A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-03

Study Completion Date

2028-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a phase III study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma

NCT05593250

Asthma

ACTIVE_NOT_RECRUITING PHASE2

A Trial of SHR-1905 in Healthy Subjects and Subjects With Mild Asthma

NCT04905602

Asthma

COMPLETED PHASE1

Pharmacokinetics, Pharmacodynamics, Safety, and Preliminary Efficacy of Subcutaneous Injection of SHR-1905 in Adolescent Asthmatic Subjects - an Open-label, Single-dose Phase II Clinical Study

NCT06786455

Adolescent Asthma

COMPLETED PHASE2

A Trial of SHR-1703 in Asthma

NCT05042401

Asthma

UNKNOWN PHASE1

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects

NCT04772365

Asthma

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SHR-1905 Group

Group Type EXPERIMENTAL

SHR-1905 Injection

Intervention Type DRUG

SHR-1905 injection.

SHR-1905 Placebo Group

Group Type PLACEBO_COMPARATOR

SHR-1905 Placebo Injection

Intervention Type DRUG

SHR-1905 placebo Injection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SHR-1905 Injection

SHR-1905 injection.

Intervention Type DRUG

SHR-1905 Placebo Injection

SHR-1905 placebo Injection.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 18.
2. Documented physician-diagnosed asthma for at least 12 months.
3. Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months.
4. Documented treatment with a total daily dose of either medium or high dose ICS (Refer to Guidelines for the prevention and management of bronchial asthma (2024 edition)) for at least 3 months.
5. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
6. Pre-BD FEV1 \< 80% predicted normal.
7. Objective evidence of asthma as documented.
8. Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
9. ACQ-6 score ≥ 1.5 at screening and on day of baseline.
10. ePRO adherence ≥ 70% in the 7 days prior to randomization.

Exclusion Criteria

1. Clinically significant pulmonary disease other than asthma.
2. History of cancer.
3. History of a clinically significant infection.
4. Current smokers or participants with smoking history ≥ 10 pack-yrs.
5. History of chronic alcohol or drug abuse within 12 months.
6. Hepatitis B, C or HIV.
7. Pregnant or breastfeeding.
8. History of anaphylaxis following any biologic therapy.
9. participant randomized in the current study or previous SHR-1905 studies.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No