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Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

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

Anti-Inflammatory

Trial status

Open to recruitment

Participating Centres
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 Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study

Trial Reference Number

106210

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

Lenabasum or Placebo

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

415

Last edited date

01 July 2019

CF sponsor

Corbus Pharmaceuticals Inc.

CF sponsor type

Commercial

Who can take part?

Top inclusion criteria
  • 12 Years and older.
  • Over 40 kg
Top exclusion criteria
  • Severe or unstable CF at screening or visit one.

CF centres running this trial

Recruiting

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

Recruitment starts

August 2018

Recruitment ends

April 2020

Contact

Downey, Damian

Get in touch

Recruiting

Cardiff & Vale UHB R&D Office - Secondary Care

Address

Cardiff and Vale UHB R&D Office 2nd Floor TB2 University Hospital of Wales Heath Park Cardiff CF14 4XW

Recruitment ends

March 2020

Contact

Duckers, Jamie

Get in touch

Recruiting

Heart of England NHS Foundation Trust

Address

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

Recruitment starts

August 2018

Recruitment ends

November 2019

Contact

Whitehouse, Joanna

Get in touch

Closed

Birmingham Children's Hospital

Address

Steelhouse Lane Birmingham West Midlands B4 6NH

Recruitment starts

October 2018

Recruitment ends

July 2019

Contact

Desai, Maya

Get in touch
Show all participating centres