Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
NCT06747858 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2026-05-08
Summary
ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not taking CFTR modulators due to drug intolerance, poor response, or lack of access to modulators.
Conditions
- Cystic Fibrosis
- CFTR Gene Mutation
Interventions
- BIOLOGICAL
-
ARCT-032
CFTR mRNA formulated in lipid nanoparticles
Sponsors & Collaborators
-
Arcturus Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-12
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Safety and Efficacy of Recombinant Adeno-Associated Virus Containing the CFTR Gene in the Treatment of Cystic Fibrosis
NCT00073463 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis
NCT02718495 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function
NCT01685801 ·Status: COMPLETED ·Phase: PHASE2
-
Observational Trial of the Longitudinal Effects of CFTR Modulator Drugs
NCT04353752 ·Status: COMPLETED
-
A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators
NCT06504589 ·Status: RECRUITING
-
Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis
NCT03607396 ·Status: UNKNOWN
-
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
NCT01807923 ·Status: COMPLETED ·Phase: PHASE3
-
A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
NCT03125395 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
NCT04038710 ·Status: COMPLETED
-
Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240
NCT03435939 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis
NCT02157922 ·Status: COMPLETED ·Phase: PHASE2
-
Surrogate Markers of Response to New Therapies in Cystic Fibrosis Patients
NCT02965326 ·Status: RECRUITING ·Phase: NA
-
Clinical Performance of the AtbFinder® Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis
NCT05584982 ·Status: COMPLETED ·Phase: NA
-
Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic Fibrosis
NCT03591094 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
NCT02797132 ·Status: COMPLETED ·Phase: PHASE3
-
A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
NCT01923753 ·Status: TERMINATED ·Phase: PHASE2
-
Early Intervention in Pulmonary Exacerbation in Cystic Fibrosis
NCT00850551 ·Status: COMPLETED ·Phase: NA
-
A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis
NCT00757848 ·Status: COMPLETED ·Phase: PHASE2
-
Prospective Study of Pregnancy in Women With Cystic Fibrosis
NCT04828382 ·Status: ACTIVE_NOT_RECRUITING
-
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
NCT01807949 ·Status: COMPLETED ·Phase: PHASE3
-
Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)
NCT03475381 ·Status: COMPLETED
-
Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis
NCT00812045 ·Status: WITHDRAWN ·Phase: PHASE2
-
The Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis
NCT00405665 ·Status: COMPLETED ·Phase: PHASE2
-
Costimulatory Molecules as Biomarkers in Cystic Fibrosis
NCT01353950 ·Status: COMPLETED
-
Miglustat in Cystic Fibrosis
NCT00742092 ·Status: COMPLETED ·Phase: PHASE2