67 mL Standard Error 349.968	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 100

Population: FAS with available data at specified time point.

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=4 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=2 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=3 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Change From Baseline in FVC at Week 100	-328.58 mL Standard Error 123.456	134.0 mL Standard Error 3.000	-93.64 mL Standard Error 321.208	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 100

Population: FAS with available data at specified time point.

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=4 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=2 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=3 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percent Change From Baseline in FVC at Week 100	-11.75 Percent change Standard Error 4.481	5.07 Percent change Standard Error 1.012	-1.46 Percent change Standard Error 11.279	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52

Population: FAS with available data at specified time point.

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=127 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=137 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=131 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤5	94.5 Percentage of participants	94.2 Percentage of participants	96.2 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 100

Population: FAS with available data at specified time point

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=4 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=2 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=3 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: FVC Change Within ≤5	100 Percentage of participants	100 Percentage of participants	66.7 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52

Population: FAS with available data at specified time point.

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=127 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=137 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=131 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤10	98.4 Percentage of participants	100 Percentage of participants	99.2 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 100

Population: FAS with available data at specified time point.

FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Outcome measures

Measure	GLPG1690, 600 mg n=4 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=2 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=3 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: FVC Change Within ≤10	100 Percentage of participants	100 Percentage of participants	66.7 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to EoS (up to Week 125)

Population: Full Analysis Set

Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.

Outcome measures

Measure	GLPG1690, 600 mg n=259 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=258 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs TEAE	81.1 Percentage of participants	85.8 Percentage of participants	75.6 Percentage of participants	—	—	—
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Serious TEAE	24.7 Percentage of participants	24.2 Percentage of participants	16.3 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS with available data at specified time point,

Cough was evaluated using the LCQ. The LCQ is a 19-item questionnaire split into three domains: physical, psychological, and social. Scores were calculated by domain (range from 1 to 7) and then the total score was calculated by adding the individual domain score. Total score ranged from 3 to 21, with higher scores indicated a better health status.

Outcome measures

Measure	GLPG1690, 600 mg n=132 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=145 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=138 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Physical score: Change at Week 52	-0.187 Score on a scale Standard Deviation 0.857	-0.103 Score on a scale Standard Deviation 0.925	-0.219 Score on a scale Standard Deviation 1.087	—	—	—
Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Physical score: Change at Week 100	-0.463 Score on a scale Standard Deviation 0.825	-0.734 Score on a scale Standard Deviation 1.141	0.000 Score on a scale Standard Deviation 1.427	—	—	—
Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Psychological score: Change at Week 52	-0.205 Score on a scale Standard Deviation 1.004	-0.040 Score on a scale Standard Deviation 1.146	-0.260 Score on a scale Standard Deviation 1.215	—	—	—
Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Psychological score: Change at Week 100	-0.857 Score on a scale Standard Deviation 1.313	-0.518 Score on a scale Standard Deviation 1.426	0.206 Score on a scale Standard Deviation 1.136	—	—	—
Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Social score: Change at Week 52	-0.178 Score on a scale Standard Deviation 0.979	-0.028 Score on a scale Standard Deviation 1.122	-0.232 Score on a scale Standard Deviation 1.252	—	—	—
Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Social score: Change at Week 100	-0.450 Score on a scale Standard Deviation 1.039	-0.563 Score on a scale Standard Deviation 1.406	-0.139 Score on a scale Standard Deviation 1.888	—	—	—
Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Total score: Change at Week 52	-0.569 Score on a scale Standard Deviation 2.606	-0.171 Score on a scale Standard Deviation 2.884	-0.711 Score on a scale Standard Deviation 3.291	—	—	—
Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Total score: Change at Week 100	-1.770 Score on a scale Standard Deviation 3.038	-1.815 Score on a scale Standard Deviation 3.755	0.067 Score on a scale Standard Deviation 3.999	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS with available data at specified time point.

Cough was assessed using VAS score, ranged from 0 (no cough) to 100 millimeter (mm) (worst possible cough).

Outcome measures

Measure	GLPG1690, 600 mg n=131 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=144 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=138 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Changes From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Week 100 Change at Week 52	2.8 mm Standard Deviation 26.4	2.8 mm Standard Deviation 23.5	6.7 mm Standard Deviation 28.9	—	—	—
Changes From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Week 100 Change at Week 100	11.0 mm Standard Deviation 34.0	14.0 mm Standard Deviation 16.3	-9.7 mm Standard Deviation 18.0	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS with available data at specified time point.

Urge to Cough was assessed using VAS score, ranged from 0 (no urge to cough) to 100 mm (highest urge to cough).

