Trial record 1 of 1 for:
NCT03725852
A Clinical Study to Test How Effective and Safe GLPG1205 is for Patients With Idiopathic Pulmonary Fibrosis (IPF) (PINTA)
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| ClinicalTrials.gov Identifier: NCT03725852 |
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Recruitment Status :
Completed
First Posted : October 31, 2018
Last Update Posted : September 11, 2020
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Sponsor:
Galapagos NV
Information provided by (Responsible Party):
Galapagos NV
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Brief Summary:
This is a randomized, double-blind, parallel group, placebo-controlled, multicenter, exploratory Phase II study including subjects with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 of top of local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib or pirfenidone).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Idiopathic Pulmonary Fibrosis | Drug: GLPG1205 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 69 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | September 27, 2018 |
| Actual Primary Completion Date : | July 21, 2020 |
| Actual Study Completion Date : | August 14, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Idiopathic pulmonary fibrosis
MedlinePlus related topics:
Pulmonary Fibrosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: GLPG1205 dose A
GLPG1205 will be taken as 2 capsules, once daily (q.d.), administered for 26 weeks on top of local standard of care.
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Drug: GLPG1205
GLPG1205 will be provided as an oral hard gelatin capsule. |
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Placebo Comparator: Placebo
Matching placebo once daily (q.d.) administered for 26 weeks on top of local standard of care.
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Drug: Placebo
matching placebo will be provided as an oral hard gelatin capsule. |
Primary Outcome Measures :
- Change from baseline in forced vital capacity (FVC) (mL) over 26 weeks compared to placebo. [ Time Frame: From Day 1 to Week 26 ]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 Outcome Measures :
- The number of incidents of Treatment-Emergent Adverse Events (TEAEs), Unlisted (Unexpected) Adverse Events, Serious Adverse Events (SAEs), and discontinuations due to Adverse Events (AEs). [ Time Frame: From Day 1 to Week 26 ]To evaluate the safety and tolerability of GLPG1205 treatment compared to placebo over 26 weeks.
- Time to any of major events (whichever occurs first) defined as below: [ Time Frame: From Day 1 through study completion up to Week 30 ]
To evaluate the impact of GLPG1205 treatment compared to placebo on time to any major events (whichever occurs first) defined as:
- Mortality (all cause and respiratory-related)
- Hospitalization (all-cause and respiratory related)
- Change from baseline in functional exercise capacity, assessed by the six-minute walk test (6MWT) at Week 26. [ Time Frame: From Day 1 to Week 26 ]To evaluate the changes from baseline in functional exercise capacity measured by the 6MWT, in IPF subjects treated with GLPG1205 compared to placebo 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. [ Time Frame: From Day 1 to Week 26 ]To evaluate the changes in quality of life measures in IPF subjects treated with GLPG1205 compared to placebo over 26 weeks.
- Plasma concentrations of GLPG1205, nintedanib and pirfenidone. [ Time Frame: From Day 1 to Week 30 ]To evaluate the pharmacokinetics (PK) of GLPG1205, nintedanib and pirfenidone in IPF subjects.
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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:
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.
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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.
This list only describes the key inclusion criteria.
Exclusion criteria:
Subjects meeting one or more of the following criteria cannot be selected for this study:
- Known hypersensitivity to any of the investigational medicinal product (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 C 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.
This list only describes the key exclusion criteria.
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): NCT03725852
Locations
Show 36 study locations
Sponsors and Collaborators
Galapagos NV
Investigators
| Study Director: | Christian Seemayer, MD | Galapagos NV |
| Responsible Party: | Galapagos NV |
| ClinicalTrials.gov Identifier: | NCT03725852 |
| Other Study ID Numbers: |
GLPG1205-CL-220 2017-004302-18 ( EudraCT Number ) |
| First Posted: | October 31, 2018 Key Record Dates |
| Last Update Posted: | September 11, 2020 |
| Last Verified: | September 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial |