Antiphospholipid Syndrome (APS)Phase 1NCT06723106
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
A Phase 1 study testing RAY121 in people with Antiphospholipid Syndrome (APS) and Bullous Pemphigoid (BP), run by Chugai Pharmaceutical at 62 sites in 19 countries.
Trial summary
This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS)
- What is being tested?
- RAY121
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 62 sitesin 19 countries
- Study dates
- 9 Dec 2024to 28 Feb 2028
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Have completed 4 doses of RAY121 administrations in RAY902CT trial and shown clinical responses
- Ability to comply with the study protocol, in the investigator's judgment
- 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
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Who cannot join
- History of anaphylaxis or hypersensitivity to a biologic agent
- Known active infection with encapsuled bacteria
- History of Neisseria meningitidis infection
- Planned surgery
- Pregnant or breastfeeding, or intending to become pregnant
- Clinically significant electrocardiogram abnormalities
Show all 10Show fewer
- Illicit drug or alcohol abuse
- Known or suspected immune deficiency
- Treatment with investigational therapy other than RAY121
- Vaccination with a live vaccine within 4 weeks
Trial locations and contacts
62 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
62 sites in 19 countries
Japan16 sites
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8519
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, Hyōgo, 670-8560
Tokai University Hospital
Isehara, Kanagawa, 259-1193
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, 586-8521
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902
Okayama University Hospital
Okayama, 700-8558
Toho University Omori Medical Center
Ōta-ku, Tokyo, 134-8540
Kindai University Hospital
Sakai, Osaka, 590-0197
Hokkaido University Hospital
Sapporo, Hokkaido, 060-0808
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Tohoku Medical and Pharmaceutical University Hospital
Sendai, Miyagi, 983-8512
The University of Osaka Hospital
Suita, Osaka, 565-0871
Toyama University Hospital
Toyama, 930-0194
Spain7 sites
Hospital Universitari Vall d'Hebron, Internal Medicine Dept.
Barcelona, Province of Barcelona and Catalonia, 08035
Hospital Universitario Reina Sofia
Córdoba, Province Of Córdoba, 14004
Hospital Universitario Ramon y Cajal, Servicio de Reumatologia
Madrid, Madrid, 28034
Hospital Universitario 12 de October
Madrid, Madrid, 28041
Clinica Universidad de Navarra
Pamplona, Community of Madrid & Navarre, 28027
Hospital Universitario Virgen del Rocio
Seville, Province Of Seville, 41013
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
Australia5 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
The Alfred Hospital
Melbourne, Victoria, 3004
Box Hill Hospital
Melbourne, Victoria, 3128
Westmead Hospital
Sydney, New South Wales, 2145
Campbelltown Public Hospital
Sydney, New South Wales, 2560
Germany5 sites
Universitaetsklinikum Erlangen
Erlangen, Bavaria, 91054
Universitaetsmedizin Goettingen
Göttingen, Göttingen District, 3075
Universitaetsklinikum Schleswig Holstein - Campus Luebeck, Klinik f Dermatologie, Allergologie u Venerologie
Lübeck, Schleswig-Holstein, 23538
Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie
Sachsen, Bundesländer, 1307
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Bulgaria3 sites
Diagnostic Consultation Center CONVEX EOOD
Sofia, Sofia City Province, 1202
"SHATHD" EAD Sofia
Sofia, Sofia City Province, 1756
UMHAT "Prof. Dr. St. Kirkovich", AD
Stara Zagora, Stara Zagora Province, 6003
Croatia3 sites
Specialty Hospital Medico
Rijeka, Primorje-Gorski Kotar County, 51000
Clinical Hospital Center "Sestre Milosrdnice"
Zagreb, City of Zagreb, 10000
University hospital centre Zagreb
Zagreb, City of Zagreb, 10000
Italy3 sites
IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST
Meldola, Forlì-Cesena Province, 47014
Istituto Clinico Humanitas
Milan, Milan Province, 20089
Ospedale San Giovanni Bosco
Torino, Turin Province, 10154
France2 sites
Hopital Lapeyronie,Service d'Immuno Rhumatologie
Montpellier, Occitanie, 34295
AP-HP Hôpital Universitaire Pitié Salpêtrière
Paris, Île-de-France Region, 75013
Hungary2 sites
Semmelweis Egyetem
Budapest, 1083
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád-Csanád County, 6720
Netherlands2 sites
University Medical Centre Groningen UMCG
Groningen, Groningen Province, 9713 GZ
UMC Utrecht
Utrecht, Utrecht Province, 3584 CX
Norway2 sites
Sorlandet sykehus Kristiansand
Kristiansand, Agder County, 4604
Stavanger Universitetssjukehus
Stavanger, Rogaland County, 4011
Portugal2 sites
Centro Clinico Academico Braga
Braga, Braga District, 471-243
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, Porto District, 4434-502
Romania2 sites
Centrul Medical Monza SRL
Bucharest, Bucharest Municipality, 400015
Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N.
