Eosinophilic Granulomatosis With PolyangiitisPhase 2NCT06046222
Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis
A Phase 2 study testing NS-229 in people with Eosinophilic Granulomatosis With Polyangiitis and Churg-Strauss Syndrome, run by NS Pharma, Inc. at 34 sites in 8 countries.
Trial summary
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Granulomatosis With Polyangiitis, Churg-Strauss Syndrome
- What is being tested?
- NS-229
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 34 sitesin 8 countries
- Study dates
- 20 Dec 2023to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 20Show fewer
- 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:
- Estimated glomerular filtration rate of <30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equations
- WBC count <4 × 109/L
- Absolute lymphocyte count <500 cells/mm3
- Absolute neutrophil count <1000 cells/mm3
- Platelet count <120,000/mm3
- 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.
Trial locations and contacts
34 sites in 8 countries.
34 sites in 8 countries
Japan11 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Chiba University Hospital
Chuo-ku, Chiba-shi, Chiba, 260-8677
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588
Saitama Medical Center
Kawagoe, Saitama, 350-8550
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka, 807-8555
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
Toho University Omori Medical Center
Ōta-ku, Tokyo, 143-8541
NHO Sagamihara National Hospital
Sagamihara, Kanagawa, 252-0392
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Tohoku University Hospital
Sendai, Miyagi, 980-8574
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, 245-8575
United States7 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
National Jewish Health
Denver, Colorado, 80206
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Italy4 sites
Istituto Auxologico Italiano IRCCS
Milan, 20145
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128
Azienda Provinciale per i Servizi Sanitari Provincia Autonoma Trento
Trento, 38122
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Canada3 sites
University of Alberta
Edmonton, Alberta, T6G 2B7
St Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N4A6
University of Toronto
Toronto, Ontario, M5G 1X5
France3 sites
CHU Nice
Nice, 06202
Hopital Cochin
Paris, 75014
Chu Rangueil
Toulouse, 31059
United Kingdom3 sites
Addenbrookes Hospital
Cambridge, CB2 2QQ
Queen Elizabeth Hospital Birmingham
Edgbaston, Birmingham, B15 2GW
Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN
Spain2 sites
Complejo Hospitalario de Navarra
Pamplona, 31008
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, 15706
Germany1 site
Medius Kliniken gGmbh
Kirchheim unter Teck, Studienzentrale, 73230
About this study
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.
Read the detailed description
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 period in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving background corticosteroid therapy with or without Mepolizumab/Benralizumab therapy. During the treatment period corticosteroid dose will be tapered.
The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of <=4 mg/day prednisolone/prednisone.
- Being tested
- NS-229, Placebo
- Medical subject headings
- Churg-Strauss Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS-229Drug
Experimental
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| NS-229 | Experimental | Self-administer NS-229 in consecutive 28 weeks. Receives: Drug: NS-229 |
| Placebo | Placebo comparator | Self-administer matching placebo in consecutive 28 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects in remission [OGC 4.0]
The proportion of subjects in remission (oral glucocorticoid [OGC] 4.0) at Week 28 of the study treatment period.
Definition of remission (OGC 4.0): BVAS of 0 AND OGC dose of prednisolone/prednisone ≤4 mg/day
Measured: From Baseline to week 28
Secondary outcomes (3)
The proportion of subjects in remission [OGC 7.5]
The proportion of subjects in remission (OGC 7.5) at Week 28 of the study treatment period Definition of remission (OGC 7.5): BVAS of 0 AND OGC dose of prednisolone/prednisone ≤7.5 mg/day
Measured: From Baseline to week 28
Time to first relapse of EGPA
Relapse of EGPA will be defined as active disease since the last visit after remission (OGC 4.0) was achieved, characterized by:
- Active vasculitis (BVAS of >0); OR
- Signs and/or symptoms of active asthma with a corresponding worsening in answers on the 6-item Asthma Control Questionnaire (compared with the most recent previous results); OR
- Active nasal and/or sinus disease (attributable to EGPA) with a corresponding worsening in at least 1 of the answers on the sinonasal symptom questionnaire (compared with the most recent previous assessment).
Measured: Up to Week 28
Time to first worsening of EGPA
Worsening of EGPA will be defined as worsening of active disease since the last visit, characterized by:
- Active vasculitis (BVAS >0) and the score greater than the previous visit; OR
- Signs and/or symptoms of active asthma with a corresponding worsening in answers on the 6-item Asthma Control Questionnaire (compared to the most recent previous score); OR
- Active nasal and/or sinus disease (attributable to EGPA) with a corresponding worsening in at least 1 of the answers on the sinonasal symptom questionnaire (compared to the most recent previous assessment).
Measured: Up to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start20 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NS Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nippon Shinyaku Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046222
- Sponsor's protocol ID
- NS229-P2-01
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Submission to the FDA
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
- ClinicalTrials.gov ID
- NCT06046222
- Acronym / sponsor ID
- NS229-P2-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- NS Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nippon Shinyaku Co., Ltd.
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.
Detailed description
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 period in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving background corticosteroid therapy with or without Mepolizumab/Benralizumab therapy. During the treatment period corticosteroid dose will be tapered.
The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of <=4 mg/day prednisolone/prednisone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NS-229 | Experimental | Drug: NS-229Self-administer NS-229 in consecutive 28 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboSelf-administer matching placebo in consecutive 28 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NS-229Experimental | Drug | NS-229 |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
The proportion of subjects in remission [OGC 4.0]
Time frame: From Baseline to week 28
The proportion of subjects in remission (oral glucocorticoid [OGC] 4.0) at Week 28 of the study treatment period. Definition of remission (OGC 4.0): BVAS of 0 AND OGC dose of prednisolone/prednisone ≤4 mg/day
3 secondary outcomes
The proportion of subjects in remission [OGC 7.5]
Time frame: From Baseline to week 28
Time to first relapse of EGPA
Time frame: Up to Week 28
Time to first worsening of EGPA
Time frame: Up to Week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. Submission to the FDA
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NS-229 in people with Eosinophilic Granulomatosis With Polyangiitis and Churg-Strauss Syndrome, run by NS Pharma, Inc. at 34 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Japan, United States, Italy, Canada, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects in remission [OGC 4.0] (time frame: From Baseline to week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.