Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IV... | NCT05153317

ID	Type	Description	Link
2020-002239-31	EudraCT Number

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2022Actual

Primary Completion Date

Jan 29, 2026Actual

Completion Date

Jan 29, 2026Actual

First Submitted Date

Nov 29, 2021

First Submission Date that Met QC Criteria

Nov 29, 2021

First Posted Date

Dec 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2026

Last Update Posted Date

Mar 3, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the long term safety, tolerability, efficacy and pharmacodynamics of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in CF participants 2 years of age and older.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ELX/TEZ/IVA	Experimental	Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.	Drug: ELX/TEZ/IVA Drug: IVA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ELX/TEZ/IVA	Drug	Fixed-dose combination granules or tablets for oral administration.	ELX/TEZ/IVA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		From Day 1 up to Week 196

Secondary Outcomes

Measure	Description	Time Frame
Absolute Change in Sweat Chloride (SwCl)		From Baseline up to Week 192
Absolute Change in Lung Clearance Index (LCI) 2.5		From Baseline up to Week 192

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

key Inclusion Criteria:

Completed study drug treatment in the parent study (VX20-445-111 Part B, NCT04537793), or had study drug interruption(s) in the parent study, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of the parent study

Key Exclusion Criteria:

History of study drug intolerance in the parent study
History of poor compliance with ELX/TEZ/IVA and/or procedures in the parent study

Other protocol defined Inclusion/Exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banner University of Arizona Medical Center		Tucson	Arizona	85724	United States
Stanford University

IPD Sharing Statement Module

Plan to Share IPD

Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007232	Infant, Newborn, Diseases

ID	Term
C000706587	elexacaftor, ivacaftor, tezacaftor drug combination
C545203	ivacaftor