Actively Recruiting
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
Led by Chugai Pharmaceutical · Updated on 2026-04-02
144
Participants Needed
69
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration 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
Official Title
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 to 75 years at consent (except for bullous pemphigoid patients up to 85 years with Karnofsky score 60%)
- Ability to comply with the study protocol
- Women of childbearing potential must agree to abstain from heterosexual intercourse or use highly effective contraception
- Men must agree to abstain from heterosexual intercourse or use contraception and not donate sperm
- APS cohort: established primary APS with specific laboratory and clinical criteria
- BP cohort: age 18 to 85 with Karnofsky score 60%, predominant skin lesions, confirmed BP diagnosis with positive immunofluorescence or serology, BPDAI score 20, weekly average PP-NRS 4, and agreement to photograph lesions
- BS cohort: diagnosed with Behet's syndrome, oral ulcers at least 3 times in last 12 months, at least 2 oral ulcers in 4 weeks before screening and at Week 0, prior non-biologic BS therapy, and need for systemic therapy
- DM cohort: diagnosed definite or probable dermatomyositis, inadequate response or intolerance to corticosteroids or immunosuppressants, MMT-8 score < 142 with specified abnormalities, moderate to severe DM with CDASI activity score > 14
- IMNM cohort: clinically diagnosed immune-mediated necrotizing myopathy as anti-HMGCR or anti-SRP myopathy, creatine kinase > 1000 U/L, inadequate response or intolerance to corticosteroids or immunosuppressants, MMT-8 score < 142
- ITP cohort: confirmed persistent/chronic immune thrombocytopenia per guidelines, platelet count 30 x 10^9/L on 2 occasions, lack of sustained response to thrombopoietin receptor agonist and other treatments, history of platelet count increase > 20 x 10^9/L with prior therapy
You will not qualify if you...
- History of anaphylaxis or hypersensitivity to biologic agents
- Active infection requiring systemic antiviral, antibiotic, or antifungal treatment
- Planned surgery during the study
- Pregnant, breastfeeding, or intending pregnancy
- Serious medical conditions or lab abnormalities preventing safe participation
- Clinically significant ECG abnormalities
- Illicit drug or alcohol abuse
- Autoimmune diseases other than target diseases (except Sj�f6gren's syndrome in DM and IMNM)
- Positive hepatitis B surface antigen
- Positive hepatitis C virus antibody
- Positive HIV antibody
- Current tuberculosis infection
- History of cancer within 5 years
- Treatment with investigational therapy within 28 days or 5 half-lives
- Previous or current treatment with anti-C1s antibody
- Use of other complement inhibitors within 3 months
- Use of prohibited therapies
- Elevated liver enzymes combined with elevated bilirubin
- APS cohort: associated systemic autoimmune disease, recent acute thrombosis, no anticoagulation for thrombotic APS, prohibited medications
- BP cohort: recent corticosteroid dose changes, drugs causing/exacerbating BP unless stable, recent topical calcineurin or PDE4 inhibitors, prohibited medications
- BS cohort: active major organ involvement needing immunosuppression, recent thrombosis, prohibited medications
- DM cohort: significant improvement between screening and baseline, overlap myositis except Sj�f6gren's syndrome, cancer-associated myositis, significant muscle damage, severe lung disease history, severe respiratory or bulbar weakness, prohibited medications
- IMNM cohort: similar exclusions as DM cohort
- ITP cohort: secondary ITP, myelodysplastic syndrome or autoimmune hemolytic anemia, recent thrombosis, recent major bleeding, prohibited medications, low hemoglobin, or elevated thyroid-stimulating hormone at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 69 locations
1
University of California-Irvine
Orange, California, United States, 92868
Actively Recruiting
2
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Not Yet Recruiting
3
Northwell Health, LLC PRIME
Lake Success, New York, United States, 11042
Active, Not Recruiting
4
Hospital for Special Surgery
New York, New York, United States, 10021
Active, Not Recruiting
5
Universtity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
6
Ohio State University
Columbus, Ohio, United States, 43203
Withdrawn
7
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
8
University of Pennsylvania, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Amarillo Center for Clinical Research
Amarillo, Texas, United States, 79124
Active, Not Recruiting
10
Austin Neuromuscular Center
Austin, Texas, United States, 78759
Actively Recruiting
11
Nerve and Muscle Center of Texas
Houston, Texas, United States, 77030
Not Yet Recruiting
12
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
13
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Actively Recruiting
14
Campbelltown Public Hospital
Sydney, New South Wales, Australia, 2560
Actively Recruiting
15
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
16
Box Hill Hospital
Melbourne, Victoria, Australia, 3128
Actively Recruiting
17
AKH - Medizinische Universitaet Wien, Abteilung fuer Klinische Pharmakologie
Vienna, Austria, 1090
