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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ABBV-3067 50 mg + Placebo for ABBV-2222 		Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
  • Drug: ABBV-3067
    Tablet taken orally.
  • Drug: Placebo ABBV-2222
    Capsule taken orally.
Experimental
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.
  • Drug: ABBV-3067
    Tablet taken orally.
  • Drug: Placebo ABBV-2222
    Capsule taken orally.
Experimental
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.
  • Drug: ABBV-3067
    Tablet taken orally.
  • Drug: ABBV-2222
    Capsule taken orally.
Experimental
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.
  • Drug: ABBV-3067
    Tablet taken orally.
  • Drug: ABBV-2222
    Capsule taken orally.
Experimental
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.
  • Drug: ABBV-3067
    Tablet taken orally.
  • Drug: ABBV-2222
    Capsule taken orally.
Experimental
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.
  • Drug: ABBV-3067
    Tablet taken orally.
  • Drug: ABBV-2222
    Capsule taken orally.
Experimental
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.
  • Drug: ABBV-3067
    Tablet taken orally.
  • Drug: ABBV-2222
    Capsule taken orally.
Placebo Comparator
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.
  • Drug: Placebo ABBV-3067
    Tablet taken orally.
  • Drug: Placebo ABBV-2222
    Capsule taken orally.

Recruiting Locations

More Details

NCT ID
NCT03969888
Status
Completed
Sponsor
AbbVie

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.