Trial Outcomes & Findings for A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care (NCT NCT03711162)

NCT ID: NCT03711162

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: 525 participants
• Primary outcome timeframe: Baseline up to week 52
• Results posted on: 2022-07-29

Participant Flow

Participants with centrally confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) were enrolled at 106 sites.

A total of 1116 participants were screened for the study, and 525 were randomized and 523 were treated.

Participant milestones

Measure	GLPG1690 600 mg Participants received GLPG1690 (ziritaxestat) 600 milligrams (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 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 for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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 for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	175	175	175
Overall Study Treated	174	175	174
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	175	175	175

Reasons for withdrawal

Measure	GLPG1690 600 mg Participants received GLPG1690 (ziritaxestat) 600 milligrams (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 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 for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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 for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	5	2	4
Overall Study Death	11	7	8
Overall Study Lost to Follow-up	1	0	1
Overall Study Study Terminated by Sponsor	139	152	146
Overall Study Withdrawal by Subject	17	10	10
Overall Study Miscellaneous	1	2	2
Overall Study Not Treated	1	0	1
Overall Study Physician Decision	0	2	0
Overall Study Lack of Efficacy	0	0	2
Overall Study Protocol Specified Withdrawal Criteria Met	0	0	1

Baseline Characteristics

A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care

Baseline characteristics by cohort

Measure	GLPG1690 600 mg n=174 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 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=175 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=174 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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=523 Participants Total of all reporting groups
Age, Continuous	69.4 years STANDARD_DEVIATION 7.2 • n=5 Participants	70.0 years STANDARD_DEVIATION 6.7 • n=7 Participants	70.6 years STANDARD_DEVIATION 7.7 • n=5 Participants	70.0 years STANDARD_DEVIATION 7.2 • n=4 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	32 Participants n=7 Participants	28 Participants n=5 Participants	92 Participants n=4 Participants
Sex: Female, Male Male	142 Participants n=5 Participants	143 Participants n=7 Participants	146 Participants n=5 Participants	431 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	44 Participants n=5 Participants	27 Participants n=7 Participants	26 Participants n=5 Participants	97 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	129 Participants n=5 Participants	145 Participants n=7 Participants	148 Participants n=5 Participants	422 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	10 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	152 Participants n=5 Participants	160 Participants n=7 Participants	159 Participants n=5 Participants	471 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Forced Vital Capacity (FVC)	2947.0 mL STANDARD_DEVIATION 820.8 • n=5 Participants	2873.2 mL STANDARD_DEVIATION 815.8 • n=7 Participants	2943.3 mL STANDARD_DEVIATION 738.7 • n=5 Participants	2921.1 mL STANDARD_DEVIATION 791.9 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to week 52

Population: Full Analysis Set - Efficacy (FAS-EF) included all randomized participants who received at least 1 dose of investigational product and excluded participants from the site found to have serious good clinical practice (GCP)-noncompliance issues.

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=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 FVC up to Week 52	-124.6 mL/year Standard Error 27.15	-173.9 mL/year Standard Error 26.31	-147.3 mL/year Standard Error 26.72	—	—	—

SECONDARY outcome

Timeframe: Up to week 52

Population: Full Analysis Set- Efficacy

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=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 Week 52	17.8 Percentage of participants	18.7 Percentage of participants	18.3 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 121)

Population: Full Analysis Set- Efficacy

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

Outcome measures

Measure	GLPG1690 600 mg n=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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)	9.5 Percentage of participants	9.4 Percentage of participants	9.8 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52

Population: Full Analysis Set- Efficacy

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=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	3.3 Score on a scale Standard Error 1.41	4.1 Score on a scale Standard Error 1.32	3.8 Score on a scale Standard Error 1.36	—	—	—

SECONDARY outcome

Timeframe: Baseline up to EoS (week 121)

Population: Full Analysis Set - Efficacy

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=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 FVC Until EoS	-127.0 mL/year Standard Error 24.01	-175.5 mL/year Standard Error 22.97	-146.4 mL/year Standard Error 23.59	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 121)

Population: Full Analysis Set - Efficacy

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=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	23.1 Percentage of participants	24.6 Percentage of participants	21.3 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 100

Population: Full Analysis Set - Efficacy

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=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	11.4 Score on a scale Interval 0.3 to 22.6	10.5 Score on a scale Interval 1.1 to 20.0	7.7 Score on a scale Interval -2.7 to 18.0	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 121)

Population: Full Analysis Set - Efficacy

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

Outcome measures

Measure	GLPG1690 600 mg n=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	18.3 Percentage of participants	21.6 Percentage of participants	18.9 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 121)

Population: Full Analysis Set - Efficacy

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

Outcome measures

Measure	GLPG1690 600 mg n=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	3.6 Percentage of participants	4.1 Percentage of participants	1.8 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 121)

Population: Full Analysis Set - Efficacy

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

Outcome measures

Measure	GLPG1690 600 mg n=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 121)

Population: Full Analysis Set - Efficacy

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

Outcome measures

Measure	GLPG1690 600 mg n=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	4.7 Percentage of participants	4.7 Percentage of participants	3.7 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 121)

Population: FAS - EF with available data at specified time point.

