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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06723106




Registration number
NCT06723106
Ethics application status
Date submitted
27/11/2024
Date registered
9/12/2024

Titles & IDs
Public title
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
Scientific title
Phase 1b Open-label, Long-term Extension Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW-LTE Trial)
Secondary ID [1] 0 0
RAY903CT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antiphospholipid Syndrome (APS) 0 0
Bullous Pemphigoid (BP) 0 0
Behçet's Syndrome (BS) 0 0
Dermatomyositis (DM) 0 0
Immune-mediated Necrotizing Myopathy (IMNM) 0 0
Immune Thrombocytopenia (ITP) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Skin 0 0 0 0
Other skin conditions
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Dermatological conditions
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RAY121

Experimental: RAY121 - All enrolled patients will receive RAY121 multiple dose


Treatment: Drugs: RAY121
Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events (AEs)
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
RAY121 concentration
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Change from baseline in active C1s
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Change from baseline in total C1s
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Change from baseline in complement activity (classical pathway)
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
Anti-RAY121 antibodies
Timepoint [5] 0 0
Baseline to Week 52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Westmead Hospital - Sydney
Recruitment hospital [3] 0 0
Campbelltown Public Hospital - Sydney
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Box Hill Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 0 0
2560 - Sydney
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3128 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Sofia City Province
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Stara Zagora Province
Country [4] 0 0
Croatia
State/province [4] 0 0
City Of Zagreb
Country [5] 0 0
Croatia
State/province [5] 0 0
Primorje-Gorski Kotar County
Country [6] 0 0
Czechia
State/province [6] 0 0
City Of Prague
Country [7] 0 0
France
State/province [7] 0 0
Occitanie
Country [8] 0 0
France
State/province [8] 0 0
Île-de-France
Country [9] 0 0
Germany
State/province [9] 0 0
Baden-Württemberg
Country [10] 0 0
Germany
State/province [10] 0 0
Bavaria
Country [11] 0 0
Germany
State/province [11] 0 0
Bundesländer
Country [12] 0 0
Germany
State/province [12] 0 0
Göttingen District
Country [13] 0 0
Germany
State/province [13] 0 0
Schleswig-Holstein
Country [14] 0 0
Hungary
State/province [14] 0 0
Csongrád-Csanád County
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Italy
State/province [16] 0 0
Forlì-Cesena Province
Country [17] 0 0
Italy
State/province [17] 0 0
Milan Province
Country [18] 0 0
Italy
State/province [18] 0 0
Turin Province
Country [19] 0 0
Japan
State/province [19] 0 0
Hokkaido
Country [20] 0 0
Japan
State/province [20] 0 0
Miyagi
Country [21] 0 0
Japan
State/province [21] 0 0
Osaka
Country [22] 0 0
Japan
State/province [22] 0 0
Shizuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Tokyo
Country [24] 0 0
Netherlands
State/province [24] 0 0
Groningen Province
Country [25] 0 0
Netherlands
State/province [25] 0 0
Utrecht Province
Country [26] 0 0
Norway
State/province [26] 0 0
Agder County
Country [27] 0 0
Norway
State/province [27] 0 0
Rogaland County
Country [28] 0 0
Poland
State/province [28] 0 0
Masovian Voivodeship
Country [29] 0 0
Portugal
State/province [29] 0 0
Braga District
Country [30] 0 0
Portugal
State/province [30] 0 0
Porto District
Country [31] 0 0
Romania
State/province [31] 0 0
Bucharest Municipality
Country [32] 0 0
Romania
State/province [32] 0 0
Cluj County
Country [33] 0 0
Spain
State/province [33] 0 0
Community Of Madrid & Navarre
Country [34] 0 0
Spain
State/province [34] 0 0
Community Of Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Province Of Barcelona And Catalonia
Country [36] 0 0
Spain
State/province [36] 0 0
Province Of Córdoba
Country [37] 0 0
Spain
State/province [37] 0 0
Province Of Seville
Country [38] 0 0
Spain
State/province [38] 0 0
Valencian Community
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taipei
Country [40] 0 0
Turkey
State/province [40] 0 0
Ankara Province
Country [41] 0 0
Turkey
State/province [41] 0 0
Istanbul Province

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Chugai Pharmaceutical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sponsor Chugai Pharmaceutical Co.Ltd
Address 0 0
clinical-trials@chugai-pharm.co.jp
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06723106