AsthmaPhase 2NCT06642961
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
A Phase 2 study testing GR1802 injection in people with Asthma, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- GR1802 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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.
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Nanshan Zhong, PhD., 020-34296151, chen_rch@163.com
Ruchong Chen, PhD., 02034296151
About this study
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
- Being tested
- GR1802 injection, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR1802 injectionDrug
GR1802 will be administered SC.
GR1802 injectionDrug
GR1802 will be administered SC.
PlaceboOther
The placebo will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: GR1802 injection |
| Placebo | Placebo comparator | Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12weeks
Secondary outcomes (13)
Change from baseline in pre-bronchodilator FEV1 at 24 weeks.
Absolute change from baseline in pre-bronchodilator FEV1 at e24 weeks.
Measured: 24weeks
Percent change from baseline in pre-bronchodilator FEV1 at 12 and 24 weeks.
Percent change from baseline in pre-bronchodilator FEV1 at 12 and 24 weeks.
Measured: 12weeks and 24weeks
Annualized rate of subjects experiencing severe asthma exacerbations.
Annualized rate of subjects experiencing severe asthma exacerbations during the 24-week randomized treatment and throughout the trial period.
Measured: 24weeks and 32weeks
Time to the first onset of the severe asthma exacerbation event.
Time from baseline to the first onset of the severe asthma exacerbation event.
Measured: 32weeks
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC).
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) during the 24-week randomized treatment and throughout the trial period.
Measured: 24weeks and 32weeks
Time to the onset of the first event of LOAC.
Time from baseline to the onset of the first event of LOAC.
Measured: 32weeks
Change from baseline in other lung function measures.
Changes from baseline in FEV1 percentage of predicted value (FEV1% Pred) and Peak diurnal and nocturnal expiratory flow (PEF)
Measured: 24weeks
Changes from baseline in the Asthma Control Questionnaire-5 (ACQ-5)score and ACQ-7 score at each evaluation time point.
The ACQ-5 is a questionnaire used to evaluate the degree of asthma control. Each question is scored from 0 to 6 (on a 7-point scale) according to its severity. The higher the score, the less satisfactory symptom control is.
Measured: 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.
The AQLQ is a disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease. Scores range 1-7, with higher scores indicating better quality of life.
Measured: 12weeks and 24weeks
Total daily use of asthma reliever
Total daily use of asthma relief medication
Measured: 24weeks
Safety evaluation indicators
Safety evaluation indicators: Adverse Events, Laboratory Tests, Vital Signs, Electrocardiograms, Physical Examination, etc.
Measured: 32weeks
Concentration of GR1802 at each evaluation time point.
To evaluate the trough concentration at steady-state of GR1802 for each dose group. Population pharmacokinetic analysis is performed using a nonlinear mixed-effects model.
Measured: Baseline up to week 32
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable).
Measured: Baseline up to week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start19 Jul 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642961
- Sponsor's protocol ID
- GR1802-003
- Status last verified
- Nov 2023
- First submitted
- 14 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06642961
- Acronym / sponsor ID
- GR1802-003
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GR1802 300mg Q2W | Experimental | Drug: GR1802 injectionGR1802 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. |
| GR1802 150mg Q2W | Experimental | Drug: GR1802 injectionGR1802 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. |
| Placebo | Placebo comparator | Other: PlaceboSubcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GR1802 injectionGR1802 will be administered SC. | Drug | GR1802 150mg Q2W |
| GR1802 injectionGR1802 will be administered SC. | Drug | GR1802 300mg Q2W |
| PlaceboThe placebo will be administered SC. | Other | Placebo |
Primary outcome
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.
13 secondary outcomes
Change from baseline in pre-bronchodilator FEV1 at 24 weeks.
Time frame: 24weeks
Percent change from baseline in pre-bronchodilator FEV1 at 12 and 24 weeks.
Time frame: 12weeks and 24weeks
Annualized rate of subjects experiencing severe asthma exacerbations.
Time frame: 24weeks and 32weeks
Time to the first onset of the severe asthma exacerbation event.
Time frame: 32weeks
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC).
Time frame: 24weeks and 32weeks
Time to the onset of the first event of LOAC.
Time frame: 32weeks
Change from baseline in other lung function measures.
Time frame: 24weeks
Changes from baseline in the Asthma Control Questionnaire-5 (ACQ-5)score and ACQ-7 score at each evaluation time point.
Time frame: 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.
Time frame: 12weeks and 24weeks
Total daily use of asthma reliever
Time frame: 24weeks
Safety evaluation indicators
Time frame: 32weeks
Concentration of GR1802 at each evaluation time point.
Time frame: Baseline up to week 32
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).
Time frame: Baseline up to week 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GR1802 injection in people with Asthma, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nanshan Zhong, PhD. (020-34296151, chen_rch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks. (time frame: 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.