Study Evaluating INS018_055 Administered Orally to Subjec... | NCT05938920

Label	Type	Description	Intervention Names
INS018_055 30 mg QD	Experimental	Group 1: INS018_055 once daily up to 12 weeks, low dose	Drug: INS018_055
INS018_055 30 mg BID	Experimental	Group 2: INS018_055 twice daily up to 12 weeks, low dose	Drug: INS018_055
INS018_055 60 mg QD	Experimental	Group 3: INS018_055 once daily up to 12 weeks, high dose	Drug: INS018_055
Placebo	Placebo Comparator	Group 4: Placebo once or twice daily up to 12 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
INS018_055	Drug	Pharmaceutical formulation: Capsules Mode of Administration: Oral	INS018_055 30 mg BID INS018_055 30 mg QD INS018_055 60 mg QD

Measure	Description	Time Frame
Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)	TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT. CTCAE=Common Terminology Criteria for Adverse Events	From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)

Measure	Description	Time Frame
Relative Change From Baseline in Forced Vital Capacity (FVC)	Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.	Week 0/Visit 2 up to Week 12
Absolute Change From Baseline in FVC in L

Facility	Status	City	State	ZIP	Country	Contacts
Anhui Chest Hospital		Hefei	Anhui	230031	China
The Second Affiliated Hospital of Anhui Medical University

PubMed Identifier	Type	Citation	Retractions
40461817	Derived	Xu Z, Ren F, Wang P, Cao J, Tan C, Ma D, Zhao L, Dai J, Ding Y, Fang H, Li H, Liu H, Luo F, Meng Y, Pan P, Xiang P, Xiao Z, Rao S, Satler C, Liu S, Lv Y, Zhao H, Chen S, Cui H, Korzinkin M, Gennert D, Zhavoronkov A. A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial. Nat Med. 2025 Aug;31(8):2602-2610. doi: 10.1038/s41591-025-03743-2. Epub 2025 Jun 3.

ID	Title	Description
FG000	INS018_055 30 mg QD	Group 1: INS018_055 once daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
FG001	INS018_055 30 mg BID

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 2, 2024	Nov 6, 2025

ID	Title	Description
BG000	INS018_055 30 mg QD	Group 1: INS018_055 once daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
BG001	INS018_055 30 mg BID	Group 2: INS018_055 twice daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
BG002	INS018_055 60 mg QD	Group 3: INS018_055 once daily up to 12 weeks, high dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
BG003	Placebo	Group 4: Placebo once or twice daily up to 12 weeks INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00018 BG00118 BG00218 BG00317 BG00471

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.8± 6.99 BG00167.2± 7.77 BG00265.7± 6.82 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

≤ 65 years

Title	Measurements
	BG0009 BG0017 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0013 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Height at Baseline

Mean

Standard Deviation

centimeters (cm)

Title

Denominators

Categories

Title	Measurements
	BG000167.77± 5.549 BG001165.78± 7.869 BG002

Weight at Baseline

Mean

Standard Deviation

kilograms (kg)

Title

Denominators

Categories

Title	Measurements
	BG00072.27± 7.395 BG00167.36± 12.141 BG002

Body Mass Index at Baseline

Mean

Standard Deviation

kg/m2

Title

Denominators

Categories

Title	Measurements
	BG00025.66± 2.080 BG00124.41± 3.399 BG002

Forced vital capacity (FVC) at Baseline

Decline (change) in FVC was assessed from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.

Mean

Standard Deviation

liters (L)

Title

Denominators

Categories

Title	Measurements
	BG0002.6961± 0.44422 BG0012.6170

Diffusion capacity of the lung for carbon monoxide (DLCO) (actual) at Baseline

DLCO was assessed during the single breath diffusion test. Each study site used its own equipment and conducted all measurements using the same equipment. Baseline measurement (Visit 2) was the reference visit and change in DLCO (actual) from Week 0/Visit 2 to Week 12 was assessed. No more than 3 DLCO sessions were performed during the screening period.

