NS-229 for Churg-Strauss Syndrome

Recruiting at 35 trial locations

Overseen By NS Pharma, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NS Pharma, Inc.

Must be taking: OGC, Mepolizumab

Disqualifiers: Cancer, Cardiovascular, Infections, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new treatment called NS-229 for individuals with Eosinophilic Granulomatosis With Polyangiitis (EGPA), a rare condition that causes inflammation in small blood vessels. Participants will receive either NS-229 or a placebo over 28 weeks to evaluate the treatment's effectiveness. The trial seeks individuals diagnosed with EGPA who are currently managing their condition with specific medications. It is not suitable for those with life-threatening cases of EGPA or serious health issues like active infections or recent cancer. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in EGPA treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can continue a stable treatment with mepolizumab and must be on a background dose of oral glucocorticoids (OGC) of at least 7.5 mg/day.

Is there any evidence suggesting that NS-229 is likely to be safe for humans?

Research shows that NS-229 is being tested for safety and effectiveness in treating Eosinophilic Granulomatosis With Polyangiitis, also known as Churg-Strauss syndrome. Although detailed safety information is limited, NS-229's progression to a phase 2 trial indicates it demonstrated some safety in earlier studies. Phase 2 trials typically mean the treatment has passed initial safety tests, suggesting NS-229 is likely well-tolerated. However, further research is necessary to confirm this. Study participants will be closely monitored for side effects to better understand the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Churg-Strauss Syndrome?

NS-229 is unique because it offers a new approach to treating Churg-Strauss Syndrome by targeting specific pathways involved in the inflammatory process, potentially leading to more precise symptom management. Unlike standard treatments like corticosteroids and immunosuppressants, which broadly suppress the immune system, NS-229 may minimize side effects by focusing on the root causes of inflammation. Researchers are excited about NS-229 because it could offer more effective control of symptoms with a potentially improved safety profile, providing a better quality of life for patients.

What evidence suggests that NS-229 might be an effective treatment for Churg-Strauss Syndrome?

Research has shown that NS-229 might be a helpful treatment for Eosinophilic Granulomatosis with Polyangiitis (EGPA), also known as Churg-Strauss Syndrome. In the past, over 90% of patients treated for EGPA went into remission, although about 38% experienced a return of symptoms. This suggests that early and effective treatment can lead to good results. In this trial, participants will receive either NS-229 or a placebo to determine if NS-229 can achieve or improve these outcomes, offering hope for better management of this condition. Early study results appear promising, but more information is needed to confirm its effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women over 18 with Eosinophilic Granulomatosis With Polyangiitis (EGPA), a rare autoimmune condition. Participants must have been diagnosed based on eosinophilia and at least two other EGPA features. They should be able to give informed consent and agree to use adequate contraception.

Inclusion Criteria

Use of adequate contraception

I have been diagnosed with EGPA and have a history of high eosinophils and two other EGPA symptoms.

Ability to provide written informed consent prior to participation in the study

Exclusion Criteria

Subjects who are pregnant, breastfeeding, or planning to become pregnant during the time of study participation

History of clinically significant drug or alcohol abuse within the last 6 months

I am HIV positive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NS-229 or placebo over a 28-week period with corticosteroid dose tapering

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NS-229

Trial Overview The study is testing the effectiveness and safety of a medication called NS-229 compared to a placebo in treating EGPA. A placebo is an inactive substance that looks like the treatment but has no therapeutic effect.

How Is the Trial Designed?

Group I: NS-229 Experimental Treatment 1 Intervention

Self-administer NS-229 in consecutive 28 weeks.

Group II: Placebo Placebo Group 1 Intervention

Self-administer matching placebo in consecutive 28 weeks.

NS-229 is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as NS-229 for:

• Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Approved in United States as NS-229 for:

• Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Approved in Japan as NS-229 for:

• Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Approved in Canada as NS-229 for:

• Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Who Is Running the Clinical Trial?

NS Pharma, Inc.

Lead Sponsor

Trials

14

Recruited

460+

Nippon Shinyaku Co., Ltd.

Industry Sponsor

Trials

14

Recruited

500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06046222

Trial of Efficacy and Safety of NS-229 Versus Placebo in ... The purpose of this randomized, double-blind study is to investigate the efficacy and safety of NS229 compared with placebo over a 28-week study treatment ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537099/

Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss ... EGPA has a favorable prognosis following timely detection and treatment, with a 5-year survival rate of 90%. · The Birmingham Vasculitis Activity Score (BVAS) is ...

3. trialx.com trialx.com/clinical-trials/listings/289507/trial-of-efficacy-and-safety-of-ns-229-versus-placebo-in-patients-with-eosinophilic-granulomatosis-with-polyangiitis/?&geo_lat=35.6728535&geo_lng=139.8174097&radius=10&place=Koto&user_country=Japan

Trial of Efficacy and Safety of NS-229 Versus Placebo in ... The purpose of this randomized, double-blind study is to investigate the efficacy and safety of NS229 compared with placebo over a 28-week study ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06046222?term=AREA%5BConditionSearch%5D(%22Allergic%20Angiitis%22)&rank=3

Trial of Efficacy and Safety of NS-229 Versus Placebo in ... The purpose of this randomized, double-blind study is to investigate the efficacy and safety of NS229 compared with placebo over a 28-week study treatment ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23590801/

Long-term outcomes of 118 patients with eosinophilic ... Treatment achieved new remissions in >90%, but relapses recurred in 38%. Overall survival was good, reaching 90% at 7 years, regardless of baseline severity.

6. emedicine.medscape.com emedicine.medscape.com/article/333492-overview

Eosinophilic Granulomatosis with Polyangiitis (Churg- ... It is a rare systemic necrotizing granulomatous vasculitis that affects small- to medium-sized vessels and can result in life-threatening multiorgan damage.

7. mayoclinic.org mayoclinic.org/diseases-conditions/churg-strauss-syndrome/symptoms-causes/syc-20353760

Churg-Strauss syndrome - Symptoms & causes Eosinophilic granulomatosis with polyangiitis is a rare blood vessel disease that may cause breathing trouble, face pain and a runny nose.

8. rarediseases.org rarediseases.org/rare-diseases/churg-strauss-syndrome/

Eosinophilic Granulomatosis with Polyangiitis Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare immune disorder of the blood vessels that can affect multiple organ systems, especially the lungs ...