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

• Register: EUCTR
• Last refreshed on: 13 September 2021
• Main ID: EUCTR2018-001405-87-ES
• Date of registration: 18/01/2019
• Prospective Registration: No
• Primary sponsor: Galapagos NV
• 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 medical treatment
• 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.
• Date of first enrolment: 12/12/2018
• Target sample size: 750
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-001405-87
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Chile, Czech Republic, Denmark, Finland, Germany, Greece, Peru, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Galapagos NV

• Name: Clinical Trial Information Desk
• Affiliation: Galapagos NV

Key inclusion & exclusion 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 (see Appendix 10) 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 <= L O2/minute.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 375
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 375

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Idiopatic pulmonary fibrosis
MedDRA version: 20.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Name: GLPG1690
Product Code: G451990
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not applicable
Current Sponsor code: G451990
Other descriptive name: GLPG1690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: GLPG1690
Product Code: G451990
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not applicable
Current Sponsor code: G451990
Other descriptive name: GLPG1690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To evaluate the efficacy of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with IPF as evaluated by the rate of decline of FVC over a period of 52 weeks

Secondary Objective: 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 St. George’s Respiratory Questionnaire [SGRQ] total score) at 52 weeks

Primary end point(s): Rate of decline of FVC (in mL) over a period of 52 weeks

Timepoint(s) of evaluation of this end point: At week 52

Secondary Outcome(s)

Secondary end point(s): - 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 at 52 weeks
- Time to first respiratory-related hospitalization until the end of the study
- Change from baseline in the SGRQ total score at 52 weeks

Timepoint(s) of evaluation of this end point: Various timepoints during the trial as specified in the protocol

Secondary ID(s)

GLPG1690-CL-303

2018-001405-87-DK

Source(s) of Monetary Support

Galapagos NV

Ethics review

Status: Approved
Approval date: 22/11/2018
Contact: