Treatment for patients with steroid-resistant pemphigus
ONO-4059-10:Multicenter, Placebo-controlled, Randomized, Double-blind, Phase 3 Study in Patients With Steroid-resistant Pemphigus (BRILLIANT Study)
PHASE3 · Ono Pharmaceutical Co., Ltd. · NCT06696716
This study is testing a new treatment for people with pemphigus who don't respond to steroids to see if it can help improve their condition.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Ono Pharmaceutical Co., Ltd. (industry) |
| Locations | 25 sites (Aichi and 24 other locations) |
| Trial ID | NCT06696716 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial evaluates the efficacy of ONO-4059, a novel treatment, in patients suffering from steroid-resistant pemphigus. The study is designed as a multicenter, placebo-controlled, randomized, and double-blind trial, ensuring rigorous testing of the treatment's effectiveness compared to a placebo. Patients will be monitored for changes in their pemphigus disease area index (PDAI) score as a primary outcome measure. The trial aims to provide a new therapeutic option for those who do not respond adequately to standard corticosteroid treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with pemphigus who have experienced a re-increase in their PDAI score while on a low dose of corticosteroids.
Not a fit: Patients with active infections, malignancies, or a history of serious allergies or anaphylaxis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new hope for patients with steroid-resistant pemphigus, potentially improving their quality of life and disease management.
How similar studies have performed: While this approach is novel in the context of steroid-resistant pemphigus, similar studies targeting autoimmune conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a diagnosis of pemphigus * Patients with a re-increase in the pemphigus disease area index (PDAI) score before oral corticosteroid tapering to 10mg/day of prednisolone (PSL) equivalent Exclusion Criteria: * Patients with an active infection * Patients with malignancy * Patients with past history of serious allergy or anaphylaxis
Where this trial is running
Aichi and 24 other locations
- Ichinomiya Municipal Hospital — Aichi, Japan (RECRUITING)
- Nagoya City University Hospital — Aichi, Japan (RECRUITING)
- Ehime University Hospital — Ehime, Japan (RECRUITING)
- Kurume University Hospital — Fukuoka, Japan (RECRUITING)
- Fukushima Medical University Hospital — Fukushima, Japan (RECRUITING)
- Gunma University Hospital — Gunma, Japan (RECRUITING)
- Hokkaido University Hospital — Hokkaido, Japan (RECRUITING)
- Kagoshima University Hospital — Kagoshima, Japan (RECRUITING)
- St.Marianna University School of Medicine Hospital — Kanagawa, Japan (RECRUITING)
- Tokai University Hospital — Kanagawa, Japan (RECRUITING)
- Yokohama City University Hospital — Kanagawa, Japan (RECRUITING)
- Kumamoto University Hospital — Kumamoto, Japan (RECRUITING)
- University Hospital Kyoto Prefectural University of Medicine — Kyoto, Japan (RECRUITING)
- Niigata University Medical & Dental Hospital — Niigata, Japan (RECRUITING)
- Kawasaki Medical School Hospital — Okayama, Japan (RECRUITING)
- University of the Ryukyus Hospital — Okinawa, Japan (RECRUITING)
- Kindai university hospital — Osaka, Japan (RECRUITING)
- Osaka Metropolitan University Hospital — Osaka, Japan (RECRUITING)
- Saitama Medical Center — Saitama, Japan (RECRUITING)
- Shiga University of Medical Science Hospital — Shiga, Japan (RECRUITING)
- Jichi Medical University Hospital — Tochigi, Japan (RECRUITING)
- Keio University Hospital — Tokyo, Japan (RECRUITING)
- Tokyo Medical and Dental University Hospital — Tokyo, Japan (RECRUITING)
- Tokyo Women'ｓ Medical University Hospital — Tokyo, Japan (RECRUITING)
- Yamagata University Hospital — Yamagata, Japan (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: North America Clinical Trial Support Desk
- Email: clinical_trial@ono-pharma.com
- Phone: +18665877745(Toll-Free)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pemphigus, Steroid-resistant Pemphigus