NS-229 for Churg-Strauss Syndrome

Recruiting at 33 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

Trial Summary

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.

What is the purpose of this trial?

This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.

Eligibility Criteria

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

I am HIV positive.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+