A Phase 2 Study of ABBV-3067 Alone and in Combination Wit... | NCT03969888 | Trialant
NCT03969888
Sponsor
AbbVie
Status
Completed
Last Update Posted
Jun 28, 2023Actual
Enrollment
78Actual
Phase
Phase 2
Conditions
Cystic Fibrosis
Interventions
ABBV-3067
Placebo ABBV-3067
ABBV-2222
Placebo ABBV-2222
Countries
United States
Belgium
Canada
Czechia
France
Hungary
Netherlands
New Zealand
Poland
Serbia
Slovakia
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03969888
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M19-530
Secondary IDs
ID
Type
Description
Link
2019-000750-63
EudraCT Number
Brief Title
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Official 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
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Jun 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 11, 2019Actual
Primary Completion Date
Jun 9, 2022Actual
Completion Date
Jun 9, 2022Actual
First Submitted Date
May 30, 2019
First Submission Date that Met QC Criteria
May 30, 2019
First Posted Date
May 31, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jun 8, 2023
Results First Submitted that Met QC Criteria
Jun 8, 2023
Results First Posted Date
Jun 28, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 8, 2023
Last Update Posted Date
Jun 28, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Cystic Fibrosis
Keywords
Cystic Fibrosis
ABBV-3067
ABBV-2222, F508del Mutation
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
78Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ABBV-3067 50 mg + Placebo for ABBV-2222
Experimental
Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Drug: ABBV-3067
Drug: Placebo ABBV-2222
ABBV-3067 150 mg + Placebo for ABBV-2222
Experimental
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Drug: ABBV-3067
Drug: Placebo ABBV-2222
ABBV-3067 150 mg + ABBV-2222 10 mg
Experimental
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
Drug: ABBV-3067
Drug: ABBV-2222
ABBV-3067 150 mg + ABBV-2222 30 mg
Experimental
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
Drug: ABBV-3067
Drug: ABBV-2222
ABBV-3067 150 mg + ABBV-2222 100 mg
Experimental
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ABBV-3067
Drug
Tablet taken orally.
ABBV-3067 150 mg + ABBV-2222 10 mg
ABBV-3067 150 mg + ABBV-2222 100 mg
ABBV-3067 150 mg + ABBV-2222 200 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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.
Day 1 (Baseline) through Day 29
Secondary Outcomes
Measure
Description
Time Frame
Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
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.
Day 1 (Baseline) through Day 29
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Exclusion Criteria:
History of solid organ or hematopoietic transplant
Cirrhosis with portal hypertension
Use of CFTR modulator therapy within 60 days prior to Screening
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
ABBVIE INC.
AbbVie
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Arkansas /ID# 212541
Little Rock
Arkansas
72205
United States
Tampa General Hospital /ID# 212342
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
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.
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/
Participants with Cystic Fibrosis (CF) who are homozygous for the F508del mutation were enrolled in this 2-part study to receive ABBV-3067 alone and in combination with ABBV-2222 for 28 days. In Part 1 participants received 2 different doses of ABBV-3067 as a single agent, and 5 different doses of ABBV-2222 as dual-combination therapy with ABBV-3067 at a fixed dose. Part 2 of the study was not conducted as it was deemed not enrollable by the time Part 1 was completed.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
Drug: ABBV-3067
Drug: ABBV-2222
ABBV-3067 150 mg + ABBV-2222 300 mg
Experimental
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
Drug: ABBV-3067
Drug: ABBV-2222
Placebo for ABBV-3067 + Placebo for ABBV-2222
Placebo Comparator
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Drug: Placebo ABBV-3067
Drug: Placebo ABBV-2222
ABBV-3067 150 mg + ABBV-2222 30 mg
ABBV-3067 150 mg + ABBV-2222 300 mg
ABBV-3067 150 mg + Placebo for ABBV-2222
ABBV-3067 50 mg + Placebo for ABBV-2222
Placebo ABBV-3067
Drug
Tablet taken orally.
