Phase 3 Vasculitis Trial, Recruiting NCT05979051 Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd Condition: Vasculitis
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Phase 3 Vasculitis Trial, Recruiting

NCT05979051
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older
  • You have been diagnosed with a condition called EGPA (a type of inflammatory disease affecting blood vessels) for at least 6 months
  • Your EGPA has come back after treatment or has not responded well to treatment
  • You have been taking oral prednisone (a steroid) at a steady dose of at least 7.5 mg per day but no more than 50 mg per day for at least 4 weeks before joining the trial
  • If you are taking other immune-suppressing medicines (not including cyclophosphamide), your dose must have been stable for at least 4 weeks before joining and must stay stable during the study

Who may not be able to join:

  • You have another disease that causes high levels of a type of white blood cell called eosinophils
  • You have been diagnosed with a related condition called GPA (granulomatosis with polyangiitis) or MPA (microscopic polyangiitis)
  • Your EGPA was life-threatening within the last 3 months
  • You have had cancer at any point in the last 5 years
  • You have a weakened immune system
  • You have high blood pressure that is not well controlled
  • You have heart or stroke-related conditions that are not well controlled
  • You have had a parasitic infection in the last 6 months
  • You have had an active infection requiring treatment in the last 4 weeks
  • You have taken more than 50 mg per day of oral prednisone in the last 4 weeks
  • You have taken a medicine called cyclophosphamide (by mouth or through a vein) in the last 4 weeks
  • You have received immunoglobulin treatment (by vein or injection under the skin) in the last 12 weeks
  • You have used certain biological medicines or immune-targeting treatments in the last 12 weeks, or within a specific window based on how long the drug stays in your body (confirm with trial site)
  • You have received a medicine called rituximab in the last 6 months
  • You have planned surgery that could affect the study results
  • You have significant abnormal results on blood or other laboratory tests (confirm with trial site)
  • You have a certain type of irregular heart rhythm or other heart electrical abnormality that poses a safety risk
  • You have had a problem with drug, substance, or alcohol misuse in the last year
  • You have taken part in another clinical trial and received an active study drug within the last 30 days, or within a specific window based on how long that drug stays in your body (confirm with trial site)
  • You are currently pregnant, breastfeeding, or planning to become pregnant
  • You have had a serious allergic reaction or bad response to similar biological medicines in the past, or a previous treatment targeting IL-5 did not work for you
  • The trial doctor decides there are other reasons the trial may not be right for you (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 0518-82342973

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Registry
ClinicalTrials.gov
Start date
16 November 2023
Est. completion
1 December 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Change from baseline in oral glucocorticoid dose (OCS); The Proportion of subjects in EGPA remission

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov