Vanderbilt Clinical Trials

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

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

Cystic Fibrosis

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

Arm	Description	Assigned 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.

More Details

Status: Completed
Sponsor: AbbVie

Study Contact