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

NCT03725852 | Completed Phase 2 Results DMC

• 2 other identifiers: GLPG1205-CL-2202017-004302-18
• Study Type: interventional
• Target: 68
• Locations: 9 countries
• Sites: 36

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Forced Vital Capacity (FVC) at Week 26

  Forced vital capacity (FVC) (in milliliter \[mL\]) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

  Baseline, Week 26

Secondary Outcomes (9)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation

  First dose date up to 30 days after the last dose of study drug (maximum up to 263 days)

• 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

  Day 1 up to Week 30

• Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26

  Baseline, Week 26

• Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26

  Baseline, Week 26

• Change From Baseline in SGRQ Domain Score at Week 26

  Baseline, Week 26

Study Arms (2)

GLPG1205 100 mg

EXPERIMENTAL

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.

Drug: GLPG1205

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

GLPG1205 DRUG

GLPG1205 will be provided as an oral hard gelatin capsule.

GLPG1205 100 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (36)

Specialized Hospital for Active Treatment Pleven

Pleven, 5800, Bulgaria

Location

SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

Rousse, 7002, Bulgaria

Location

Acibadem City Clinic Tokuda Hospital, EAD

Sofia, Bulgaria

Location

Klinicki Bolnicki Centar Rijeka - Susak

Rijeka, 51000, Croatia

Location

Klinička Bolnica Dubrava

Zagreb, Croatia

Location

Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac

Zagreb, Croatia

Location

Helsinki University Hospital Heart and Lung Center

Helsinki, 00290, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Hôpital Avicenne

Bobigny, France

Location

CHU de Brest - Hôpital Cavale Blanche

Brest, France

Location

CHU de Lyon - Hôpital Louis Pradel

Bron, France

Location

CHU de Grenoble

La Tronche, France

Location

Hôpital Albert Calmette

Lille, 59037, France

Location

CHU de Nice - Hôpital Pasteur

Nice, France

Location

Hôpital Européen Georges Pompidou (HEGP)

Paris, France

Location

Hôpital Larrey

Toulouse, France

Location

CHRU de Tours - Hôpital Bretonneau

Tours, France

Location

Hôpitaux Prives de Metz (HPMetz) - Hôpital Robert Schuman

Vantoux, France

Location

National Oncology Centre - The Royal Hospital Muscat

Muscat, Oman

Location

Institutul de Pneumoftiziologie Marius Nasta

Bucharest, 50159, Romania

Location

Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj-Napoca

Cluj-Napoca, 400371, Romania

Location

Spitalul Clinic de Pneumoftiziologie Iasi

Iași, 700115, Romania

Location

Clinica Medicala Lavinia Davidescu

Oradea, 410169, Romania

Location

ZAPA JJ s.r.o.

Levice, 934 01, Slovakia

Location

Pľúcna Ambulancia Hrebenár, s.r.o.

Spišská Nová Ves, 05201, Slovakia

Location

National Institute of Tuberculosis, Pulmonary Diseases and Chest Surgery

Vyšné Hágy, 059 84, Slovakia

Location

Universitetssjukhuset i Lund

Lund, 22185, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

Akademiska Sjukhuset - Uppsala Centrum for Cystisk Fibros

Uppsala, Sweden

Location

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

Dnipropetrovsk, 49074, Ukraine

Location

The Ivano-Frankivsk National Medical Univeristy

Ivano-Frankivsk, Ukraine

Location

Communal Nonprofit Enterprise City Clinical Hospital

Kharkiv, Ukraine

Location

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

Kherson, Ukraine

Location

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

Kyiv, 3680, Ukraine

Location

Odessa Regional Hospital

Odesa, Ukraine

Location

Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

Vinnytsia, Ukraine

Location

Related Publications (2)

• 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.

  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.

  PMID: 36328358 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

GLPG1205

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study was not powered to detect statistical significance and was limited by its small sample size, high variability of the primary endpoint (FVC), and a high rate of early treatment discontinuations.

Results Point of Contact

• Title: Galapagos Medical Information
• Organization: Galapagos NV

medicalinfo@glpg.com

+32 15 342 900

Study Officials

• Christian Seemayer, MD

  Galapagos NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: October 31, 2018
• Study Start: September 27, 2018
• Primary Completion: July 21, 2020
• Study Completion: August 14, 2020
• Last Updated: September 14, 2021
• Results First Posted: September 14, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BU (3); RO (4); SL (3); FR (10); FI (2); SE (3); OM (1); UA (7); CR (3)