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VX-152

Phase 2

Cystic Fibrosis | Small molecule | Respiratory |Vertex Pharmaceuticals Incorporated|Trials Updated: Jan 28, 2021

VX-152 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Nov 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

VX-152 clinical trials

VX-152 · 1 trial · 1 indication

Phase 2 1
NCT02951195A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic FibrosisCystic Fibrosis
COMPLETED80 Analytics
PHASE2COMPLETED
A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2)
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 15 for Part 1 and Part 2 Cohort 2A
From Baseline at Day 15

FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.

Absolute Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B
From Baseline Through Day 29

FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.

Secondary Endpoints

Absolute Change in Sweat Chloride Concentrations at Day 15 for Part 1 and Part 2 Cohort 2A
From Baseline at Day 15
Absolute Change in Sweat Chloride Concentrations Through Day 29 for Part 2 Cohort 2B
From Baseline Through Day 29
Relative Change in ppFEV1 at Day 15 for Part 1 and Part 2 Cohort 2A
From Baseline at Day 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: PlaceboPLACEBO_COMPARATOR -
Part 1 Cohort 1A: TCEXPERIMENTAL -
Part 1 Cohort 1B: TCEXPERIMENTAL -
Part 1 Cohort 1C: TCEXPERIMENTAL -
Part 2 Cohort 2A: TEZ/IVAACTIVE_COMPARATOR -
Part 2 Cohort 2A: TCEXPERIMENTAL -
Part 2 Cohort 2B: TEZ/IVAACTIVE_COMPARATOR -
Part 2 Cohort 2B: TCEXPERIMENTAL -

Interventions

NameTypeDescription
VX-152DRUGTablet for oral administration.
TEZ/IVADRUGFixed-dose combination tablet for oral administration.
IVADRUGTablet for oral administration.
PlaceboDRUGPlacebo matched to VX-152.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Willing and able to comply with scheduled visits, treatment pan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures. * Body weight ≥35 kg. * Sweat chloride value ≥ 60 mmol/L from test results obtained during screening. * Subjects must ha...

Countries:United States
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Competitive Landscape -Cystic Fibrosis 20 trials

Frequently asked questions about VX-152

What is VX-152 used for in cystic fibrosis?

VX-152 is an investigational small molecule developed by Vertex Pharmaceuticals for the treatment of cystic fibrosis, a respiratory disease. It was studied as part of a combination therapy regimen in adults with cystic fibrosis. VX-152 has not been approved and remains in clinical development.

Who is developing VX-152?

VX-152 is being developed by Vertex Pharmaceuticals Incorporated, which trades on the Nasdaq under the ticker VRTX. Vertex is the sponsor of the clinical program evaluating VX-152 in cystic fibrosis.

What phase is VX-152 in?

VX-152 is in Phase 2 development. Its single recorded trial, NCT02951195, was a Phase 2 study that has been completed. VX-152 is investigational and has not been approved for any indication.

What clinical trials is VX-152 in?

VX-152 has been evaluated in one clinical trial, NCT02951195, titled A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis. The Phase 2 trial enrolled 80 participants in the United States, was randomized, double-blind, and placebo-controlled, and is now completed.

How was the VX-152 Phase 2 trial designed?

The Phase 2 trial NCT02951195 enrolled 80 adults aged 18 years and older with cystic fibrosis in the United States. It was a randomized, double-blind, placebo-controlled study, and participants were selected based on a biomarker. The trial has been completed.