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Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis

NCT ID: NCT04853368

Last Updated: 2024-07-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2023-06-05

Brief Summary

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Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objective of this study is to assess how safe and effective is the combination therapy of galicaftor/navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 in adult participants with CF who are homozygous or heterozygous for the F508del mutation in each arm.

Galicaftor/Navocaftor/ABBV-119 combination therapy and Galicaftor/Navocaftor/ABBV-576 is being developed as an investigational drug for the treatment of CF. Study doctors place participants in 1 of the 4 groups, called treatment arms. Each group receives a different treatment. Around 90 adult participants with a diagnosis of CF will be enrolled in the study around approximately 35 sites worldwide.

Participants in arm 1 will receive oral capsules of galicaftor/navocaftor dual combination for 28 days followed by galicaftor/navocaftor/ABBV-119 triple combination for 28 days. Participants in arms 2 and 3 will receive the galicaftor/navocaftor/ABBV-119 triple combination or placebo for 28 days. Participants in arm 4 will receive galicaftor/navocaftor/ABBV-576 triple combination therapy for 28 days. For all study arms, ABBV-576, galicaftor, navocaftor, will be given once daily and ABBV-119 twice a day.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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Detailed Description

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Participants in Cohorts 1 and 3 will receive Open-label therapy. Participants in Cohorts 2 will receive Double-blinded therapy.

Conditions

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Cystic Fibrosis (CF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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F508del Homozygous Cystic Fibrosis (CF) Participants

F508del homozygous cystic fibrosis (CF) participants receive galicaftor/navocaftor dual combination (28 days) followed by galicaftor/navocaftor/ABBV-119 triple combination therapy (28 days).

Group Type EXPERIMENTAL

Galicaftor

Intervention Type DRUG

Oral capsules

Navocaftor

Intervention Type DRUG

Oral capsules

ABBV-119

Intervention Type DRUG

Oral capsules

F508del Heterozygous CF Participants (Active Drug Group)

F508del heterozygous CF participants receive galicaftor/navocaftor/ABBV-119 combination therapy (28 days).

Group Type EXPERIMENTAL

Galicaftor

Intervention Type DRUG

Oral capsules

Navocaftor

Intervention Type DRUG

Oral capsules

ABBV-119

Intervention Type DRUG

Oral capsules

F508del Heterozygous CF Participants (Placebo Group)

F508del heterozygous CF participants receive placebo (28 days).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral capsules

F508del Homozygous and Heterozygous CF Participants

F508del homozygous and heterozygous CF participants receive galicaftor/navocaftor/ABBV-576 triple combination therapy for 28 days.

Group Type EXPERIMENTAL

ABBV-576

Intervention Type DRUG

Oral capsules

Galicaftor

Intervention Type DRUG

Oral capsules

Navocaftor

Intervention Type DRUG

Oral capsules

Interventions

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ABBV-576

Oral capsules

Intervention Type DRUG

Galicaftor

Oral capsules

Intervention Type DRUG

Placebo

Oral capsules

Intervention Type DRUG

Navocaftor

Oral capsules

Intervention Type DRUG

ABBV-119

Oral capsules

Intervention Type DRUG

Other Intervention Names

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ABBV-2222 ABBV-3067

Eligibility Criteria

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Inclusion Criteria

* Confirmed clinical diagnosis of cystic fibrosis (CF).
* Arm 1 participants with genotype homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation and not receiving elexacaftor/tezacaftor/ivacaftor (ETI) treatment .
* Arm 2 and 3 participants with genotype heterozygous for the F508del CFTR mutation and a minimal function mutation and not receiving ETI treatment.
* Arm 4 participants with genotype either homozygous or heterozygous for the F508del mutation. Participants must be receiving stable ETI treatment.
* Percent predicted forced expiratory volume in 1 second (ppFEV1) \>= 40% and \<=90% of predicted normal for age, gender and height at screening.
* For arms 1 and 2: sweat chloride (SwCl) \>= 60 mmol/L at screening. For participants who participated in Study M19-530, it is acceptable to use a SwCl value that the central lab provided in Study M19-530 to establish eligibility.
* Weight \>= 35 kg at screening and Day -28 for arm 1 or day 1 for arms 2 to 4.

