A double blind (sponsor open) placebo-controlled, stratified, parallel group study to evaluate the efficacy and safety of repeat doses of GSK3772847 in participants with moderate to severe asthma with allergic fungal airway disease (AFAD) (207972)

A double blind (sponsor open) placebo-controlled, stratified, parallel group study to evaluate the efficacy and safety of repeat doses of GSK3772847 in participants with moderate to severe asthma with allergic fungal airway disease (AFAD) (207972) - 207972

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46085

Enrollment

Registered

2018-04-17

Start date

2018-10-09

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bronchial asthma

Interventions

Treatment with GSK3772847 or placebo on top of standard therapy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Males and females >=18 years of age. • Documented diagnosis of moderate to severe asthma for >=12 months. • Treated with inhaled corticosteroid and long-acting beta-2-agonist for at least 4 months (>=500 ug/day fluticasone propionate or equivalent). • Pre-bronchodilator FEV1 35-79% of predicted. • FeNO >=25ppb at Screening. • ACQ-5 score >=1.5 at Screening • Blood eosinophils >=300 cells/microliter at Screening. • Evidence of allergic fungal airway disease. See protocol page 38 for details. • Female participants of childbearing potential: see protocol page 38-39 for details..

Exclusion criteria

Exclusion criteria: • Concurrent respiratory diseases. See protocol page 39 for details. • History of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection. See protocol page 39 for details. • Serious infection within 8 weeks of enrolment. See protocol page 39 for details. • Clinically significant organic heart disease. See protocol page 39 for details. • Eosinophilic diseases. See protocol page 40 for details. • Prior or concomitant therapy as in Table 2 on protocol page 40. • Abnormal and clinically significant ECG findings as in Table 3 on protocol page 41. • Current smokers or former smokers with a smoking history >=10 pack years.

Design outcomes

Primary

Measure	Time frame
Change from baseline (Week 0) in blood eosinophils over time. Change from baseline (Week 0) in fractional exhaled nitric oxide (FeNO) over time	—

Secondary

Measure	Time frame
Serum concentrations of GSK3772847. Serum levels of free and total soluble ST2. anti-GSK3772847 antibodies. ACQ-5 and AQLQ questionnaires. Change from baseline in FEV1. Adverse events.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)