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M19-530: Ph2 Cystic Fibrosis ABBV-3067 & ABBV-2222 in F508del

  • Research type

    Research Study

  • Full title

    A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation

  • IRAS ID

    268446

  • Contact name

    Daniel Peckham

  • Contact email

    Daniel.Peckham@nhs.net

  • Sponsor organisation

    AbbVie Ltd.

  • Eudract number

    2019-000750-63

  • Clinicaltrials.gov Identifier

    NCT03969888

  • Duration of Study in the UK

    1 years, 7 months, 25 days

  • Research summary

    Cystic Fibrosis (CF) is a genetic condition that affects many parts of the body causing reduced functions in organs like lungs and pancreas. Disease symptoms include breathing difficulties, infections, digestive problems and diabetes. People with CF often have short life spans with reduced quality of life.\n\nCF is caused by mutations in Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene that affect production and function of CFTR protein. CFTR works on cell surface by transporting chemicals in and out of the cell. When CFTR is not produced correctly, it affects the salt and fluid balance inside and outside of the cell. CFTR modulators can help cells produce more CFTR on the surface by helping the protein form the correct shape (“correctors”) or helping CFTR work better (“potentiators”). \n\nIn this study, patients will be given ABBV-3067 (“potentiator”) and ABBV-2222 (“corrector”) to see if treatment improves patients’ lung function. Different groups of patients will receive different doses, and some will receive a dummy drug (“placebo”). This study evaluates the safety and efficacy (how well the drugs work) of the drugs and the best dose of each drug to be used in future studies.\n\nThis is a Phase 2, double-blinded (treatment type is unknown to patients and investigators) study in CF patients who have two copies of the F508del mutation (the most common CFTR gene mutation). \n\nPatients go through a screening process (up to a month) and receive study treatment for up to a month, followed by a review, a month later. Tests done for the study include lung function tests, sweat chloride tests, blood and urine tests, and ECG. Side effects are monitored through the course of the study.\n\nApproximately 189 adult patients (male and female) will take part in approximately 59 sites worldwide. AbbVie is funding this study.

  • REC name

    Yorkshire & The Humber - Leeds East Research Ethics Committee

  • REC reference

    19/YH/0301

  • Date of REC Opinion

    31 Oct 2019

  • REC opinion

    Further Information Favourable Opinion