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A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

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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

Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 31, 2019
Estimated Study Start Date  ICMJE August 27, 2019
Estimated Primary Completion Date February 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • Drug: ABBV-3067
    Tablet or capsule taken orally
  • Drug: Placebo ABBV-3067
    Tablet or capsule taken orally
  • Drug: ABBV-2222
    Capsule taken orally
  • Drug: Placebo ABBV-2222
    Capsule taken orally
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: ABBV-3067
    • Drug: Placebo ABBV-2222
  • 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.
    Interventions:
    • Drug: ABBV-3067
    • Drug: ABBV-2222
  • 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.
    Interventions:
    • Drug: Placebo ABBV-3067
    • Drug: Placebo ABBV-2222
  • 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.
    Interventions:
    • Drug: ABBV-3067
    • Drug: ABBV-2222
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2019)
189
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 26, 2021
Estimated Primary Completion Date February 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969888
Other Study ID Numbers  ICMJE M19-530
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP