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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03969888
Ethics application status
Date submitted
30/05/2019
Date registered
31/05/2019

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03969888