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

NCT ID: NCT03969888

Last Updated: 2023-06-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-11

Study Completion Date

2022-06-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ABBV-3067 50 mg + Placebo for ABBV-2222

Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

Group Type EXPERIMENTAL

ABBV-3067

Intervention Type DRUG

Tablet taken orally.

Placebo ABBV-2222

Intervention Type DRUG

Capsule taken orally.

ABBV-3067 150 mg + Placebo for ABBV-2222

Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

Group Type EXPERIMENTAL

ABBV-3067

Intervention Type DRUG

Tablet taken orally.

Placebo ABBV-2222

Intervention Type DRUG

Capsule taken orally.

ABBV-3067 150 mg + ABBV-2222 10 mg

Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.

Group Type EXPERIMENTAL

ABBV-3067

Intervention Type DRUG

Tablet taken orally.

ABBV-2222

Intervention Type DRUG

Capsule taken orally.

ABBV-3067 150 mg + ABBV-2222 30 mg

Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.

Group Type EXPERIMENTAL

ABBV-3067

Intervention Type DRUG

Tablet taken orally.

ABBV-2222

Intervention Type DRUG

Capsule taken orally.

ABBV-3067 150 mg + ABBV-2222 100 mg

Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.

Group Type EXPERIMENTAL

ABBV-3067

Intervention Type DRUG

Tablet taken orally.

ABBV-2222

Intervention Type DRUG

Capsule taken orally.

ABBV-3067 150 mg + ABBV-2222 200 mg

Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.

Group Type EXPERIMENTAL

ABBV-3067

Intervention Type DRUG

Tablet taken orally.

ABBV-2222

Intervention Type DRUG

Capsule taken orally.

ABBV-3067 150 mg + ABBV-2222 300 mg

Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.

Group Type EXPERIMENTAL

ABBV-3067

Intervention Type DRUG

Tablet taken orally.

ABBV-2222

Intervention Type DRUG

Capsule taken orally.

Placebo for ABBV-3067 + Placebo for ABBV-2222

Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

Group Type PLACEBO_COMPARATOR

Placebo ABBV-3067

Intervention Type DRUG

Tablet taken orally.

Placebo ABBV-2222

Intervention Type DRUG

Capsule taken orally.

Interventions

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ABBV-3067

Tablet taken orally.

Intervention Type DRUG

Placebo ABBV-3067

Tablet taken orally.

Intervention Type DRUG

ABBV-2222

Capsule taken orally.

Intervention Type DRUG

Placebo ABBV-2222

Capsule taken orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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University of Arkansas /ID# 212541

Little Rock, Arkansas, United States

Site Status

Tampa General Hospital /ID# 212342

Tampa, Florida, United States

Site Status

University of Iowa Hospitals and Clinics /ID# 212351

Iowa City, Iowa, United States

Site Status

Univ Michigan Med Ctr /ID# 212657

Ann Arbor, Michigan, United States

Site Status

Cardinal Glennon Children's Hospital /ID# 212349

St Louis, Missouri, United States

Site Status

Washington University-School of Medicine /ID# 212352

St Louis, Missouri, United States

Site Status

Nationwide Children's Hospital /ID# 213158

Columbus, Ohio, United States

Site Status

Medical University of South Carolina /ID# 212187

Charleston, South Carolina, United States

Site Status

Vanderbilt University Medical Center /ID# 212353

Nashville, Tennessee, United States

Site Status

University of Utah /ID# 212350

Salt Lake City, Utah, United States

Site Status

Uza /Id# 213412

Edegem, Antwerpen, Belgium

Site Status

Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 213413

Brussels, Brussels Capital, Belgium

Site Status

UZ Brussel /ID# 212812

Jette, Brussels Capital, Belgium

Site Status

UZ Gent /ID# 213411

Ghent, Oost-Vlaanderen, Belgium

Site Status

Universitair Ziekenhuis Leuven /ID# 213050

Leuven, Vlaams-Brabant, Belgium

Site Status

University of Calgary /ID# 212555

Calgary, Alberta, Canada

Site Status

St. Paul's Hospital /ID# 212554

Vancouver, British Columbia, Canada

Site Status

QEII - Health Sciences Centre /ID# 212656

Halifax, Nova Scotia, Canada

Site Status

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

Toronto, Ontario, Canada

Site Status

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

Montreal, Quebec, Canada

Site Status

McGill University Health Center Research Institute /ID# 212553

Montreal, Quebec, Canada

Site Status

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

Québec, Quebec, Canada

Site Status

Fakultni Nemocnice Brno /ID# 213437

Brno, , Czechia

Site Status

Fakultni Nemocnice v Motole /ID# 212966

Prague, , Czechia

Site Status

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

Nice, Alpes-Maritimes, France

Site Status

HCL - Hopital Lyon Sud /ID# 212899

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Site Status

CHU Bordeaux - Hopital Haut Leveque /ID# 212898

Pessac, Gironde, France

Site Status

CHU Montpellier - Hôpital Saint Eloi /ID# 212856

Montpellier, Herault, France

Site Status

AP-HP - Hopital Cochin /ID# 212864

Paris, , France

Site Status

CHU de Reims - Hôpital Maison Blanche /ID# 212910

Reims, , France

Site Status

Fondation ILDYS /ID# 212857

Roscoff, , France

Site Status

CHU Nantes - Hopital Laennec /ID# 212897

Saint-Herblain, , France

Site Status

Orszagos Koranyi Pulmonologiai Intezet /ID# 213494

Budapest, , Hungary

Site Status

HagaZiekenhuis /ID# 212926

The Hague, , Netherlands

Site Status

Universitair Medisch Centrum Utrecht /ID# 212935

Utrecht, , Netherlands

Site Status

Greenlane Clinical Centre /ID# 221103

Epsom, Auckland, New Zealand

Site Status

Christchurch Hospital /ID# 221105

Christchurch, Canterbury, New Zealand

Site Status

Dunedin Hospital /ID# 221104

Otago, Otago, New Zealand

Site Status

Waikato Hospital /ID# 221102

Hamilton, Waikato Region, New Zealand

Site Status

Szpital Dzieciecy Polanki /ID# 221330

Gdansk, Pomeranian Voivodeship, Poland

Site Status

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

Belgrade, Beograd, Serbia

Site Status

Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213146

Bratislava, , Slovakia

Site Status

Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213596

Bratislava, , Slovakia

Site Status

Barts Health NHS Trust /ID# 213016

London, London, City of, United Kingdom

Site Status

Nottingham University Hospitals NHS Trust /ID# 212531

Nottingham, Nottinghamshire, United Kingdom

Site Status

Cardiff & Vale University Health Board /ID# 212504

Cardiff, Wales, United Kingdom

Site Status

Royal Papworth Hospital NHS Foundation Trust /ID# 212507

Cambridge, , United Kingdom

Site Status

Leeds Teaching Hospitals NHS Trust /ID# 212491

Leeds, , United Kingdom

Site Status

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

Liverpool, , United Kingdom

Site Status

Royal Brompton and Harefield Hospitals /ID# 212490

London, , United Kingdom

Site Status

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

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States Belgium Canada Czechia France Hungary Netherlands New Zealand Poland Serbia Slovakia United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-000750-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M19-530

Identifier Type: -

Identifier Source: org_study_id

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