Brief Summary

This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Dec 2019

Geographic Reach

12 countries

51 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

May 30, 2019

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed

6 months until next milestone

Study Start

First participant enrolled

December 11, 2019

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2022

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

June 28, 2023

Completed

Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

2.5 years

First QC Date

May 30, 2019

Results QC Date

June 8, 2023

Last Update Submit

June 8, 2023

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisABBV-3067ABBV-2222, F508del Mutation

Outcome Measures

Primary Outcomes (1)

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 (6)

Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
Day 1 (Baseline) through Day 29
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
Day 1 (Baseline) through Day 29
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
Day 1 (Baseline) through Day 29
Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Day 1 (Baseline) through Day 29
Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
Day 1 (Baseline) through Day 29
+1 more secondary outcomes

Study Arms (8)

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-3067Drug: 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-3067Drug: 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.