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=161 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	7.1 Percentage of participants	4.7 Percentage of participants	4.9 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 121)

Population: Full Analysis Set - Efficacy

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

Outcome measures

Measure	GLPG1690 600 mg n=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	7.1 Percentage of participants	4.7 Percentage of participants	4.9 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 121)

Population: Full Analysis Set - Efficacy

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=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	13.6 Percentage of participants	11.1 Percentage of participants	14.0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to EoS (week 121)

Population: Full Analysis Set - Efficacy

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

Outcome measures

Measure	GLPG1690 600 mg n=169 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 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=171 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=164 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	13.6 Percentage of participants	11.1 Percentage of participants	14.0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Week 52

Population: FAS-EF 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=82 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 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=97 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=94 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	2886.20 mL Standard Error 83.969	2662.90 mL Standard Error 79.056	3021.99 mL Standard Error 78.415	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52

Population: FAS-EF 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=82 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 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=97 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=94 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	-145.94 mL Standard Error 31.799	-182.29 mL Standard Error 30.286	-133.24 mL Standard Error 31.819	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52

Population: FAS-EF 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=82 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 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=97 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=94 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	-4.57 Percent change Standard Error 0.992	-6.46 Percent change Standard Error 1.115	-4.48 Percent change Standard Error 0.978	—	—	—

SECONDARY outcome

Timeframe: Week 112

Population: FAS-EF with available data at specified time point. No participant was available for analysis at Week 112 for arm "GLPG1690 200 mg" and "Placebo".

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=2 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 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 for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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 for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 112	3262.00 mL Standard Error 15.000	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 112

Population: FAS - EF with available data at specified time point. No participant was available for analysis at Week 112 for arms "GLPG1690 200 mg" and "Placebo".

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=2 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 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 for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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 for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 112	-55.75 mL Standard Error 277.750	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 112

Population: FAS - EF with available data at specified time point. No participant was available for analysis at Week 112 for arms "GLPG1690 200 mg" and "Placebo".

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=2 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 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 for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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 for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 112	-0.95 Percent change Standard Error 8.288	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52

Population: FAS - EF 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=82 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 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=97 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=94 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	90.2 Percentage of participants	92.8 Percentage of participants	89.4 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 112

Population: FAS - EF with available data at specified time point. No participant was available for analysis at Week 112 for arms "GLPG1690 200 mg" and "Placebo".

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=2 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 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 for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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 for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 112: FVC Change Within ≤5	50.0 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52

Population: FAS - EF 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=82 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 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=97 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=94 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	97.6 Percentage of participants	97.9 Percentage of participants	96.8 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 112

Population: FAS - EF with available data at specified time point. No participant was available for analysis at Week 112 for arms "GLPG1690 200 mg" and "Placebo".

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=2 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 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 for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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 for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 112: FVC Change Within ≤10	100 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 30 days after the last dose (up to week 121)

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product.

Safety was assessed by AEs, which included abnormalities identified during a medical test (example, 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=174 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 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=175 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=174 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 TEAEs	78.7 Percentage of participants	84.6 Percentage of participants	84.5 Percentage of participants	—	—	—
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Serious TEAEs	21.8 Percentage of participants	21.7 Percentage of participants	20.7 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS - EF with available data at specified time point.

