75 Participants Needed

Tarperprumig for Vasculitis

Recruiting at 63 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Alexion Pharmaceuticals, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tarperprumig for individuals with ANCA-associated vasculitis, a condition that inflames blood vessels. The main goal is to determine if tarperprumig is safe and tolerable for patients. Participants will be divided into two groups to receive either different doses of tarperprumig or a placebo (a substance with no active drug). Ideal candidates for this trial include those newly diagnosed with ANCA-associated vasculitis or experiencing a relapse, especially if their condition might require treatment with certain strong medications. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that tarperprumig is likely to be safe for humans?

Research has shown that tarperprumig is being tested for its safety in treating ANCA-associated vasculitis. Specific safety information remains limited. However, the current phase of the trial shows that researchers are still gathering initial safety data. They are closely monitoring how participants handle the drug and are looking for any side effects. No major safety problems have been reported so far. This is a positive sign, but more information is needed to fully understand the treatment's safety.12345

Why do researchers think this study treatment might be promising for vasculitis?

Researchers are excited about Tarperprumig for treating vasculitis because it offers a novel approach compared to standard treatments like corticosteroids and immunosuppressants. Unlike these conventional therapies, which broadly suppress the immune system, Tarperprumig targets specific pathways involved in inflammation. This precision could mean fewer side effects and a more effective reduction of symptoms. Additionally, Tarperprumig might provide faster relief, potentially improving patient outcomes more quickly than current options.

What evidence suggests that tarperprumig might be an effective treatment for vasculitis?

Research suggests that tarperprumig may help treat conditions like vasculitis by targeting the complement alternative pathway, a part of the immune system. This pathway can become overly active in certain diseases, leading to inflammation and damage. Animal studies found tarperprumig to be safe and well-tolerated at specific doses. Although human studies provide limited information, these early results offer hope that tarperprumig could be effective for people with vasculitis. Participants in this trial will receive either tarperprumig at one of two dose regimens or a placebo, enabling researchers to evaluate its effectiveness and safety in treating vasculitis.14567

Are You a Good Fit for This Trial?

This trial is for adults with ANCA-associated vasculitis, which is a type of inflammation in the blood vessels. It's open to those who have just been diagnosed or are experiencing a relapse.

Inclusion Criteria

At least one major item, or at least 3 minor items, or at least 2 renal items in the BVAS
I have tested positive for PR3-ANCA or MPO-ANCA antibodies.
I have been diagnosed with ANCA-associated vasculitis and need treatment.

Exclusion Criteria

Any diseases or conditions that, in the judgment of the Investigator, present a substantial clinical risk to participate in this study
I do not have a primary illness like lupus, rheumatoid arthritis, or other listed autoimmune diseases.
I needed a breathing machine due to bleeding in my lungs.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tarperprumig or placebo to evaluate safety and tolerability

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tarperprumig
Trial Overview The study is testing Tarperprumig against a placebo to see if it's safe and can be tolerated by patients. Participants will randomly receive either the actual drug or an inactive substance.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Tarperprumig Group 2Experimental Treatment2 Interventions
Group II: Tarperprumig Group 1Experimental Treatment1 Intervention
Group III: Placebo Group 3Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alexion Pharmaceuticals, Inc.

Lead Sponsor

Trials
267
Recruited
141,000+
Dr. Alberto R. Martinez profile image

Dr. Alberto R. Martinez

Alexion Pharmaceuticals, Inc.

Chief Medical Officer since 2010

MD from University of Sao Paulo

Marc Dunoyer profile image

Marc Dunoyer

Alexion Pharmaceuticals, Inc.

Chief Executive Officer since 2021

PhD in Molecular Biology

Citations

NCT07160608 | Safety and Efficacy of Tarperprumig in ...The primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing anti-neutrophil ...
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics ...Tarperprumig appears to be safe and well tolerated at doses up to 300 mg/kg in a 6‐month toxicity study conducted in cynomolgus monkeys (unpublished data). In ...
Tarperprumig for VasculitisThe primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing anti-neutrophil ...
Safety and Efficacy of Tarperprumig in Adult Participants ...The primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing ...
Tarperprumig (Alexion) - Drug Targets, Indications, PatentsThe bispecific antibody tarperprumig (ALXN1820) was developed as a treatment option for diseases involving dysregulated complement alternative pathway (AP) ...
Safety and Efficacy of Tarperprumig in Adult Participants With ...The primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing ...
tarperprumig (ALXN1820) / AstraZenecaSafety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis ... safety and efficacy data." ...
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