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Flamingo

Details

Therapeutic category
The type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Restore CFTR Function

Trial status

Open to recruitment

Full title

A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation.

Cystic fibrosis is caused by changes in the genes of your DNA (Deoxyribonucleic Acid) encoding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein. These changes cause the CFTR to stop working as it should. CFTR is a protein present in some specific cells of the body and its correct functioning is important for those cells. GLPG2222 is being studied for treatment of cystic fibrosis. The study drug is designed to improve the amount and function of CFTR, which may improve some of the symptoms of cystic fibrosis. The purpose of this study is to find out whether GLPG2222, taken by mouth as tablet once a day, is safe, well-tolerated and effective in improving your signs and symptoms of cystic fibrosis. The study will also evaluate how the body takes in and breaks down the study drug (GLPG2222). The amount of drug in your blood will be measured at specific study visits after you start taking the drug. These measurements will show how quickly the drug is taken up by the body, how quickly it is broken down, when it reaches a steady level in the blood, and how long it stays in the body.

Trial type

Medication

Length of participation
The length of time a participant will take part in a trial, from the first to the last appointment

6 - 10 weeks

Intervention
The name of the treatment or therapy being researched

GLPG2222 or Placebo

Last edited date

01 September 2017

Sponsor

Galapagos NV

Sponsor type

Commercial

Who can take part?

Mutation

Two copies of F508del (delta F508)

Age

18+

Top inclusion criteria
  • A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation
  • Stable concomitant treatment for at least 4 weeks (28 days) prior to baseline
  • FEV1 > = 40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator)
Top exclusion criteria
  • Need for supplemental oxygen during the day, and > 2 L/minute while sleeping
  • History of hepatic cirrhosis with portal hypertension
  • Use of CFTR modulator therapy (e.g. lumacaftor or ivacaftor) within 4 weeks prior to the first study drug administration

CF centres running this trial

Closed

Papworth Hospital NHS Foundation Trust

Address

Papworth Hall Papworth Everard Cambridge Cambridgeshire CB23 3RE

Recruitment starts

June 2017

Recruitment ends

September 2017

Contact

Haworth, Charles

Get in touch

Closed

Southampton General Hospital

Address

Tremona Road Southampton Hampshire SO16 6YD

Recruitment starts

June 2017

Recruitment ends

October 2017

Contact

Carroll, Mary

Get in touch