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A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard Medical Treatment (ISABELA1)

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ClinicalTrials.gov Identifier: NCT03711162
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

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).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: GLPG1690 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: GLPG1690 Dose A
GLPG1690 will be administered as film-coated tablets for oral use once daily.
Drug: GLPG1690
GLPG1690, film-coated tablets for oral use.

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

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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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. [ Time Frame: At week 52 ]
    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.

  2. Time to first respiratory-related hospitalization until the end of the study [ Time Frame: From screening through study completion, a minimum of 52 weeks ]
    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.

  3. Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score. [ Time Frame: At week 52 ]
    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject aged ≥40 years on the day of signing the ICF.
  • A diagnosis of IPF within 5 years prior to the screening visit, as per applicable ATS/ERS/JRS/ALAT guidelines.
  • Chest 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 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, or neither pirfenidone nor nintedanib (for any reason).
  • 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, 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 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 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 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 ≤4 L O2/minute.

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.
  • 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).
  • Underwent major surgery within 3 months prior to screening or have major surgery planned during the study period.
  • Abnormal LFT at screening, defined as AST, and/or ALT, and/or total bilirubin ≥1.5xULN, and/or GGT ≥3xULN. Retesting is allowed once.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711162


Contacts
Contact: Evelyn Fox 0032 15 34 29 00 evelyn.fox@glpg.com

Locations
United States, Arizona
Pulmonary Associates Recruiting
Phoenix, Arizona, United States, 85006
United States, Minnesota
Minnesota Lung Center Recruiting
Minneapolis, Minnesota, United States, 55407
United States, North Carolina
PulmonIx LLC Recruiting
Greensboro, North Carolina, United States, 27403
United States, Texas
Metroplex Pulmonary and Sleep Medicine Center Recruiting
McKinney, Texas, United States, 75069
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Ann Fieuw, MD, MSc Galapagos NV

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03711162     History of Changes
Other Study ID Numbers: GLPG1690-CL-303
2018-001405-87 ( EudraCT Number )
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial