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CFTR Modulator

F508del Homozygous and Heterozygous CF Participants 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 up to 29 days
Awards & highlights

Study Summary

This trialis testing a new drug combination to treat Cystic Fibrosis, a life-threatening genetic disease. 90 adults with CF, from 35 sites worldwide, will be enrolled and receive different treatments, with regular check-ups to see the effects.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 29 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 29 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 3: Absolute change in Sweat Chloride (SwCl).
Cohorts 1 and 2: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Secondary outcome measures
Absolute Change From Baseline in Forced Expiratory Flow at Mid-Lung Capacity [FEF25-75]
Absolute Change From Baseline in Forced Vital Capacity [FVC]
Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: F508del Homozygous and Heterozygous CF ParticipantsExperimental Treatment3 Interventions
F508del homozygous and heterozygous CF participants receive galicaftor/navocaftor/ABBV-576 triple combination therapy for 28 days.
Group II: F508del Homozygous Cystic Fibrosis (CF) ParticipantsExperimental Treatment3 Interventions
F508del homozygous cystic fibrosis (CF) participants receive galicaftor/navocaftor dual combination (28 days) followed by galicaftor/navocaftor/ABBV-119 triple combination therapy (28 days).
Group III: F508del Heterozygous CF Participants (Active Drug Group)Experimental Treatment3 Interventions
F508del heterozygous CF participants receive galicaftor/navocaftor/ABBV-119 combination therapy (28 days).
Group IV: F508del Heterozygous CF Participants (Placebo Group)Placebo Group1 Intervention
F508del heterozygous CF participants receive placebo (28 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-576
2022
Completed Phase 1
~30
Galicaftor
2022
Completed Phase 1
~50
Navocaftor
2022
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,996 Total Patients Enrolled
9 Trials studying Cystic Fibrosis
1,645 Patients Enrolled for Cystic Fibrosis
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,830 Total Patients Enrolled
5 Trials studying Cystic Fibrosis
168 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.

In what capacity are hospitals conducting this investigation?

"This medical trial currently has 11 active sites, such as the Medical University of South carolina in Charleston (ID# 245403), Ventura County Medical Center in Ventura (ID# 248586) and Dartmouth-Hitchcock Medical Centre in Lebanon (ID#245706)."

Answered by AI

What findings have been reported from prior experiments involving F508del Homozygous and Heterozygous CF Subjects?

"Currently there is one clinical trial examining the treatment of F508del Homozygous and Heterozygous CF Participants, though this study has not yet progressed to Phase 3. Research for this medical intervention is mainly centred in Cleveland, Ohio with 50 other sites running trials as well."

Answered by AI

To what extent is enrollment for this trial progressing?

"Unfortunately, the recruitment period for this trial has closed. The original posting went up on September 20th 2021 and was last updated October 20th 2022. For those looking to join other studies, there are currently 412 clinical trials recruiting participants suffering from cystic fibrosis (CF) as well as one study geared towards F508del Homozygous and Heterozygous CF Patients actively accepting enrolment."

Answered by AI

What is the purpose of this clinical experiment?

"The purpose of this study, which will take up to 29 days and be monitored accordingly is to observe the absolute change in sweat chloride (SwCl) across 3 different cohorts. Secondary objectives include tracking the percent predicted forced expiratory volume in 1 second (ppFEV1), as well as assessing the alteration of SwCl within both Cohorts 1 and 2. This biomarker operationally measures cystic fibrosis transmembrane conductance regulator (CFTR) ion channel function."

Answered by AI

Can any additional participants join this trial?

"According to clinicaltrials.gov, the recruitment period for this trial was closed on October 20th 2022; thus, it is no longer actively recruiting patients. However, there are currently 413 medical trials that have open enrollments across the country."

Answered by AI

Does the FDA recognize F508del Homozygous and Heterozygous CF Participants?

"Our team at Power evaluated the safety of F508del Homozygous and Heterozygous CF Participants to be a 2. This rating is due to this being classified as Phase 2 trial, meaning there exists data that affirms its security but not necessarily it's efficacy."

Answered by AI

Does this medical trial mark a revolutionary advancement in the field?

"Since 2021, research on F508del homozygous and heterozygotes CF patients has been ongoing. The initial study was conducted in 2021 by AbbVie with 90 participants completing the phase 2 approval stage of this drug trial. Currently, there is one active clinical trial for these individuals funded by AbbVie."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04853368.
~13 spots leftby Apr 2025
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