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 : December 20, 2018
|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:
- Respiratory-related mortality
- Hospitalization (all-cause and respiratory related)
- Need for placement on a lung transplant list
- 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.
- 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: Evelyn Fox||0032 15 34 29 firstname.lastname@example.org|
|Specialized Hospital for Active Treatment Pleven||Recruiting|
|Pleven, Bulgaria, 5800|
|SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.||Recruiting|
|Ruse, Bulgaria, 7002|
|ZAPA JJ s.r.o.||Recruiting|
|Levice, Slovakia, 934 01|
|Pľúcna Ambulancia Hrebenár, s.r.o.||Recruiting|
|Spišská Nová Ves, Slovakia, 05201|
|Study Director:||Christian Seemayer, MD||Galapagos NV|