Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis, ABBV-3067, ABBV-2222, F508del Mutation
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.
Interventions
DRUGABBV-3067
Tablet taken orally.
DRUGPlacebo ABBV-3067
Tablet taken orally.
DRUGABBV-2222
Capsule taken orally.
DRUGPlacebo ABBV-2222
Capsule taken orally.
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | Day 1 (Baseline) through Day 29 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | Day 1 (Baseline) through Day 29 | 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. |
| Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | Day 1 (Baseline) through Day 29 | 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. |
| Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) | Day 1 (Baseline) through Day 29 | 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. |
| Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | Day 1 (Baseline) through Day 29 | 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. |
| Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | Day 1 (Baseline) through Day 29 | 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. |
| Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | Day 1 (Baseline) through Day 29 | 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. |
Countries
Belgium, Canada, Czechia, France, Hungary, Netherlands, New Zealand, Poland, Serbia, Slovakia, United Kingdom, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 7 |
| 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. | 5 |
| 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. | 12 |
| 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. | 11 |
| 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. | 12 |
| 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. | 14 |
| 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. | 11 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Never Received Study Drug | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Reason Not Specified | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | ABBV-3067 50 mg + Placebo for ABBV-2222 | ABBV-3067 150 mg + Placebo for ABBV-2222 | ABBV-3067 150 mg + ABBV-2222 10 mg | ABBV-3067 150 mg + ABBV-2222 30 mg | ABBV-3067 150 mg + ABBV-2222 100 mg | ABBV-3067 150 mg + ABBV-2222 200 mg | ABBV-3067 150 mg + ABBV-2222 300 mg | Placebo for ABBV-3067 + Placebo for ABBV-2222 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 26.5 years STANDARD_DEVIATION 4.46 | 31.6 years STANDARD_DEVIATION 7.39 | 36.4 years STANDARD_DEVIATION 15.5 | 33.8 years STANDARD_DEVIATION 12.67 | 32.5 years STANDARD_DEVIATION 12.53 | 32.5 years STANDARD_DEVIATION 13.13 | 31.9 years STANDARD_DEVIATION 9 | 26.8 years STANDARD_DEVIATION 6.68 | 31.5 years STANDARD_DEVIATION 10.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 7 Participants | 5 Participants | 12 Participants | 11 Participants | 12 Participants | 14 Participants | 11 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1 ) at Baseline | 67.0 percent predicted FEV1 (%) STANDARD_DEVIATION 15.89 | 68.6 percent predicted FEV1 (%) STANDARD_DEVIATION 11.16 | 65.8 percent predicted FEV1 (%) STANDARD_DEVIATION 18.96 | 64.6 percent predicted FEV1 (%) STANDARD_DEVIATION 16.84 | 68.1 percent predicted FEV1 (%) STANDARD_DEVIATION 14.48 | 62.0 percent predicted FEV1 (%) STANDARD_DEVIATION 15.18 | 67.6 percent predicted FEV1 (%) STANDARD_DEVIATION 17.83 | 67.8 percent predicted FEV1 (%) STANDARD_DEVIATION 13.19 | 66.3 percent predicted FEV1 (%) STANDARD_DEVIATION 14.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 7 Participants | 5 Participants | 12 Participants | 11 Participants | 12 Participants | 14 Participants | 11 Participants | 78 Participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 2 Participants | 6 Participants | 5 Participants | 2 Participants | 3 Participants | 4 Participants | 30 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants | 6 Participants | 6 Participants | 10 Participants | 11 Participants | 7 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 | 0 / 4 | 0 / 12 | 0 / 11 | 0 / 12 | 0 / 13 | 0 / 11 |
| other Total, other adverse events | 2 / 6 | 5 / 7 | 4 / 4 | 8 / 12 | 10 / 11 | 6 / 12 | 6 / 13 | 6 / 11 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 | 0 / 4 | 2 / 12 | 0 / 11 | 0 / 12 | 0 / 13 | 0 / 11 |
Outcome results
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.
Time frame: Day 1 (Baseline) through Day 29
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| ABBV-3067 50 mg + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 0.3 percent predicted FEV1 (%) |
| ABBV-3067 150 mg + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | -2.2 percent predicted FEV1 (%) |
| ABBV-3067 150 mg + ABBV-2222 10 mg | Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 2.0 percent predicted FEV1 (%) |
| ABBV-3067 150 mg + ABBV-2222 30 mg | Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 4.5 percent predicted FEV1 (%) |
| ABBV-3067 150 mg + ABBV-2222 100 mg | Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 0.3 percent predicted FEV1 (%) |
| ABBV-3067 150 mg + ABBV-2222 200 mg | Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 4.0 percent predicted FEV1 (%) |
| ABBV-3067 150 mg + ABBV-2222 300 mg | Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 2.4 percent predicted FEV1 (%) |
| Placebo for ABBV-3067 + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | -2.2 percent predicted FEV1 (%) |
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.
