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Trial record 1 of 1 for:    abbvie m19-530
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A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

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: NCT03969888
Recruitment Status : Completed
First Posted : May 31, 2019
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: ABBV-3067 Drug: Placebo ABBV-3067 Drug: ABBV-2222 Drug: Placebo ABBV-2222 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation
Actual Study Start Date : December 11, 2019
Actual Primary Completion Date : June 9, 2022
Actual Study Completion Date : June 9, 2022

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: 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


Outcome Measures
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Primary Outcome Measures :
  1. Absolute change in percent predicted forced expiratory volume in 1 second (ppFEV1) [ Time Frame: Week 0 (Baseline) through Day 29 ]
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function.


Secondary Outcome Measures :
  1. Absolute change in sweat chloride (SwCl) [ Time Frame: Week 0 (Baseline) through Day 29 ]
    SwCl is a biomarker of CFTR activity. Persons with CF have higher levels of chloride in their sweat.

  2. Absolute change in forced vital capacity (FVC) [ Time Frame: Week 0 (Baseline) through Day 29 ]
    Forced vital capacity (FVC) is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry.

  3. Absolute change in forced expiratory flow at mid-lung capacity (FEF25-75) [ Time Frame: Week 0 (Baseline) through Day 29 ]
    Forced expiratory flow at mid-lung capacity (FEF25-75) is a lung function test that is measured during spirometry.

  4. Relative change in percent predicted forced expiratory volume in 1 second (ppFEV1) [ Time Frame: Week 0 (Baseline) through Day 29 ]
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function.

  5. Relative change in forced expiratory flow at mid-lung capacity (FEF25-75) [ Time Frame: Week 0 (Baseline) through Day 29 ]
    Forced expiratory flow at mid-lung capacity (FEF25-75) is a lung function test that is measured during spirometry.

  6. Relative change in forced vital capacity (FVC) [ Time Frame: Week 0 (Baseline) through Day 29 ]
    Forced vital capacity (FVC) is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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) 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
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): NCT03969888


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: NCT03969888    
Other Study ID Numbers: M19-530
2019-000750-63 ( EudraCT Number )
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022
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.: No
Keywords provided by AbbVie:
Cystic Fibrosis
ABBV-3067
ABBV-2222, F508del Mutation
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