Cough was evaluated using the LCQ. The LCQ was a 19-item questionnaire split into three domains: physical, psychological, and social. Scores were calculated by domain (range from 1 to 7, higher scores indicated a better health status) 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=89 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 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=104 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=97 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Total Score: Change at Week 52	-0.163 Score on a scale Standard Deviation 3.778	-0.791 Score on a scale Standard Deviation 3.028	-0.247 Score on a scale Standard Deviation 2.680	—	—	—
Changes From Baseline Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Total Score: Change at Week 100	-1.262 Score on a scale Standard Deviation 2.295	-0.810 Score on a scale Standard Deviation 0.9249	0.403 Score on a scale Standard Deviation 2.497	—	—	—
Changes From Baseline Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Physical Score: Change at Week 52	0.024 Score on a scale Standard Deviation 1.218	-0.215 Score on a scale Standard Deviation 0.966	-0.151 Score on a scale Standard Deviation 0.835	—	—	—
Changes From Baseline Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Physical Score: Change at Week 100	-0.208 Score on a scale Standard Deviation 0.452	-0.222 Score on a scale Standard Deviation 1.200	-0.286 Score on a scale Standard Deviation 0.847	—	—	—
Changes From Baseline Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Psychological Score: Change at Week 52	-0.122 Score on a scale Standard Deviation 1.397	-0.225 Score on a scale Standard Deviation 1.204	-0.044 Score on a scale Standard Deviation 1.020	—	—	—
Changes From Baseline Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Psychological Score: Change at Week 100	-0.595 Score on a scale Standard Deviation 0.941	-0.254 Score on a scale Standard Deviation 0.892	0.367 Score on a scale Standard Deviation 0.899	—	—	—
Changes From Baseline Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Social Score: Change at Week 52	-0.065 Score on a scale Standard Deviation 1.344	-0.351 Score on a scale Standard Deviation 1.147	-0.052 Score on a scale Standard Deviation 1.080	—	—	—
Changes From Baseline Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100 Social Score: Change at Week 100	-0.458 Score on a scale Standard Deviation 1.269	-0.333 Score on a scale Standard Deviation 1.237	0.321 Score on a scale Standard Deviation 0.997	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS-EF 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=89 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 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=104 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=96 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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): Cough at Week 52 and Week 100 Change at Week 52	2.9 mm Standard Deviation 27.9	3.2 mm Standard Deviation 25.1	2.3 mm Standard Deviation 27.3	—	—	—
Change From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Week 100 Change at Week 100	8.0 mm Standard Deviation 23.1	0.3 mm Standard Deviation 24.0	25.4 mm Standard Deviation 39.1	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS-EF 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=89 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 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=104 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=96 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	1.8 mm Standard Deviation 26.8	1.5 mm Standard Deviation 23.2	1.1 mm Standard Deviation 24.9	—	—	—
Change From Baseline in Visual Analogue Score (VAS): Urge to Cough at Week 52 and Week 100 Change at Week 100	5.7 mm Standard Deviation 22.0	-1.9 mm Standard Deviation 24.8	24.3 mm Standard Deviation 40.6	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS-EF with available data at specified time point.

EuroQol outcome measurements is a printed 20 cm 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=90 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 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=104 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=97 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 European Quality Of Life (EQ) VAS at Week 52 and Week 100 Change at Week 52	-1.4 Score on a scale Standard Deviation 16.2	-6.1 Score on a scale Standard Deviation 17.3	-3.7 Score on a scale Standard Deviation 16.5	—	—	—
Change From Baseline in European Quality Of Life (EQ) VAS at Week 52 and Week 100 Change at Week 100	7.2 Score on a scale Standard Deviation 12.3	-9.3 Score on a scale Standard Deviation 25.2	-2.1 Score on a scale Standard Deviation 23.8	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS-EF with available data at specified time point.

The K-BILD questionnaire was specifically developed to analyze the health status of participants with ILD. The questionnaire consists of 15 items (assessed by the participants on a scale ranging from 1 to 7, where 1 and 7 represent 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=89 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 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=104 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=96 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Breathlessness and Activities Score: Change at Week 52	-0.256 Score on a scale Standard Deviation 20.896	-5.031 Score on a scale Standard Deviation 13.512	-4.545 Score on a scale Standard Deviation 15.250	—	—	—
Change 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	1.417 Score on a scale Standard Deviation 19.427	-9.733 Score on a scale Standard Deviation 15.973	-3.843 Score on a scale Standard Deviation 19.788	—	—	—
Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Psychological Score: Change at Week 52	0.429 Score on a scale Standard Deviation 18.240	-2.583 Score on a scale Standard Deviation 15.555	-2.421 Score on a scale Standard Deviation 17.049	—	—	—
Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Psychological Score: Change at Week 100	-4.417 Score on a scale Standard Deviation 30.117	-6.478 Score on a scale Standard Deviation 9.193	-2.743 Score on a scale Standard Deviation 10.930	—	—	—
Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Chest Symptoms Score: Change at Week 52	-1.624 Score on a scale Standard Deviation 20.367	-2.095 Score on a scale Standard Deviation 20.002	-2.790 Score on a scale Standard Deviation 20.052	—	—	—
Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Chest Symptoms Score: Change at Week 100	0.850 Score on a scale Standard Deviation 13.686	-2.667 Score on a scale Standard Deviation 19.951	-3.371 Score on a scale Standard Deviation 16.023	—	—	—
Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Total Score: Change at Week 52	-0.276 Score on a scale Standard Deviation 13.690	-2.306 Score on a scale Standard Deviation 10.398	-2.484 Score on a scale Standard Deviation 10.863	—	—	—
Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100 Total Score: Change at Week 100	-0.383 Score on a scale Standard Deviation 15.090	-5.444 Score on a scale Standard Deviation 7.726	-2.371 Score on a scale Standard Deviation 10.520	—	—	—