Time frame: Day 1 (Baseline) through Day 29
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| ABBV-3067 50 mg + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 0.0 liter per seconds (L/sec) |
| ABBV-3067 150 mg + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | -0.0 liter per seconds (L/sec) |
| ABBV-3067 150 mg + ABBV-2222 10 mg | Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 0.2 liter per seconds (L/sec) |
| ABBV-3067 150 mg + ABBV-2222 30 mg | Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 0.2 liter per seconds (L/sec) |
| ABBV-3067 150 mg + ABBV-2222 100 mg | Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | -0.0 liter per seconds (L/sec) |
| ABBV-3067 150 mg + ABBV-2222 200 mg | Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 0.3 liter per seconds (L/sec) |
| ABBV-3067 150 mg + ABBV-2222 300 mg | Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 0.1 liter per seconds (L/sec) |
| Placebo for ABBV-3067 + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 0.0 liter per seconds (L/sec) |
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.
Time frame: Day 1 (Baseline) through Day 29
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| ABBV-3067 50 mg + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 0.0 liter (L) |
| ABBV-3067 150 mg + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | -0.0 liter (L) |
| ABBV-3067 150 mg + ABBV-2222 10 mg | Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 0.0 liter (L) |
| ABBV-3067 150 mg + ABBV-2222 30 mg | Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 0.1 liter (L) |
| ABBV-3067 150 mg + ABBV-2222 100 mg | Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 0.1 liter (L) |
| ABBV-3067 150 mg + ABBV-2222 200 mg | Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 0.0 liter (L) |
| ABBV-3067 150 mg + ABBV-2222 300 mg | Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 0.0 liter (L) |
| Placebo for ABBV-3067 + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | -0.2 liter (L) |
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.
Time frame: Day 1 (Baseline) through Day 29
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| ABBV-3067 50 mg + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) | -4.5 millimole per liter (mmol/L) |
| ABBV-3067 150 mg + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) | -8.9 millimole per liter (mmol/L) |
| ABBV-3067 150 mg + ABBV-2222 10 mg | Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) | -2.3 millimole per liter (mmol/L) |
| ABBV-3067 150 mg + ABBV-2222 30 mg | Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) | -15.7 millimole per liter (mmol/L) |
| ABBV-3067 150 mg + ABBV-2222 100 mg | Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) | -12.3 millimole per liter (mmol/L) |
| ABBV-3067 150 mg + ABBV-2222 200 mg | Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) | -18.6 millimole per liter (mmol/L) |
| ABBV-3067 150 mg + ABBV-2222 300 mg | Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) | -19.9 millimole per liter (mmol/L) |
| Placebo for ABBV-3067 + Placebo for ABBV-2222 | Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) | -2.1 millimole per liter (mmol/L) |
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.
Time frame: Day 1 (Baseline) through Day 29
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| ABBV-3067 50 mg + Placebo for ABBV-2222 | Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 0.8 L/sec |
| ABBV-3067 150 mg + Placebo for ABBV-2222 | Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | -0.1 L/sec |
| ABBV-3067 150 mg + ABBV-2222 10 mg | Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 8.8 L/sec |
| ABBV-3067 150 mg + ABBV-2222 30 mg | Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 19.9 L/sec |
| ABBV-3067 150 mg + ABBV-2222 100 mg | Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 0.1 L/sec |
| ABBV-3067 150 mg + ABBV-2222 200 mg | Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 18.5 L/sec |
| ABBV-3067 150 mg + ABBV-2222 300 mg | Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 10.9 L/sec |
| Placebo for ABBV-3067 + Placebo for ABBV-2222 | Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75) | 1.0 L/sec |
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.
Time frame: Day 1 (Baseline) through Day 29
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| ABBV-3067 50 mg + Placebo for ABBV-2222 | Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 0.1 liter |
| ABBV-3067 150 mg + Placebo for ABBV-2222 | Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | -1.0 liter |
| ABBV-3067 150 mg + ABBV-2222 10 mg | Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 0.2 liter |
| ABBV-3067 150 mg + ABBV-2222 30 mg | Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 2.2 liter |
| ABBV-3067 150 mg + ABBV-2222 100 mg | Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 2.2 liter |
| ABBV-3067 150 mg + ABBV-2222 200 mg | Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 0.9 liter |
| ABBV-3067 150 mg + ABBV-2222 300 mg | Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | 1.1 liter |
| Placebo for ABBV-3067 + Placebo for ABBV-2222 | Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC) | -4.3 liter |
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.
Time frame: Day 1 (Baseline) through Day 29
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| ABBV-3067 50 mg + Placebo for ABBV-2222 | Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 1.0 percent predicted FEV1 |
| ABBV-3067 150 mg + Placebo for ABBV-2222 | Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | -2.9 percent predicted FEV1 |
| ABBV-3067 150 mg + ABBV-2222 10 mg | Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 3.4 percent predicted FEV1 |
| ABBV-3067 150 mg + ABBV-2222 30 mg | Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 8.0 percent predicted FEV1 |
| ABBV-3067 150 mg + ABBV-2222 100 mg | Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 1.4 percent predicted FEV1 |
| ABBV-3067 150 mg + ABBV-2222 200 mg | Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 5.7 percent predicted FEV1 |
| ABBV-3067 150 mg + ABBV-2222 300 mg | Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | 4.7 percent predicted FEV1 |
| Placebo for ABBV-3067 + Placebo for ABBV-2222 | Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | -3.3 percent predicted FEV1 |