Phase 3 Vasculitis Trial, Recruiting NCT07168161 Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd Condition: Vasculitis
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Phase 3 Vasculitis Trial, Recruiting

NCT07168161
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 between 18 and 75 years old (male or female)
  • You have been diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) — these are conditions where the immune system attacks blood vessels
  • You have been newly diagnosed or have had a return of GPA or MPA that needs treatment with steroids plus certain other medicines (cyclophosphamide, azathioprine, or rituximab)
  • Your blood test shows positive results for certain antibodies linked to these conditions (called PR3 or MPO antibodies)
  • Your kidneys are working at a minimum level, as measured by a standard kidney function test (eGFR of at least 15 mL/min/1.73m²)
  • Your disease is active enough to meet a minimum score on a standard disease activity assessment used by doctors (called BVAS) (confirm with trial site)

Who may not be able to join:

  • You currently have an active tuberculosis (TB) infection
  • You have severe lung bleeding that requires the use of a breathing machine (ventilator)
  • You have been diagnosed with most types of cancer in the last 5 years — though certain fully removed skin or in-situ cancers with no signs of return may be acceptable (confirm with trial site)
  • You have another autoimmune disease affecting multiple parts of the body, such as lupus, rheumatoid vasculitis, or several other related conditions
  • You have tested positive for certain markers of hepatitis B infection in your blood
  • You have received certain medicines too recently — for example, cyclophosphamide within the last 3 months, or rituximab within the last 12 months
  • You have received high-dose steroid "pulse" treatment in the last 4 weeks
  • You have been taking oral steroids at a dose higher than 10 mg prednisone (or equivalent) every day for more than 6 weeks continuously before joining
  • You have received certain biological (anti-TNF or similar) treatments within the last 12 weeks
  • You have been on long-term dialysis (12 weeks or more), or had any dialysis within the last week
  • You have received intravenous immunoglobulin or plasma exchange treatment within the last 4 weeks
  • You are currently pregnant or breastfeeding

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 28 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

Principal Investigator: Minghui Zhao, M.D., Peking University First Hospital

Phone: +86 010-67519614

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
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Registry
ClinicalTrials.gov
Start date
10 November 2025
Est. completion
16 April 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS)

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: 28 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