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A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis

Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline at week 12

Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline at week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Secondary study objectives
Absolute Change in Sweat Chloride (SwCl)

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: VX-561: 50 mgExperimental Treatment2 Interventions
Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.
Group II: VX-561: 250 mgExperimental Treatment2 Interventions
Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
Group III: VX-561: 25 mgExperimental Treatment2 Interventions
Participants received VX-561 25 mg orally daily (qd) in the treatment period for 12 weeks.
Group IV: VX-561: 150 mgExperimental Treatment2 Interventions
Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.
Group V: IvacaftorActive Control2 Interventions
Participants received IVA 150 milligrams (mg) orally every 12 hours (q12h) in the treatment period for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-561
2017
Completed Phase 2
~520
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
257 Previous Clinical Trials
34,992 Total Patients Enrolled
128 Trials studying Cystic Fibrosis
17,868 Patients Enrolled for Cystic Fibrosis
~12 spots leftby Jan 2026
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