Actively Recruiting
Phase 1b Open-label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW Trial)
Led by Chugai Pharmaceutical · Updated on 2026-04-02
144
Participants Needed
69
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating RAY121, an inhibitor of the classical complement pathway, in a Phase 1b basket trial involving patients with various immunological diseases. These conditions include antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), and immune thrombocytopenia (ITP). The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and early signs of effectiveness of multiple doses of RAY121. All patients enrolled in the study will receive multiple doses of RAY121 administered by injection. The trial is open-label, meaning both researchers and participants know the treatment being given. The treatment period and assessments will continue up to 32 weeks, during which the effects of RAY121 on the classical complement pathway and its activity will be monitored. Participants will be closely observed throughout the trial with regular evaluations to track adverse events and measure drug levels in the body. Various laboratory tests will assess pharmacokinetic parameters such as concentration and exposure (AUCτ, Cmax, Cmin) as well as pharmacodynamic markers like active and total C1s and complement activity. The presence of antibodies against RAY121 will also be measured. Safety and tolerability will be carefully monitored from baseline through week 32, providing important information about the treatment's impact over time.
CONDITIONS
Brief 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 at consent (for bullous pemphigoid patients, age 18 to 85 with Karnofsky score ≥ 60% at screening)
- Ability to comply with study protocol
- Women of childbearing potential agree to abstain or use highly effective contraception
- Men agree to abstain or use contraception and not donate sperm
- APS patients meet laboratory and clinical criteria for primary antiphospholipid syndrome
- BP patients have predominant skin lesions, diagnosis confirmed by immunofluorescence or serology, BPDAI score ≥ 20, and peak itch score ≥ 4
- BS patients diagnosed with Behçet's syndrome, with frequent oral ulcers and prior non-biologic therapy
- DM patients diagnosed with dermatomyositis, inadequate response or intolerance to treatments, muscle weakness, and moderate to severe disease
- IMNM patients clinically diagnosed with immune-mediated necrotizing myopathy, elevated creatine kinase, and inadequate response or intolerance to therapies
- ITP patients with confirmed persistent/chronic immune thrombocytopenia, low platelet counts, and prior treatment response history
You will not qualify if you...
- History of anaphylaxis or hypersensitivity to biologic agents
- Active infection requiring systemic treatment
- Planned surgery during the study
- Pregnant, breastfeeding, or intending pregnancy
- Serious medical conditions or lab abnormalities preventing safe participation
- Significant ECG abnormalities
- Illicit drug or alcohol abuse
- Autoimmune diseases other than target diseases (except Sjögren's in DM and IMNM)
- Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
- Active tuberculosis infection
- History of cancer within 5 years
- Recent treatment with investigational therapy
- Previous treatment with anti-C1s antibody or recent complement inhibitors
- Use of prohibited therapies
- Elevated liver enzymes combined with high bilirubin
- Disease-specific exclusions including recent thrombosis, medication changes, severe organ involvement, overlapping myositis, severe lung or muscle conditions, major bleeding, and abnormal lab values
- APS patients with other systemic autoimmune diseases or recent thrombosis
- BP patients with recent corticosteroid changes or certain drug treatments
- BS patients with active major organ involvement or recent thrombosis
- DM and IMNM patients with specific improvements, overlaps, or severe conditions
- ITP patients with secondary causes, recent thrombosis, bleeding, or lab abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 32 weeks
Participants receive multiple doses of the drug RAY121 to inhibit the classical complement pathway in immunological diseases.
Regular visits during treatment period
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
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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