A Clinical Study to Test How Effective and Safe GLPG1205 is for Patients With Idiopathic Pulmonary Fibrosis (IPF) (PINTA)
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|ClinicalTrials.gov Identifier: NCT03725852|
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: GLPG1205 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||September 27, 2018|
|Estimated Primary Completion Date :||April 25, 2020|
|Estimated Study Completion Date :||May 16, 2020|
Experimental: GLPG1205 dose A
GLPG1205 will be taken as 2 capsules, once daily (q.d.), administered for 26 weeks on top of local standard of care.
GLPG1205 will be provided as an oral hard gelatin capsule.
Placebo Comparator: Placebo
Matching placebo once daily (q.d.) administered for 26 weeks on top of local standard of care.
matching placebo will be provided as an oral hard gelatin capsule.
- Change from baseline in forced vital capacity (FVC) (mL) over 26 weeks compared to placebo. [ Time Frame: From Day 1 to Week 26 ]To evaluate the efficacy of GLPG1205 treatment in subjects with IPF on pulmonary function as evaluated by FVC compared to placebo over 26 weeks.
- The number of incidents of Treatment-Emergent Adverse Events (TEAEs), Unlisted (Unexpected) Adverse Events, Serious Adverse Events (SAEs), and discontinuations due to Adverse Events (AEs). [ Time Frame: From Day 1 to Week 26 ]To evaluate the safety and tolerability of GLPG1205 treatment compared to placebo over 26 weeks.
- Time to any of major events (whichever occurs first) defined as below: [ Time Frame: From Day 1 through study completion up to Week 30 ]
To evaluate the impact of GLPG1205 treatment compared to placebo on time to any major events (whichever occurs first) defined as:
- Mortality (all cause and respiratory-related)
- Hospitalization (all-cause and respiratory related)
- Change from baseline in functional exercise capacity, assessed by the six-minute walk test (6MWT) at Week 26. [ Time Frame: From Day 1 to Week 26 ]To evaluate the changes from baseline in functional exercise capacity measured by the 6MWT, in IPF subjects treated with GLPG1205 compared to placebo at Week 26.
- Change from baseline until 26 weeks in quality of life measures, assessed by the St.George's Respiratory Questionnaire (SGRQ) total score and domains and proportion of SGRQ responders. [ Time Frame: From Day 1 to Week 26 ]To evaluate the changes in quality of life measures in IPF subjects treated with GLPG1205 compared to placebo over 26 weeks.
- Plasma concentrations of GLPG1205, nintedanib and pirfenidone. [ Time Frame: From Day 1 to Week 30 ]To evaluate the pharmacokinetics (PK) of GLPG1205, nintedanib and pirfenidone in IPF subjects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725852
|Contact: Galapagos Medical Information||+32 15 34 29 email@example.com|
|Specialized Hospital for Active Treatment Pleven||Recruiting|
|Pleven, Bulgaria, 5800|
|SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.||Recruiting|
|Ruse, Bulgaria, 7002|
|Acibadem City Clinic Tokuda Hospital, EAD||Recruiting|
|Klinicki Bolnicki Centar Rijeka - Susak||Recruiting|
|Rijeka, Croatia, 51000|
|Klinička Bolnica Dubrava||Recruiting|
|Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac||Recruiting|
|Tampere University Hospital||Recruiting|
|Tampere, Finland, 33521|
|CHU de Brest - Hôpital Cavale Blanche||Recruiting|
|CHU de Lyon - Hôpital Louis Pradel||Recruiting|
|CHU de Grenoble||Recruiting|
|La Tronche, France|
|Hôpital Albert Calmette||Recruiting|
|Lille, France, 59037|
|CHU de Nice - Hôpital Pasteur||Recruiting|
|Hôpital Européen Georges Pompidou (HEGP)||Recruiting|
|CHRU de Tours - Hôpital Bretonneau||Recruiting|
|Hôpitaux Prives de Metz (HPMetz) - Hôpital Robert Schuman||Recruiting|
|National Oncology Centre - The Royal Hospital Muscat||Recruiting|
|ZAPA JJ s.r.o.||Recruiting|
|Levice, Slovakia, 934 01|
|Pľúcna Ambulancia Hrebenár, s.r.o.||Recruiting|
|Spišská Nová Ves, Slovakia, 05201|
|National Institute of Tuberculosis, Pulmonary Diseases and Chest Surgery||Recruiting|
|Vyšné Hágy, Slovakia, 059 84|
|Universitetssjukhuset i Lund||Recruiting|
|Lund, Sweden, 22185|
|Akademiska Sjukhuset - Uppsala Centrum for Cystisk Fibros||Recruiting|
|Dnipropetrovsk State Medical Academy - Dnipropetrovsk City Clinical Hospital No. 6||Recruiting|
|Dnipropetrovsk, Ukraine, 49074|
|The Ivano-Frankivsk National Medical Univeristy||Recruiting|
|Communal Nonprofit Enterprise City Clinical Hospital||Recruiting|
|Municipal Institution "Kherson city clinical hospital named after E.E. Karabelesh"||Recruiting|
|National Institute of Phthisiology and Pulmonology named after F.G. Yanovskyi of NAMS of Ukraine||Recruiting|
|Kyiv, Ukraine, 3680|
|Odessa Regional Hospital||Recruiting|
|Vinnitsa Regional Clinical Hospital im. N.I. Pirogov||Recruiting|
|Study Director:||Christian Seemayer, MD||Galapagos NV|