Mean

Standard Deviation

mmol/min/kPa

Title

Denominators

Categories

Title	Measurements
	BG0003.7832± 1.03476 BG001

Diffusion capacity of the lung for carbon monoxide (DLCO) (% predicted) at Baseline

DLCO (% predicted) is the percentage of the DLCO that is predicted based on the participant's hemoglobin level. DLCO was assessed during the single breath diffusion test. Each study site used its own equipment and conducted all measurements using the same equipment. Baseline measurement (Visit 2) was the reference visit and change in DLCO% predicted from Week 0/Visit 2 to Week 12 was assessed. No more than 3 DLCO sessions were performed during the screening period.

Mean

Standard Deviation

percentage

Title

Denominators

Categories

Title	Measurements
	BG00047.6952± 12.41070 BG001

6-minute walk distance (6-MWD) test (in meters) at Baseline

Participants had to rest for 30 minutes prior to performing the 6-minute walk test. The participant was instructed to walk on a flat, hard surface. The walk for 6 minutes was timed. After 6 minutes the distance the participant had walked was measured. Participants graded their level of dyspnea on a scale of 0 (no dyspnea) to 10 (maximal dyspnea) before walking. After walking, they were reminded of the level they selected pre-walk and then asked to grade again their level of dyspnea. Change in 6-MWD in meters, from Week 0 to Week 12 was assessed.

Mean

Standard Deviation

meters (m)

Title

Denominators

Categories

Title	Measurements
	BG000420.81± 122.020 BG001

Leicester Cough Questionnaire (LCQ) total score at Baseline

The LCQ is a 19-item self-administered questionnaire that assesses cough-related quality of life (QoL). Change in LCQ from Week 0 to Weeks 4, 8, and 12 was assessed. It examines 3 domains: physical, psychological, and social. The range for the total score on the LCQ is 3 to 21, and each domain score ranges from 1 to 7. The overall score for the LCQ for each participant was calculated by adding the individual domain scores. A higher score indicates a better QoL.

Mean

Standard Deviation

scores on a scale

Title

Denominators

Categories

Title	Measurements
	BG00017.1290± 3.08860 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)

TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT.

CTCAE=Common Terminology Criteria for Adverse Events

Safety Population: The safety population included all participants who received at least 1 dose of study treatment.

Posted

Count of Participants

Participants

From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)

ID	Title	Description
OG000	INS018_055 30 mg QD	Group 1: INS018_055 once daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG001	INS018_055 30 mg BID	Group 2: INS018_055 twice daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG002	INS018_055 60 mg QD	Group 3: INS018_055 once daily up to 12 weeks, high dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG003	Placebo	Group 4: Placebo once or twice daily up to 12 weeks Placebo: Pharmaceutical formulation: Capsules Mode of Administration: Oral

Units	Counts
Participants	OG00018 OG00118 OG00218 OG003

Title

Denominators

Categories

Any TEAE

Title	Measurements
	OG00013 OG00115 OG00215 OG003

Secondary

Relative Change From Baseline in Forced Vital Capacity (FVC)

Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.

Intent-to-treat Population: The ITT population included any randomized participant. The ITT Population was used for summary of demographic and baseline characteristics, and it was used for analysis of secondary endpoints except PK analysis

Posted

Mean

Standard Deviation

percentage change in FVC

Week 0/Visit 2 up to Week 12

ID	Title	Description
OG000	INS018_055 30 mg QD	Group 1: INS018_055 once daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG001	INS018_055 30 mg BID	Group 2: INS018_055 twice daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG002	INS018_055 60 mg QD	Group 3: INS018_055 once daily up to 12 weeks, high dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG003	Placebo

Secondary

Absolute Change From Baseline in FVC in L

Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.

Intent-to-treat Population: The ITT population included any randomized participants. The ITT Population was used for summary of demographic and baseline characteristics, and it was used for analysis of secondary endpoints except PK analysis

Posted

Mean

Standard Deviation

Week 0/Visit 2 up to Week 12

ID	Title	Description
OG000	INS018_055 30 mg QD	Group 1: INS018_055 once daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG001	INS018_055 30 mg BID	Group 2: INS018_055 twice daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG002	INS018_055 60 mg QD	Group 3: INS018_055 once daily up to 12 weeks, high dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG003	Placebo

