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ABBV-3067

Phase 2

Cystic Fibrosis | Small molecule | Respiratory |AbbVie Inc.|Last Updated: Jun 28, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-3067 · 1 trial · 1 indication

Phase 2 1
NCT03969888A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222Cystic Fibrosis
COMPLETED78 Analytics
PHASE2COMPLETED
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Day 1 (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. Mixed-effect model with repeated measures (MMRM) was used for the analyses.

Secondary Endpoints

Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
Day 1 (Baseline) through Day 29
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
Day 1 (Baseline) through Day 29
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
Day 1 (Baseline) through Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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.
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.
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.
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.
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.
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.
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.
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.

Interventions

NameTypeDescription
ABBV-3067DRUGTablet taken orally.
Placebo ABBV-3067DRUGTablet taken orally.
ABBV-2222DRUGCapsule taken orally.
Placebo ABBV-2222DRUGCapsule taken orally.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites51

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 Cr...

Countries:United StatesBelgiumCanadaCzechiaFranceHungaryNetherlandsNew ZealandPolandSerbiaSlovakiaUnited Kingdom
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Frequently asked questions about ABBV-3067

What is ABBV-3067 used for?

ABBV-3067 is an investigational small molecule being developed for the treatment of cystic fibrosis. It is a Phase 2 drug candidate that has been studied in a completed clinical trial involving 78 participants. The drug is intended for use in adults aged 18 years and older with cystic fibrosis.

Who makes ABBV-3067?

ABBV-3067 is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV. The company has conducted a Phase 2 clinical trial of the drug for cystic fibrosis, which has been completed.

What phase is ABBV-3067 in?

ABBV-3067 is in Phase 2 clinical development. It has completed a Phase 2 study, meaning it is still investigational and has not been approved by regulatory authorities. The drug is being studied for the treatment of cystic fibrosis in adult patients.

What clinical trials is ABBV-3067 in?

ABBV-3067 has been studied in one clinical trial, identified as NCT03969888. This was a Phase 2, randomized, double-blind, placebo-controlled study of ABBV-3067 alone and in combination with ABBV-2222 for cystic fibrosis. The trial enrolled 78 participants and has been completed.

Is ABBV-3067 the same as ABBV-2222?

No, ABBV-3067 is not the same as ABBV-2222. They are separate investigational drugs developed by AbbVie. In the clinical trial NCT03969888, ABBV-3067 was studied both alone and in combination with ABBV-2222 to evaluate their effects in patients with cystic fibrosis.