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New hope for rare disease: can NS-229 help patients reduce steroids?

NCT ID NCT06046222

Disease control Sponsor: NS Pharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicine, NS-229, in 45 adults with a rare disease called eosinophilic granulomatosis with polyangiitis (EGPA), which causes inflammation in blood vessels. The goal is to see if NS-229 can help patients achieve remission while lowering their daily steroid dose. Participants will receive either NS-229 or a placebo, and doctors will check disease activity and steroid use after 28 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ability to provide written informed consent prior to participation in the study. * Male or female subjects aged ≥18 years at the time the informed consent form is signed. * Diagnosis of EGPA: Subjects who have been diagnosed with EGPA based on the history or presence of eosinophilia plus at least a history or presence of 2 of additional features of EGPA. * Subjects receive background OGC dose of ≥7.5 mg/day with or without stable treatment with Mepolizumab/Benralizumab. * Use of adequate contraception. * Other inclusion criteria may apply. Exclusion Criteria: * Current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis * Imminently life-threatening EGPA at the time of screening. * History or presence of any form of cancer within 5 years prior to screening. * Serious liver, renal, blood, or psychiatric disease * Severe or clinically significant cardiovascular disease uncontrolled with standard treatment * Active systemic infections (including TB, pneumonia, Pneumocystis pneumonia, sepsis, and opportunistic infections) * Parasitic infection: Subjects with a known parasitic infestation within 6 months prior to screening. * HIV positive status * Active hepatitis due to hepatitis B virus or hepatitis C virus * Known history or presence of venous thromboembolism/venous thrombotic events (deep vein thrombosis and/or pulmonary embolus) * laboratory parameter exclusions: 1. Estimated glomerular filtration rate of \<30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equations 2. WBC count \<4 × 109/L 3. Absolute lymphocyte count \<500 cells/mm3 4. Absolute neutrophil count \<1000 cells/mm3 5. Platelet count \<120,000/mm3 6. Hemoglobin \<8 g/dL (\<80 g/L) * 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 * Other exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

eosinophilic granulomatosis with polyangiitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Churg-Strauss syndrome Eosinophilic granulomatosis with polyangiitis

Contacts and locations

Locations

  • Addenbrookes Hospital

    Cambridge, CB2 2QQ, United Kingdom

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126, Italy

  • Azienda Provinciale per i Servizi Sanitari Provincia Autonoma Trento

    Trento, 38122, Italy

  • CHU Nice

    Nice, 06202, France

  • Chiba University Hospital

    Chuo-ku, Chiba-shi, Chiba, 260-8677, Japan

  • Chu Rangueil

    Toulouse, 31059, France

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruna, 15706, Spain

  • Complejo Hospitalario de Navarra

    Pamplona, 31008, Spain

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma, 00128, Italy

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hopital Cochin

    Paris, 75014, France

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kitakyushu, Fukuoka, 807-8555, Japan

  • Istituto Auxologico Italiano IRCCS

    Milan, 20145, Italy

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611, Japan

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medius Kliniken gGmbh

    Kirchheim unter Teck, Studienzentrale, 73230, Germany

  • NHO Sagamihara National Hospital

    Sagamihara, Kanagawa, 252-0392, Japan

  • National Hospital Organization Yokohama Medical Center

    Yokohama, Kanagawa, 245-8575, Japan

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • Osaka Habikino Medical Center

    Habikino, Osaka, 583-8588, Japan

  • Queen Elizabeth Hospital Birmingham

    Edgbaston, Birmingham, B15 2GW, United Kingdom

  • Royal Berkshire NHS Foundation Trust

    Reading, RG1 5AN, United Kingdom

  • Saitama Medical Center

    Kawagoe, Saitama, 350-8550, Japan

  • St Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N4A6, Canada

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Toho University Omori Medical Center

    Ōta-ku, Tokyo, 143-8541, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • University of Alberta

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Toronto

    Toronto, Ontario, M5G 1X5, Canada

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.