Rationale, design and objectives of two phase III, randomised, placebo-controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and 2)
| Autor: | Michael Kreuter, Ann Fieuw, Paul Ford, Marlies S. Wijsenbeek, Simone Stutvoet, Nadia Verbruggen, David J. Lederer, Wim A. Wuyts, Toby M. Maher, Walid Abi-Saab, Kevin K. Brown |
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| Přispěvatelé: | Pulmonary Medicine |
| Rok vydání: | 2019 |
| Předmět: |
Male
Vital capacity Respiratory System PATHOGENESIS Vital Capacity GUIDELINES NINTEDANIB Placebos Idiopathic pulmonary fibrosis 0302 clinical medicine Quality of life Clinical endpoint Randomized Controlled Trials as Topic HEALTH-STATUS rare lung diseases STATEMENT PIRFENIDONE Imidazoles Treatment Outcome Research Design 030220 oncology & carcinogenesis SURVIVAL Disease Progression Female Life Sciences & Biomedicine Pulmonary and Respiratory Medicine Adult medicine.medical_specialty Placebo DIAGNOSIS Interstitial Lung Disease 03 medical and health sciences FEV1/FVC ratio Double-Blind Method Internal medicine medicine Humans Science & Technology PHASE-3 TRIAL business.industry Phosphoric Diester Hydrolases interstitial fibrosis medicine.disease Idiopathic Pulmonary Fibrosis COMBINATION THERAPY Pyrimidines 030228 respiratory system Clinical Trials Phase III as Topic Good clinical practice Quality of Life business Declaration of Helsinki |
| Zdroj: | BMJ Open Respiratory Research BMJ Open Respiratory Research, 6(1):UNSP e000422. BMJ Publishing Group |
| ISSN: | 2052-4439 |
| Popis: | IntroductionWhile current standard of care (SOC) for idiopathic pulmonary fibrosis (IPF) slows disease progression, prognosis remains poor. Therefore, an unmet need exists for novel, well-tolerated agents that reduce lung function decline and improve quality of life. Here we report the design of two phase III studies of the novel IPF therapy, GLPG1690.Methods and analysisTwo identically designed, phase III, international, randomised, double-blind, placebo-controlled, parallel-group, multicentre studies (ISABELA 1 and 2) were initiated in November 2018. It is planned that, in each study, 750 subjects with IPF will be randomised 1:1:1 to receive oral GLPG1690 600 mg, GLPG1690 200 mg or placebo, once daily, on top of local SOC, for at least 52 weeks. The primary endpoint is rate of decline of forced vital capacity (FVC) over 52 weeks. Key secondary endpoints are week 52 composite endpoint of disease progression or all-cause mortality (defined as composite endpoint of first occurrence of ≥10% absolute decline in per cent predicted FVC or all-cause mortality at week 52); time to first respiratory-related hospitalisation until end of study; and week 52 change from baseline in the St George’s Respiratory Questionnaire total score (a quality-of-life measure).Ethics and disseminationStudies will be conducted in accordance with Good Clinical Practice guidelines, Declaration of Helsinki principles, and local ethical and legal requirements. Results will be reported in a peer-reviewed publication.Trial registration numbersNCT03711162; NCT03733444. |
| Databáze: | OpenAIRE |
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