Health TrialsbyHealthPanel

Efficacy and Safety Study of 610 in Patients With Severe Asthma

ConditionAsthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to give written informed consent prior to participation in the study.

Male or female adults ages 18 to 75 years old when signing the informed consent.

Documented diagnosis of asthma for at least one year prior to screening.

History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 610

    Drug

    610 subcutaneously injection.

  • Placebo

    Drug

    Placebo subcutaneously injection.

Treatment groups

480 Participants
are divided into 2 treatment groups
Group A: 610 groupExperimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Annualized rate of severe exacerbation events

Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period

Time frame
Up to 52 weeks

Secondary outcomes

1

Time to first severe exacerbation event

Time to first severe exacerbation event during the 52-week placebo-controlled treatment period

Time frame
Up to 52 weeks
2

Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit

Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 52-week placebo-controlled treatment period

Time frame
Up to 52 weeks
3

Change from baseline in ACQ score

Change from baseline to week 52 in ACQ score

Time frame
Up to 52 weeks
4

Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)

Change from baseline to week 52 in SGRQ score

Time frame
Up to 52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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