GLPG3067-CL-202 Assessment multiple oral doses of GLPG3067/2222/2737

• Research type

  Research Study

• Full title

  A Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered combination of GLPG3067, GLPG2222 and GLPG2737, in adult subjects with cystic fibrosis homozygous or heterozygous for F508del CFTR

• IRAS ID

  246108

• Contact name

  Peter Barry

• Contact email

  peter.barry@mft.nhs.uk

• Sponsor organisation

  Galapagos NV

• Eudract number

  2018-000098-61

• Duration of Study in the UK

  0 years, 10 months, 25 days

• Research summary

  This a Phase II, randomised, double-blind, placebo-controlled, multi-centre study in adult participants with Cystic Fibrosis (CF) who are homozygous or heterozygous for F508del CFTR.
  The purpose of this study is to provide efficacy (assessed by means of pharmacodynamic [PD]/clinical endpoints), safety and tolerability, and pharmacokinetic (PK) results when multiple doses of dual combination of GLPG3067 and GLPG2222, followed by multiple doses of triple combination of GLPG3067, GLPG2222 and GLPG2737 (including a dose range of GLPG3067 and GLPG2737), are given to adult CF participants.

  The study will consist of two parts conducted in parallel: Part I will include CF participants homozygous for F508del and Part II will include participants heterozygous for F508del for people who carry an unresponsive mutation on the second allele.

  Approximately 144 participants are planned to take part in this study for approximately 20 weeks (including a 28-day screening period, 12 weeks treatment period and a follow-up period of 4 weeks). UK sample size is 20 randomised participants.

  Participants have the option to participate in a sub-study, in which blood
  samples for PK analysis of GLPG3067, GLPG2222, and GLPG2737 and its active metabolite (a small molecule that is produced when the body processes the drug) G1125498 (M4) will be collected at pre-determined time points.
  In a second sub-study, one blood sample for exploratory pharmacogenomic analysis (the study of how a person's genes affect their response to particular drugs) will be taken. Participants are required to sign separate consent forms for these optional sub-studies.

  Countries planned to participate in this study;
  Australia, Belgium, Denmark, France, Germany, Ireland, Netherlands, Republic of Serbia, United Kingdom, United States of America.

  Enrolment timelines:
  Planned start date in the UK: 6 August 2018
  Planned Last Patient In (clinical interventions): 15 May 2019
  Planned end date (all trial procedures): 30 June 2019

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  18/YH/0167

• Date of REC Opinion

  19 Jun 2018

• REC opinion

  Further Information Favourable Opinion