Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06723106

Enrolling By InvitationPhase 1

Sponsor: Chugai Pharmaceutical

Conditions: Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM), Immune-mediated Necrotizing Myopathy (IMNM)

Interventions: RAY121

Countries: Australia, Austria, Bulgaria, Canada, Croatia, Czechia, France, Germany

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (62)
  • Camperdown, New South Wales, Australia
  • Sydney, New South Wales, Australia
  • Sydney, New South Wales, Australia
  • Melbourne, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Vienna, Austria
  • Sofia, Sofia City Province, Bulgaria
  • Sofia, Sofia City Province, Bulgaria
  • Stara Zagora, Stara Zagora Province, Bulgaria
  • Sherbrooke, Quebec, Canada
  • Zagreb, City of Zagreb, Croatia
  • Zagreb, City of Zagreb, Croatia
  • Rijeka, Primorje-Gorski Kotar County, Croatia
  • Prague, Prague, Czechia
  • Montpellier, Occitanie, France
  • Paris, Île-de-France Region, France
  • Tübingen, Baden-Wurttemberg, Germany
  • Erlangen, Bavaria, Germany
  • Sachsen, Bundesländer, Germany
  • Göttingen, Göttingen District, Germany
  • Lübeck, Schleswig-Holstein, Germany
  • Szeged, Csongrád-Csanád County, Hungary
  • Budapest, Hungary
  • Meldola, Forlì-Cesena Province, Italy
  • Milan, Milan Province, Italy
  • Torino, Turin Province, Italy
  • Sapporo, Hokkaido, Japan
  • Himeji, Hyōgo, Japan
  • Isehara, Kanagawa, Japan
  • Sendai, Miyagi, Japan
  • + 32 more on CT.gov