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CFTR Modulator

LUM/IVA for Cystic Fibrosis

Phase 3
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 weeks
Awards & highlights

Study Summary

This trial is testing a new drug for kids ages 12-24 months old. The drug is Lumacaftor/Ivacaftor (LUM/IVA) and it is given to subjects who are 12 to <24 months of age.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability as assessed by the number of adverse events (AEs) and serious adverse events (SAEs)
Secondary outcome measures
Absolute change in sweat chloride

Side effects data

From 2017 Phase 4 trial • 70 Patients • NCT02875366
24%
Infective pulmonary exacerbation of cystic fibrosis
15%
Cough
15%
Respiration abnormal
12%
Upper respiratory tract infection
9%
Haemoptysis
9%
Increased viscosity of bronchial secretion
9%
Gastrooesophageal reflux disease
9%
Nausea
9%
Nasopharyngitis
6%
Sputum increased
6%
Toothache
6%
Distal intestinal obstruction syndrome
6%
Pyrexia
6%
Anxiety
6%
Blood creatine phosphokinase increased
3%
Dyspnoea
3%
Fatigue
3%
Lower respiratory tract infection bacterial
3%
Testicular torsion
3%
Oropharyngeal pain
3%
Diarrhoea
3%
Inguinal hernia
3%
Tachycardia
3%
Infection
3%
Productive cough
3%
Viral upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
LUM/IVA

Trial Design

1Treatment groups
Experimental Treatment
Group I: LUM/IVAExperimental Treatment1 Intervention
Subjects will receive LUM/IVA for 96 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LUM/IVA
2018
Completed Phase 4
~560

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
32,335 Total Patients Enrolled
126 Trials studying Cystic Fibrosis
17,697 Patients Enrolled for Cystic Fibrosis

Media Library

LUM/IVA (CFTR Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04235140 — Phase 3
Cystic Fibrosis Research Study Groups: LUM/IVA
Cystic Fibrosis Clinical Trial 2023: LUM/IVA Highlights & Side Effects. Trial Name: NCT04235140 — Phase 3
LUM/IVA (CFTR Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04235140 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other case studies like this one?

"LUM/IVA has been under clinical investigation since 2015. The first study was completed in that same year and was funded by Vertex Pharmaceuticals Incorporated. Phase 3 approval for LUM/IVA came after the initial trial in 2015, which had 1044 participants. As of now, there are 22 active studies involving LUM/IVA being conducted in 110 cities and 23 different countries around the world."

Answered by AI

Has LUM/IVA undergone drug trials that have been cleared by the FDA?

"LUM/IVA is a Phase 3 trial medication, which means that while there is data supporting its efficacy, there are also multiple rounds of data confirming its safety. Our team at Power rates LUM/IVA as having a 3 out of 3 safety rating."

Answered by AI

How many study participants are currently enrolled?

"This clinical trial is not currently recruiting participants at this time. The clinical trial was originally posted on 2/24/2020 and was most recently edited on 11/26/2021. However, if you are searching for other studies, there are 432 trials actively searching for patients with cystic fibrosis and 22 studies for LUM/IVA that need participants."

Answered by AI

Are there different facilities testing this within the state limits?

"To make participation as convenient as possible for patients, this trial is being conducted at 23 different locations. these include major centres like Montreal, Toronto and Vancouver, with 20 other clinics located throughout."

Answered by AI

Are researchers still actively seeking participants for this study?

"Right now, this particular trial is not looking for more patients. According to the latest update on clinicaltrials.gov, it was last edited on November 26th, 2021. There are 432 other trials related to cystic fibrosis currently admitting patients and 22 LUM/IVA studies searching for participants."

Answered by AI

Are there other published works that explore the effects of LUM/IVA?

"At present, there are 22 clinical trials underway that are studying the efficacy of LUM/IVA. Of those active trials, 15 are in Phase 3. The majority of trials for LUM/IVA are taking place in Bochum, but there are also 1038 locations across California running trials for this treatment."

Answered by AI

What is the main reason that doctors prescribe LUM/IVA?

"The drug LUM/IVA can be used to treat ivacaftor-responsive cftr mutation, homozygous for f508del mutation in the cftr gene, and cystic fibrosis (cf)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation
2020. "Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04235140.
~10 spots leftby Apr 2025
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