Not Yet Recruiting
18
Diagnostic Consultation Center CONVEX EOOD
Sofia, Sofia City Province, Bulgaria, 1202
Not Yet Recruiting
19
"SHATHD" EAD Sofia
Sofia, Sofia City Province, Bulgaria, 1756
Not Yet Recruiting
20
UMHAT "Prof. Dr. St. Kirkovich", AD
Stara Zagora, Stara Zagora Province, Bulgaria, 6003
Not Yet Recruiting
21
University of Alberta Hospital - Department of Anesthesiology and Pain Medicine
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
22
University of Alberta Hospital - Dermatology
Edmonton, Alberta, Canada, T6G 2G3
Actively Recruiting
23
The Royal Institution for the Advancement of Learning/McGill University
Montreal, Quebec, Canada, H3A 0G4
Actively Recruiting
24
Centre de Rhumatologie de l'Est du Quebec
Rimouski, Quebec, Canada, G5L 8W1
Actively Recruiting
25
DIEX Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1L 0H8
Actively Recruiting
26
Clinical Hospital Center "Sestre Milosrdnice"
Zagreb, City of Zagreb, Croatia, 10000
Not Yet Recruiting
27
University hospital centre Zagreb
Zagreb, City of Zagreb, Croatia, 10000
Not Yet Recruiting
28
Specialty Hospital Medico
Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
Not Yet Recruiting
29
Sanatorium Profesora Arenbergera
Prague, Prague, Czechia, 11000
Not Yet Recruiting
30
Hopital Lapeyronie,Service d'Immuno Rhumatologie
Montpellier, Occitanie, France, 34295
Not Yet Recruiting
31
AP-HP Hôpital Universitaire Pitié Salpêtrière
Paris, Île-de-France Region, France, 75013
Actively Recruiting
32
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Not Yet Recruiting
33
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Not Yet Recruiting
34
Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie
Sachsen, Bundesländer, Germany, 1307
Not Yet Recruiting
35
Universitaetsmedizin Goettingen
Göttingen, Göttingen District, Germany, 3075
Not Yet Recruiting
36
Universitaetsklinikum Schleswig Holstein - Campus Luebeck, Klinik f Dermatologie, Allergologie u Venerologie
Lübeck, Schleswig-Holstein, Germany, 23538
Not Yet Recruiting
37
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád-Csanád County, Hungary, 6720
Not Yet Recruiting
38
Semmelweis Egyetem
Budapest, Hungary, 1083
Not Yet Recruiting
39
IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST
Meldola, Forlì-Cesena Province, Italy, 47014
Not Yet Recruiting
40
Istituto Clinico Humanitas
Milan, Milan Province, Italy, 20089
Not Yet Recruiting
41
Ospedale San Giovanni Bosco
Torino, Turin Province, Italy, 10154
Not Yet Recruiting
42
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-0808
Actively Recruiting
43
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
44
Kindai University Hospital
Sayama, Osaka, Japan, 589-8511
Not Yet Recruiting
45
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Actively Recruiting
46
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan, 431-3192
Actively Recruiting
47
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan, 187-8551
Actively Recruiting
48
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan, 143-8540
Actively Recruiting
49
Okayama University Hospital
Okayama, Japan, 700-8558
Actively Recruiting
50
University Medical Centre Groningen UMCG
Groningen, Groningen Province, Netherlands, 9713 GZ
Not Yet Recruiting
51
UMC Utrecht
Utrecht, Utrecht Province, Netherlands, 3584 CX
Not Yet Recruiting
52
Sorlandet sykehus Kristiansand
Kristiansand, Agder County, Norway, 4604
Not Yet Recruiting
53
Stavanger Universitetssjukehus
Stavanger, Rogaland County, Norway, 4011
Not Yet Recruiting
54
Institute Reumatologii I'm. Eleonory Reicher
Warsaw, Masovian Voivodeship, Poland, 02-637
Actively Recruiting
55
Centro Clinico Academico Braga
Braga, Braga District, Portugal, 471-243
Not Yet Recruiting
56
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, Porto District, Portugal, 4434-502
Not Yet Recruiting
57
Centrul Medical Monza SRL
Bucharest, Bucharest Municipality, Romania, 400015
Actively Recruiting
58
Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N.
Cluj-Napoca, Cluj, Romania, 11658
Actively Recruiting
59
Clinica Universidad de Navarra
Pamplona, Community of Madrid & Navarre, Spain, 28027
Not Yet Recruiting
60
Hospital Universitario Ramon y Cajal, Servicio de Reumatologia
Madrid, Madrid, Spain, 28034
Not Yet Recruiting
61
Hospital Universitario 12 de October
Madrid, Madrid, Spain, 28041
Not Yet Recruiting
62
Hospital Universitari Vall d'Hebron, Internal Medicine Dept.
Barcelona, Province of Barcelona and Catalonia, Spain, 08035
Not Yet Recruiting
63
Hospital Universitario Reina Sofia
Córdoba, Province Of Córdoba, Spain, 14004
Not Yet Recruiting
64
Hospital Universitario Virgen del Rocio
Seville, Province Of Seville, Spain, 41013
Actively Recruiting
65
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain, 46026
Not Yet Recruiting
66
National Taiwan University Hospital
Taipei, Taiwan, 100229
Actively Recruiting
67
Taichung Veterans General Hospital
Taipei, Taiwan, 407219
Not Yet Recruiting
68
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, Ankara, Turkey (Türkiye), 06200
Not Yet Recruiting
69
Istanbul University Istanbul Medical Faculty
Istanbul, Istanbul, Turkey (Türkiye), 34093
Not Yet Recruiting
Research Team
C
Clinical trials information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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