Placebo for ABBV-3067 + Placebo for ABBV-2222
ABBV-2222
Drug
Capsule taken orally.
ABBV-3067 150 mg + ABBV-2222 10 mg
ABBV-3067 150 mg + ABBV-2222 100 mg
ABBV-3067 150 mg + ABBV-2222 200 mg
ABBV-3067 150 mg + ABBV-2222 30 mg
ABBV-3067 150 mg + ABBV-2222 300 mg
Placebo ABBV-2222
Drug
Capsule taken orally.
ABBV-3067 150 mg + Placebo for ABBV-2222
ABBV-3067 50 mg + Placebo for ABBV-2222
Placebo for ABBV-3067 + Placebo for ABBV-2222
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
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.
Day 1 (Baseline) through Day 29
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
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.
Day 1 (Baseline) through Day 29
Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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.
Day 1 (Baseline) through Day 29
Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
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.
Day 1 (Baseline) through Day 29
Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
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.
Day 1 (Baseline) through Day 29
Tampa
Florida
33606
United States
University of Iowa Hospitals and Clinics /ID# 212351
Iowa City
Iowa
52242
United States
Univ Michigan Med Ctr /ID# 212657
Ann Arbor
Michigan
48109
United States
Cardinal Glennon Children's Hospital /ID# 212349
St Louis
Missouri
63104
United States
Washington University-School of Medicine /ID# 212352
St Louis
Missouri
63110
United States
Nationwide Children's Hospital /ID# 213158
Columbus
Ohio
43205-2664
United States
Medical University of South Carolina /ID# 212187
Charleston
South Carolina
29425
United States
Vanderbilt University Medical Center /ID# 212353
Nashville
Tennessee
37232
United States
University of Utah /ID# 212350
Salt Lake City
Utah
84112-5500
United States
Uza /Id# 213412
Edegem
Antwerpen
2650
Belgium
Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 213413
Brussels
Brussels Capital
1070
Belgium
UZ Brussel /ID# 212812
Jette
Brussels Capital
1090
Belgium
UZ Gent /ID# 213411
Ghent
Oost-Vlaanderen
9000
Belgium
Universitair Ziekenhuis Leuven /ID# 213050
Leuven
Vlaams-Brabant
3000
Belgium
University of Calgary /ID# 212555
Calgary
Alberta
T2N 4Z6
Canada
St. Paul's Hospital /ID# 212554
Vancouver
British Columbia
V6Z 1Y6
Canada
QEII - Health Sciences Centre /ID# 212656
Halifax
Nova Scotia
B3H 2Y9
Canada
Unity Health Toronto - St. Michael's Hospital /ID# 212552
Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 212820
Belgrade
Beograd
11000
Serbia
Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213146
Bratislava
821 01
Slovakia
Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213596
Bratislava
821 06
Slovakia
Barts Health NHS Trust /ID# 213016
London
London, City of
E1 2ES
United Kingdom
Nottingham University Hospitals NHS Trust /ID# 212531
Nottingham
Nottinghamshire
NG5 1PB
United Kingdom
Cardiff & Vale University Health Board /ID# 212504
Cardiff
Wales
CF14 4XN
United Kingdom
Royal Papworth Hospital NHS Foundation Trust /ID# 212507
Cambridge
CB2 0AY
United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 212491
Leeds
LS9 7TF
United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust /ID# 212291
Liverpool
L14 3PE
United Kingdom
Royal Brompton and Harefield Hospitals /ID# 212490
London
SW3 6NP
United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 212665
Newcastle upon Tyne
NE7 7DN
United Kingdom
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG006
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.
FG007
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.
FG0006 subjects
FG0017 subjects
FG0025 subjects
FG00312 subjects
FG00411 subjects
FG00512 subjects
FG00614 subjects
FG00711 subjects
COMPLETED
FG0006 subjects
FG0017 subjects
FG0024 subjects
FG00312 subjects
FG00411 subjects
FG00512 subjects
FG00613 subjects
FG00710 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
Type
Comment
Reasons
Never Received Study Drug
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Reason Not Specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Full Analysis Set (FAS) includes all randomized participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
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.
