Clinical trial NCT03725852: A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2018-10-31
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter, exploratory Phase 2 study including participants with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 in addition to the local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib nor pirfenidone).


Eligibility criteria: Inclusion criteria:

Participants who meet all of the following criteria are eligible for the study:

* 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. Participants 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 less than or equal to 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.
* Meeting all of the following criteria at screening and during the screening period:

  * Forced vital capacity (FVC) greater than or equal to 50% predicted of normal
  * Disease progression, defined as a decline of FVC (% predicted or milliliters \[mL\]) 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) greater than or equal to 30% predicted of normal (corrected for hemoglobin)
  * Ratio of forced expiratory volume in one second (FEV1) to FVC greater than or equal to 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 electrocardiogram (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 6 Minute Walk Test (6MWT) at screening; without having a contraindication to perform the 6MWT.

This list only describes the key inclusion criteria.

Exclusion criteria:

Participants 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 (HCV) antibody (if positive, confirmed by HCV ribonucleic acid \[RNA\] positivity). Note: Participants 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).
* Participant 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.

Primary outcomes:
measure: Change From Baseline in Forced Vital Capacity (FVC) at Week 26
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation
timeFrame: First dose date up to 30 days after the last dose of study drug (maximum up to 263 days)
measure: Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations
timeFrame: Day 1 up to Week 30
measure: Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in SGRQ Domain Score at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of SGRQ Responders
timeFrame: Baseline up to Week 26
measure: Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26
timeFrame: Week 26 (pre-dose)
measure: Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20
timeFrame: Week 20 (pre-dose)
measure: Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20
timeFrame: Week 20 (pre-dose)
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Specialized Hospital for Active Treatment Pleven
city: Ruse
country: Bulgaria
facility: SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital, EAD
city: Rijeka
country: Croatia
facility: Klinicki Bolnicki Centar Rijeka - Susak
city: Zagreb
country: Croatia
facility: Klinička Bolnica Dubrava
city: Zagreb
country: Croatia
facility: Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac
city: Helsinki
country: Finland
facility: Helsinki University Hospital Heart and Lung Center
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Brest
country: France
facility: CHU de Brest - Hôpital Cavale Blanche
city: Bron
country: France
facility: CHU de Lyon - Hôpital Louis Pradel
city: La Tronche
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: Hôpital Albert Calmette
city: Nice
country: France
facility: CHU de Nice - Hôpital Pasteur
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou (HEGP)
city: Toulouse
country: France
facility: Hôpital Larrey
city: Tours
country: France
facility: CHRU de Tours - Hôpital Bretonneau
city: Vantoux
country: France
facility: Hôpitaux Prives de Metz (HPMetz) - Hôpital Robert Schuman
city: Muscat
country: Oman
facility: National Oncology Centre - The Royal Hospital Muscat
city: Bucuresti
country: Romania
facility: Institutul de Pneumoftiziologie Marius Nasta
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj-Napoca
city: Iaşi
country: Romania
facility: Spitalul Clinic de Pneumoftiziologie Iasi
city: Oradea
country: Romania
facility: Clinica Medicala Lavinia Davidescu
city: Levice
country: Slovakia
facility: ZAPA JJ s.r.o.
city: Spišská Nová Ves
country: Slovakia
facility: Pľúcna Ambulancia Hrebenár, s.r.o.
city: Vyšné Hágy
country: Slovakia
facility: National Institute of Tuberculosis, Pulmonary Diseases and Chest Surgery
city: Lund
country: Sweden
facility: Universitetssjukhuset i Lund
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset - Uppsala Centrum for Cystisk Fibros
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk State Medical Academy - Dnipropetrovsk City Clinical Hospital No. 6
city: Ivano-Frankivs'k
country: Ukraine
facility: The Ivano-Frankivsk National Medical Univeristy
city: Kharkiv
country: Ukraine
facility: Communal Nonprofit Enterprise City Clinical Hospital
city: Kherson
country: Ukraine
facility: Municipal Institution "Kherson city clinical hospital named after E.E. Karabelesh"
city: Kyiv
country: Ukraine
facility: National Institute of Phthisiology and Pulmonology named after F.G. Yanovskyi of NAMS of Ukraine
city: Odessa
country: Ukraine
facility: Odessa Regional Hospital
city: Vinnytsia
country: Ukraine
facility: Vinnitsa Regional Clinical Hospital im. N.I. Pirogov
Study officials:
affiliation: Galapagos NV
name: Christian Seemayer, MD
role: STUDY_DIRECTOR
References:
citation: Strambu IR, Fagard L, Ford P, Van Der Aa T, De Haas-Amatsaleh A, Santermans E, Seemayer C. (2020). Idiopathic pulmonary fibrosis (IPF): observations from a Phase 2 trial of GLPG1205 (PINTA). Abstract for European Respiratory Society International Congress 7-9 September 2020.