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

Details

Therapeutic approach
Restore CFTR Function
Trial status
Closed with results Participating Centres
Trials Tracker ID
TT002041
Last updated
13/07/2020

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

Study details

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.


Phase
Phase 2
Recruitment target
189
CF sponsor
AbbVie
CF sponsor type
Commercial

Who can take part?

Age range
18 years and older
Including people

Homozygous for the F508del Mutation (2 copies of F508d)
18 Years and older
Lung function > 40 and <90%

Excluding people

Cirrhosis with portal hypertension
Use of CFTR modulator therapy within 60 days prior to Screening

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CF centres running this trial

Closed

Freeman Hospital - Newcastle

NHS Trust
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Address
Freeman Road
NE7 7DN
Closed

Liverpool Heart and Chest Hospital

NHS Trust
Liverpool Heart and Chest Hospital NHS Foundation Trust
Address
Thomas Drive
Liverpool
L14 3PE
Recruitment starts
Recruitment ends
Local site investigator
James Greenwood
Closed

Nottingham City Hospital (Adults)

CTAP centre
NHS Trust
Nottingham University Hospitals NHS Foundation Trust
Address
City Hospital, Wolfson Cystic Fibrosis Centre
Hucknall Road
NG5 1PB
Local site investigator
Helen Barr
Trial Coordinators
Fozia Naushahi
Closed

Royal Brompton Hospital (London)

CTAP centre
NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Address
Royal Brompton Hospital
Sydney Street
SW3 6NP
Recruitment starts
Recruitment ends
Local site investigator
Jane Davies
Trial Coordinators
Sophie Pinnell
Closed

St Bartholomew's Hospital (London) - Adults

CTAP centre
NHS Trust
Barts Health NHS Trust
Address
West Smithfield
EC1A 7BE
Trial Coordinators
Sandra Pereira
Closed

St James's University Hospital - Leeds (Adults)

CTAP centre
NHS Trust
The Leeds Teaching Hospitals NHS Trust
Address
St James's University Hospital
Beckett Street
LS9 7TF
Recruitment starts
Recruitment ends
Local site investigator
Daniel Peckham
Trial Coordinators
Helen Chadwick