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A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis

NCT03045523 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-11-21

No results posted yet for this study

Summary

This clinical study is a phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR mutation and a second gating (class III) mutation and on stable treatment with ivacaftor.

Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days. Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from screening until the follow-up visit.

Conditions

Interventions

DRUG

GLPG2222 150 mg q.d.

GLPG2222 150 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days

DRUG

GLPG2222 300 mg q.d.

GLPG2222 300 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days

DRUG

Placebo

Placebo administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Olivier Van Steen, MD, MBA · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-08-11
Completion
2017-08-11

Countries

  • Australia
  • Belgium
  • Czechia
  • Germany
  • Ireland
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03045523 on ClinicalTrials.gov