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Date of registration	July. 08, 2020
Last modified on	Oct. 25, 2021
Trial ID	jRCT2080225268

Scientific Title	A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis
Public Title	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

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	PPDSNBL K.K.
	Address	St Luke's Tover 12F, 8-1 Akashi-cho,Chuo-ku, Tokyo 104-0044, Japan
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	PPDSNBL K.K.
	Address	St Luke's Tover 12F, 8-1 Akashi-cho,Chuo-ku, Tokyo 104-0044, Japan
	Phone Number
	E-mail Address

Recruitment Status	terminated

Date of First Enrolment		Jan. 20, 2020
Target Sample Size		750
Study Type		Interventional
Study Design	Study Design	This clinical Phase 3 study is a randomized, double-blind, parallel-group, placebo-controlled multicenter study designed to evaluate the efficacy and safety of two doses (200 mg q.d. and 600 mg q.d.) of orally administered GLPG1690 in addition to local standard of care for at least 52 weeks in adult subjects with a centrally confirmed diagnosis of IPF. Local standard of care for IPF is defined as receiving either pirfenidone or nintedanib, or neither pirfenidone nor nintedanib (for any reason). A total of approximately 750 subjects with confirmed diagnosis of IPF will be randomized, 250 subjects in each treatment group (GLPG1690 600 mg q.d., GLPG1690 200 mg q.d., or matching placebo).
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	- A diagnosis of IPF within 5 years prior to the screening visit, as per applicable ATS/ERS/JRS/ALAT guideline at the time of diagnosis Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines at the time of diagnosis. - Chest high-resolution computed tomography (HRCT) historically performed within 12 months prior to the screening visit and according to the minimum requirements for IPF diagnosis by central review based on subject's HRCT only (if no lung biopsy (LB) available), or based on both HRCT and LB (with application of the different criteria in either situation). If an evaluable HRCT <12 months prior to screening is not available, an HRCT can be performed at screening to determine eligibility, according to the same requirements as the historical HRCT. - Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone or nintedanib at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months - The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (investigator-determined). - Estimated minimum life expectancy of at least 30 months for non IPF related disease in the opinion of the investigator. - Male subjects and female subjects of childbearing potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of investigational medicinal product (IMP) (for the male subject) or the signing of the ICF (for the female subject), during the study, and until 90 days (male) or 30 days (female) after the last dose of IMP.
	Exclusion Criteria	- History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, prostate cancer that has been medically managed through active surveillance or watchful waiting, squamous cell carcinoma of the skin if fully resected, and Ductal Carcinoma In Situ). - Clinically significant abnormalities detected on ECG of either rhythm or conduction, a QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms, or a known long QT syndrome. Patients with implantable cardiovascular devices (e.g. pacemaker) affecting the QT interval time may be enrolled in the study based upon investigator judgment following cardiologist consultation if deemed necessary, and only after discussion with the medical monitor. - Acute IPF exacerbation within 6 months prior to screening and/or during the screening period. The definition of an acute IPF exacerbation is as follows: Previous or concurrent diagnosis of IPF; Acute worsening or development of dyspnea typically < 1 month duration; Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern and deterioration not fully explained by cardiac failure or fluid overload - Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period. - Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis and amyloidosis), exposures (e.g. radiation, silica, asbestos, and coal dust), or drugs (e.g. amiodarone). - Diagnosis of severe pulmonary hypertension (investigator determined). - Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period (e.g. acute coronary disease, heart failure, and stroke).
	Minimum Age	40age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Idiopathic Pulmonary Fibrosis
Intervention(s)		investigational material(s) Generic name etc : INN of investigational material : Ziritaxestat Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Subjects with Idiopathic pulmonary fibrosis will be randomized in a 1:1:1 ratio to receive GLPG1690 600 mg q.d., GLPG1690 200 mg q.d., or matching placebo for at least 52 weeks. control material(s) Generic name etc : INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety efficacy confirmatory - Rate of decline of forced vital capacity (FVC) in mL. [ Time Frame: From baseline through week 52 ] - To evaluate the efficacy of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with Idiopathic Pulmonary Fibrosis (IPF) as evaluated by the rate of decline of FVC.
Secondary Outcome		safety efficacy confirmatory To evaluate the impact of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with IPF on: - disease progression defined as deterioration of FVC or all-cause mortality at 52 weeks - respiratory-related hospitalization until the end of the study - changes in quality of life (measured by Respiratory Questionnaire[SGRQ] total score of St. George) at 52 weeks

Primary Sponsor	Galapagos NV(ICCC;PPDSNBL)
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Nagoya University Hospital IRB
Address of IRB	65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 27, 2019

Name of IRB	Kanagawa Cardiovascular and Respiratory Center IRB
Address of IRB	6-16-1 Kanazawaku, Tomiokahigashi, Yokohama-shi, Kanagawa
Phone Number of IRB	+81-45-701-9581
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 27, 2019

Name of IRB	Kobe City Medical Center General Hospital IRB
Address of IRB	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe-shi, Hyogo
Phone Number of IRB	+81-78-302-4321
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 27, 2019

Name of IRB	Tokyo Medical University Hospital IRB
Address of IRB	6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
Phone Number of IRB	+81-3-3342-6111
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 27, 2019

Name of IRB	Saiseikai Kumamoto Hospital IRB
Address of IRB	5-3-1 Chikami Minami-ku, Kumamoto-shi, Kumamoto
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 27, 2019

Name of IRB	Fukuoka University Hospital IRB
Address of IRB	7-45-1 Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka
Phone Number of IRB	+81-92-801-1011
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 27, 2019

Name of IRB	National Hospital Organization Tenryu Hospital IRB
Address of IRB	4201-2, Oro, Hamakita-ku, Hamamatsu-shi, Shizuoka
Phone Number of IRB	+81-53-583-3111
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 27, 2019

Name of IRB	Juntendo University Hospital IRB
Address of IRB	3-1-3 Hongo, Bunkyo-ku, Tokyo
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 27, 2019

Name of IRB	Nagasaki University Hospital IRB
Address of IRB	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki
Phone Number of IRB	+81-95-819-7200
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 27, 2019

Name of IRB	National Hospital Organization Kyushu Medical Center IRB
Address of IRB	1-8-1 Jigyohama, Chuo-ku, Fukuoka-shi, Fukuoka
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 27, 2019

Secondary ID No.	NCT03733444
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	2018-001406-29
Name of Other Registries	EU Clinical Trials Register (EU-CTR)

Secondary ID No.	JapicCTI-205364
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/Europe

History of Changes

No	Publication date
2	Oct. 25, 2021	(this page)	Changes
1	July. 14, 2020	Detail

List of change history