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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03969888




Registration number
NCT03969888
Ethics application status
Date submitted
30/05/2019
Date registered
31/05/2019
Date last updated
28/06/2023

Titles & IDs
Public title
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Scientific 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
Secondary ID [1] 0 0
2019-000750-63
Secondary ID [2] 0 0
M19-530
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-3067
Treatment: Drugs - Placebo ABBV-3067
Treatment: Drugs - ABBV-2222
Treatment: Drugs - Placebo ABBV-2222

Experimental: ABBV-3067 50 mg + Placebo for ABBV-2222 - Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

Experimental: ABBV-3067 150 mg + Placebo for ABBV-2222 - Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

Experimental: ABBV-3067 150 mg + ABBV-2222 10 mg - Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.

Experimental: ABBV-3067 150 mg + ABBV-2222 30 mg - Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.

Experimental: ABBV-3067 150 mg + ABBV-2222 100 mg - Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.

Experimental: ABBV-3067 150 mg + ABBV-2222 200 mg - Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.

Experimental: ABBV-3067 150 mg + ABBV-2222 300 mg - Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.

Placebo Comparator: Placebo for ABBV-3067 + Placebo for ABBV-2222 - Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.


Treatment: Drugs: ABBV-3067
Tablet taken orally.

Treatment: Drugs: Placebo ABBV-3067
Tablet taken orally.

Treatment: Drugs: ABBV-2222
Capsule taken orally.

Treatment: Drugs: Placebo ABBV-2222
Capsule taken orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Timepoint [1] 0 0
Day 1 (Baseline) through Day 29
Secondary outcome [1] 0 0
Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
Timepoint [1] 0 0
Day 1 (Baseline) through Day 29
Secondary outcome [2] 0 0
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
Timepoint [2] 0 0
Day 1 (Baseline) through Day 29
Secondary outcome [3] 0 0
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
Timepoint [3] 0 0
Day 1 (Baseline) through Day 29
Secondary outcome [4] 0 0
Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Timepoint [4] 0 0
Day 1 (Baseline) through Day 29
Secondary outcome [5] 0 0
Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
Timepoint [5] 0 0
Day 1 (Baseline) through Day 29
Secondary outcome [6] 0 0
Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
Timepoint [6] 0 0
Day 1 (Baseline) through Day 29

Eligibility
Key inclusion criteria
- Confirmed clinical diagnosis of Cystic Fibrosis (CF) who are homozygous for the
F508del CF transmembrane conductance regulator (CFTR) mutation

- Stable pulmonary status

- Lung function >= 40 and <= 90% of predicted normal for age, gender and height at
Screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of solid organ or hematopoietic transplant

- Cirrhosis with portal hypertension

- Use of CFTR modulator therapy within 60 days prior to Screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/06/2022
Sample size
Target
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerpen
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles-Capitale
Country [12] 0 0
Belgium
State/province [12] 0 0
Oost-Vlaanderen
Country [13] 0 0
Belgium
State/province [13] 0 0
Vlaams-Brabant
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Nova Scotia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Czechia
State/province [19] 0 0
Brno
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha
Country [21] 0 0
France
State/province [21] 0 0
Alpes-Maritimes
Country [22] 0 0
France
State/province [22] 0 0
Auvergne-Rhone-Alpes
Country [23] 0 0
France
State/province [23] 0 0
Gironde
Country [24] 0 0
France
State/province [24] 0 0
Herault
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Reims
Country [27] 0 0
France
State/province [27] 0 0
Roscoff
Country [28] 0 0
France
State/province [28] 0 0
Saint-Herblain
Country [29] 0 0
Hungary
State/province [29] 0 0
Budapest
Country [30] 0 0
Netherlands
State/province [30] 0 0
Den Haag
Country [31] 0 0
Netherlands
State/province [31] 0 0
Utrecht
Country [32] 0 0
New Zealand
State/province [32] 0 0
Auckland
Country [33] 0 0
New Zealand
State/province [33] 0 0
Canterbury
Country [34] 0 0
New Zealand
State/province [34] 0 0
Waikato
Country [35] 0 0
New Zealand
State/province [35] 0 0
Otago
Country [36] 0 0
Poland
State/province [36] 0 0
Pomorskie
Country [37] 0 0
Serbia
State/province [37] 0 0
Beograd
Country [38] 0 0
Slovakia
State/province [38] 0 0
Bratislava
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London, City Of
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Nottinghamshire
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Wales
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Cambridge
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Leeds
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Liverpool
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and
in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are
homozygous for the F508del mutation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03969888
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries