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Cystic FibrosisPhase 2NCT03969888

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

A Phase 2 study testing ABBV-3067 and ABBV-2222 in people with Cystic Fibrosis, run by AbbVie at 51 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cystic Fibrosis
What is being tested?
ABBV-3067 and ABBV-2222
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
51 sitesin 12 countries
Study dates
11 Dec 2019to 9 Jun 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • History of solid organ or hematopoietic transplant
  • Cirrhosis with portal hypertension
  • Use of CFTR modulator therapy within 60 days prior to Screening

Trial locations and contacts

51 sites in 12 countries.

51 sites in 12 countries

United States10 sites

  • Univ Michigan Med Ctr /ID# 212657

    Ann Arbor, Michigan, 48109

  • Medical University of South Carolina /ID# 212187

    Charleston, South Carolina, 29425

  • Nationwide Children's Hospital /ID# 213158

    Columbus, Ohio, 43205-2664

  • University of Iowa Hospitals and Clinics /ID# 212351

    Iowa City, Iowa, 52242

  • University of Arkansas /ID# 212541

    Little Rock, Arkansas, 72205

  • Vanderbilt University Medical Center /ID# 212353

    Nashville, Tennessee, 37232

  • University of Utah /ID# 212350

    Salt Lake City, Utah, 84112-5500

  • Cardinal Glennon Children's Hospital /ID# 212349

    St Louis, Missouri, 63104

  • Washington University-School of Medicine /ID# 212352

    St Louis, Missouri, 63110

  • Tampa General Hospital /ID# 212342

    Tampa, Florida, 33606

Other trials in United States

France8 sites

  • CHU Montpellier - Hôpital Saint Eloi /ID# 212856

    Montpellier, Herault, 34295

  • Chu de Nice-Hopital L'Archet Ii /Id# 212862

    Nice, Alpes-Maritimes, 06200

  • AP-HP - Hopital Cochin /ID# 212864

    Paris, 75014

  • CHU Bordeaux - Hopital Haut Leveque /ID# 212898

    Pessac, Gironde, 33604

  • HCL - Hopital Lyon Sud /ID# 212899

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • CHU de Reims - Hôpital Maison Blanche /ID# 212910

    Reims, 51092

  • Fondation ILDYS /ID# 212857

    Roscoff, 29684

  • CHU Nantes - Hopital Laennec /ID# 212897

    Saint-Herblain, 44800

Other trials in France

United Kingdom8 sites

  • Royal Papworth Hospital NHS Foundation Trust /ID# 212507

    Cambridge, CB2 0AY

  • Cardiff & Vale University Health Board /ID# 212504

    Cardiff, Wales, CF14 4XN

  • Leeds Teaching Hospitals NHS Trust /ID# 212491

    Leeds, LS9 7TF

  • Liverpool Heart and Chest Hospital NHS Foundation Trust /ID# 212291

    Liverpool, L14 3PE

  • Barts Health NHS Trust /ID# 213016

    London, London, City of, E1 2ES

  • Royal Brompton and Harefield Hospitals /ID# 212490

    London, SW3 6NP

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 212665

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospitals NHS Trust /ID# 212531

    Nottingham, Nottinghamshire, NG5 1PB

Other trials in United Kingdom

Canada7 sites

  • University of Calgary /ID# 212555

    Calgary, Alberta, T2N 4Z6

  • QEII - Health Sciences Centre /ID# 212656

    Halifax, Nova Scotia, B3H 2Y9

  • CHUM - Centre hospitalier de l'Universite de Montréal /ID# 227815

    Montreal, Quebec, H2X 3E4

  • McGill University Health Center Research Institute /ID# 212553

    Montreal, Quebec, H4A 3J1

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 212655

    Québec, Quebec, G1V 4G5

  • Unity Health Toronto - St. Michael's Hospital /ID# 212552

    Toronto, Ontario, M5B 1W8

  • St. Paul's Hospital /ID# 212554

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Belgium5 sites

  • Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 213413

    Brussels, Brussels Capital, 1070

  • Uza /Id# 213412

    Edegem, Antwerpen, 2650

  • UZ Gent /ID# 213411

    Ghent, Oost-Vlaanderen, 9000

  • UZ Brussel /ID# 212812

    Jette, Brussels Capital, 1090

  • Universitair Ziekenhuis Leuven /ID# 213050

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

New Zealand4 sites

  • Christchurch Hospital /ID# 221105

    Christchurch, Canterbury, 8011

  • Greenlane Clinical Centre /ID# 221103

    Epsom, Auckland, 1051

  • Waikato Hospital /ID# 221102

    Hamilton, Waikato Region, 3240

  • Dunedin Hospital /ID# 221104

    Otago, Otago, 9016

Other trials in New Zealand

Czechia2 sites

  • Fakultni Nemocnice Brno /ID# 213437

    Brno, 625 00

  • Fakultni Nemocnice v Motole /ID# 212966

    Prague, 150 06

Other trials in Czechia

Netherlands2 sites

  • HagaZiekenhuis /ID# 212926

    The Hague, 2545 AA

  • Universitair Medisch Centrum Utrecht /ID# 212935

    Utrecht, 3584 CX

Other trials in Netherlands

Slovakia2 sites

  • Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213146

    Bratislava, 821 01

  • Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213596

    Bratislava, 821 06

Other trials in Slovakia

Hungary1 site

  • Orszagos Koranyi Pulmonologiai Intezet /ID# 213494

    Budapest, 1121

Other trials in Hungary

Poland1 site

  • Szpital Dzieciecy Polanki /ID# 221330

    Gdansk, Pomeranian Voivodeship, 80-308

Other trials in Poland

Serbia1 site

  • Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 212820

    Belgrade, Beograd, 11000

Other trials in Serbia

About this study

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

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.

Conditions
Cystic Fibrosis
Being tested
ABBV-3067, Placebo ABBV-3067, ABBV-2222, Placebo ABBV-2222
Keywords
Cystic Fibrosis, ABBV-3067, ABBV-2222, F508del Mutation
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-3067Drug

    Tablet taken orally.

  • Placebo ABBV-3067Drug

    Tablet taken orally.

  • ABBV-2222Drug

    Capsule taken orally.

  • Placebo ABBV-2222Drug

    Capsule taken orally.

Study groups in NCT03969888
Study groupRoleWhat they receive
ABBV-3067 50 mg + Placebo for ABBV-2222ExperimentalParticipants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Receives: Drug: ABBV-3067; Drug: Placebo ABBV-2222
ABBV-3067 150 mg + Placebo for ABBV-2222ExperimentalParticipants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Receives: Drug: ABBV-3067; Drug: Placebo ABBV-2222
ABBV-3067 150 mg + ABBV-2222 10 mgExperimentalParticipants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
Receives: Drug: ABBV-3067; Drug: ABBV-2222
ABBV-3067 150 mg + ABBV-2222 30 mgExperimentalParticipants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
Receives: Drug: ABBV-3067; Drug: ABBV-2222
ABBV-3067 150 mg + ABBV-2222 100 mgExperimentalParticipants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
Receives: Drug: ABBV-3067; Drug: ABBV-2222
ABBV-3067 150 mg + ABBV-2222 200 mgExperimentalParticipants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
Receives: Drug: ABBV-3067; Drug: ABBV-2222
ABBV-3067 150 mg + ABBV-2222 300 mgExperimentalParticipants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
Receives: Drug: ABBV-3067; Drug: ABBV-2222
Placebo for ABBV-3067 + Placebo for ABBV-2222Placebo comparatorParticipants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Receives: Drug: Placebo ABBV-3067; Drug: Placebo ABBV-2222

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)

    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. Mixed-effect model with repeated measures (MMRM) was used for the analyses.

    Measured: Day 1 (Baseline) through Day 29

Secondary outcomes (6)

  1. Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)

    Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.

    Measured: Day 1 (Baseline) through Day 29

  2. Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)

    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. MMRM was used for the analyses.

    Measured: Day 1 (Baseline) through Day 29

  3. Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)

    FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.

    Measured: Day 1 (Baseline) through Day 29

  4. Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)

    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. MMRM was used for analyses.

    Measured: Day 1 (Baseline) through Day 29

  5. Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)

    FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.

    Measured: Day 1 (Baseline) through Day 29

  6. Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)

    FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.

    Measured: Day 1 (Baseline) through Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2019
  2. Study start11 Dec 2019
  3. Primary completion9 Jun 2022
  4. Study completion9 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03969888
Sponsor's protocol ID
M19-530
Other IDs
2019-000750-63, 2019
Status last verified
Jun 2023
First submitted
30 May 2019
Last updated
28 Jun 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-3067 and ABBV-2222 in people with Cystic Fibrosis, run by AbbVie at 51 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, France, United Kingdom, Canada, Belgium and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (time frame: Day 1 (Baseline) through Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03969888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.

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