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Albatross

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

Phase
The different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Phase II

Full title

A phase IIa, randomized, double- blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation GLPG2222-CL-202

This is a Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis (CF) with one F508del CFTR mutation and a second gating (class III) mutation. Up to 35 participants are planned to be included in the study for a minimum of 6 weeks and a maximum of 10 weeks. All participants will be at least 18 years of age and have cystic fibrosis with at least one copy of the F508del (Class II) mutation. This study will investigate whether treatment with the corrector GLPG2222 in patients heterozygous for F508del and a gating mutation who are already receiving ivacaftor treatment (standard of care), will result in an additional improvement in CFTR function, as measured by sweat chloride and lung function.

Trial type

Medication

Intervention
The name of the treatment or therapy being researched

GLPG2222 or Placebo

Recruitment target
The number of participants who need to be recruited for the trial in the UK

35

Last edited date

18 August 2017

Sponsor

Galapagos NV

Sponsor type

Commercial

Who can take part?

Age

18+

Top inclusion criteria
  • A confirmed clinical diagnosis of CF
  • One F508del mutation on one allele in the CFTR gene, a gating (class III) mutation (one of the following: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R) on the 2nd allele in the CFTR gene
  • Forced expiratory volume in 1 second (FEV1) = 40% of predicted normal for age, gender and height at screening (pre- or post-bronchodilator)
  • Stable concomitant treatment for at least 4 weeks (28 days) prior to baseline (including physician prescribed ivacaftor (Kalydeco®) 150 mg b.i.d.).
Top exclusion criteria
  • History of solid organ or hematopoietic cell transplantation
  • Positive serology for hepatitis B virus infection and/or hepatitis C virus infection and/or any history from hepatitis from any cause, with the exception of hepatitis A
  • Need for supplemental oxygen during the day, and >2 liters per minute (LPM) while sleeping

CF centres running this trial

Closed

Belfast Health and Social Care Trust

Address

Belfast Health and Social Care Trust Trust Headquarters A Floor Belfast City Hospital Lisburn Road Belfast BT9 7AB

Contact

Downey, Damian

Get in touch

Closed

Heart of England NHS Foundation Trust

Address

Birmingham Heartlands Hospital Bordesley Green East Birmingham West Midlands B9 5SS

Recruitment starts

March 2017

Recruitment ends

August 2017

Contact

Nash, Edward

Get in touch

Closed

Leeds Teaching Hospitals NHS Trust

Address

St. James's University Hospital Beckett Street Leeds West Yorkshire LS9 7TF

Recruitment starts

March 2017

Recruitment ends

September 2017

Contact

Peckham, Daniel

Get in touch

Closed

Papworth Hospital NHS Foundation Trust

Address

Papworth Hall Papworth Everard Cambridge Cambridgeshire CB23 3RE

Recruitment starts

March 2017

Recruitment ends

June 2017

Contact

Haworth, Charles

Get in touch
Show all participating centres