A randomized, double-blind, placebo-controlled, parallel-group, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis

Conditions

Bronchiectasis

Brief summary

Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period

Detailed description

Time to first moderate or severe PE over the treatment period, Percentage of participants who are PE free over the treatment period, Annualized rate of severe PEs over the treatment period, Percentage of participants who are severe PE free over the treatment period, Time to first severe PE over the treatment period, Change From Baseline in FEV1 at Week 8 and Week 24, Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use, Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24, Change from baseline in SGRQ total score at Week 24, Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24, Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period, Serum concentrations of itepekimab from baseline to end of study, Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses throughout the study

Related papers

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Interventions

DRUGItepekimab

DRUGMatched placebo for test product

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period	—

Secondary

Measure	Time frame
Time to first moderate or severe PE over the treatment period, Percentage of participants who are PE free over the treatment period, Annualized rate of severe PEs over the treatment period, Percentage of participants who are severe PE free over the treatment period, Time to first severe PE over the treatment period, Change From Baseline in FEV1 at Week 8 and Week 24, Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use, Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24, Change from baseline in SGRQ total score at Week 24, Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24, Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period, Serum concentrations of itepekimab from baseline to end of study, Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses	—

Measure

Time frame

Time to first moderate or severe PE over the treatment period, Percentage of participants who are PE free over the treatment period, Annualized rate of severe PEs over the treatment period, Percentage of participants who are severe PE free over the treatment period, Time to first severe PE over the treatment period, Change From Baseline in FEV1 at Week 8 and Week 24, Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use, Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24, Change from baseline in SGRQ total score at Week 24, Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24, Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period, Serum concentrations of itepekimab from baseline to end of study, Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses

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Countries

Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Spain

Outcome results

None listed