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Restore CFTR Protein Completed with Results

Phase 2a study of Galapagos GLPG2222 in adults with CF (GLPG2222-CL-202)

This study evaluated the safety and effectiveness of the CFTR modulator GLPG2222. This study was for people with CF who have two copies of the F508del mutation.

 In this study, participants were enrolled into Group A and Group B. In Group A, participants were randomly assigned to receive one of two doses of GLPG2222 (50mg or 100mg) or placebo.  In Group B, participants were randomly assigned to receive one of two doses of GLPG2222 (200mg or 400mg) or placebo. Both groups received GLPG2222 or placebo for 29 days.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    Two Copies F508del

  • FEV1% Predicted:

    40% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

To participate, adults with CF must not use supplemental oxygen and must not take ivacaftor or lumacaftor for four weeks before taking the first dose of study drug.

Study Results

  • What We Learned:

    This study found that GLPG2222 was well-tolerated. It was associated with a decrease in sweat chloride at the 50mg, 100mg and 200mg doses when compared with placebo. The biggest decrease was seen at the 200mg dose. GLPG2222 did not have a significant impact on lung function when compared with placebo.  

  • Primary Findings:

    Effectiveness:

    Safety:

    This study was conducted between March 2017 and October 2017. In Group A, 25 participants were enrolled (GLPG222 50mg n=10; 100mg n=10; placebo n=5). In Group B, 34 participants were enrolled (GLPG2222 200mg n=14; 400mg n=14; placebo n=6).

     

    The primary endpoint was safety and tolerability of GLPG2222. Overall, GLPG2222 was well-tolerated. No participants stopped participating in the study due to the study drug.

     

    When compared from the beginning of the study to the end of the study, sweat chloride decreased at the 50, 100, and 200mg doses. The decrease was dependent on the specific dose, with the biggest decrease at the 200mg dose (-15.8 mmol/L p< 0.0001). There was no difference in lung function between GLPG2222 and placebo from the beginning to the end of the study.

  • Citation:

    J Cyst Fibros ;DOI 10.1016/j.jcf.2019.04.014 [Epub ahead of print];S1569-1993(19):30073-30076

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    10 weeks

  • Number of Study Visits:

    5

Additional Information

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    Two Copies F508del

  • FEV1% Predicted:

    40% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

To participate, adults with CF must not use supplemental oxygen and must not take ivacaftor or lumacaftor for four weeks before taking the first dose of study drug.

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