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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
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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
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Secondary ID [1]
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2019-000750-63
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Secondary ID [2]
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M19-530
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Cystic fibrosis
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Respiratory
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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Assessment method [1]
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FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.
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Timepoint [1]
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Day 1 (Baseline) through Day 29
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Secondary outcome [1]
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Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
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Assessment method [1]
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Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.
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Timepoint [1]
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Day 1 (Baseline) through Day 29
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Secondary outcome [2]
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Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
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Assessment method [2]
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FVC is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
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Timepoint [2]
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Day 1 (Baseline) through Day 29
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Secondary outcome [3]
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Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
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Assessment method [3]
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FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
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Timepoint [3]
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Day 1 (Baseline) through Day 29
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Secondary outcome [4]
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Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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Assessment method [4]
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FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for analyses.
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Timepoint [4]
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Day 1 (Baseline) through Day 29
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Secondary outcome [5]
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Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
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Assessment method [5]
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FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
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Timepoint [5]
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Day 1 (Baseline) through Day 29
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Secondary outcome [6]
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Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
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Assessment method [6]
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FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
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Timepoint [6]
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Day 1 (Baseline) through Day 29
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/06/2022
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Sample size
Target
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Accrual to date
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Final
78
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Arkansas
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Florida
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Iowa
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Michigan
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Missouri
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Ohio
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South Carolina
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Antwerpen
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Herault
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Paris
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Reims
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Roscoff
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Pomorskie
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Serbia
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Beograd
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Bratislava
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Newcastle upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03969888
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03969888
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