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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

Closed to recruitment - in follow up

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 study is designed to evaluate the effectiveness and safety of lenabasum (JBT-101) in people with CF who have had pulmonary exacerbations. Lenabasum (JBT-101) is an oral medication that is aimed at reducing inflammation. It is thought to help the body increase production of anti-inflammatory molecules while reducing production of molecules that increase inflammation. Reduction of inflammation helps prevent permanent tissue damage in the lungs that happens when CF patients have pulmonary exacerbations. For study participants this study includes 6 months of study treatment with a 1 month follow up period. Study participants may remain on their current CF treatments

Trial Reference Number

106210

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

Lenabasum (anti-inflammatory)

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

415

Last edited date

03 September 2019

CF sponsor

Corbus Pharmaceuticals Inc.

CF sponsor type

Commercial

Who can take part?

Top inclusion criteria
  • 12 Years and older
  • Over 40 kg
  • Able to perform pulmonary function tests
Top exclusion criteria
  • Severe or unstable CF at screening or visit one
  • Actively listed on an organ transplant list or have had an organ transplant other than corneal transplant

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

Recruitment starts

August 2018

Recruitment ends

April 2020

Contact

Downey, Damian

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

Closed

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

Closed

Liverpool Heart and Chest Hospital

Address

Thomas Drive Liverpool Merseyside L14 3PE

Recruitment starts

September 2018

Recruitment ends

March 2019

Contact

Greenwood, James

Get in touch
Show all participating centres