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Restore CFTR Protein Completed with Results

Study of ABBV-3067 and ABBV-2222 in adults with cystic fibrosis who have two copies of the F508del mutation (AbbVie M19-530)

This study evaluated the safety and effectiveness of ABBV-3067, a CFTR modulator intended to improve CFTR function. ABBV-3067 was tested alone and in combination with another CFTR modulator, ABBV-2222. 

 
This study had two parts. In Part 1, participants were randomly assigned to receive one of the following treatments: the study drug ABBV-3067 alone; both ABBV-3067 and ABBV-2222; or a placebo. In Part 2 of the study, some participants received both ABBV-3067 and ABBV-2222, and some participants received a placebo. Researchers tested the effectiveness of ABBV-3067 alone and in combination with ABBV-2222 by measuring changes in lung function and sweat chloride. 

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    Two Copies F508del

  • FEV1% Predicted:

    40 to 90%

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

Other Primary Eligibility Criteria

Participants must have two copies of the F508del mutation. In addition, they must not have taken CFTR modulator therapies (e.g., ivacaftor, lumacaftor, tezacaftor) for at least 60 days prior to screening.

Study Results

  • What We Learned:

    The combination of ABBV-3067 and ABBV-2222 did not result in significantly better lung function after 4 weeks when compared with placebo. The sponsor has halted development of this drug combination. 

  • Primary Findings:

    Effectiveness:

    This study was conducted between December 2019 and June 2022. The study enrolled a total of 78 patients. Seven different dosing regimens were tested and compared with placebo.  

    The primary outcome was change in ppFEV1 from baseline to Day 29. This study did not meet its primary efficacy outcome as there was no significant improvement in FEV1 for any of the seven dosing regimens compared with placebo. 

     

    Changes in sweat chloride were measured through Day 29 and compared between treatment groups, along with several other outcomes of interest. At highest combined dosage of both ABBV-3067 and ABBV-2222, sweat chloride was decreased by 19.9 mmol/L. 

    Safety:

    The number of all adverse events and serious adverse events was similar across all groups.

     

    Results have not been peer-reviewed and come from https://clinicaltrials.gov/study/NCT03969888 

     

     

  • Citation:

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:

    3 months

  • 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 to 90%

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

Other Primary Eligibility Criteria

Participants must have two copies of the F508del mutation. In addition, they must not have taken CFTR modulator therapies (e.g., ivacaftor, lumacaftor, tezacaftor) for at least 60 days prior to screening.

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