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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More 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.
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03725852
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Galapagos NV
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Christian Seemayer, MD
Principal Investigator Affiliation Galapagos NV
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Bulgaria, Croatia, Finland, France, Oman, Slovakia, Sweden, Ukraine
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Vinnytsia, Ukraine

Status

Recruiting

Address

Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

Vinnytsia, ,

Odessa Regional Hospital, Odessa, Ukraine

Status

Recruiting

Address

Odessa Regional Hospital

Odessa, ,

Kyiv, Ukraine

Status

Recruiting

Address

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

Kyiv, , 3680

Kherson, Ukraine

Status

Recruiting

Address

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

Kherson, ,

Kharkiv, Ukraine

Status

Recruiting

Address

Communal Nonprofit Enterprise City Clinical Hospital

Kharkiv, ,

Ivano-Frankivs'k, Ukraine

Status

Recruiting

Address

The Ivano-Frankivsk National Medical Univeristy

Ivano-Frankivs'k, ,

Dnipropetrovsk, Ukraine

Status

Recruiting

Address

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

Dnipropetrovsk, , 49074

Uppsala, Sweden

Status

Recruiting

Address

Akademiska Sjukhuset - Uppsala Centrum for Cystisk Fibros

Uppsala, ,

Karolinska Universitetssjukhuset, Stockholm, Sweden

Status

Recruiting

Address

Karolinska Universitetssjukhuset

Stockholm, ,

Universitetssjukhuset i Lund, Lund, Sweden

Status

Recruiting

Address

Universitetssjukhuset i Lund

Lund, , 22185

Pľúcna Ambulancia Hrebenár, s.r.o., Spišská Nová Ves, Slovakia

Status

Recruiting

Address

Pľúcna Ambulancia Hrebenár, s.r.o.

Spišská Nová Ves, , 05201

ZAPA JJ s.r.o., Levice, Slovakia

Status

Recruiting

Address

ZAPA JJ s.r.o.

Levice, , 934 01

Muscat, Oman

Status

Recruiting

Address

National Oncology Centre - The Royal Hospital Muscat

Muscat, ,

Vantoux, France

Status

Recruiting

Address

Hôpitaux Prives de Metz (HPMetz) - Hôpital Robert Schuman

Vantoux, ,

CHRU de Tours - Hôpital Bretonneau, Tours, France

Status

Recruiting

Address

CHRU de Tours - Hôpital Bretonneau

Tours, ,

Hôpital Larrey, Toulouse, France

Status

Recruiting

Address

Hôpital Larrey

Toulouse, ,

Hôpital Européen Georges Pompidou (HEGP), Paris, France

Status

Recruiting

Address

Hôpital Européen Georges Pompidou (HEGP)

Paris, ,

CHU de Nice - Hôpital Pasteur, Nice, France

Status

Recruiting

Address

CHU de Nice - Hôpital Pasteur

Nice, ,

Hôpital Albert Calmette, Lille, France

Status

Recruiting

Address

Hôpital Albert Calmette

Lille, , 59037

CHU de Grenoble, La Tronche, France

Status

Recruiting

Address

CHU de Grenoble

La Tronche, ,

CHU de Lyon - Hôpital Louis Pradel, Bron, France

Status

Recruiting

Address

CHU de Lyon - Hôpital Louis Pradel

Bron, ,

CHU de Brest - Hôpital Cavale Blanche, Brest, France

Status

Recruiting

Address

CHU de Brest - Hôpital Cavale Blanche

Brest, ,

Hôpital Avicenne, Bobigny, France

Status

Recruiting

Address

Hôpital Avicenne

Bobigny, ,

Tampere University Hospital, Tampere, Finland

Status

Recruiting

Address

Tampere University Hospital

Tampere, , 33521

Zagreb, Croatia

Status

Recruiting

Address

Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac

Zagreb, ,

Klinička Bolnica Dubrava, Zagreb, Croatia

Status

Recruiting

Address

Klinička Bolnica Dubrava

Zagreb, ,

Klinicki Bolnicki Centar Rijeka - Susak, Rijeka, Croatia

Status

Recruiting

Address

Klinicki Bolnicki Centar Rijeka - Susak

Rijeka, , 51000

Sofia, Bulgaria

Status

Recruiting

Address

Acibadem City Clinic Tokuda Hospital, EAD

Sofia, ,

Ruse, Bulgaria

Status

Recruiting

Address

SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

Ruse, , 7002

Pleven, Bulgaria

Status

Recruiting

Address

Specialized Hospital for Active Treatment Pleven

Pleven, , 5800

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