GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-29

Study Completion Date

2018-04-10

Brief Summary

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This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate GLPG2737 administered orally b.i.d. for 28 days to adult male and female subjects with a confirmed diagnosis of cystic fibrosis homozygous for the F508del CFTR mutation and on stable treatment with Orkambi.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GLPG2737

GLPG2737 will be provided as capsules for oral use.

Group Type EXPERIMENTAL

GLPG2737

Intervention Type DRUG

GLPG2737 oral capsules administered twice daily for 28 days on top of Orkambi.

Placebo

Placebo will be provided as capsules for oral use.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral capsules administered twice daily for 28 days on top of Orkambi.

Interventions

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GLPG2737

GLPG2737 oral capsules administered twice daily for 28 days on top of Orkambi.

Intervention Type DRUG

Placebo

Placebo oral capsules administered twice daily for 28 days on top of Orkambi.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subject ≥18 years of age on the day of signing the ICF.
* A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation.
* Stable intake of physician prescribed Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.) for at least 12 weeks prior to the first study drug administration, and planned continuation of Orkambi for the duration of the study.
* FEV1 ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).
* Sweat chloride concentration ≥60 mmol/L at screening.

Exclusion Criteria

* History of serious allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization) and/or known sensitivity to any component of the study drug.
* History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
* Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 4 weeks prior to the first study drug administration.
* History of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices, etc.).
* Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or alkaline phosphatase and/or gammaglutamyl transferase (GGT) ≥3 x the upper limit of normal (ULN), and/or total bilirubin ≥1.5 x the ULN at screening.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No