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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03969888
Recruitment Status : Not yet recruiting
First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 189 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
Estimated Study Start Date : August 27, 2019
Estimated Primary Completion Date : February 19, 2021
Estimated Study Completion Date : April 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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




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.



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

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


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics /ID# 212351 Not yet recruiting
Iowa City, Iowa, United States, 52242
United States, South Carolina
Medical University of South Carolina /ID# 212187 Not yet recruiting
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03969888     History of Changes
Other Study ID Numbers: M19-530
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
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 and 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)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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