Outcome measures

Measure	GLPG1690, 600 mg n=131 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=144 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=138 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Change From Baseline in Visual Analogue Score (VAS): Urge to Cough at Week 52 and Week 100 Change at Week 52	4.8 mm Standard Deviation 26.3	1.9 mm Standard Deviation 25.9	6.7 mm Standard Deviation 28.2	—	—	—
Change From Baseline in Visual Analogue Score (VAS): Urge to Cough at Week 52 and Week 100 Change at Week 100	8.7 mm Standard Deviation 27.4	5.0 mm Standard Deviation 17.1	-15.8 mm Standard Deviation 19.3	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS with available data at specified time point.

EuroQol outcome measurements was a printed 20 centimeter (cm) EQ visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) was marked by the participant (or, when necessary, their proxy) with the scale in view.

Outcome measures

Measure	GLPG1690, 600 mg n=133 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=146 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=139 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Changes From Baseline in EuroQOL 5-Dimensions Questionnaire at Week 52 and Week 100 Change at Week 52	-5.9 Score on a scale Standard Deviation 13.5	-6.1 Score on a scale Standard Deviation 15.3	-3.7 Score on a scale Standard Deviation 16.8	—	—	—
Changes From Baseline in EuroQOL 5-Dimensions Questionnaire at Week 52 and Week 100 Change at Week 100	-11.2 Score on a scale Standard Deviation 19.4	-11.6 Score on a scale Standard Deviation 20.1	-4.7 Score on a scale Standard Deviation 17.7	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS with available data at specified time point.

The King's Brief Interstitial Lung Disease questionnaire (K-BILD) was specifically developed to analyze the health status of participants with OLD, the questionnaire consists of of 15 items (assessed by participants on scale ranging from 1 to 7, where 1 and 7 represents worst and best health status). Items are compiled into 3 domains: breathlessness and activities (range: 0-21), psychological (range: 0-34), and chest symptoms (range: 0-8). To score the K-BILD, the Likert response scale weightings for individual items are combined and scores are transformed to a range of 0-100 by using logit values (higher scores indicate better health status).

Outcome measures

Measure	GLPG1690, 600 mg n=132 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=144 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=138 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Breathlessness and Activities Score: Change at Week 52	-2.876 Score on a scale Standard Deviation 14.375	-3.897 Score on a scale Standard Deviation 13.668	-2.414 Score on a scale Standard Deviation 15.146	—	—	—
Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Breathlessness and Activities Score: Change at Week 100	-8.530 Score on a scale Standard Deviation 10.854	-14.425 Score on a scale Standard Deviation 12.995	-1.411 Score on a scale Standard Deviation 19.779	—	—	—
Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Psychological Score: Change at Week 52	-3.508 Score on a scale Standard Deviation 14.858	-0.334 Score on a scale Standard Deviation 16.875	-1.769 Score on a scale Standard Deviation 15.757	—	—	—
Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Psychological Score: Change at Week 100	-4.170 Score on a scale Standard Deviation 14.095	1.337 Score on a scale Standard Deviation 22.141	0.778 Score on a scale Standard Deviation 17.225	—	—	—
Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Chest Symptoms Score: Change at Week 52	-4.213 Score on a scale Standard Deviation 17.865	-2.980 Score on a scale Standard Deviation 17.775	-5.159 Score on a scale Standard Deviation 18.986	—	—	—
Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Chest Symptoms Score: Change at Week 100	-4.760 Score on a scale Standard Deviation 16.485	-17.275 Score on a scale Standard Deviation 21.758	4.333 Score on a scale Standard Deviation 13.605	—	—	—
Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Total Score: Change at Week 52	-2.241 Score on a scale Standard Deviation 9.816	-1.397 Score on a scale Standard Deviation 10.030	-2.009 Score on a scale Standard Deviation 9.876	—	—	—
Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Total Score: Change at Week 100	-5.080 Score on a scale Standard Deviation 8.977	-6.125 Score on a scale Standard Deviation 14.278	-0.156 Score on a scale Standard Deviation 11.250	—	—	—

SECONDARY outcome

Timeframe: Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose

Population: Pharmacokinetic Analysis Set: All randomized participants who received at least one dose of IP and for whom evaluable PK data were available.

Area under the concentration time curve of ziritaxtestat was reported

Outcome measures

Measure	GLPG1690, 600 mg n=31 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=29 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=45 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib n=47 Participants Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone n=51 Participants Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone n=49 Participants Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Area Under The Concentration Time Curve of Ziritaxtestat	12058 Nanogram * milliliter per hour (ng*mL/h) Interval 10935.81 to 13180.19	43640 Nanogram * milliliter per hour (ng*mL/h) Interval 40056.29 to 47223.71	8006 Nanogram * milliliter per hour (ng*mL/h) Interval 7210.62 to 8801.38	36135 Nanogram * milliliter per hour (ng*mL/h) Interval 33155.43 to 39114.57	6570 Nanogram * milliliter per hour (ng*mL/h) Interval 6022.87 to 7117.13	24777 Nanogram * milliliter per hour (ng*mL/h) Interval 22452.09 to 27101.91

SECONDARY outcome

Timeframe: Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose

Population: Pharmacokinetic Analysis Set

Maximum Observed Plasma Concentration of Ziritaxtestat was reported.

