Idiopathic Pulmonary FibrosisPhase 2PINTANCT03725852
A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing GLPG1205 in people with Idiopathic Pulmonary Fibrosis, run by Lakefront Biotherapeutics NV at 36 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- GLPG1205
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 36 sitesin 9 countries
- Study dates
- 27 Sep 2018to 14 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
36 sites in 9 countries.
36 sites in 9 countries
France10 sites
Hôpital Avicenne
Bobigny
CHU de Brest - Hôpital Cavale Blanche
Brest
CHU de Lyon - Hôpital Louis Pradel
Bron
CHU de Grenoble
La Tronche
Hôpital Albert Calmette
Lille, 59037
CHU de Nice - Hôpital Pasteur
Nice
Hôpital Européen Georges Pompidou (HEGP)
Paris
Hôpital Larrey
Toulouse
CHRU de Tours - Hôpital Bretonneau
Tours
Hôpitaux Prives de Metz (HPMetz) - Hôpital Robert Schuman
Vantoux
Ukraine7 sites
Dnipropetrovsk State Medical Academy - Dnipropetrovsk City Clinical Hospital No. 6
Dnipropetrovsk, 49074
The Ivano-Frankivsk National Medical Univeristy
Ivano-Frankivsk
Communal Nonprofit Enterprise City Clinical Hospital
Kharkiv
Municipal Institution "Kherson city clinical hospital named after E.E. Karabelesh"
Kherson
National Institute of Phthisiology and Pulmonology named after F.G. Yanovskyi of NAMS of Ukraine
Kyiv, 3680
Odessa Regional Hospital
Odesa
Vinnitsa Regional Clinical Hospital im. N.I. Pirogov
Vinnytsia
Romania4 sites
Institutul de Pneumoftiziologie Marius Nasta
Bucharest, 50159
Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj-Napoca
Cluj-Napoca, 400371
Spitalul Clinic de Pneumoftiziologie Iasi
Iași, 700115
Clinica Medicala Lavinia Davidescu
Oradea, 410169
Bulgaria3 sites
Specialized Hospital for Active Treatment Pleven
Pleven, 5800
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Rousse, 7002
Acibadem City Clinic Tokuda Hospital, EAD
Sofia
Croatia3 sites
Klinicki Bolnicki Centar Rijeka - Susak
Rijeka, 51000
Klinička Bolnica Dubrava
Zagreb
Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac
Zagreb
Slovakia3 sites
ZAPA JJ s.r.o.
Levice, 934 01
Pľúcna Ambulancia Hrebenár, s.r.o.
Spišská Nová Ves, 05201
National Institute of Tuberculosis, Pulmonary Diseases and Chest Surgery
Vyšné Hágy, 059 84
Sweden3 sites
Universitetssjukhuset i Lund
Lund, 22185
Karolinska Universitetssjukhuset
Stockholm
Akademiska Sjukhuset - Uppsala Centrum for Cystisk Fibros
Uppsala
Finland2 sites
Helsinki University Hospital Heart and Lung Center
Helsinki, 00290
Tampere University Hospital
Tampere, 33521
About this study
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
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
- Being tested
- GLPG1205, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG1205Drug
GLPG1205 will be provided as an oral hard gelatin capsule.
PlaceboDrug
GLPG1205 matching placebo will be provided as an oral hard gelatin capsule.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A TEAE was any AE with an onset date on or after the start of study drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of study drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant.
Measured: 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
Treatment effect on time to death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related) were assessed using the log-rank test. Kaplan-Meier estimates were derived for the probability of death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related). Cumulative percentage of participants with all-cause deaths, respiratory-related deaths, all-cause hospitalizations, and respiratory-related hospitalizations were reported.
Measured: Day 1 up to Week 30
Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26
The 6-MWT depicts the total distance covered by a participant during 6 minutes of walking.
Measured: Baseline, Week 26
Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26
The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.
Measured: Baseline, Week 26
Change From Baseline in SGRQ Domain Score at Week 26
The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.
Measured: Baseline, Week 26
Percentage of SGRQ Responders
The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. SGRQ responders are those with absolute change from baseline in SGRQ total score less than or equal to -4 percent (%) at least once.
Measured: Baseline up to Week 26
Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26
GLPG1205 pre-dose plasma concentration (Ctrough) at Week 26 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).
Measured: Week 26 (pre-dose)
Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20
Nintedanib pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).
Measured: Week 20 (pre-dose)
Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20
Pirfenidone pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).
Measured: Week 20 (pre-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start27 Sep 2018
- Primary completion21 Jul 2020
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Seemayer, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725852
- Sponsor's protocol ID
- GLPG1205-CL-220
- Other IDs
- 2017-004302-18, 2017
- Acronym
- PINTA
- Status last verified
- Aug 2021
- First submitted
- 8 Jun 2018
- Last updated
- 14 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 36328358
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03725852
- Acronym / sponsor ID
- PINTA / GLPG1205-CL-220
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Posted 14 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLPG1205 100 mg | Experimental | Drug: GLPG1205Participants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLPG1205GLPG1205 will be provided as an oral hard gelatin capsule. | Drug | GLPG1205 100 mg |
| PlaceboGLPG1205 matching placebo will be provided as an oral hard gelatin capsule. | Drug | Placebo |
Primary outcome
Change From Baseline in Forced Vital Capacity (FVC) at Week 26
Time frame: Baseline, 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.
9 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation
Time frame: 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
Time frame: Day 1 up to Week 30
Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26
Time frame: Baseline, Week 26
Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26
Time frame: Baseline, Week 26
Change From Baseline in SGRQ Domain Score at Week 26
Time frame: Baseline, Week 26
Percentage of SGRQ Responders
Time frame: Baseline up to Week 26
Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26
Time frame: Week 26 (pre-dose)
Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20
Time frame: Week 20 (pre-dose)
Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20
Time frame: Week 20 (pre-dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundStrambu 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.
- Derived from this study: PubMed 36328358Strambu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Seemayer, MD study director
Lakefront Biotherapeutics NV
36 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLPG1205 in people with Idiopathic Pulmonary Fibrosis, run by Lakefront Biotherapeutics NV at 36 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in France, Ukraine, Romania, Bulgaria, Croatia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Forced Vital Capacity (FVC) at Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03725852, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.