Phase 2 Vasculitis Trial, Recruiting NCT06941376 Sponsor: University of Pennsylvania Condition: Vasculitis
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Phase 2 Vasculitis Trial, Recruiting

NCT06941376
Recruiting Phase 2

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 Relapsing Polychondritis (RP) based on one of three recognized sets of diagnostic criteria involving symptoms such as inflammation of the ears, nose, airways, eyes, or joints, and/or problems with hearing or balance (confirm with trial site for which criteria apply to you)
  • You have mild to moderate active RP symptoms within the past 60 days that your doctor believes cannot be explained by anything other than RP, and that would require a prednisone dose of between 20 and 60 mg per day
  • You have had at least one of the following active symptoms in the past 60 days: ear inflammation, nose inflammation, eye inflammation, joint inflammation, or mild to moderate airway inflammation
  • You are willing and able to follow the treatment plan and attend all required follow-up visits
  • You are willing to use effective birth control throughout the study if there is any chance you could become pregnant or father a child (this applies to both men and women)
  • You are willing and able to sign a consent form agreeing to take part in the trial

Who may not be able to join:

  • You have had a severe RP flare in the past 28 days, such as needing extra oxygen, a breathing tube, or hospitalization for serious heart, brain, or eye problems linked to RP
  • You have recently needed very high-dose steroids given through a drip (IV), or a strong chemotherapy-type drug called cyclophosphamide, due to a severe RP complication
  • You have previously been treated with certain biological medicines (called biologic DMARDs) used for immune or inflammatory conditions
  • You currently have an active infection of any kind
  • You are known to be infected with HIV or hepatitis C, or have tested positive for hepatitis B
  • You have active tuberculosis (TB), a past history of TB that was not properly treated, or a positive TB test showing latent (hidden) TB unless you have already started and been on TB treatment for at least 4 weeks with no signs of active TB
  • Your blood counts are too low — specifically, your platelets, neutrophils (a type of white blood cell), or red blood cell levels fall below certain minimum levels
  • You have another serious uncontrolled health condition that could make it unsafe for you to participate or prevent you from completing the study
  • You have had cancer in the past 5 years, or have a current suspicious finding that might be cancer (some types of fully treated skin cancer or cervical changes may be exceptions — confirm with trial site)
  • You have taken part in another clinical trial or used an experimental treatment or device within the past 30 days
  • You have received a live vaccine (such as MMR or chickenpox vaccine) within 4 weeks before joining the trial
  • You have been diagnosed with certain other autoimmune, inflammatory, or infectious conditions, including lupus, rheumatoid arthritis, sarcoidosis, certain types of vasculitis, lymphoma, deep fungal infections, or a condition called VEXAS syndrome, among others (confirm with trial site for the full list)

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 2: approximately ~30% 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: Shubhasree Banerjee, MD, University of Pennsylvania

Phone: 781-321-4567

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 2
Registry
ClinicalTrials.gov
Start date
1 August 2025
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Efficacy of the study drugs for the treatment of relapsing polychondritis.

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