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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

Primary Purpose

Cystic Fibrosis (CF)

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABBV-576
Galicaftor
Placebo
Navocaftor
ABBV-119
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis (CF) focused on measuring Cystic Fibrosis (CF), Galicaftor, Navocaftor, ABBV-119, ABBV-576

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Velocity Clinical Research /ID# 248675
  • University of Southern California /ID# 249147
  • Ventura County Medical Center /ID# 248586
  • Central FL Pulmonary Orlando /ID# 245432
  • University of Kansas Health Sy /ID# 249056
  • Boston Children's Hospital /ID# 248646
  • Harper University Hospital /ID# 248917
  • Washington University-School of Medicine /ID# 245393
  • Dartmouth-Hitchcock Medical Center /ID# 245706
  • Dartmouth Hitchcock Manchester /ID# 248795
  • Albany Medical College-Pulmonary /ID# 248838
  • Northwell Health/Long Island Jewish Hospital /ID# 248916
  • New York Medical College /ID# 248640
  • University of Cincinnati /ID# 249646
  • UH Cleveland Medical Center /ID# 245433
  • ProMedica Toledo Harris McIntosh /ID# 248627
  • University of Oklahoma HSC /ID# 249190
  • Penn State Health /ID# 248585
  • Medical University of South Carolina /ID# 245403
  • Vanderbilt University Medical Center /ID# 245400
  • Ascension Seton - Medical Park Tower /ID# 248643
  • The Univ Texas HSC at Tyler /ID# 248498
  • Children's Hospital of Richmond at VCU /ID# 248561
  • Medical College of Wisconsin - Plank Rd /ID# 249079
  • Royal Prince Alfred Hospital /ID# 228781
  • Westmead Hospital /ID# 227281
  • Mater Misericordiae Limited /ID# 227279
  • Royal Adelaide Hospital /ID# 228486
  • Alfred Health /ID# 227283
  • Royal Children's Hospital /ID# 227280
  • Institute for Respiratory Health /ID# 227624
  • Uza /Id# 228533
  • UZ Brussel /ID# 226607
  • UZ Gent /ID# 226605
  • Universitair Ziekenhuis Leuven /ID# 226608
  • Orszagos Koranyi Pulmonologiai Intezet /ID# 228810
  • Erasmus Medisch Centrum /ID# 234254
  • Academisch Medisch Centrum /ID# 234253
  • HagaZiekenhuis /ID# 234138
  • Greenlane Clinical Centre /ID# 227282
  • Christchurch Hospital /ID# 227335
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 228044
  • Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 228042
  • University Hospital Southampton NHS Foundation Trust /ID# 238634
  • Manchester University NHS Foundation Trust /ID# 238637
  • Nottingham University Hospitals NHS Trust /ID# 238636
  • NHS Greater Glasgow and Clyde /ID# 238630
  • Cardiff & Vale University Health Board /ID# 238631
  • Royal Papworth Hospital NHS Foundation Trust /ID# 238629
  • Leeds Teaching Hospitals NHS Trust /ID# 238632
  • King's College Hospital NHS Foundation Trust /ID# 238628
  • Royal Brompton and Harefield Hospitals /ID# 238635

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

F508del Homozygous Cystic Fibrosis (CF) Participants

F508del Heterozygous CF Participants (Active Drug Group)

F508del Heterozygous CF Participants (Placebo Group)

F508del Homozygous and Heterozygous CF Participants

Arm Description

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

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

F508del heterozygous CF participants receive placebo (28 days).

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

Outcomes

Primary Outcome Measures

Cohorts 1 and 2: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Percent predicted forced expiratory volume in 1 second (ppFEV1).
Cohort 3: Absolute change in Sweat Chloride (SwCl).
Sweat chloride (SwCl) concentration is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) ion channel function.

Secondary Outcome Measures

Cohorts 1 and 2: Absolute Change From Baseline in Sweat Chloride (SwCl)
SwCl concentration is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) ion channel function.
Absolute Change From Baseline in Forced Vital Capacity [FVC]
Forced vital capacity (FVC).
Absolute Change From Baseline in Forced Expiratory Flow at Mid-Lung Capacity [FEF25-75]
Forced expiratory flow between 25% and 75% of exhaled volume (FEF25-75).
Relative Changes From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Percent predicted forced expiratory volume in 1 second (ppFEV1).
Relative Changes From Baseline in Forced Vital Capacity [FVC]
Forced vital capacity (FVC).
Relative Changes From Baseline in Forced Expiratory Flow Between 25% and 75% of Exhaled Volume (FEF25-75)
Forced expiratory flow between 25% and 75% of exhaled volume (FEF25-75).
Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline
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.
Cohort 3: Absolute Changes From Baseline in ppFEV1
Percent predicted forced expiratory volume in 1 second (ppFEV1).

Full Information

First Posted
April 19, 2021
Last Updated
June 21, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04853368
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Strategic considerations
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
June 5, 2023 (Actual)
Study Completion Date
June 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis (CF)
Keywords
Cystic Fibrosis (CF), Galicaftor, Navocaftor, ABBV-119, ABBV-576

