Clinical Study on the Efficacy and Safety of SHR-4597 Inhalant in Adult Patients With Asthma

NCT06940700 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-4597-201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of SHR-4597 inhalants in adults with asthma: a multicenter, randomized, open-label, positive-controlled Phase II clinical study

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Changes in FEV1 (Pre-BD) from baseline

  6 weeks

Secondary Outcomes (7)

• Changes in FEV1 before bronchodilator (Pre-BD) administration compared with baseline at week 42

  at week 42

• Changes in forced vital capacity (FVC) before bronchodilator (Pre-BD) use compared with baseline at week 42

  at week 42

• Changes in peak expiratory flow (PEF) before bronchodilator (Pre-BD) use compared with baseline at week 42

  at week 42

• Changes in exhaled nitric oxide (FeNO) from baseline at 42 weeks

  at 42 weeks

• Changes in Asthma Control Questionnaire (ACQ-6) scores from baseline at 42 weeks

  at 42 weeks

Study Arms (3)

Treatment group A

EXPERIMENTAL

SHR4597

Drug: SHR4597

Treatment group B

EXPERIMENTAL

SHR4597

Drug: SHR4597

Treatment group C

ACTIVE COMPARATOR

Budesonide inhalant

Drug: Budesonide inhalant

Interventions

SHR4597 DRUG

SHR4597

Treatment group A; Treatment group B

Budesonide inhalant DRUG

Budesonide inhalant

Treatment group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old and ≤75 years old, gender is not limited;
• Body mass index (BMI) ≥18 and ≤30 kg/m2 during screening period;
• Medical history and objective evidence consistent with current guidelines supporting an asthma diagnosis within the 12 months prior to randomization;
• Did not receive inhaled corticosteroids (ICS) and/or combined with other asthma control medications within 2 weeks prior to randomization;
• FEV1 during the screening period and before bronchodilator inhalation at baseline accounted for ≥40% and \< 80% of the estimated value;
• Screening and baseline visit, Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5;
• FeNO values at screening period and baseline ≥25 ppb;
• Patients with asthma who were treated for the first time or who had previously taken irregular medication were selected; Among them, the definition of irregular past use was: patients did not regularly use asthma control drugs within the first 3 months of enrollment, and the average weekly use compliance was \< 50%.
• A fertile female subject or a male subject whose partner is a fertile female must agree not to have a family plan and to voluntarily use highly effective contraception (including the partner) from the time of signing the informed consent until 1 month after the last study drug administration, and refrain from sperm/egg donation;
• Voluntarily sign informed consent to participate in this study.
• The subjects were unable to complete the questionnaires due to their limited educational level, or neither the subjects themselves nor their families could fill in the subject log card.
• The researchers determined that there were other circumstances that were not suitable for participation in this study.

You may not qualify if:

• Combined diseases or conditions
• Clinically significant pulmonary diseases, including but not limited to active pulmonary tuberculosis, bronchiectasis, atelectasis, idiopathic pulmonary fibrosis, bronchopulmonary aspergillosis, and chronic obstructive pulmonary disease (COPD);
• Malignant tumors diagnosed within 5 years prior to randomization (except those with a low risk of metastasis and death, such as well-treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
• Combined with poorly controlled hypertension (systolic blood pressure ≥180mmHg, and/or diastolic blood pressure ≥110mmHg during the screening period) or uncontrolled severe cardiovascular and cerebrovascular diseases; ④ Known immunodeficiency;
• A history of infection requiring clinical intervention within 4 weeks prior to randomization, including but not limited to respiratory infection;
• ⑥ Known presence of parasitic infection within 6 months prior to randomization;
• ⑦ Blood donation or significant blood loss (≥400ml), or transfusion of blood products or immunoglobulin within 4 weeks prior to randomization;
• ⑧ A history of life-threatening acute asthma attacks (including admission to the intensive care unit and/or the need for invasive ventilator support \[intubation/tracheotomy\]);
• ⑨ History of acute asthma attack in the 4 weeks prior to randomization.
• Combination of medication or treatment
• Receiving non-selective beta-blockers (e.g., propranolol) within 1 week prior to screening;
• Live attenuated vaccine or recombinant vaccine with viral vector were received within 4 weeks before randomization;
• Receiving allergen immunotherapy 8 weeks before randomization;
• Within 12 weeks before randomization or within 5 half-lives of the drug (refer to the drug instructions, whichever is older; For those with unknown half-lives, the first 12 weeks of randomization will be the use of systemic immunosuppressants (except for systemic glucocorticoids for asthma treatment, and systemic glucocorticoids for other conditions \<3 days) or immunomodulators, or biologics or Th2 cytokine inhibitors, Including but not limited to methotrexate, cyclosporine, interferon-alpha, anti-IL-5 monoclonal antibody,anti-TSLP monoclonal antibody, anti-IGE monoclonal antibody, mesulast, etc.
• Receiving a single dose of long-acting β2 agonist within 4 weeks prior to screening; ⑥4 weeks before randomization, inhaled corticosteroids (\>500 micrograms of beclomethasone dipropionate per day \[BDP\] or equivalent dose);

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

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

Zi Lin

CONTACT

+0518-81220121; zi.lin.zl30@hengrui.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: April 16, 2025
• First Posted: April 23, 2025
• Study Start: April 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

CN (1)