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A Phase 2 study of ABBV-3067 alone and in combination with ABBV-2222

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

In set 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 Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation

In this study, participants will be given ABBV-3067 (“potentiator”) and ABBV-2222 (“corrector”) to see if treatment improves participants’ lung function. Different groups of participants will receive different doses, and some will receive a dummy drug (“placebo”). This study evaluates the safety and efficacy (how well the medications work) of the medications and the best dose of each medicine to be used in future studies. This is a Phase 2, double-blinded (treatment type is unknown to participants and investigators) study in people with CF who have two copies of the F508del mutation (the most common CFTR gene mutation). Participants go through a screening process (up to a month) and receive study treatment for up to a month, followed by a review, a month later. Tests done for the study include lung function tests, sweat chloride tests, blood and urine tests, and ECG. Side effects are monitored through the course of the study.

Trial Reference Number

123868

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

CFTR Modulators

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

189

Last edited date

24 August 2020

CF sponsor

AbbVie

CF sponsor type

Commercial

Who can take part?

Top inclusion criteria
  • Homozygous for the F508del Mutation (2 copies of F508d)
  • 18 Years and older
  • Lung function > 40 and <90%
Top exclusion criteria
  • Cirrhosis with portal hypertension
  • Use of CFTR modulator therapy within 60 days prior to Screening

CF centres running this trial

Recruiting

Liverpool Heart and Chest Hospital

Address

Thomas Drive Liverpool Merseyside L14 3PE

Recruitment starts

December 2019

Recruitment ends

March 2021

Contact

Greenwood, James

Get in touch

Recruiting

ST JAMES'S UNIVERSITY HOSPITAL

Address

BECKETT STREET, LEEDS, WEST YORKSHIRE LS9 7TF

Recruitment starts

February 2020

Recruitment ends

March 2021

Contact

Peckham, Daniel

Get in touch

Closed

Barts Health NHS Trust

Address

Trust headquarters 5th Floor Aneurin Bevan House 81 Commercial Road London E1 1RD

Contact

,

Get in touch

Closed

Nottingham University Hospitals NHS Trust - City Campus

Address

Hucknall RoadNottingham City HospitalNottinghamNottingham City HospitalNottinghamshire NG5 1PB

Contact

Barr, Helen

Get in touch
Show all participating centres