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=24 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 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=18 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=24 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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=26 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=30 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=27 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 (AUC) of Ziritaxtestat	10367 Nanogram * milliliter per hour (ng*mL/h) Interval 7960.4 to 12773.6	51136 Nanogram * milliliter per hour (ng*mL/h) Interval 40132.9 to 62139.1	7095 Nanogram * milliliter per hour (ng*mL/h) Interval 6411.3 to 7778.7	33796 Nanogram * milliliter per hour (ng*mL/h) Interval 29021.56 to 38570.44	6375 Nanogram * milliliter per hour (ng*mL/h) Interval 5907.28 to 6842.72	21188 Nanogram * milliliter per hour (ng*mL/h) Interval 16847.76 to 25528.24

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=24 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 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=18 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=24 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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=26 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=30 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=27 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	864 Nanogram per milliliter (ng/mL) Interval 721.42 to 1006.58	3962 Nanogram per milliliter (ng/mL) Interval 3330.09 to 4593.91	583 Nanogram per milliliter (ng/mL) Interval 541.55 to 624.45	2686 Nanogram per milliliter (ng/mL) Interval 2414.7 to 2957.3	591 Nanogram per milliliter (ng/mL) Interval 556.46 to 625.54	2009 Nanogram per milliliter (ng/mL) Interval 1692.94 to 2325.06

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS - EF with available data at specified time point.

The 6-MWT depicted the total distance covered by a participant during 6 minutes of walking.

Outcome measures

Measure	GLPG1690 600 mg n=67 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 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=73 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=80 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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 Total Distance Walked in Six-minute Walk Test (6MWT) at Week 52 and Week 100 Change at Week 100	-83.00 Meter Standard Error 17.521	-79.00 Meter Standard Error 13.00	-137.87 Meter Standard Error 93.135	—	—	—
Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 52 and Week 100 Change at Week 52	-36.34 Meter Standard Error 7.805	-15.65 Meter Standard Error 9.865	-34.75 Meter Standard Error 11.546	—	—	—

SECONDARY outcome

Timeframe: Baseline, week 52, week 100

Population: FAS - EF with available data at specified time point.

Change from baseline in DLCO (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=60 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 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=77 Participants Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=73 Participants Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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	-0.640 mmol/min/kPa Standard Error 0.1205	-0.137 mmol/min/kPa Standard Error 0.1288	-0.193 mmol/min/kPa Standard Error 0.0907	—	—	—
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	-0.215 mmol/min/kPa Standard Error 0.6737	-1.670 mmol/min/kPa	-2.134 mmol/min/kPa Standard Error 1.9836	—	—	—

