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

NCT06642961 | Unknown Phase 2

• 1 other identifier: GR1802-003
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

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

  12weeks

Secondary Outcomes (13)

• 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

Study Arms (3)

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.

Drug: GR1802 injection

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.

Drug: GR1802 injection

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

GR1802 injection DRUG

GR1802 will be administered SC.

GR1802 150mg Q2W

Placebo OTHER

The placebo will be administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genrix (Shanghai) Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Nanshan Zhong, PhD.

CONTACT

020-34296151; chen_rch@163.com

Ruchong Chen, PhD.

CONTACT

13710723826; chen_rch@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 15, 2024
• Study Start: July 19, 2022
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2023-11

Locations

CN (1)