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NCT06642961 | RECRUITING | Asthma

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
Sponsor:

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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.

Condition or disease

Asthma

Intervention/treatment

GR1802 injection

GR1802 injection

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2022-07-19
Estimated Primary Completion Date : 2025-03-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Age ≥18 and ≤70 years old, male or female.
  • 2. 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.
    • 3\. 35%≤ Pre-bronchodilator FEV1 measured ≤ 80% of the normal predicted value at screening and baseline visits.
    • 4\. Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5 at screening and baseline visits.
    • 5\. A positive bronchodilation test (≥12% increase in the FEV1 post-bronchodilator and an absolute FEV1 increase of ≥200 mL) within 12 months before screening.
    • 6\. 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.
    • 7\. 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
    • 1. Chronic obstructive pulmonary disease (COPD) or other lung disease that may impair lung function, as judged by the investigator.
    • 2. Have experienced a severe asthma exacerbation event within 1 month before baseline visit.
    • 3. 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.
    • 4. Evidence of active tuberculosis infection at screening.
    • 5. Current smokers or former smokers who quit smoking less than 6 months.
    • 6. Former smokers with a smoking history of more than 10 pack-years.
    • 7. 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.
    • 8. Long-term reversal of daily sleep patterns (e.g., long-term night shift workers).
    • 9. 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.
    • 10. 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).
    • 11. Treatment with herbs and pCms with asthma-alleviating effects within 4 weeks prior to the baseline visit (except topical herbs).
    • 12. 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.
    • 13. Underwent bronchial thermoplasty within 3years before baseline visit or plan to be treated with the therapy during the trial.
    • 14. 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.
    • 15. Prolonged QTc interval or ventricular tachycardia requiring pharmacological treatment.
    • 16. Pregnant or lactating women.
    • 17. 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).
    • 18. 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.
    • 19. Received live or attenuated vaccine within 12 weeks before baseline visit or planned to receive live or attenuated vaccine during the study period.
    • 20. History of vital organ transplantation (e.g. heart, lung, kidney, liver) or haematopoietic stem cell/bone marrow transplantation.
    • 21. 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).
    • 22. History of severe herpes virus infections, e.g., herpes encephalitis, disseminated herpes.
    • 23. 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).
    • 24. 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).
    • 25. 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.
      • 26. 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;
      • 27. Participation in another clinical trial treatment within 12 weeks prior to the baseline visit.
      • 28. The investigator considers that there are any conditionswhich are inappropriate to participate in this study.
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

Location Details

NCT06642961

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Locations

RECRUITING

China, Guangdong

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510120