NCT06680947

Brief Summary

This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for phase_2 asthma

Timeline
16mo left

Started Dec 2024

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Dec 2024Sep 2027

First Submitted

Initial submission to the registry

November 7, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

November 7, 2024

Last Update Submit

January 27, 2026

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52

    FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.

    Baseline (Day 1) and at week 52

Secondary Outcomes (7)

  • Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16

    Baseline (Day 1) and at week 16

  • Percentage change from baseline in pre-bronchodilator FEV1 at weeks 4, 8,12,16, 20, 28, 36, 44, 52

    Baseline (Day 1) and at week 4, 8,12,16, 20, 28, 36, 44, 52

  • Number of asthma exacerbation through study week 52

    From baseline (Day 1) to week 52

  • Number of asthma exacerbations requiring hospitalization or emergency room visits

    From baseline (Day 1) to week 52

  • Change from baseline in Asthma Control Questionnaire (ACQ) score.

    From baseline (Day 1) to week 52

  • +2 more secondary outcomes

Study Arms (3)

Group A

EXPERIMENTAL

Subjects will receive 610 for 52 weeks.

Drug: 610

Group B

EXPERIMENTAL

Subjects will receive 610 for 52 weeks.

Drug: 610

Placebo group

PLACEBO COMPARATOR

Subjects will receive placebo for 52 weeks.

Drug: Placebo

Interventions

610DRUG

Subcutaneously injection.

Group A
PlaceboDRUG

Subcutaneously injection.

Placebo group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
  • \. Female and male aged 18 to 75 years.
  • \. Diagnosed with asthma for ≥12 months that meet GINA.
  • \. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
  • \. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
  • \. Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit.

You may not qualify if:

  • \. Presence of a known pre-existing, clinically important lung condition other than Asthma.
  • \. Severe asthma exacerbation within 4 weeks prior to randomization.
  • \. Subjects with any eosinophilic diseases other than asthma.
  • \. Known, pre-existing severe or clinically significant cardiovascular disease.
  • \. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
  • \. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
  • \. Subjects with allergy/intolerance to a monoclonal antibody.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Min Zhang, Doctor

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 8, 2024

Study Start

December 20, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations

CN(1)