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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03711162




Registration number
NCT03711162
Ethics application status
Date submitted
15/10/2018
Date registered
18/10/2018
Date last updated
14/08/2019

Titles & IDs
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
Scientific title
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter 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
Secondary ID [1] 0 0
2018-001405-87
Secondary ID [2] 0 0
GLPG1690-CL-303
Universal Trial Number (UTN)
Trial acronym
ISABELA1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GLPG1690
Treatment: Drugs - Placebo

Experimental: GLPG1690 Dose A - GLPG1690 will be administered as film-coated tablets for oral use once daily.

Experimental: GLPG1690 Dose B - GLPG1690 will be administered as film-coated tablets for oral use once daily.

Placebo Comparator: Placebo - Placebo to match will be administered as film-coated tablets for oral use once daily.


Treatment: Drugs: GLPG1690
GLPG1690, film-coated tablets for oral use.

Treatment: Drugs: Placebo
Matching placebo, film-coated tablets for oral use.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of decline of forced vital capacity (FVC) in mL. - 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.
Timepoint [1] 0 0
From baseline through week 52
Secondary outcome [1] 0 0
Disease progression defined as the composite endpoint of first occurrence of =10% absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality. - To evaluate the impact of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with Idiopathic Pulmonary Fibrosis (IPF) on disease progression defined as deterioration of FVC or all-cause mortality.
Timepoint [1] 0 0
At week 52
Secondary outcome [2] 0 0
Time to first respiratory-related hospitalization until the end of the study - To evaluate the impact of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with Idiopathic Pulmonary Fibrosis (IPF) on respiratory-related hospitalization until the end of the study.
Timepoint [2] 0 0
From screening through study completion, a minimum of 52 weeks
Secondary outcome [3] 0 0
Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score. - To evaluate the impact of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with Idiopathic Pulmonary Fibrosis (IPF) on changes in quality of life (measured by SGRQ total score).The SGRQ is a 50-item questionnaire split into three domains: symptoms, activity and impact. Scores are weighted such that every domain score and the total score range from 0 to 100, with higher scores indicating a poorer health-related quality of life.
Timepoint [3] 0 0
At week 52

Eligibility
Key inclusion criteria
- Male or female subject aged =40 years on the day of signing the Informed Consent Form
(ICF).

- A diagnosis of IPF within 5 years prior to the screening visit, as per applicable
American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese
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).

- Meeting all of the following criteria during the screening period: FVC =45% predicted
of normal, Forced expiratory volume in 1 second (FEV1)/FVC =0.7, diffusing capacity of
the lung for carbon monoxide (DLCO) corrected for Hb =30% predicted of normal.

- 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.

- Able to walk at least 150 meters during the 6-Minute Walk Test (6MWT) at screening
Visit 1; without having a contraindication to perform the 6MWT or without a condition
putting the subject at risk of falling during the test (investigator's discretion).
The use of a cane is allowed, the use of a stroller is not allowed at all for any
condition. At Visit 2, for the oxygen titration test, resting oxygen saturation (SpO2)
should be =88% with maximum 6 L O2/minute; during the walk, SpO2 should be =83% with 6
L O2/minute or =88% with 0, 2 or 4 L O2/minute.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

- 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).

- Had gastric perforation within 3 months prior to screening or during screening, and/or
underwent major surgery within 3 months prior to screening, during screening or have
major surgery planned during the study period.

- Moderate to severe hepatic impairment (Child-Pugh B or C) and/or abnormal liver
function test (LFT) at screening, defined as aspartate aminotransferase (AST), and/or
alanine aminotransferase (ALT), and/or total bilirubin =1.5 x upper limit of the
normal range (ULN), and/or gamma glutamyl transferase (GGT) =3 x ULN. Retesting is
allowed once for abnormal LFT.

- Abnormal renal function defined as estimated creatinine clearance, calculated
according to Cockcroft-Gault calculation (CCr) <30 mL/min. Retesting is allowed once.

- Use of any of the following therapies within 4 weeks prior to screening and during the
screening period, or planned during the study: warfarin, imatinib, ambrisentan,
azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil
(except for occasional use), prednisone at steady dose >10 mg/day or equivalent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Corte Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
Lung Research Queensland - Chermside
Recruitment hospital [5] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [6] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [7] 0 0
Respiratory Clinical Trials Pty Ltd - Kent Town
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
VIC 3128 - Box Hill
Recruitment postcode(s) [3] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [4] 0 0
QLD 4060 - Chermside
Recruitment postcode(s) [5] 0 0
NSW 2139 - Concord
Recruitment postcode(s) [6] 0 0
NSW 2010 - Darlinghurst
Recruitment postcode(s) [7] 0 0
SA 5067 - Kent Town
Recruitment postcode(s) [8] 0 0
VIC 3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
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Iowa
Country [7] 0 0
United States of America
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Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
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Massachusetts
Country [10] 0 0
United States of America
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Minnesota
Country [11] 0 0
United States of America
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Missouri
Country [12] 0 0
United States of America
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Nebraska
Country [13] 0 0
United States of America
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North Carolina
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United States of America
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Ohio
Country [15] 0 0
United States of America
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Oregon
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United States of America
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Rhode Island
Country [17] 0 0
United States of America
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Tennessee
Country [18] 0 0
United States of America
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Texas
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United States of America
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Utah
Country [20] 0 0
United States of America
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Wisconsin
Country [21] 0 0
Belgium
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Antwerp
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Belgium
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Brussels
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Belgium
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Leuven
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Belgium
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Yvoir
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Chile
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Concepción
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Chile
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Santiago
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Czechia
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Brno
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Czechia
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Ostrava
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Czechia
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Praha
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Denmark
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Aarhus
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Denmark
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Hellerup
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Denmark
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Odense
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Germany
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Berlin
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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Rosenheim
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Greece
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Athens
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Greece
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Iraklio
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Greece
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Larissa
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Greece
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Thessaloníki
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Peru
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Lima
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Spain
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Pontevedra
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Santander
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Spain
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Valencia
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Taiwan
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Kaohsiung City
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Taiwan
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New Taipei City
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Taiwan
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Taipei
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Turkey
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Izmir
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Turkey
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Mersin
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United Kingdom
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Exeter
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Nottingham
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United Kingdom
State/province [59] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Galapagos NV
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to see how GLPG1690 works together with your current
standard treatment on your lung function and IPF disease in general. The study will also
investigate how well GLPG1690 is tolerated (for example if you get any side effects while on
study drug).
Trial website
https://clinicaltrials.gov/show/NCT03711162
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ann Fieuw, MD, MSc
Address 0 0
Galapagos NV
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Galapagos Medical Information
Address 0 0
Country 0 0
Phone 0 0
+32 15 342900
Fax 0 0
Email 0 0
medicalinfo@glpg.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03711162