Anifrolumab for Systemic Sclerosis
(DAISY Trial)
Recruiting in Palo Alto (17 mi)
+150 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AstraZeneca
Disqualifiers: Severe cardiopulmonary, Overlap syndromes, Malignancy, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
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.
12345Eligibility 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
My daily activities are somewhat limited due to my health.
I have been diagnosed with systemic sclerosis.
I am a woman who can have children and my pregnancy test is negative.
+7 more
Exclusion Criteria
Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with the efficacy or safety evaluation of the study intervention or put participant at safety risk
I have no cancer history in the last 5 years, except for treated skin or cervical cancer.
I have had a stem cell or organ transplant.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
6 weeks
1 or more visits (in-person)
Double Blind Treatment
Participants receive once weekly injections of anifrolumab or matching placebo
52 weeks
In-clinic visits at Weeks 0, 1, 4, 8, 16, 24, 36, 48, and 52
Open Label Treatment
All participants receive anifrolumab once weekly
52 weeks
In-clinic visits at Weeks 52, 53, 56, 64, 76, 88, and 104
Safety Follow-up
Participants are monitored for safety after treatment
12 weeks
1 visit (in-person)
Participant Groups
The trial is testing Anifrolumab's effectiveness against a placebo in adults with systemic sclerosis. Participants will receive either the real drug or a placebo without knowing which one they're getting. Some may later get Anifrolumab openly.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Anifrolumab (subcutaneous weekly injection)Experimental Treatment2 Interventions
Anifrolumab subcutaneous injection once weekly
Group II: matched placebo control (subcutaneous weekly injection)Placebo Group1 Intervention
matched placebo control subcutaneous injection once weekly
Anifrolumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Saphnelo for:
- Moderate to severe systemic lupus erythematosus (SLE)
🇪🇺 Approved in European Union as Saphnelo for:
- Moderate to severe systemic lupus erythematosus (SLE)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SiteBrooklyn, NY
Research SiteCalgary, Canada
Research SiteScottsdale, AZ
Research SiteFort Lauderdale, FL
More Trial Locations
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Who Is Running the Clinical Trial?
AstraZenecaLead Sponsor
References
[Adalimumab plus methotrexate for the treatment of rheumatoid arthritis: a multi-center randomized, double-blind, placebo-controlled clinical study.]. [2018]To investigate the efficacy and safety of adalimumab plus methotrexate (MTX) for the treatment of rheumatoid arthritis (RA).
[Current "off label use" of methotrexate for chronic inflammatory rheumatic diseases]. [2021]Methotrexate (MTX) is probably the most commonly used off-label drug in rheumatology. It is used as an immunosuppressant for a wide range of chronic inflammatory rheumatic diseases. In most cases there is limited evidence from controlled studies for the efficacy of MTX in this off-label scenario. Only a few controlled clinical trials exist for different types of connective tissue diseases and vasculitis. In most indications, however, MTX could help to avoid using steroids and/or to prevent relapses. Thus, there is a great deal of experience with MTX in an off-label use and MTX is employed in the daily practice by most rheumatologists with success. A commonly used register indexing the off-label use of MTX and also of other disease-modifying antirheumatic drugs (DMARDs) and biologicals would help to improve the acceptance and the safety of MTX as an orphan drug.
Comparison of the efficacy and safety of tocilizumab, sarilumab, and olokizumab in patients with active rheumatoid arthritis: a network meta-analysis of randomized controlled trials. [2023]This study compared the relative efficacy and safety of olokizumab, tocilizumab, and sarilumab in rheumatoid arthritis (RA) patients who were intolerant or responding inadequately to methotrexate (MTX).
Two years of sarilumab in patients with rheumatoid arthritis and an inadequate response to MTX: safety, efficacy and radiographic outcomes. [2019]To examine 2-year safety, efficacy and radiographic outcomes of sarilumab in adults with RA and inadequate response to MTX (MTX-IR).
Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study. [2022]To evaluate the efficacy and safety of sarilumab in combination with methotrexate (MTX) for the treatment of rheumatoid arthritis (RA).