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F508del Homozygous Cystic Fibrosis (CF) Participants
Arm Type
Experimental
Arm Description
F508del homozygous cystic fibrosis (CF) participants receive galicaftor/navocaftor dual combination (28 days) followed by galicaftor/navocaftor/ABBV-119 triple combination therapy (28 days).
Arm Title
F508del Heterozygous CF Participants (Active Drug Group)
Arm Type
Experimental
Arm Description
F508del heterozygous CF participants receive galicaftor/navocaftor/ABBV-119 combination therapy (28 days).
Arm Title
F508del Heterozygous CF Participants (Placebo Group)
Arm Type
Placebo Comparator
Arm Description
F508del heterozygous CF participants receive placebo (28 days).
Arm Title
F508del Homozygous and Heterozygous CF Participants
Arm Type
Experimental
Arm Description
F508del homozygous and heterozygous CF participants receive galicaftor/navocaftor/ABBV-576 triple combination therapy for 28 days.
Intervention Type
Drug
Intervention Name(s)
ABBV-576
Intervention Description
Oral capsules
Intervention Type
Drug
Intervention Name(s)
Galicaftor
Intervention Description
Oral capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsules
Intervention Type
Drug
Intervention Name(s)
Navocaftor
Intervention Description
Oral capsules
Intervention Type
Drug
Intervention Name(s)
ABBV-119
Intervention Description
Oral capsules
Primary Outcome Measure Information:
Title
Cohorts 1 and 2: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Description
Percent predicted forced expiratory volume in 1 second (ppFEV1).
Time Frame
Up to 29 days
Title
Cohort 3: Absolute change in Sweat Chloride (SwCl).
Description
Sweat chloride (SwCl) concentration is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) ion channel function.
Time Frame
Up to 29 days
Secondary Outcome Measure Information:
Title
Cohorts 1 and 2: Absolute Change From Baseline in Sweat Chloride (SwCl)
Description
SwCl concentration is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) ion channel function.
Time Frame
Up to 29 days
Title
Absolute Change From Baseline in Forced Vital Capacity [FVC]
Description
Forced vital capacity (FVC).
Time Frame
Up to 29 days
Title
Absolute Change From Baseline in Forced Expiratory Flow at Mid-Lung Capacity [FEF25-75]
Description
Forced expiratory flow between 25% and 75% of exhaled volume (FEF25-75).
Time Frame
Up to 29 days
Title
Relative Changes From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Description
Percent predicted forced expiratory volume in 1 second (ppFEV1).
Time Frame
Up to 29 days
Title
Relative Changes From Baseline in Forced Vital Capacity [FVC]
Description
Forced vital capacity (FVC).
Time Frame
Up to 29 days
Title
Relative Changes From Baseline in Forced Expiratory Flow Between 25% and 75% of Exhaled Volume (FEF25-75)
Description
Forced expiratory flow between 25% and 75% of exhaled volume (FEF25-75).
Time Frame
Up to 29 days
Title
Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline
Description
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.
Time Frame
Up to 29 days
Title
Cohort 3: Absolute Changes From Baseline in ppFEV1
Description
Percent predicted forced expiratory volume in 1 second (ppFEV1).
Time Frame
Up to 29 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Velocity Clinical Research /ID# 248675
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608-1771
Country
United States
Facility Name
University of Southern California /ID# 249147
City
Los Angeles
State/Province
California
ZIP/Postal Code
90030
Country
United States
Facility Name
Ventura County Medical Center /ID# 248586
City
Ventura
State/Province
California
ZIP/Postal Code
93003-1651
Country
United States
Facility Name
Central FL Pulmonary Orlando /ID# 245432
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
University of Kansas Health Sy /ID# 249056
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-8500
Country
United States
Facility Name
Boston Children's Hospital /ID# 248646
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Harper University Hospital /ID# 248917
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University-School of Medicine /ID# 245393
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 245706
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Dartmouth Hitchcock Manchester /ID# 248795
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03104-4125
Country
United States
Facility Name
Albany Medical College-Pulmonary /ID# 248838
City
Albany
State/Province
New York
ZIP/Postal Code
12208-3504
Country
United States
Facility Name
Northwell Health/Long Island Jewish Hospital /ID# 248916
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
New York Medical College /ID# 248640
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University of Cincinnati /ID# 249646
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
UH Cleveland Medical Center /ID# 245433
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
ProMedica Toledo Harris McIntosh /ID# 248627
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606-3845
Country
United States
Facility Name
University of Oklahoma HSC /ID# 249190
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104-5410
Country
United States
Facility Name
Penn State Health /ID# 248585
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Medical University of South Carolina /ID# 245403
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 245400
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Ascension Seton - Medical Park Tower /ID# 248643
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-1000
Country
United States
Facility Name
The Univ Texas HSC at Tyler /ID# 248498
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
Children's Hospital of Richmond at VCU /ID# 248561
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Medical College of Wisconsin - Plank Rd /ID# 249079
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3548
Country
United States
Facility Name
Royal Prince Alfred Hospital /ID# 228781
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Westmead Hospital /ID# 227281
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Mater Misericordiae Limited /ID# 227279
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 228486
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Alfred Health /ID# 227283
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Children's Hospital /ID# 227280
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Institute for Respiratory Health /ID# 227624
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Uza /Id# 228533
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Brussel /ID# 226607
City
Jette
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ Gent /ID# 226605
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven /ID# 226608
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Orszagos Koranyi Pulmonologiai Intezet /ID# 228810
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Erasmus Medisch Centrum /ID# 234254
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Academisch Medisch Centrum /ID# 234253
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
HagaZiekenhuis /ID# 234138
City
Den Haag
ZIP/Postal Code
2545 AA
Country
Netherlands
Facility Name
Greenlane Clinical Centre /ID# 227282
City
Epsom
State/Province
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Christchurch Hospital /ID# 227335
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 228044
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 228042
City
Bratislava
ZIP/Postal Code
821 06
Country
Slovakia
Facility Name
University Hospital Southampton NHS Foundation Trust /ID# 238634
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust /ID# 238637
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust /ID# 238636
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde /ID# 238630
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Facility Name
Cardiff & Vale University Health Board /ID# 238631
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Royal Papworth Hospital NHS Foundation Trust /ID# 238629
City
Cambridge
ZIP/Postal Code
CB2 0AY
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust /ID# 238632
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 238628
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Royal Brompton and Harefield Hospitals /ID# 238635
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

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

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