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VX-152

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

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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Frequently asked questions about VX-152

What is VX-152 used for?

VX-152 is an investigational small molecule being developed for the treatment of cystic fibrosis. It is being studied in combination therapy for adults with the condition. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes VX-152?

VX-152 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for cystic fibrosis.

What phase is VX-152 in?

VX-152 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The drug is being studied in a completed Phase 2 trial that evaluated its safety in combination therapy for adults with cystic fibrosis.

What clinical trials is VX-152 in?

VX-152 has been studied in one clinical trial, identified as NCT02951195. This was a Phase 2, randomized, double-blind, placebo-controlled study that evaluated the safety of VX-152 combination therapy in adults with cystic fibrosis. The trial enrolled 80 participants in the United States and has been completed.

Is VX-152 the same as other Vertex cystic fibrosis drugs?

VX-152 is a distinct investigational compound developed by Vertex Pharmaceuticals. It is being studied as a combination therapy for cystic fibrosis, but it is not the same as other approved Vertex medications. The drug is still in clinical development and has not been approved for use.