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NS-229 for Churg-Strauss Syndrome

Phase 2

Recruiting

Research Sponsored by NS Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of EGPA based on the history or presence of eosinophilia plus at least a history or presence of 2 additional features of EGPA

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 28

Awards & highlights

Study Summary

"This trial is looking for men and women who are 18 years old or older and have a condition called Eosinophilic Granulomatosis With Polyangiitis."

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects of NS-229 are not provided, common side effects for drugs treating autoimmune conditions may include increased risk of infections, nausea, headaches, possible liver damage, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The proportion of subjects in remission [OGC 4.0]

Secondary outcome measures

The proportion of subjects in remission [OGC 7.5]

Time to first relapse of EGPA

Time to first worsening of EGPA

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NS-229Experimental Treatment1 Intervention

Self-administer NS-229 in consecutive 28 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Self-administer matching placebo in consecutive 28 weeks.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NS Pharma, Inc.Lead Sponsor

13 Previous Clinical Trials

529 Total Patients Enrolled

Nippon Shinyaku Co., Ltd.Industry Sponsor

12 Previous Clinical Trials

556 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants being recruited for this clinical study?

"Affirmative. Data from clinicaltrials.gov indicates that this clinical investigation is currently in the patient recruitment phase. Initially shared on December 20, 2023, with the most recent update made on February 16, 2024, the trial aims to enroll a total of 45 participants across four distinct locations."

Answered by AI

What are the potential hazards associated with NS-229 for individuals?

"Our team at Power has rated the safety of NS-229 as a 2 on a scale from 1 to 3. This rating reflects that, being in Phase 2, there is existing data supporting its safety but not yet for efficacy."

Answered by AI

Is it presently possible for individuals to participate in this clinical trial?

"Indeed, information from clinicaltrials.gov confirms that this trial is actively seeking candidates. The initial posting date was 20th December 2023 with the most recent update on 16th February 2024. This study aims to enroll a total of 45 participants distributed across four locations."

Answered by AI

Are there several medical facilities in North America conducting this study?

"Patients are being enrolled at Mayo Clinic in Rochester, Minnesota; Hospital of the University of Occupational and Environmental Health, Japan in Kitakyushu, Fukuoka; Juntendo University Hospital in Bunkyo-ku, Tokyo. Additionally, there are four more sites where recruitment is ongoing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis

2023. "Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046222.

All > Granulomatosis With Polyangiitis