UAMS - Translational Research Institute

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 Part 1: ABBV-3067 + Placebo	Participants will receive various dosing regimens for ABBV-3067 plus placebo ABBV-2222 taken orally depending on arm assignment.	Drug: ABBV-3067 Tablet or capsule taken orally Drug: Placebo ABBV-2222 Capsule taken orally
Experimental Part 1: ABBV-3067 + ABBV-2222	Participants will receive fixed dose of ABBV-3067 plus various dosing regimens for ABBV-2222 taken orally depending on arm assignment.	Drug: ABBV-3067 Tablet or capsule taken orally Drug: ABBV-2222 Capsule taken orally
Placebo Comparator Part 1 and Part 2: Placebo	Participants in Part 1 and Part 2 will receive placebo ABBV-3067 plus placebo ABBV-2222 taken orally.	Drug: Placebo ABBV-3067 Tablet or capsule taken orally Drug: Placebo ABBV-2222 Capsule taken orally
Experimental Part 2: ABBV-3067 + ABBV-2222	Participants will receive various dosing regimens for ABBV-3067 plus a fixed dose of ABBV-2222 taken orally depending on arm assignment.	Drug: ABBV-3067 Tablet or capsule taken orally Drug: ABBV-2222 Capsule taken orally

Recruiting Locations

University of Arkansas /ID# 212541
Little Rock, Arkansas 72205

Tampa General Hospital /ID# 212342
Tampa, Florida 33606

University of Iowa Hospitals and Clinics /ID# 212351
Iowa City, Iowa 52242

Washington University-School of Medicine /ID# 212352
Saint Louis, Missouri 63110

Medical University of South Carolina /ID# 212187
Charleston, South Carolina 29425

Vanderbilt University Med Ctr /ID# 212353
Nashville, Tennessee 37232-6307

University of Utah /ID# 212350
Salt Lake City, Utah 84112-5500

More Details

NCT ID: NCT03969888
Status: Recruiting
Sponsor: AbbVie

Study Contact

ABBVIE CALL CENTER
847.283.8955
abbvieclinicaltrials@abbvie.com

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.