Cluj-Napoca, Cluj, 11658
Taiwan2 sites
National Taiwan University Hospital
Taipei, 100229
Taichung Veterans General Hospital
Taipei, 407219
Turkey (Türkiye)2 sites
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, Ankara, 06200
Istanbul University Istanbul Medical Faculty
Istanbul, Istanbul, 34093
Austria1 site
AKH - Medizinische Universitaet Wien, Abteilung fuer Klinische Pharmakologie
Vienna, 1090
Poland1 site
Institute Reumatologii I'm. Eleonory Reicher
Warsaw, Masovian Voivodeship, 02-637
About this study
Official title: Phase 1b Open-label, Long-term Extension Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW-LTE Trial)
This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).
- Conditions
- Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM), Immune-mediated Necrotizing Myopathy (IMNM), Immune Thrombocytopenia (ITP)
- Being tested
- RAY121
- Medical subject headings
- Antiphospholipid Syndrome, Pemphigoid, Bullous, Behcet Syndrome, Dermatomyositis, Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAY121Drug
Injection
| Study group | Role | What they receive |
|---|---|---|
| RAY121 | Experimental | All enrolled patients will receive RAY121 multiple dose Receives: Drug: RAY121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence, severity, and causal relationship of AEs
Measured: Baseline to Week 52
Secondary outcomes (5)
RAY121 concentration
Serum RAY121 concentration
Measured: Baseline to Week 52
Change from baseline in active C1s
Concentration of active C1s will be measured and assessed against baseline values
Measured: Baseline to Week 52
Change from baseline in total C1s
Concentration of total C1s will be measured and assessed against baseline values
Measured: Baseline to Week 52
Change from baseline in complement activity (classical pathway)
Level of complement activity (classical pathway) will be measured and assessed against baseline values
Measured: Baseline to Week 52
Anti-RAY121 antibodies
Titer of anti-RAY121 antibodies
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start9 Dec 2024
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid Syndrome (APS)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Chugai Pharmaceutical Co.Ltd, Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723106
- Sponsor's protocol ID
- RAY903CT
- Status last verified
- Jul 2026
- First submitted
- 27 Nov 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Open-label, Long-term Extension Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW-LTE Trial)
- ClinicalTrials.gov ID
- NCT06723106
- Acronym / sponsor ID
- RAY903CT
- Conditions
- Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM), Immune-mediated Necrotizing Myopathy (IMNM), Immune Thrombocytopenia (ITP)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 9 Dec 2024 (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 is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAY121 | Experimental | Drug: RAY121All enrolled patients will receive RAY121 multiple dose |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent form
- Have completed 4 doses of RAY121 administrations in RAY902CT trial and shown clinical responses
- Ability to comply with the study protocol, in the investigator's judgment
- 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
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Key exclusion criteria (10 listed)
- History of anaphylaxis or hypersensitivity to a biologic agent
- Known active infection with encapsuled bacteria
- History of Neisseria meningitidis infection
- Planned surgery
- Pregnant or breastfeeding, or intending to become pregnant
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 |
|---|---|---|
| RAY121Injection | Drug | RAY121 |
Primary outcome
Adverse events (AEs)
Time frame: Baseline to Week 52
Incidence, severity, and causal relationship of AEs
5 secondary outcomes
RAY121 concentration
Time frame: Baseline to Week 52
Change from baseline in active C1s
Time frame: Baseline to Week 52
Change from baseline in total C1s
Time frame: Baseline to Week 52
Change from baseline in complement activity (classical pathway)
Time frame: Baseline to Week 52
Anti-RAY121 antibodies
Time frame: Baseline to Week 52
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 17 Jul 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).
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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.
Sponsor Chugai Pharmaceutical Co.Ltd study director
clinical-trials@chugai-pharm.co.jp
62 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RAY121 in people with Antiphospholipid Syndrome (APS) and Bullous Pemphigoid (BP), run by Chugai Pharmaceutical at 62 sites in 19 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 5 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Japan, Spain, Australia, Germany, Bulgaria and 14 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse events (AEs) (time frame: Baseline to Week 52). 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 17 Jul 2026.