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

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial completed
    • Primary completion date changed from estimate of Dec 30, 2026 to Dec 5, 2025
    • Study completion date changed from estimate of Dec 30, 2026 to May 21, 2026
    • Eligibility criteria expanded, about 28 words
  2. Primary and study completion dates: Apr 30, 2025 to Dec 30, 2026v6
  3. Primary completion date: Oct 31, 2024 to Apr 30, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 248 to confirmed 260
    • Site details revised
    v5
  4. Trial status: Enrolling by Invitation to Recruiting
    • Secondary endpoints: 24 to 12
    • Site details revised
    • Eligibility criteria expanded, about 1 word
    v4
  5. Start date: Oct 25, 2022 to Jan 17, 2023
    • Trial status: Recruiting to Enrolling by Invitation
    • Interventions: SHR-1905 、Placebo (Drug) to SHR-1905 (Drug), placebo (Drug)
    • Site details revised
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 31, 2022 to Oct 25, 2022
    v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a phase 2 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.
Trial Details
NCT Number NCT05593250
Lead Sponsor Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Asthma
Related terms Asthma
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov