Anifrolumab for Systemic Sclerosis
(DAISY Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing anifrolumab, an injectable medication, in adults with systemic sclerosis. The goal is to see if it can reduce immune system attacks to lessen symptoms and prevent further damage. Anifrolumab is a human monoclonal antibody that targets the type I interferon receptor and has been tested in multiple studies for systemic lupus erythematosus (SLE) and other autoimmune diseases.
Do I need to stop my current medications for the trial?
The trial allows participants to continue stable background therapies, including medications like hydroxychloroquine, methotrexate, and others. It does not specify a need to stop current medications.
How is the drug Anifrolumab different from other treatments for systemic sclerosis?
Anifrolumab is unique because it targets the type I interferon receptor, which is a different mechanism of action compared to other treatments for systemic sclerosis. This approach is novel as it specifically blocks the activity of interferons, proteins that play a role in inflammation and autoimmune diseases.12345
Research Team
Eligibility Criteria
Adults aged 18-70 with systemic sclerosis, meeting specific criteria and having the condition for less than 6 years. They must have certain severity scores, stable therapies are allowed. Excludes those with overlap syndromes, recent malignancies (except some skin cancers), severe organ diseases, or conditions that might affect study results.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double Blind Treatment
Participants receive once weekly injections of anifrolumab or matching placebo
Open Label Treatment
All participants receive anifrolumab once weekly
Safety Follow-up
Participants are monitored for safety after treatment
Treatment Details
Interventions
- Anifrolumab (Monoclonal Antibodies)
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor