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Trial record 1 of 1 for:    Abbvie M19-771 | Cystic Fibrosis
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04853368
Recruitment Status : Active, not recruiting
First Posted : April 21, 2021
Last Update Posted : May 1, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis (CF) Drug: ABBV-576 Drug: Galicaftor Drug: Placebo Drug: Navocaftor Drug: ABBV-119 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
Actual Study Start Date : September 20, 2021
Estimated Primary Completion Date : June 7, 2023
Estimated Study Completion Date : June 7, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Drug: Galicaftor
Oral capsules

Drug: Navocaftor
Oral capsules

Drug: ABBV-119
Oral capsules
Experimental: F508del Heterozygous CF Participants (Active Drug Group)
F508del heterozygous CF participants receive galicaftor/navocaftor/ABBV-119 combination therapy (28 days).
 Drug: Galicaftor
Oral capsules

Drug: Navocaftor
Oral capsules

Drug: ABBV-119
Oral capsules
Placebo Comparator: F508del Heterozygous CF Participants (Placebo Group)
F508del heterozygous CF participants receive placebo (28 days).
 Drug: Placebo
Oral capsules
Experimental: F508del Homozygous and Heterozygous CF Participants
F508del homozygous and heterozygous CF participants receive galicaftor/navocaftor/ABBV-576 triple combination therapy for 28 days.
 Drug: ABBV-576
Oral capsules

Drug: Galicaftor
Oral capsules

Drug: Navocaftor
Oral capsules


Outcome Measures
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Primary Outcome Measures :
  1. Cohorts 1 and 2: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) [ Time Frame: Up to 29 days ]
    Percent predicted forced expiratory volume in 1 second (ppFEV1).

  2. Cohort 3: Absolute change in Sweat Chloride (SwCl). [ Time Frame: Up to 29 days ]
    Sweat chloride (SwCl) concentration is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) ion channel function.


Secondary Outcome Measures :
  1. Cohorts 1 and 2: Absolute Change From Baseline in Sweat Chloride (SwCl) [ Time Frame: Up to 29 days ]
    SwCl concentration is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) ion channel function.

  2. Absolute Change From Baseline in Forced Vital Capacity [FVC] [ Time Frame: Up to 29 days ]
    Forced vital capacity (FVC).

  3. Absolute Change From Baseline in Forced Expiratory Flow at Mid-Lung Capacity [FEF25-75] [ Time Frame: Up to 29 days ]
    Forced expiratory flow between 25% and 75% of exhaled volume (FEF25-75).

  4. Relative Changes From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) [ Time Frame: Up to 29 days ]
    Percent predicted forced expiratory volume in 1 second (ppFEV1).

  5. Relative Changes From Baseline in Forced Vital Capacity [FVC] [ Time Frame: Up to 29 days ]
    Forced vital capacity (FVC).

  6. Relative Changes From Baseline in Forced Expiratory Flow Between 25% and 75% of Exhaled Volume (FEF25-75) [ Time Frame: Up to 29 days ]
    Forced expiratory flow between 25% and 75% of exhaled volume (FEF25-75).

  7. Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline [ Time Frame: Up to 29 days ]
    The CFQ-R is designed for use in participants with a diagnosis of cystic fibrosis and is designed to measure impact on overall health, daily life, perceived well-being, and symptoms. Participants will complete the CFQ-R electronically via a tablet device.

  8. Cohort 3: Absolute Changes From Baseline in ppFEV1 [ Time Frame: Up to 29 days ]
    Percent predicted forced expiratory volume in 1 second (ppFEV1).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853368


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04853368    
Other Study ID Numbers: M19-771
2020-005805-25 ( EudraCT Number )
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Cystic Fibrosis (CF)
Galicaftor
Navocaftor
ABBV-119
ABBV-576
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases