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GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis (PELICAN)

G

Galapagos

Status and phase

Completed
Phase 2

Conditions

Cystic Fibrosis

Treatments

Drug: GLPG2737
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03474042
GLPG2737-CL-202
2017-002181-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

22 participants in 2 patient groups, including a placebo group

GLPG2737
Experimental group
Description:
GLPG2737 will be provided as capsules for oral use.
Treatment:
Drug: GLPG2737
Placebo
Placebo Comparator group
Description:
Placebo will be provided as capsules for oral use.
Treatment:
Drug: Placebo

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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