A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutatio

Phase 2

Withdrawn

• Conditions: CF; mucoviscidosis; 10038686

• Registration Number: NL-OMON48171
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Trial never started

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

*Adults 18 years or older
*Confirmed diagnosis of CF and homozygous for F508del CFTR mutation
*Lung function >= 40% and <= 90% of predicted normal for age, gender, and height
*Stable pulmonary status

Exclusion Criteria

*Cirrhosis with portal hypertension
*History of solid organ or hematopoietic transplantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change from Baseline through Day 29 in overall lung function.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Change from Baseline through Day 29 in sweat chloride<br /><br>2) Change from Baseline through Day 29 in other spirometric measures<br /><br>3) Change from Baseline through Day 29 in lung function</p><br>