NCT06642961RecruitingPhase 2
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 enrollmentStarted: July 19, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
- •Treatment with herbs and pCms with asthma-alleviating effects within 4 weeks prior to the baseline visit (except topical herbs).
- •Underwent immunoglobulin (IVIG) therapy, allergen-specific immunotherapy (SIT) within 3 months prior to the baseline visit or plan to be treated with the therapy during the trial.
- •Underwent bronchial thermoplasty within 3years before baseline visit or plan to be treated with the therapy during the trial.
- •Comorbidities requiring ICS (e.g. TB) or LABA (e.g. severe heart disease, insulin-dependent diabetes mellitus, uncontrolled hypertension, hyperthyroidism, etc.) resulting in compromised treatment of the comorbidities.
- •Prolonged QTc interval or ventricular tachycardia requiring pharmacological treatment.
- •Pregnant or lactating women.
- •Positive hepatitis B surface antigen (except for HBVDNA test below 500 IU/ml) and hepatitis B core antibody (except for HBVDNA test below 500 IU/ml) at screening; positive HCV antibody, HIV antibody, and TP-Ab (except for those who are RPR or TRUST negative).
- •Those with existing or suspected acute or chronic infections in the 4 weeks prior to the baseline visit and who have received antibacterial, antiviral, antifungal, antiparasitic or antiprotozoal therapy.
- •Received live or attenuated vaccine within 12 weeks before baseline visit or planned to receive live or attenuated vaccine during the study period.
- •History of vital organ transplantation (e.g. heart, lung, kidney, liver) or haematopoietic stem cell/bone marrow transplantation.
- •Patients with active autoimmune diseases, or autoimmune diseases being treated with immunosuppressive drugs (e.g. inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, psoriasis, Hashimoto's thyroiditis, Graves' disease).
- •History of severe herpes virus infections, e.g., herpes encephalitis, disseminated herpes.
- •Malignancy within 5 yearsbefore baseline visit (except squamous carcinoma in situ, basal cell carcinoma and cervical carcinoma in situ of the skin, which have been completely treated without any sign of recurrence).
- •Poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg. Note: Determined by 2 consecutive elevated readings. If the initial blood pressure reading exceeds this limit, the blood pressure may be re-measured after the subject has rested for ≥10 minutes. If the repeated measurement is below the limit, the second value is acceptable).
- •The following laboratory test abnormalities were present at screening:
- •Haemoglobin <10.0 g/dL (100.0 g/L) (men) or <9.0 g/dL (90.0 g/L) (women); white blood cell count <3.0×109/L; neutrophil count <1.5 x 109 /L; platelet count <100 x 109 /L; alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ) > 1.5 times upper limit of normal (ULN); serum creatinine > 1.0 times ULN; total bilirubin > 1.5 times ULN; alkaline phosphatase > 1.5 times ULN.
- •Females and/or males of childbearing potential and their partners who refuse to: use highly effective (female subjects and their partners)/effective (male subjects and their partners) contraception, have a childbearing, egg donation programme (females), or a sperm donation programme (males), from the time of signing the Informed Consent Form until 6 months after the end of the last dose;
- •Participation in another clinical trial treatment within 12 weeks prior to the baseline visit.
- •The investigator considers that there are any conditionswhich are inappropriate to participate in this study.
Arms & Interventions
GR1802 300mg Q2W
Experimental
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 (Drug)
GR1802 150mg Q2W
Experimental
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 (Drug)
Placebo
Placebo Comparator
Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses
Intervention: Placebo (Other)
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)
Investigators
Study Sites (1)
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