A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)

• Register: EUCTR
• Last refreshed on: 19 October 2020
• Main ID: EUCTR2017-004302-18-SK
• Date of registration: 04/05/2018
• Prospective Registration: Yes
• Primary sponsor: Galapagos NV
• Public title: A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)
• Scientific title: A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis.
• Date of first enrolment: 18/06/2018
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004302-18
• 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: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Croatia, Egypt, Finland, France, Oman, Romania, Slovakia, Sweden, Ukraine

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects who meet all of the following criteria are eligible for the study:
- Signed informed consent form (ICF) obtained prior to any study-related
procedures and/or assessments performed.
- Males or females of non-child-bearing potential, 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 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guideline. Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone, or nintedanib at a stable dose for at least 8 weeks before screening, and during screening; or neither pirfenidone nor nintedanib (for any reason). A stable dose is defined as the highest tolerated dose. Prednisone at steady dose =10 mg/day or equivalent glucocorticoid dose is allowed (stabilized 4 weeks prior to screening and continued without variation of dose or regimen). Supportive care like supplemental oxygen or pulmonary rehabilitation is allowed.
- 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 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 is not available, a HRCT can be performed at screening to determine eligibility, according to the same requirements as the
historical HRCT.
- Meeting all of the following criteria at screening and during the screening period:
* FVC =50% predicted of normal
* Disease progression, defined as a decline of FVC (% predicted or mL) at the investigator's discretion, during the 9 months prior to the screening period and confirmed at the screening visit * Diffusing capacity for the lungs for carbon monoxide (DLCO) =30% predicted of normal (corrected for hemoglobin)
* Ratio of forced expiratory volume in one second (FEV1) to FVC =0.70
- In a stable condition and suitable for study participation based on the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation. Stable condition is based on the clinical judgment of the investigator, co-morbidities should be treated according to the local applicable guidelines. Concomitant medication for chronic comorbidities should be stabilized from 4 weeks before screening and during the screening period (stable defined as no clinically relevant change according to the investigator's judgement).
- Able to walk at least 150 meters during the 6MWT at screening; without having a contraindication to perform the 6MWT, or without a condition putting the subject at risk of falling during the test (at investigator's discretion). The use of a cane is allowed, the use of a stroller is not allowed at all under any circumstances.

For a complete overview of the inclusion criteria refer to the protocol.
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 39
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion criteria:
Subjects meeting one or more of the following criteria cannot be
selected for this study:
- Known hypersensitivity to any of the IMP ingredients or a history of a significant allergic reaction to any drug as determined by the investigator (e.g. anaphylaxis requiring hospitalization).
- Current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, congenital, acquired, medication induced, organ transplantation).
- Positive blood testing for hepatitis B surface antigen (HBs Ag) or hepatitis virus antibody (if positive, confirmed by hepatitis C virus (HCV) RNA positivity). Note: Subjects with a resolved hepatitis A at least 3 months prior to first dosing of the IMP can be included.
- 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, and prostate cancer medically managed through active surveillance or watchful waiting, and squamous cell carcinoma of the skin if fully resected).
- Acute IPF exacerbation within 3 months prior to screening and 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, amyloidosis), exposures (e.g. radiation, silica, asbestos, coal dust), and drugs (e.g. amiodarone).
- History of lung volume reduction surgery or lung transplant.
- Unstable cardiovascular, pulmonary (other than IPF) or other disease within 6 months prior to screening or during the screening period (e.g. coronary heart disease, heart failure, stroke).
- Subject participating in a drug, device or biologic investigational research study, concurrently with the current study, within 12 weeks or 5-half-lives of the agent whichever is longer, prior to screening, or prior participation in an investigational drug antibody/biologic study within 6 months prior to screening.

For a complete overview of the exclusion criteria refer to the protocol.


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

Health Condition(s) or Problem(s) studied

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

Idiopathic pulmonary fibrosis
MedDRA version: 20.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: GLPG1205
Product Code: G321605
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: 1445847-37-9
Current Sponsor code: G321605
Other descriptive name: GLPG1205
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Change from baseline in FVC (mL) over 26 weeks compared to placebo.

Timepoint(s) of evaluation of this end point: Various time points throughout the clinical study as specified in the protocol

Main Objective: To evaluate the efficacy of GLPG1205 treatment in subjects with IPF on pulmonary function as evaluated by FVC compared to placebo over 26 weeks.

Secondary Objective: 1. To evaluate the safety and tolerability of GLPG1205 treatment
compared to placebo over 26 weeks.
2. To evaluate the impact of GLPG1205 treatment compared to placebo on time to any major events (whichever occurs first) defined as:
? a. Mortality (all cause and respiratory-related)
? b. Hospitalization (all-cause and respiratory related)
3. To evaluate the changes from baseline in functional exercise capacity
measured by the 6-Minute Walk Test (6MWT), in IPF subjects treated with GLPG1205 compared to placebo at Week 26.
4. To evaluate the changes in quality of life measures in IPF subjects treated with GLPG1205 compared to placebo over 26 weeks.
5. To evaluate the PK of GLPG1205, nintedanib and pirfenidone in IPF subjects.

Secondary Outcome(s)

Secondary end point(s): - Safety and tolerability changes over time (baseline to 26 weeks).
- Time to any of major events (whichever occurs first) defined as:
?* Death (all-cause and respiratory-related)
?* First hospitalization (all-cause and respiratory-related)
- Change from baseline 26 weeks in functional exercise capacity, assessed by the 6MWT at Week 26.
- Change from baseline until 26 weeks in quality of life measures,
assessed by the St. George's Respiratory Questionnaire (SGRQ) total score and domains and proportion of SGRQ responders.
- Plasma concentrations of GLPG1205, nintedanib and pirfenidone

Timepoint(s) of evaluation of this end point: Various time points throughout the clinical study as specified in the protocol

Secondary ID(s)

NCT03725852

GLPG1205-CL-220

Source(s) of Monetary Support

Galapagos NV

Ethics review

Status: Approved
Approval date: 16/05/2018
Contact: