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ABBV-3067 for Cystic Fibrosis

Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (baseline) through day 29
Awards & highlights

Study Summary

This study is evaluating whether a drug may help treat cystic fibrosis.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (baseline) through day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (baseline) through day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Secondary outcome measures
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
+3 more

Side effects data

From 2022 Phase 2 trial • 78 Patients • NCT03969888
8%
ABDOMINAL PAIN UPPER
8%
VOMITING
8%
MUSCLE STRAIN
8%
HEADACHE
8%
PANIC ATTACK
8%
DRY THROAT
8%
ABDOMINAL PAIN
8%
SIALOADENITIS
8%
BRONCHOSPASM
8%
CHEST DISCOMFORT
8%
RESPIRATORY TRACT INFECTION VIRAL
8%
DIARRHOEA
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABBV-3067 150 mg + Placebo for ABBV-2222
ABBV-3067 150 mg + ABBV-2222 300 mg
ABBV-3067 50 mg + Placebo for ABBV-2222
ABBV-3067 150 mg + ABBV-2222 200 mg
ABBV-3067 150 mg + ABBV-2222 30 mg
ABBV-3067 150 mg + ABBV-2222 100 mg
ABBV-3067 150 mg + ABBV-2222 10 mg
Placebo for ABBV-3067 + Placebo for ABBV-2222

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: ABBV-3067 50 mg + Placebo for ABBV-2222Experimental Treatment2 Interventions
Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Group II: ABBV-3067 150 mg + Placebo for ABBV-2222Experimental Treatment2 Interventions
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Group III: ABBV-3067 150 mg + ABBV-2222 300 mgExperimental Treatment2 Interventions
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
Group IV: ABBV-3067 150 mg + ABBV-2222 30 mgExperimental Treatment2 Interventions
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
Group V: ABBV-3067 150 mg + ABBV-2222 200 mgExperimental Treatment2 Interventions
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
Group VI: ABBV-3067 150 mg + ABBV-2222 100 mgExperimental Treatment2 Interventions
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
Group VII: ABBV-3067 150 mg + ABBV-2222 10 mgExperimental Treatment2 Interventions
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
Group VIII: Placebo for ABBV-3067 + Placebo for ABBV-2222Placebo Group2 Interventions
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-3067
2019
Completed Phase 2
~80
Placebo ABBV-2222
2019
Completed Phase 2
~80
ABBV-2222
2019
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
952 Previous Clinical Trials
499,692 Total Patients Enrolled
9 Trials studying Cystic Fibrosis
1,615 Patients Enrolled for Cystic Fibrosis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,479 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
36 Patients Enrolled for Cystic Fibrosis
ABBVIE INC.Study DirectorAbbVie
392 Previous Clinical Trials
144,476 Total Patients Enrolled
5 Trials studying Cystic Fibrosis
138 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
2019. "A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03969888.
~15 spots leftby Apr 2025
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