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New drug RAY121 tested for Long-Term control of autoimmune diseases

NCT ID NCT06723106

Disease control Sponsor: Chugai Pharmaceutical 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 1 time

Summary

This study is a long-term extension of an earlier trial, testing the safety of a drug called RAY121 in people with six different immune system disorders, including antiphospholipid syndrome and immune thrombocytopenia. Participants have already completed four doses of RAY121 and shown improvement. The goal is to see if the drug remains safe and effective over a longer period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RAY121 (a drug that blocks a part of the immune system called the classical complement pathway)
What this could lead to
If successful, this could show that RAY121 is safe and effective for long-term control of several autoimmune diseases, potentially offering a new treatment option.
What could go wrong
This is a very early (Phase 1) and small study (144 people). It only includes patients who already responded to RAY121, so results may not apply to everyone. Long-term safety is still unknown.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 144 people

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

Started

Dec 2024

Expected to finish

Feb 2028

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 to 85 years

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: 1. Signed informed consent form 2. Have completed 4 doses of RAY121 administrations in RAY902CT trial and shown clinical responses 3. Ability to comply with the study protocol, in the investigator's judgment 4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods during the treatment period and 20 weeks (140 days) after the last dose of RAY121 5. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm Exclusion Criteria: 1. History of anaphylaxis or hypersensitivity to a biologic agent 2. Known active infection with encapsuled bacteria 3. History of Neisseria meningitidis infection 4. Planned surgery 5. Pregnant or breastfeeding, or intending to become pregnant 6. Clinically significant electrocardiogram abnormalities 7. Illicit drug or alcohol abuse 8. Known or suspected immune deficiency 9. Treatment with investigational therapy other than RAY121 10. Vaccination with a live vaccine within 4 weeks

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Conditions

The condition(s) this trial relates to.

antiphospholipid syndrome Behcet disease bullous pemphigoid dermatomyositis immune-mediated necrotizing myopathy Purpura, Thrombocytopenic, Idiopathic thrombocytopenia due to immune destruction

As listed by the trial registrant

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

Antiphospholipid syndrome (APS) Behçet's syndrome (BS) Bullous pemphigoid (BP) Dermatomyositis (DM) Immune thrombocytopenia (ITP) Immune-mediated necrotizing myopathy (IMNM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    62 sites in 19 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "SHATHD" EAD Sofia

    Sofia, Sofia City Province, 1756, Bulgaria

  • AKH - Medizinische Universitaet Wien, Abteilung fuer Klinische Pharmakologie

    Vienna, 1090, Austria

  • AP-HP Hôpital Universitaire Pitié Salpêtrière

    Paris, Île-de-France Region, 75013, France

  • Box Hill Hospital

    Melbourne, Victoria, 3128, Australia

  • Campbelltown Public Hospital

    Sydney, New South Wales, 2560, Australia

  • Centro Clinico Academico Braga

    Braga, Braga District, 471-243, Portugal

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

    Vila Nova de Gaia, Porto District, 4434-502, Portugal

  • Centrul Medical Monza SRL

    Bucharest, Bucharest Municipality, 400015, Romania

  • Clinica Universidad de Navarra

    Pamplona, Community of Madrid & Navarre, 28027, Spain

  • Clinical Hospital Center "Sestre Milosrdnice"

    Zagreb, City of Zagreb, 10000, Croatia

  • DiIEX Recherche Sherbrooke, Inc

    Sherbrooke, Quebec, J1L 0H8, Canada

  • Diagnostic Consultation Center CONVEX EOOD

    Sofia, Sofia City Province, 1202, Bulgaria

  • Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

    Ankara, Ankara, 06200, Turkey (Türkiye)

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-0808, Japan

  • Hopital Lapeyronie,Service d'Immuno Rhumatologie

    Montpellier, Occitanie, 34295, France

  • Hospital Universitari Vall d'Hebron, Internal Medicine Dept.

    Barcelona, Province of Barcelona and Catalonia, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario 12 de October

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal, Servicio de Reumatologia

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Province Of Córdoba, 14004, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Province Of Seville, 41013, Spain

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Himeji, Hyōgo, 670-8560, Japan

  • IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST

    Meldola, Forlì-Cesena Province, 47014, Italy

  • Institute Reumatologii I'm. Eleonory Reicher

    Warsaw, Masovian Voivodeship, 02-637, Poland

  • Institute of Science Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Istanbul University Istanbul Medical Faculty

    Istanbul, Istanbul, 34093, Turkey (Türkiye)

  • Istituto Clinico Humanitas

    Milan, Milan Province, 20089, Italy

  • Kindai University Hospital

    Sakai, Osaka, 590-0197, Japan

  • National Center of Neurology and Psychiatry

    Kodaira, Tokyo, 187-8551, Japan

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563, Japan

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, Osaka, 586-8521, Japan

  • National Hospital Organization Tokyo Medical Center

    Meguro-ku, Tokyo, 152-8902, Japan

  • National Taiwan University Hospital

    Taipei, 100229, Taiwan

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N.

    Cluj-Napoca, Cluj, 11658, Romania

  • Ospedale San Giovanni Bosco

    Torino, Turin Province, 10154, Italy

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • Sanatorium Profesora Arenbergera

    Prague, Prague, 11000, Czechia

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Sorlandet sykehus Kristiansand

    Kristiansand, Agder County, 4604, Norway

  • Specialty Hospital Medico

    Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

  • Stavanger Universitetssjukehus

    Stavanger, Rogaland County, 4011, Norway

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, Csongrád-Csanád County, 6720, Hungary

  • Taichung Veterans General Hospital

    Taipei, 407219, Taiwan

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The University of Osaka Hospital

    Suita, Osaka, 565-0871, Japan

  • Toho University Omori Medical Center

    Ōta-ku, Tokyo, 134-8540, Japan

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai, Miyagi, 983-8512, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193, Japan

  • Toyama University Hospital

    Toyama, 930-0194, Japan

  • UMC Utrecht

    Utrecht, Utrecht Province, 3584 CX, Netherlands

  • UMHAT "Prof. Dr. St. Kirkovich", AD

    Stara Zagora, Stara Zagora Province, 6003, Bulgaria

  • Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie

    Sachsen, Bundesländer, 1307, Germany

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91054, Germany

  • Universitaetsklinikum Schleswig Holstein - Campus Luebeck, Klinik f Dermatologie, Allergologie u Venerologie

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitaetsmedizin Goettingen

    Göttingen, Göttingen District, 3075, Germany

  • University Medical Centre Groningen UMCG

    Groningen, Groningen Province, 9713 GZ, Netherlands

  • University hospital centre Zagreb

    Zagreb, City of Zagreb, 10000, Croatia

  • Westmead Hospital

    Sydney, New South Wales, 2145, Australia

More trials for these conditions

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