Enrolling by invitationPhase 1

Long-term use of RAY121 in adults with several immune-related diseases

Tests RAY121 over a longer time in adults with immune diseases.

Key facts

Who runs it: Chugai Pharmaceutical
Where: Montpellier and Paris, FranceSee the 2 sitesAlso in 18 other countries, 60 sites
Trial code: NCT06723106
Registry title: Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
Status: Enrolling by invitation
Phase: Phase 1
People taking part: 144 people, planned
Started: 9 Dec 2024
Expected to end: 28 Feb 2028
Type of study: Interventional
Treatments tested: RAY121
Record updated: 17 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with immune diseases who got 4 doses of RAY121 in the RAY902CT trial and responded to it. Diseases include APS, bullous pemphigoid, Behçet's syndrome, dermatomyositis, IMNM and ITP.

Age: 18 Years to 85 Years
Sex: All sexes can join.
Disease stage: Immune diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) or immune thrombocytopenia (ITP).
Earlier treatment: Must have completed 4 doses of RAY121 in the RAY902CT trial and shown a response. Cannot have other trial drugs besides RAY121.

Main reasons for not taking part

Past severe allergic reaction (anaphylaxis) or hypersensitivity to a biologic drug
Active infection with encapsulated bacteria, or past Neisseria meningitidis infection
Known or suspected weak immune system
Pregnant, breastfeeding or planning pregnancy
Planned surgery, or a live vaccine within 4 weeks

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

Signed informed consent form
Have completed 4 doses of RAY121 administrations in RAY902CT trial and shown clinical responses
Ability to comply with the study protocol, in the investigator's judgment
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
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Who cannot take part

Planned surgery
Illicit drug or alcohol abuse
Treatment with investigational therapy other than RAY121
Vaccination with a live vaccine within 4 weeks
History of anaphylaxis or hypersensitivity to a biologic agent
Known active infection with encapsuled bacteria
History of Neisseria meningitidis infection
Pregnant or breastfeeding, or intending to become pregnant
Clinically significant electrocardiogram abnormalities
Known or suspected immune deficiency

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 85 years old?

Where in France

Also in 18 other countries, 60 sites

Hopital Lapeyronie,Service d'Immuno RhumatologieMontpellier, FranceEnrolling by invitation
AP-HP - Hôpital Universitaire Pitié-SalpêtrièreParis, FranceEnrolling by invitation

About the trial

What the trial wants to find out

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).