Exclusion Criteria

\- Clinically significant laboratory values at screening that would pose undue risk for the participant or interfere with safety assessments (per the investigator).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Velocity Clinical Research /ID# 248675

Mobile, Alabama, United States

Site Status

University of Southern California /ID# 249147

Los Angeles, California, United States

Site Status

Ventura County Medical Center /ID# 248586

Ventura, California, United States

Site Status

Central FL Pulmonary Orlando /ID# 245432

Orlando, Florida, United States

Site Status

University of Kansas Health Sy /ID# 249056

Kansas City, Kansas, United States

Site Status

Boston Children's Hospital /ID# 248646

Boston, Massachusetts, United States

Site Status

Harper University Hospital /ID# 248917

Detroit, Michigan, United States

Site Status

Washington University-School of Medicine /ID# 245393

St Louis, Missouri, United States

Site Status

Dartmouth-Hitchcock Medical Center /ID# 245706

Lebanon, New Hampshire, United States

Site Status

Dartmouth Hitchcock Manchester /ID# 248795

Manchester, New Hampshire, United States

Site Status

Albany Medical College-Pulmonary /ID# 248838

Albany, New York, United States

Site Status

Northwell Health/Long Island Jewish Hospital /ID# 248916

New Hyde Park, New York, United States

Site Status

New York Medical College /ID# 248640

Valhalla, New York, United States

Site Status

UH Cleveland Medical Center /ID# 245433

Cleveland, Ohio, United States

Site Status

ProMedica Toledo Harris McIntosh /ID# 248627

Toledo, Ohio, United States

Site Status

University of Oklahoma HSC /ID# 249190

Oklahoma City, Oklahoma, United States

Site Status

Penn State Health /ID# 248585

Hershey, Pennsylvania, United States

Site Status

Medical University of South Carolina /ID# 245403

Charleston, South Carolina, United States

Site Status

Vanderbilt University Medical Center /ID# 245400

Nashville, Tennessee, United States

Site Status

The Univ Texas HSC at Tyler /ID# 248498

Tyler, Texas, United States

Site Status

Children's Hospital of Richmond at VCU /ID# 248561

Richmond, Virginia, United States

Site Status

Medical College of Wisconsin - Plank Rd /ID# 249079

Milwaukee, Wisconsin, United States

Site Status

Royal Prince Alfred Hospital /ID# 228781

Camperdown, New South Wales, Australia

Site Status

Westmead Hospital /ID# 227281

Westmead, New South Wales, Australia

Site Status

Mater Misericordiae Limited /ID# 227279

South Brisbane, Queensland, Australia

Site Status

Royal Adelaide Hospital /ID# 228486

Adelaide, South Australia, Australia

Site Status

Alfred Health /ID# 227283

Melbourne, Victoria, Australia

Site Status

Royal Children's Hospital /ID# 227280

Parkville, Victoria, Australia

Site Status

Institute for Respiratory Health /ID# 227624

Nedlands, Western Australia, Australia

Site Status

Uza /Id# 228533

Edegem, Antwerpen, Belgium

Site Status

UZ Brussel /ID# 226607

Jette, Brussels Capital, Belgium

Site Status

UZ Gent /ID# 226605

Ghent, Oost-Vlaanderen, Belgium

Site Status

Universitair Ziekenhuis Leuven /ID# 226608

Leuven, Vlaams-Brabant, Belgium

Site Status

Orszagos Koranyi Pulmonologiai Intezet /ID# 228810

Budapest, , Hungary

Site Status

Erasmus Medisch Centrum /ID# 234254

Rotterdam, South Holland, Netherlands

Site Status

Academisch Medisch Centrum /ID# 234253

Amsterdam, , Netherlands

Site Status

HagaZiekenhuis /ID# 234138

The Hague, , Netherlands

Site Status

Greenlane Clinical Centre /ID# 227282

Epsom, Auckland, New Zealand

Site Status

Christchurch Hospital /ID# 227335

Christchurch, Canterbury, New Zealand

Site Status

Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 228044

Banská Bystrica, , Slovakia

Site Status

Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 228042

Bratislava, , Slovakia

Site Status

Countries

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United States Australia Belgium Hungary Netherlands New Zealand Slovakia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2020-005805-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M19-771

Identifier Type: -

Identifier Source: org_study_id

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