A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil Phenotype

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Hengrui Medicine

Status and phase

Active, not recruiting
Phase 2

Conditions

Asthma With Eosinophilic Phenotype

Treatments

Drug: SHR-1703 Placebo
Drug: SHR-1703

Study type

Interventional

Funder types

Industry

Identifiers

NCT05522439
SHR-1703-201

Details and patient eligibility

About

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype.

Enrollment

85 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged 18 to 75years (inclusive).
  • Weight ≥40 kg.
  • History of asthma≥ 1 year.
  • Documented treatment with Medium or high daily dose inhaled corticosteroid with additional controller medication within the 3 months prior to randomization.
  • Previously confirmed history of one or more asthma exacerbations within 1 year prior to randomization.
  • Blood eosinophils of ≥150 cells/µL at screening and baseline.
  • Pre-Bronchodilator FEV1% pred≥40% and<80% at screening and baseline.
  • Asthma Control Questionnaire-6 score≥1.5.
  • Use highly effective contraceptive measures.
  • Willing to sign the informed consent form to participate in this study.

Exclusion criteria

  • Subjects with Clinically significant pulmonary diseases;
  • Subjects with other diseases that could lead to elevated eosinophils;
  • Subjects with Immunodeficiency;
  • Poorly controlled hypertension;
  • Subjects with severe cerebrovascular disease;
  • Subjects with infection history requiring clinical intervention;
  • Subjects with parasitic infection;
  • Diagnosed Malignant tumor within 5 years prior to randomization;
  • Used non-selective β-blockers within 1 week prior to randomization;
  • Used either 5-lipoxygenase inhibitor or Phosphodiesterase-4 inhibitor within 1 week prior to randomization;
  • Blood donation or massive blood loss, or transfusion of blood products or immunoglobulins within 4 weeks prior to randomization;
  • Live attenuated vaccine inoculated within 4 weeks before randomization;
  • Allergen Immunotherapy within 8 weeks prior to randomization;
  • Used systemic immunosuppressants or immunomodulators, or biologics or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug;
  • Bronchial thermoplasty within 1 year prior to randomization;
  • Subjects have planned Surgery or other medical procedures that may affect evaluation during the study period;
  • Subjects with significant laboratory abnormality at screening;
  • Subjects have prolonged QTc interval or other electrocardiogram abnormality with significant safety risk at screening;
  • Current smokers or ex-smokers who have given up smoking for <6 months ,or positive smoke test, and/or have a smoking pack history of > 10 pack years;
  • History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
  • Subjects participated another clinical studies and received active drug within 30 days or 5 half-lives prior to screening;
  • Subjects is pregnant, lactating,or planning to become pregnant;
  • Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents;
  • Other conditions unsuitable for participation in the study per investigator judgement.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

85 participants in 4 patient groups, including a placebo group

Subjects receiving SHR-1703 dose 1
Experimental group
Treatment:
Drug: SHR-1703
Drug: SHR-1703 Placebo
Subjects receiving SHR-1703 dose 2
Experimental group
Treatment:
Drug: SHR-1703
Subjects receiving SHR-1703 dose 3
Experimental group
Treatment:
Drug: SHR-1703
Drug: SHR-1703 Placebo
Placebo
Placebo Comparator group
Treatment:
Drug: SHR-1703 Placebo

Trial contacts and locations

0

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Central trial contact

Xiaopeng Wang

Data sourced from clinicaltrials.gov

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