BHV-1400 for IgA Nephropathy

Recruiting at 7 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Biohaven Therapeutics Ltd.

Disqualifiers: Secondary IgAN, Non-IgAN kidney disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BHV-1400 to determine its safety and tolerability for people with IgA Nephropathy (IgAN), a kidney disease. IgAN can damage the kidneys, causing blood or protein in the urine and swelling. The trial aims to understand how individuals with biopsy-confirmed IgAN respond to this treatment. It suits those diagnosed with IgAN and no other kidney conditions. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the chance to be among the first to receive it.

Do I need to stop my current medications for the trial?

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

Is there any evidence suggesting that BHV-1400 is likely to be safe for humans?

Research has shown that BHV-1400 is being developed to help the body naturally remove certain proteins that can lead to kidney issues. This treatment remains in the early testing phase for individuals with IgA Nephropathy (IgAN), a type of kidney disease. As a new treatment in the first phase of testing, detailed safety information in humans is not yet available.

Early trials like this aim to determine the treatment's safety, so researchers will closely monitor any side effects or negative reactions. Participants in the trial will be observed carefully to assess their response to BHV-1400 and identify any unwanted effects. If deemed safe, the treatment can advance to later testing stages with more participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for IgA nephropathy, which typically involve medications like corticosteroids or immunosuppressants to reduce inflammation, BHV-1400 offers a new approach. Researchers are excited about BHV-1400 because it targets the underlying causes of the disease differently. While traditional options focus on dampening the immune response, BHV-1400 may work by specifically modulating pathways involved in the formation of IgA deposits, potentially reducing kidney damage more effectively. This novel mechanism of action gives hope for more efficient and precise treatment, possibly leading to better outcomes for patients.

What evidence suggests that BHV-1400 might be an effective treatment for IgA Nephropathy?

Research has shown that BHV-1400, the investigational treatment in this trial, may help treat IgA Nephropathy (IgAN). Studies have found that this treatment can quickly and significantly lower levels of the harmful protein Gd-IgA1, which plays a major role in IgAN. This decrease occurs rapidly and lasts, which is crucial for long-term management of the condition. Evidence supports that BHV-1400 effectively targets and reduces harmful proteins in the blood and kidneys, key areas affected by IgAN. These early results suggest that BHV-1400 could effectively manage IgAN symptoms and slow its progression. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals who have been diagnosed with IgA Nephropathy (IgAN) through a kidney biopsy. It's not open to people whose chronic kidney disease isn't caused by IgAN or those with secondary forms of the condition.

Inclusion Criteria

Participants must have biopsy-confirmed IgA Nephropathy

Exclusion Criteria

My kidney disease is not caused by IgA nephropathy.

I have a secondary type of IgA nephropathy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BHV-1400 to assess safety and tolerability

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BHV-1400

Trial Overview The study is testing BHV-1400 to see if it's safe and can be tolerated as a treatment option for patients with IgA Nephropathy, which is a type of kidney inflammation that affects the glomeruli.

How Is the Trial Designed?

Group I: BHV-1400 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+

Citations

1. ir.biohaven.com ir.biohaven.com/news-releases/news-release-details/biohaven-highlights-innovation-and-advancement-across-mode-and

Press Release Details Optimized subcutaneous (SC) administration of BHV-1400 achieved rapid, deep, selective, and sustained lowering of Gd-IgA1, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07054684

NCT07054684 | Study of BHV-1400 in IgA Nephropathy Study Plan​​ To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 ...

3. prnewswire.com prnewswire.com/news-releases/biohaven-highlights-innovation-and-advancement-across-mode-and-trap-degrader-platform-at-rd-day-announcing-positive-trap-degrader-data-achieving--80-sustained-reductions-in-galactose-deficient-iga1-gd-iga1-with-potential-fir-302467429.html

Biohaven Highlights Innovation and Advancement Across ... Optimized subcutaneous (SC) administration of BHV-1400 achieved rapid, deep, selective, and sustained lowering of Gd-IgA1, ...

4. journals.lww.com journals.lww.com/jasn/fulltext/2024/10001/first_in_class_antigen_specific_extracellular.3474.aspx

First-in-Class Antigen-Specific Extracellular Protein... Pharmacological data indicates that BHV-1400 facilitates a rapid reduction of exogenous dg-IgA both in the bloodstream and tissues, most notably within kidney ...

5. asn-online.org asn-online.org/education/kidneyweek/2024/program-abstract.aspx?controlId=4128556

Kidney Week Pharmacological data indicates that BHV-1400 facilitates a rapid reduction of exogenous dg-IgA both in the bloodstream and tissues, most notably within kidney ...

6. ctv.veeva.com ctv.veeva.com/study/study-of-bhv-1400-in-iga-nephropathy

Study of BHV-1400 in IgA Nephropathy - ClinicalTrials.Veeva The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).