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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

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 - M19-530

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48171
Enrollment
4
Registered
2019-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CF mucoviscidosis

Interventions

ABBV-3067 and/or ABBV-2222 in different doses, placebo controlled.

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *Adults 18 years or older *Confirmed diagnosis of CF and homozygous for F508del CFTR mutation *Lung function >= 40% and

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change from Baseline through Day 29 in overall lung function.—

Secondary

MeasureTime frame
1) Change from Baseline through Day 29 in sweat chloride 2) Change from Baseline through Day 29 in other spirometric measures 3) Change from Baseline through Day 29 in lung function—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)