Eosinophilic Granulomatosis With PolyangiitisPhase 2/3NCT05979051
A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
A Phase 2/3 study testing SHR-1703 and Mepolizumab Injection in people with Eosinophilic Granulomatosis With Polyangiitis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 2 sites in China.
Trial summary
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Granulomatosis With Polyangiitis
- What is being tested?
- SHR-1703 and Mepolizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 2 sitesChina
- Study dates
- 16 Nov 2023to Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects age 18 years or older;
- Diagnosed with EGPA for at least 6 months;
- History of relapsing or refractory EGPA；
- Stable dose of oral prednisone of ≥7.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to randomization;
- If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.
Who cannot join
- Subjects with other eosinophilic-related diseases;
- Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
- Life-threatening EGPA within 3 months prior to randomization;
- Malignancy history within 5 years prior to randomization;
- Immunodeficiency;
- Uncontrolled hypertension；
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- Uncontrolled cerebrovascular and cardiovascular disease;
- parasitic infection within 6 months prior to randomization;
- Active infectious disease requiring clinical treatment within 4 weeks prior to randomization;
- Subjects with a dose of oral prednisone of >50 mg/day within 4 weeks prior to randomization;
- Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization;
- Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization;
- Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug;
- Rituximab used within 6 months prior to randomization；
- Surgical plans that might affect the evaluation;
- Significant laboratory abnormalities；
- Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening;
- History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
- Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening;
- Subjects is pregnant, lactating, or planning to be pregnant;
- Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents or previous failure of IL-5/IL-5R therapy;
- Other conditions unsuitable for participation in the study per investigator judgement.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Xuan Zhang, Doctor, 010-85132266, zxlab@outlook.com
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Huahao Shen, Doctor, 0571-87783777, huahaoshen@163.com
About this study
Official title: A Multicenter, Single-arm/Randomized, Double-blind, Active-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
- Being tested
- SHR-1703, Mepolizumab Injection
- Medical subject headings
- Churg-Strauss Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1703Drug
SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.
Mepolizumab InjectionDrug
Mepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR-1703 Receives: Drug: SHR-1703 |
| Mepolizumab Injection | Active comparator | SHR-1703 Placebo Receives: Drug: Mepolizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in oral glucocorticoid dose (OCS)
Phase 2
Measured: Up to week 12
The Proportion of subjects in EGPA remission
Phase 3
Measured: week 36 and week 48
Secondary outcomes (24)
Change from baseline in oral glucocorticoid dose
Effectiveness Indicators (Phase 2)
Measured: Up to week 24, week 48
The proportion of subjects with OCS dosage ≤5 mg/d
Effectiveness Indicators (Phase 2)
Measured: week 12, week 24, week 48
The proportion of subjects with at least 50% reduction of OCS dosage from baseline
Effectiveness Indicators (Phase 2)
Measured: week 12, week 24, week 48
The Proportion of subjects with EULAR remission
Effectiveness Indicators (Phase 2)
Measured: week 12, week 24, week 48
The Proportion of subjects achieving EULAR remission at week 12 and week 24 of treatment and maintaining it up to week 48
Effectiveness Indicators (Phase 2)
Measured: week 12, week 24, week 48
The Proportion of subjects with EGPA remission
Effectiveness Indicators (Phase 2)
Measured: week 24, week 48
The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48
Effectiveness Indicators (Phase 2)
Measured: week 24, week 48
The proportion of subjects with EGPA relapse
Effectiveness Indicators (Phase 2)
Measured: week 12, week 24, week 48
The time to the first relapse of EGPA
Effectiveness Indicators (Phase 2)
Measured: Up to week 48
The proportion of subjects with Severe relapse of EGPA
Effectiveness Indicators (Phase 2)
Measured: week 12, week 24, week 48
The time of the first Severe relapse of EGPA
Effectiveness Indicators (Phase 2)
Measured: Up to week 48
Changes from baseline in Pre- and post-Bronchodilator FEV1
Effectiveness Indicators (Phase 2)
Measured: Up to week 48
The Proportion of subjects with EULAR remission
Effectiveness Indicators (Phase 3)
Measured: week 36, week 48
The Proportion of subjects with EGPA remission
Effectiveness Indicators (Phase 3)
Measured: week 36, week 48
The Proportion of subjects achieving EULAR remission within 24 weeks of treatment and maintaining it up to week 48
Effectiveness Indicators (Phase 3)
Measured: week 24, week 48
The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48
Effectiveness Indicators (Phase 3)
Measured: week 24, week 48
Cumulative weeks of EGPA remission through week 48, categorized as 0 weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks; or ≥36 weeks
Effectiveness Indicators (Phase 3)
Measured: week 0, week 12, week 24, week 36, week 48
Change from baseline in OCS
Effectiveness indicators (Phase 3)
Measured: Week 24, Week 48
The proportion of subjects with OCS dosage ≤5 mg/d
Effectiveness indicators (Phase 3)
Measured: week 24, week 48
The proportion of subjects with at least 50% reduction of OCS dosage from baseline
Effectiveness indicators (Phase 3)
Measured: week 24, week 48
The Proportion of subjects with EGPA relapse
Effectiveness indicators (Phase 3)
Measured: week 24, week 48
The Proportion of subjects with Severe relapse of EGPA
Effectiveness indicators (Phase 3)
Measured: week 24, week 48
The time to the first relapse of EGPA
Effectiveness indicators (Phase 3)
Measured: Up to week 48
The time of the first Severe relapse occurred of EGPA
Effectiveness indicators (Phase 3)
Measured: Up to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start16 Nov 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-arm/randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 clinical study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979051
- Sponsor's protocol ID
- SHR-1703-301
- Status last verified
- Nov 2025
- First submitted
- 30 Jul 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm/Randomized, Double-blind, Active-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA
- ClinicalTrials.gov ID
- NCT05979051
- Acronym / sponsor ID
- SHR-1703-301
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A single-arm/randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 clinical study.