Secondary

Absolute Change in FVC % Predicted

Absolute change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment

Posted

Mean

Standard Deviation

Percent predicted

Week 0/Visit 2 up to Week 12

ID	Title	Description
OG000	INS018_055 30 mg QD	Group 1: INS018_055 once daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG001	INS018_055 30 mg BID	Group 2: INS018_055 twice daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG002	INS018_055 60 mg QD	Group 3: INS018_055 once daily up to 12 weeks, high dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG003	Placebo

Secondary

Relative Change in FVC % Predicted

Relative change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment

Posted

Mean

Standard Deviation

Percent predicted

Week 0/Visit 2 up to Week 12

ID	Title	Description
OG000	INS018_055 30 mg QD	Group 1: INS018_055 once daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG001	INS018_055 30 mg BID	Group 2: INS018_055 twice daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
OG002	INS018_055 60 mg QD	Group 3: INS018_055 once daily up to 12 weeks, high dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration:Oral
OG003	Placebo

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected18 at risk EG0026 affected18 at risk EG0031 affected17 at risk
Blood bilirubin increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0024 affected18 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected18 at risk EG0022 affected18 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0022 affected18 at risk EG003
Blood urea increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0021 affected18 at risk EG003
C-reactive protein increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Carbohydrate antigen 19-9 increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0021 affected18 at risk EG003
Protein urine present	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Red blood cell sedimentation rate increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0021 affected18 at risk EG003
Weight decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Alpha hydroxybutyrate dehydrogenase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Bile acids increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Blood creatine phosphokinase MB increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Blood creatinine increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Blood fibrinogen increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Blood glucose increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Blood pressure increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Carbon dioxide decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Carotid intima-media thickness increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Electrocardiogram ST segment abnormal	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Electrocardiogram T wave abnormal	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Electrocardiogram high voltage	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Glutamate dehydrogenase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Hepatic enzyme abnormal	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Immunoglobulins increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Interferon gamma level increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Liver function test abnormal	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Neutrophil count increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
QRS axis abnormal	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Red blood cells urine positive	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Reticulocyte count increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Throxine free decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Tri-iodothyronine increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Weight increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
White blood cell count increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0014 affected18 at risk EG0021 affected18 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0022 affected18 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Gingivitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Oral herpes	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Paronychia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0003 affected18 at risk EG0015 affected18 at risk EG0024 affected18 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0012 affected18 at risk EG0021 affected18 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected18 at risk EG0011 affected18 at risk EG0021 affected18 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0021 affected18 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0022 affected18 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0021 affected18 at risk EG003
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected18 at risk EG0014 affected18 at risk EG0023 affected18 at risk EG003
Liver injury	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0012 affected18 at risk EG0021 affected18 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0012 affected18 at risk EG0020 affected18 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected18 at risk EG0013 affected18 at risk EG0025 affected18 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected18 at risk EG0022 affected18 at risk EG003
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0021 affected18 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0012 affected18 at risk EG0020 affected18 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Eosinophilia myalgia syndrome	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0012 affected18 at risk EG0020 affected18 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0021 affected18 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Eye swelling	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Vision blurred	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Xerophthalmia	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Chest discomfort	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Fatigue	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Influenza like illness	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0021 affected18 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0021 affected18 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0022 affected18 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0021 affected18 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected18 at risk EG0020 affected18 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003
Prostatic calcification	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected18 at risk EG0020 affected18 at risk EG003

ID	Term
D054990	Idiopathic Pulmonary Fibrosis
D011658	Pulmonary Fibrosis
D005355	Fibrosis
D010335	Pathologic Processes
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	INS018_055 30 mg QD	Group 1: INS018_055 once daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral	0	18	2	18	13	18
EG001	INS018_055 30 mg BID	Group 2: INS018_055 twice daily up to 12 weeks, low dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral	1	18	4	18	15	18
EG002	INS018_055 60 mg QD	Group 3: INS018_055 once daily up to 12 weeks, high dose INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral	0	18	7	18	15	18
EG003	Placebo	Group 4: Placebo once or twice daily up to 12 weeks INS018_055: Pharmaceutical formulation: Capsules Mode of administration: Oral	0	17	3	17	12	17