BG007
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.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0017
BG0025
BG00312
BG00411
BG00512
BG00614
BG00711
BG00878
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0017
ParticipantsBG0025
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0017
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0017
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0017
ParticipantsBG002
Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1 ) at Baseline
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Number analyzed are the number of participants with data available for analysis for ppFEV1 at baseline
Mean
Standard Deviation
percent predicted FEV1 (%)
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0017
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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.
FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
Posted
Least Squares Mean
95% Confidence Interval
percent predicted FEV1 (%)
Day 1 (Baseline) through Day 29
ID
Title
Description
OG000
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG0005
OG0015
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.3(-4.38 to 4.98)
OG001-2.2(-7.03 to 2.66)
OG0022.0(-5.07 to 9.07)
OG003
Secondary
Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
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.
FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
Posted
Least Squares Mean
95% Confidence Interval
millimole per liter (mmol/L)
Day 1 (Baseline) through Day 29
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Secondary
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
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.
FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
Posted
Least Squares Mean
95% Confidence Interval
liter (L)
Day 1 (Baseline) through Day 29
ID
Title
Description
OG000
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
OG001
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.
OG002
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.
OG003
Secondary
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
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.
FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
Posted
Least Squares Mean
95% Confidence Interval
liter per seconds (L/sec)
Day 1 (Baseline) through Day 29
ID
Title
Description
OG000
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
OG001
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.
OG002
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.
Secondary
Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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.
FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
Posted
Least Squares Mean
95% Confidence Interval
percent predicted FEV1
Day 1 (Baseline) through Day 29
ID
Title
Description
OG000
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
OG001
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.
OG002
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.
OG003
Secondary
Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
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.
FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
Posted
Least Squares Mean
95% Confidence Interval
L/sec
Day 1 (Baseline) through Day 29
ID
Title
Description
OG000
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
OG001
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.
OG002
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.
OG003
Secondary
Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
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.
FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
Posted
Least Squares Mean
95% Confidence Interval
liter
Day 1 (Baseline) through Day 29
ID
Title
Description
OG000
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
OG001
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.
OG002
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.
OG003
ABBV-3067 150 mg + ABBV-2222 30 mg
Time Frame
All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
Description
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
0
6
0
6
2
6
EG001
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.
0
7
0
7
5
7
EG002
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.
0
4
0
4
4
4
EG003
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.
0
12
2
12
8
12
EG004
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.
0
11
0
11
10
11
EG005
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.
0
12
0
12
6
12
EG006
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.
0
13
0
13
6
13
EG007
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.
0
11
0
11
6
11
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ILEUS
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected12 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected11 at risk
CHOLECYSTITIS ACUTE
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
CYSTIC FIBROSIS
Congenital, familial and genetic disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected12 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected12 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected11 at risk
VERTIGO
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
MYOPIA
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0022 events2 affected4 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
FAECES DISCOLOURED
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
FREQUENT BOWEL MOVEMENTS
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
RETCHING
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
CHEST DISCOMFORT
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
CHEST PAIN
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
FATIGUE
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
PYREXIA
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
BACTERIURIA
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
RASH PUSTULAR
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
SIALOADENITIS
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD GLUCOSE DECREASED
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
C-REACTIVE PROTEIN INCREASED
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
FORCED EXPIRATORY VOLUME DECREASED
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
INTERNATIONAL NORMALISED RATIO INCREASED
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
NEUTROPHIL COUNT INCREASED
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
WHITE BLOOD CELL COUNT INCREASED
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
INCREASED APPETITE
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
MYOSITIS
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
PANIC ATTACK
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
BRONCHOSPASM
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
DRY THROAT
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
PHARYNGEAL ERYTHEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
PLEURITIC PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
RALES
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
SPUTUM INCREASED
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
PAPULE
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
FLUSHING
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.