A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase II Trail Evaluating the Efficacy and Safety of GR1802 Injection in Patients with Moderate to Severe Asthma

Genrix (Shanghai) Biopharmaceutical Co., Ltd.1 site in 1 country150 target enrollmentJuly 19, 2022

ConditionsAsthma

InterventionsGR1802 injection Placebo

Overview

Phase: Phase 2
Intervention: GR1802 injection
Conditions: Asthma
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Enrollment: 150
Locations: 1
Primary Endpoint: Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks.

Registry

clinicaltrials.gov

Start Date

July 19, 2022

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 and ≤70 years old, male or female.
•The subject meet the diagnostic criteria of GINA 2021 requiring a diagnosis of asthma for at least 12 months and fulfilled one of the following criteria:
•(1) The subject has received medium-to-high dose ICS combined with at least one control drug, such as LABA, LTRA, theophylline, for at least 3 months before baseline visit, and maintained stable treatment regimen and dosage for at least 1 month before baseline visit; (2) The subject have been on a 3rd controlled drug for at least 3 consecutive months and on a stable dose for ≥1 month prior to baseline visit; (3) The subject must have been on maintenance therapy with ≤10mg/day prednisone or equivalent dose of OCS continuously for at least 3 months and have been receiving therapy at a stable dose for ≥1 month prior to the baseline visit.
•35%≤ Pre-bronchodilator FEV1 measured ≤ 80% of the normal predicted value at screening and baseline visits.
•Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5 at screening and baseline visits.
•A positive bronchodilation test (≥12% increase in the FEV1 post-bronchodilator and an absolute FEV1 increase of ≥200 mL) within 12 months before screening.
•Subjects must have experienced at least one severe asthma exacerbation event within 12 months before screening, denfined as: systemic use of glucocorticoids for ≥3 days (at least twice the dose of current use); and/or an emergency visit due to asthma symptoms resulting in hospitalisation, and/or asthma requiring additional systemic glucocorticoid intervention therapy.
•Willingness to follow the requirements of the study protocol and willingness of the patient or his/her legal representative to sign a written informed consent.

Exclusion Criteria

•Chronic obstructive pulmonary disease (COPD) or other lung disease that may impair lung function, as judged by the investigator.
•Have experienced a severe asthma exacerbation event within 1 month before baseline visit.
•Lung disease other than asthma with clinically significant impact on efficacy or safety evaluation confirmed by clinical or imaging evidence （e.g., chest X-ray, CT, MRI）within 12 months before baseline visit.
•Evidence of active tuberculosis infection at screening.
•Current smokers or former smokers who quit smoking less than 6 months.
•Former smokers with a smoking history of more than 10 pack-years.
•Subjects who have history of drug or alcohol abuse (alcohol abuse defined as consumption of more than 28 units of alcohol per week :1 unit = 285 ml of beer or 25 ml of spirits ≥40% alcohol by volume or 1 glass of wine) within 2 years before baseline visit.
•Long-term reversal of daily sleep patterns (e.g., long-term night shift workers).
•Subjects who need to be treated with non-selective β1-adrenergic receptor blockers for any reason, or who are on selective β1-blockers but have unstable doses in the 1 month prior to the baseline visit.
•Underwent an IgE antibody within 130 days prior to the baseline visit, or received prior treatment with an IL-4R antibody (e.g., dupilumab); and those who have received other biologics within 5 half-lives (half-life known) or 6 months (half-life unknown).

Arms & Interventions

GR1802 300mg Q2W

GR1802 is injected subcutaneously (SC) with a loading dose of 600 mg at the first dose, and then 300 mg each time, once every 2 weeks (Q2W) for a total of 12 doses.

Intervention: GR1802 injection

GR1802 150mg Q2W

GR1802 is injected subcutaneously (SC) with a loading dose of 300 mg at the first dose, and then 150 mg each time, once every 2 weeks (Q2W) for a total of 12 doses.

Intervention: GR1802 injection

Placebo

Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses

Intervention: Placebo

Outcomes

Primary Outcomes

Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.

Time Frame: 12weeks

Absolute change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of GR1802 treatment compared with placebo.

Secondary Outcomes

Change from baseline in pre-bronchodilator FEV1 at 24 weeks.(24weeks)
Percent change from baseline in pre-bronchodilator FEV1 at 12 and 24 weeks.(12weeks and 24weeks)
Annualized rate of subjects experiencing severe asthma exacerbations.(24weeks and 32weeks)
Time to the first onset of the severe asthma exacerbation event.(32weeks)
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC).(24weeks and 32weeks)
Time to the onset of the first event of LOAC.(32weeks)
Change from baseline in other lung function measures.(24weeks)
Changes from baseline in the Asthma Control Questionnaire-5 (ACQ-5)score and ACQ-7 score at each evaluation time point.(2、4、8、12、16、20、24、28 、32weeks)
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ) score at 12weeks and 24 weeks.(12weeks and 24weeks)
Total daily use of asthma reliever(24weeks)
Safety evaluation indicators(32weeks)
Concentration of GR1802 at each evaluation time point.(Baseline up to week 32)
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).(Baseline up to week 32)