Outcome measures

Measure	GLPG1690, 600 mg n=31 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=29 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=45 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib n=47 Participants Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone n=51 Participants Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone n=49 Participants Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Maximum Observed Plasma Concentration (Cmax) of Ziritaxtestat	968 Nanogram per milliliter (ng/mL) Interval 902.25 to 1033.75	3529 Nanogram per milliliter (ng/mL) Interval 3315.25 to 3742.75	638 Nanogram per milliliter (ng/mL) Interval 591.23 to 684.77	2822 Nanogram per milliliter (ng/mL) Interval 2648.77 to 2995.23	606 Nanogram per milliliter (ng/mL) Interval 566.13 to 645.87	2280 Nanogram per milliliter (ng/mL) Interval 2111.2 to 2448.8

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS with available data at specified time point.

The 6MWT depicts the total distance covered by a participant during 6 minutes walking.

Outcome measures

Measure	GLPG1690, 600 mg n=101 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=107 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=108 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Change From Baseline in Functional Exercise Capacity, Assessed by The 6-Minute Walk Test (6MWT) Distance, at Week 52 and Week 100 Change at Week 52	-14.47 Meter Standard Error 6.610	-36.33 Meter Standard Error 15.383	-22.58 Meter Standard Error 6.128	—	—	—
Change From Baseline in Functional Exercise Capacity, Assessed by The 6-Minute Walk Test (6MWT) Distance, at Week 52 and Week 100 Change at Week 100	—	—	-3.00 Meter	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52 and week 100

Population: FAS with available data at specified time point.

Change from baseline in diffusing capacity of the lung for carbon monoxide (percent predicted hemoglobin level corrected) was reported for this measure.

mmol/min/kPa: Millimole per minute per kilopascal

Outcome measures

Measure	GLPG1690, 600 mg n=97 Participants Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=111 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	Placebo n=104 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690 600 mg/Nintedanib Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 200 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;	GLPG1690 600 mg/Pirfenidone Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening;
Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) (Corrected for Hemoglobin [Hb]) at Week 52 and Week 100 Change at week 52	-0.307 mmol/min/kPa Standard Error 0.1004	-0.247 mmol/min/kPa Standard Error 0.1019	-0.394 mmol/min/kPa Standard Error 0.1104	—	—	—
Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) (Corrected for Hemoglobin [Hb]) at Week 52 and Week 100 Change at week 100	—	—	-1.323 mmol/min/kPa	—	—	—

