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New drug aims to tame rare inflammatory disease EGPA

NCT ID NCT05979051

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, SHR-1703, for people with eosinophilic granulomatosis with polyangiitis (EGPA), a rare disease that causes inflammation in blood vessels. The trial will include 166 adults who have not responded well to standard treatments. The goal is to see if SHR-1703 can help reduce the need for steroids and bring the disease under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR-1703 (a drug given by injection under the skin)
What this could lead to
If successful, this could offer a new treatment option for EGPA, potentially reducing the need for high-dose steroids and helping more patients achieve remission.
What could go wrong
This is an early-to-mid-stage trial with only 166 participants, so results may not apply to everyone. The drug's safety and effectiveness are not yet proven, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 166 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female subjects age 18 years or older; 2. Diagnosed with EGPA for at least 6 months; 3. History of relapsing or refractory EGPA; 4. Stable dose of oral prednisone of ≥7.5 mg/day (but not \>50 mg/day) for at least 4 weeks prior to randomization; 5. If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study. Exclusion Criteria: 1. Subjects with other eosinophilic-related diseases; 2. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). 3. Life-threatening EGPA within 3 months prior to randomization; 4. Malignancy history within 5 years prior to randomization; 5. Immunodeficiency; 6. Uncontrolled hypertension; 7. Uncontrolled cerebrovascular and cardiovascular disease; 8. parasitic infection within 6 months prior to randomization; 9. Active infectious disease requiring clinical treatment within 4 weeks prior to randomization; 10. Subjects with a dose of oral prednisone of \>50 mg/day within 4 weeks prior to randomization; 11. Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization; 12. Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization; 13. Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug; 14. Rituximab used within 6 months prior to randomization; 15. Surgical plans that might affect the evaluation; 16. Significant laboratory abnormalities; 17. Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening; 18. History of drug or substance abuse or alcohol abuse within 1 year prior to screening; 19. Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening; 20. Subjects is pregnant, lactating, or planning to be pregnant; 21. 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; 22. Other conditions unsuitable for participation in the study per investigator judgement.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

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