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Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)

Phase 1
Conditions
Antiphospholipid Syndrome (APS)
Bullous Pemphigoid (BP)
Dermatomyositis (DM)
Immune-mediated Necrotizing Myopathy (IMNM)
Behçet's Syndrome (BS)
Immune Thrombocytopenia (ITP)
Interventions
Registration Number
NCT06723106
Lead Sponsor
Chugai Pharmaceutical
Brief 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).

Detailed Description

Not available

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
144
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
RAY121RAY121All enrolled patients will receive RAY121 multiple dose
Primary Outcome Measures
NameTimeMethod
Adverse events (AEs)Baseline to Week 52

Incidence, severity, and causal relationship of AEs

Secondary Outcome Measures
NameTimeMethod
RAY121 concentrationBaseline to Week 52

Serum RAY121 concentration

Change from baseline in complement activity (classical pathway)Baseline to Week 52

Level of complement activity (classical pathway) will be measured and assessed against baseline values

Anti-RAY121 antibodiesBaseline to Week 52

Titer of anti-RAY121 antibodies

Change from baseline in active C1sBaseline to Week 52

Concentration of active C1s will be measured and assessed against baseline values

Change from baseline in total C1sBaseline to Week 52

Concentration of total C1s will be measured and assessed against baseline values

Trial Locations

Locations (54)

DiIEX Recherche Sherbrooke, Inc

🇨🇦

Sherbrooke, Quebec, Canada

Okayama University Hospital

🇯🇵

Okayama, Japan

Royal Prince Alfred Hospital

🇦🇺

Camperdown, New South Wales, Australia

Westmead Hospital

🇦🇺

Sydney, New South Wales, Australia

Campbelltown Public Hospital

🇦🇺

Sydney, New South Wales, Australia

The Alfred Hospital

🇦🇺

Melbourne, Victoria, Australia

Box Hill Hospital

🇦🇺

Melbourne, Victoria, Australia

AKH - Medizinische Universitaet Wien, Abteilung fuer Klinische Pharmakologie

🇦🇹

Vienna, Austria

Diagnostic Consultation Center CONVEX EOOD

🇧🇬

Sofia, Sofia City Province, Bulgaria

"SHATHD" EAD Sofia

🇧🇬

Sofia, Sofia City Province, Bulgaria

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DiIEX Recherche Sherbrooke, Inc
🇨🇦Sherbrooke, Quebec, Canada
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