Adverse Events

Placebo

Serious events: 42 serious events

Other events: 117 other events

Deaths: 12 deaths

GLPG1690, 600 mg

Serious events: 64 serious events

Other events: 141 other events

Deaths: 23 deaths

GLPG1690, 200 mg

Serious events: 63 serious events

Other events: 134 other events

Deaths: 21 deaths

Serious adverse events

Measure	Placebo n=258 participants at risk Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 600 mg n=259 participants at risk Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 participants at risk Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
Nervous system disorders Presyncope	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Vascular disorders Peripheral artery stenosis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Vascular disorders Hypertensive emergency	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Vascular disorders Peripheral artery thrombosis	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Vascular disorders Varicose vein	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.39% 1/258 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.39% 1/258 • Number of events 3 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal squamous cell carcinoma	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
General disorders Non-cardiac chest pain	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
General disorders Death	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
General disorders Pyrexia	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Investigations Lung diffusion test abnormal	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Investigations Oxygen saturation decreased	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Investigations SARS-CoV-2 test positive	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Investigations Scan myocardial perfusion abnormal	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Acute cardiac event	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Angina pectoris	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Acute myocardial infarction	0.78% 2/258 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 3 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Angina unstable	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Atrial fibrillation	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Aortic valve stenosis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Cardiac arrest	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Cardiac failure	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Cardiogenic shock	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Cardiac failure acute	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Cor pulmonale	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Coronary artery disease	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Myocardial infarction	0.78% 2/258 • Number of events 5 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 3 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Supraventricular tachycardia	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Cardiac disorders Right ventricular failure	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Blood and lymphatic system disorders Pancytopenia	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Blood and lymphatic system disorders Polycythaemia	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 4 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.39% 1/258 • Number of events 3 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 3 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 3 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Eosinophilic pneumonia	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Hypersensitivity pneumonitis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	4.3% 11/258 • Number of events 15 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	7.7% 20/259 • Number of events 32 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	6.5% 17/260 • Number of events 24 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.78% 2/258 • Number of events 3 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Gastroenteritis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	2.7% 7/259 • Number of events 12 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Nervous system disorders Cerebral haemorrhage	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Nervous system disorders Cerebrovascular accident	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Nervous system disorders Cerebral infarction	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Nervous system disorders Ischaemic stroke	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/259 • Number of events 3 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Nervous system disorders Parkinsonism	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Nervous system disorders Syncope	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Eye disorders Cataract	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 3 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Eye disorders Glaucoma	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Gastrointestinal disorders Abdominal pain	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Gastrointestinal disorders Colitis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Gastrointestinal disorders Abdominal pain upper	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Gastrointestinal disorders Duodenal ulcer perforation	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Gastrointestinal disorders Gastrointestinal haemorrhage	0.78% 2/258 • Number of events 4 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Gastrointestinal disorders Intestinal perforation	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Gastrointestinal disorders Pancreatitis acute	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Gastrointestinal disorders Sigmoid mesocolon hernia	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Hepatobiliary disorders Hyperplastic cholecystopathy	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Hepatobiliary disorders Gallbladder cholesterolosis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Renal and urinary disorders Autoimmune nephritis	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Renal and urinary disorders Hydronephrosis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Renal and urinary disorders Glomerulonephritis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Renal and urinary disorders Nephrolithiasis	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Renal and urinary disorders Renal cyst	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Renal and urinary disorders Renal colic	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Renal and urinary disorders Ureterolithiasis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Renal and urinary disorders Renal vasculitis	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Product Issues Device failure	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 3 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Metabolism and nutrition disorders Cachexia	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Appendicitis	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations COVID-19	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	1.5% 4/259 • Number of events 7 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	1.5% 4/260 • Number of events 9 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations COVID-19 pneumonia	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/260 • Number of events 4 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Clostridium difficile colitis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Erysipelas	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Influenza	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Peritonitis	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Liver abscess	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Pneumonia bacterial	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Pneumonia	0.78% 2/258 • Number of events 4 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	2.3% 6/259 • Number of events 11 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	1.9% 5/260 • Number of events 5 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Pneumonia influenzal	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Pyelonephritis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Respiratory tract infection	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Sepsis	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Urinary tract infection	0.39% 1/258 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/259 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Upper respiratory tract infection	0.00% 0/258 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.77% 2/259 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.38% 1/260 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Hepatobiliary disorders Cholecystitis acute	0.78% 2/258 • Number of events 2 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.39% 1/259 • Number of events 1 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	0.00% 0/260 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set

Other adverse events

Measure	Placebo n=258 participants at risk Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 600 mg n=259 participants at risk Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).	GLPG1690, 200 mg n=260 participants at risk Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
Investigations Weight decreased	3.1% 8/258 • Number of events 9 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	5.4% 14/259 • Number of events 16 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	3.5% 9/260 • Number of events 14 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Cough	8.5% 22/258 • Number of events 27 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	9.3% 24/259 • Number of events 32 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	7.7% 20/260 • Number of events 23 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	5.4% 14/258 • Number of events 17 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	9.3% 24/259 • Number of events 34 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	6.9% 18/260 • Number of events 21 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.5% 22/258 • Number of events 25 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	5.4% 14/259 • Number of events 14 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	4.6% 12/260 • Number of events 14 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Nervous system disorders Headache	5.8% 15/258 • Number of events 16 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	6.2% 16/259 • Number of events 19 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	5.4% 14/260 • Number of events 17 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Gastrointestinal disorders Diarrhoea	18.2% 47/258 • Number of events 89 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	28.6% 74/259 • Number of events 199 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	22.3% 58/260 • Number of events 104 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Gastrointestinal disorders Nausea	5.0% 13/258 • Number of events 14 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	8.9% 23/259 • Number of events 36 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	6.2% 16/260 • Number of events 22 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Musculoskeletal and connective tissue disorders Back pain	2.3% 6/258 • Number of events 6 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	5.0% 13/259 • Number of events 14 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	2.3% 6/260 • Number of events 7 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Metabolism and nutrition disorders Decreased appetite	3.5% 9/258 • Number of events 11 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	7.7% 20/259 • Number of events 23 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	5.4% 14/260 • Number of events 19 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Bronchitis	1.6% 4/258 • Number of events 9 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	5.4% 14/259 • Number of events 18 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	4.2% 11/260 • Number of events 17 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Nasopharyngitis	5.0% 13/258 • Number of events 14 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	6.2% 16/259 • Number of events 19 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	6.2% 16/260 • Number of events 22 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set
Infections and infestations Upper respiratory tract infection	6.6% 17/258 • Number of events 22 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	6.9% 18/259 • Number of events 24 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set	8.1% 21/260 • Number of events 24 • Baseline up to 30 days after the last dose (Up to week 125) Full Analysis Set

Additional Information

Galapagos Medical Information

Galapagos NV

Phone: +32 15 342900

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