RECRUITING

Safety, Tolerability and Efficacy Study of ARCT-032 in People with Cystic Fibrosis

Conditions

Cystic Fibrosis CFTR Gene Mutation CFTR mRNA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People with Cystic Fibrosis

Quick Facts

Study Start:2024-12-12

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06747858

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Confirmed diagnosis of Cystic Fibrosis 2. Not eligible for CFTR modulator therapy, or not taking CFTR modulators for at least 60 days prior to dosing (e.g. due to intolerance, poor response, or lack of access to modulators). 3. FEV1 between 40% and 100% of predicted value	1. History of illness or medical condition that might pose an additional risk or may confound study results 2. Recent moderate or severe hemoptysis 3. Recent major surgery 4. Solid organ or hematologic transplant 5. Requirement of supplemental oxygen while awake or \> 2L per minute while sleeping. 6. Chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day 7. Adequate liver and kidney function as determined by lab tests

Inclusion Criteria

Exclusion Criteria

1. Confirmed diagnosis of Cystic Fibrosis
2. Not eligible for CFTR modulator therapy, or not taking CFTR modulators for at least 60 days prior to dosing (e.g. due to intolerance, poor response, or lack of access to modulators).
3. FEV1 between 40% and 100% of predicted value

1. History of illness or medical condition that might pose an additional risk or may confound study results
2. Recent moderate or severe hemoptysis
3. Recent major surgery
4. Solid organ or hematologic transplant
5. Requirement of supplemental oxygen while awake or \> 2L per minute while sleeping.
6. Chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day
7. Adequate liver and kidney function as determined by lab tests

Contacts and Locations

Study Contact

Clinical Trial Disclosure Manager Central Email Box

CONTACT

858-900-2660

clinicaltrials@arcturusrx.com

Study Locations (Sites)

The Cystic Fibrosis Institute

Northfield, Illinois, 60093

United States

Collaborators and Investigators

Sponsor: Arcturus Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-12-12

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

CFTR
mRNA

Additional Relevant MeSH Terms

Cystic Fibrosis
CFTR Gene Mutation