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A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis

NCT03119649 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-11-16

Study results available
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Summary

This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to adult subjects with a confirmed diagnosis of CF and homozygous for the F508del Cystic Fibrosis Transmembrane conductance Regulator (CFTR) mutation.

Conditions

Interventions

DRUG

GLPG2222 50 mg

Oral tablet(s) containing GLPG2222

DRUG

GLPG2222 100 mg

Oral tablet(s) containing GLPG2222

DRUG

Placebo

Matching oral tablet(s) containing placebo

DRUG

GLPG2222 200 mg

Oral tablet(s) containing GLPG2222

DRUG

GLPG2222 400 mg

Oral tablet(s) containing GLPG2222

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
2017-03-18
Primary Completion
2017-10-19
Completion
2017-10-19
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Netherlands
  • Serbia
  • Spain
  • 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 NCT03119649 on ClinicalTrials.gov