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Completed

NCT Number: NCT03969888

A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

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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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Uza /Id# 213412, Edegem, Antwerpen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABBV-3067

Drug

Tablet taken orally.

Placebo ABBV-3067

Drug

Tablet taken orally.

ABBV-2222

Drug

Capsule taken orally.

Placebo ABBV-2222

Drug

Capsule taken orally.

Primary outcomes

  1. Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)

    Time frame: 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 outcomes

  1. Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)

    Time frame: 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.

  2. Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)

    Time frame: 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.

  3. Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)

    Time frame: 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.

  4. Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)

    Time frame: 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.

  5. Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)

    Time frame: 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.

  6. Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 31, 2019
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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