Adverse Events

GLPG1690 600 mg

Serious events: 38 serious events

Other events: 91 other events

Deaths: 12 deaths

GLPG1690 200 mg

Serious events: 38 serious events

Other events: 99 other events

Deaths: 8 deaths

Placebo

Serious events: 36 serious events

Other events: 82 other events

Deaths: 8 deaths

Serious adverse events

Measure	GLPG1690 600 mg n=174 participants at risk 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 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=175 participants at risk Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=174 participants at risk Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Acute coronary syndrome	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Acute myocardial infarction	1.1% 2/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Angina unstable	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Aortic valve incompetence	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Atrioventricular block complete	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Cardiac failure congestive	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Cardiomyopathy	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Coronary artery disease	1.1% 2/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Coronary artery stenosis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Myocardial infarction	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	1.1% 2/174 • Number of events 3 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Myocardial rupture	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Cardiac disorders Pericardial haemorrhage	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Congenital, familial and genetic disorders Hydrocele	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Ear and labyrinth disorders Hypoacusis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Eye disorders Cataract	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Eye disorders Visual impairment	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Gastrointestinal disorders Diarrhoea	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Gastrointestinal disorders Femoral hernia strangulated	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Gastrointestinal disorders Haemorrhoids	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
General disorders Chest pain	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
General disorders Drug intolerance	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
General disorders Sudden death	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Hepatobiliary disorders Bile duct stone	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Hepatobiliary disorders Cholecystitis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Hepatobiliary disorders Cholecystitis acute	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Hepatobiliary disorders Cholelithiasis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Immune system disorders Anaphylactic reaction	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Appendicitis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Bacterial infection	0.57% 1/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations COVID-19	1.1% 2/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	1.1% 2/174 • Number of events 3 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations COVID-19 pneumonia	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	1.7% 3/175 • Number of events 6 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Cellulitis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Gastroenteritis	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Influenza	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Lower respiratory tract infection	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	1.1% 2/174 • Number of events 3 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Pneumonia	2.3% 4/174 • Number of events 7 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	1.1% 2/175 • Number of events 3 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Respiratory syncytial virus infection	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Scrotal abscess	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Suspected COVID-19	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Femoral neck fracture	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Rib fracture	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Investigations Blood bilirubin increased	0.57% 1/174 • Number of events 3 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Investigations Platelet morphology abnormal	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Investigations Transaminases increased	0.57% 1/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hyponatraemia	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoproliferative disorder	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Nervous system disorders Carotid artery stenosis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Nervous system disorders Cerebrovascular accident	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Nervous system disorders Cubital tunnel syndrome	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Nervous system disorders Dizziness	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Nervous system disorders Encephalopathy	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Nervous system disorders Ischaemic stroke	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Nervous system disorders Limbic encephalitis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Nervous system disorders Status epilepticus	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Nervous system disorders Syncope	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Product Issues Device loosening	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Psychiatric disorders Anxiety	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 3 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Psychiatric disorders Suicide attempt	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Renal and urinary disorders Acute kidney injury	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	1.1% 2/175 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Renal and urinary disorders Calculus bladder	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Renal and urinary disorders Nephrolithiasis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	1.1% 2/175 • Number of events 5 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/174 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	6.9% 12/174 • Number of events 20 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	4.0% 7/175 • Number of events 16 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	6.9% 12/174 • Number of events 19 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.3% 4/174 • Number of events 5 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 2/174 • Number of events 4 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/175 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	1.1% 2/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Vascular disorders Aortic stenosis	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Vascular disorders Hypertension	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Vascular disorders Orthostatic hypotension	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.57% 1/175 • Number of events 1 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	0.00% 0/174 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.

Other adverse events

Measure	GLPG1690 600 mg n=174 participants at risk 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 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=175 participants at risk Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. 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=174 participants at risk Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. 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).
Gastrointestinal disorders Diarrhoea	29.3% 51/174 • Number of events 111 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	22.9% 40/175 • Number of events 84 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	11.5% 20/174 • Number of events 33 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.2% 9/174 • Number of events 10 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	1.7% 3/175 • Number of events 3 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	1.1% 2/174 • Number of events 2 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Gastrointestinal disorders Nausea	9.2% 16/174 • Number of events 18 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	8.0% 14/175 • Number of events 20 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	5.7% 10/174 • Number of events 14 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
General disorders Fatigue	5.7% 10/174 • Number of events 10 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	5.1% 9/175 • Number of events 12 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	3.4% 6/174 • Number of events 7 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Bronchitis	4.6% 8/174 • Number of events 10 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	6.3% 11/175 • Number of events 13 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	2.3% 4/174 • Number of events 4 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Nasopharyngitis	6.3% 11/174 • Number of events 14 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	4.0% 7/175 • Number of events 10 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	5.7% 10/174 • Number of events 11 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Infections and infestations Upper respiratory tract infection	5.7% 10/174 • Number of events 10 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	6.9% 12/175 • Number of events 15 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	6.3% 11/174 • Number of events 14 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Back pain	1.7% 3/174 • Number of events 3 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	5.1% 9/175 • Number of events 13 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	5.2% 9/174 • Number of events 10 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Nervous system disorders Dizziness	4.6% 8/174 • Number of events 10 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	2.3% 4/175 • Number of events 4 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	5.2% 9/174 • Number of events 9 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Nervous system disorders Headache	5.2% 9/174 • Number of events 14 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	7.4% 13/175 • Number of events 15 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	5.7% 10/174 • Number of events 11 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Cough	9.2% 16/174 • Number of events 18 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	12.0% 21/175 • Number of events 25 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	9.2% 16/174 • Number of events 18 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.7% 10/174 • Number of events 12 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	9.7% 17/175 • Number of events 25 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	5.7% 10/174 • Number of events 10 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	7.5% 13/174 • Number of events 15 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	6.9% 12/175 • Number of events 15 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.	7.5% 13/174 • Number of events 18 • Baseline Up to 30 days after the last dose (Up to week 121) FAS consisted of all randomized participants who received at least 1 dose of investigational product.

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