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-1703SHR-1703 |
| Mepolizumab Injection | Active comparator | Drug: Mepolizumab InjectionSHR-1703 Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects age 18 years or older;
- Diagnosed with EGPA for at least 6 months;
- History of relapsing or refractory EGPA；
- Stable dose of oral prednisone of ≥7.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to randomization;
- If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.
Key exclusion criteria (22 listed)
- Subjects with other eosinophilic-related diseases;
- Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
- Life-threatening EGPA within 3 months prior to randomization;
- Malignancy history within 5 years prior to randomization;
- Immunodeficiency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1703SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3. | Drug | Treatment group A |
| Mepolizumab InjectionMepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3 | Drug | Mepolizumab Injection |
Primary outcome
Change from baseline in oral glucocorticoid dose (OCS)
Time frame: Up to week 12
Phase 2
The Proportion of subjects in EGPA remission
Time frame: week 36 and week 48
Phase 3
24 secondary outcomes
Change from baseline in oral glucocorticoid dose
Time frame: Up to week 24, week 48
The proportion of subjects with OCS dosage ≤5 mg/d
Time frame: week 12, week 24, week 48
The proportion of subjects with at least 50% reduction of OCS dosage from baseline
Time frame: week 12, week 24, week 48
The Proportion of subjects with EULAR remission
Time frame: week 12, week 24, week 48
The Proportion of subjects achieving EULAR remission at week 12 and week 24 of treatment and maintaining it up to week 48
Time frame: week 12, week 24, week 48
The Proportion of subjects with EGPA remission
Time frame: week 24, week 48
The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48
Time frame: week 24, week 48
The proportion of subjects with EGPA relapse
Time frame: week 12, week 24, week 48
The time to the first relapse of EGPA
Time frame: Up to week 48
The proportion of subjects with Severe relapse of EGPA
Time frame: week 12, week 24, week 48
The time of the first Severe relapse of EGPA
Time frame: Up to week 48
Changes from baseline in Pre- and post-Bronchodilator FEV1
Time frame: Up to week 48
The Proportion of subjects with EULAR remission
Time frame: week 36, week 48
The Proportion of subjects with EGPA remission
Time frame: week 36, week 48
The Proportion of subjects achieving EULAR remission within 24 weeks of treatment and maintaining it up to week 48
Time frame: week 24, week 48
The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48
Time frame: week 24, week 48
Cumulative weeks of EGPA remission through week 48, categorized as 0 weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks; or ≥36 weeks
Time frame: week 0, week 12, week 24, week 36, week 48
Change from baseline in OCS
Time frame: Week 24, Week 48
The proportion of subjects with OCS dosage ≤5 mg/d
Time frame: week 24, week 48
The proportion of subjects with at least 50% reduction of OCS dosage from baseline
Time frame: week 24, week 48
The Proportion of subjects with EGPA relapse
Time frame: week 24, week 48
The Proportion of subjects with Severe relapse of EGPA
Time frame: week 24, week 48
The time to the first relapse of EGPA
Time frame: Up to week 48
The time of the first Severe relapse occurred of EGPA
Time frame: Up to week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SHR-1703 and Mepolizumab Injection in people with Eosinophilic Granulomatosis With Polyangiitis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siai Sun (0518-82342973, siai.sun@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in oral glucocorticoid dose (OCS) (time frame: Up to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.