A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT ID: NCT03725852

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-27
• Study Completion Date: 2020-08-14

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).

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GLPG1205 100 mg

Participants will receive GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.

Group Type: EXPERIMENTAL

GLPG1205

Intervention Type: DRUG

GLPG1205 will be provided as an oral hard gelatin capsule.

Placebo

Participants will receive GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

GLPG1205 matching placebo will be provided as an oral hard gelatin capsule.

Interventions

GLPG1205

GLPG1205 will be provided as an oral hard gelatin capsule.

Intervention Type: DRUG

Placebo

GLPG1205 matching placebo will be provided as an oral hard gelatin capsule.

Intervention Type: DRUG

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.

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Seemayer, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Specialized Hospital for Active Treatment Pleven

Pleven, , Bulgaria

SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

Rousse, , Bulgaria

Acibadem City Clinic Tokuda Hospital, EAD

Sofia, , Bulgaria

Klinicki Bolnicki Centar Rijeka - Susak

Rijeka, , Croatia

Klinička Bolnica Dubrava

Zagreb, , Croatia

Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac

Zagreb, , Croatia

Helsinki University Hospital Heart and Lung Center

Helsinki, , Finland

Tampere University Hospital

Tampere, , Finland

Hôpital Avicenne

Bobigny, , France

CHU de Brest - Hôpital Cavale Blanche

Brest, , France

CHU de Lyon - Hôpital Louis Pradel

Bron, , France

CHU de Grenoble

La Tronche, , France

Hôpital Albert Calmette

Lille, , France

CHU de Nice - Hôpital Pasteur

Nice, , France

Hôpital Européen Georges Pompidou (HEGP)

Paris, , France

Hôpital Larrey

Toulouse, , France

CHRU de Tours - Hôpital Bretonneau

Tours, , France

Hôpitaux Prives de Metz (HPMetz) - Hôpital Robert Schuman

Vantoux, , France

National Oncology Centre - The Royal Hospital Muscat

Muscat, , Oman

Institutul de Pneumoftiziologie Marius Nasta

Bucharest, , Romania

Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj-Napoca

Cluj-Napoca, , Romania

Spitalul Clinic de Pneumoftiziologie Iasi

Iași, , Romania

Clinica Medicala Lavinia Davidescu

Oradea, , Romania

ZAPA JJ s.r.o.

Levice, , Slovakia

Pľúcna Ambulancia Hrebenár, s.r.o.

Spišská Nová Ves, , Slovakia

National Institute of Tuberculosis, Pulmonary Diseases and Chest Surgery

Vyšné Hágy, , Slovakia

Universitetssjukhuset i Lund

Lund, , Sweden

Karolinska Universitetssjukhuset

Stockholm, , Sweden

Akademiska Sjukhuset - Uppsala Centrum for Cystisk Fibros

Uppsala, , Sweden

Dnipropetrovsk State Medical Academy - Dnipropetrovsk City Clinical Hospital No. 6

Dnipropetrovsk, , Ukraine

The Ivano-Frankivsk National Medical Univeristy

Ivano-Frankivsk, , Ukraine

Communal Nonprofit Enterprise City Clinical Hospital

Kharkiv, , Ukraine

Municipal Institution "Kherson city clinical hospital named after E.E. Karabelesh"

Kherson, , Ukraine

National Institute of Phthisiology and Pulmonology named after F.G. Yanovskyi of NAMS of Ukraine

Kyiv, , Ukraine

Odessa Regional Hospital

Odesa, , Ukraine

Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

Vinnytsia, , Ukraine

Countries

Bulgaria; Croatia; Finland; France; Oman; Romania; Slovakia; Sweden; Ukraine

References

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.

Reference Type: BACKGROUND

Strambu IR, Seemayer CA, Fagard LMA, Ford PA, Van der Aa TAK, de Haas-Amatsaleh AA, Modgill V, Santermans E, Sondag EN, Helmer EG, Maher TM, Costabel U, Cottin V. GLPG1205 for idiopathic pulmonary fibrosis: a phase 2 randomised placebo-controlled trial. Eur Respir J. 2023 Mar 2;61(3):2201794. doi: 10.1183/13993003.01794-2022. Print 2023 Mar.

Reference Type: DERIVED

PMID: 36328358 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-004302-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG1205-CL-220

Identifier Type: -

Identifier Source: org_study_id