What side effects are associated with this type of intervention?

Common treatments for systemic sclerosis, particularly those involving monoclonal antibodies like anifrolumab, include drugs such as rituximab and tocilizumab. Known side effects of these treatments can include infusion reactions, increased risk of infections, and potential liver enzyme abnormalities. Rituximab may also cause serum sickness and pulmonary toxicity, while tocilizumab can lead to gastrointestinal perforations and elevated cholesterol levels. Patients should discuss these potential side effects with their healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Systemic Sclerosis, though not all are monoclonal antibodies. One notable biologic agent is rituximab, a monoclonal antibody targeting CD20 on B cells, which has been used off-label for Systemic Sclerosis. Another treatment is tocilizumab, an IL-6 receptor inhibitor, which has shown efficacy in reducing skin thickening and improving lung function in Systemic Sclerosis patients. While these treatments differ in their specific targets, they share a common goal of modulating the immune system, similar to anifrolumab, which targets the type I interferon receptor to reduce inflammation and autoimmunity.

What other types of research exist?

Promising novel alternatives to Anifrolumab for Systemic Sclerosis patients include Nintedanib, a tyrosine kinase inhibitor that targets pathways involved in fibrosis, and Tocilizumab, an IL-6 receptor antagonist. Both have shown efficacy in reducing disease progression and improving outcomes in SSc patients.

← Back to Search

Monoclonal Antibodies

Anifrolumab for Systemic Sclerosis (DAISY Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points

Systemic sclerosis according to 2013 ACR/EULAR classification criteria

Must not have

Hematopoietic stem cell transplantation or solid organ/limb transplantation

Major surgery within 8 weeks prior to and/or during study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Anifrolumab could include reactions at injection sites, increased risk of infections due to immune system suppression, and possible infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My daily activities are somewhat limited due to my health.

Select...

I have been diagnosed with systemic sclerosis.

Select...

My skin condition affects either small or large areas.

Select...

My systemic sclerosis symptoms started within the last 6 years, not counting Raynaud's.

Select...

My skin is healthy where injections are given.

Select...

I am between 18 and 70 years old.

Select...

My skin condition has been severe and active for at least 18 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a stem cell or organ transplant.

Select...

I have not had major surgery in the last 8 weeks.

Select...

I have a specific autoimmune condition like lupus or rheumatoid arthritis with certain antibodies.

Select...

My test shows positive for anticentromere antibodies.

Select...

I have had a severe kidney issue due to systemic sclerosis in the last year.

Select...

I do not have severe liver, kidney, nerve, hormone, or digestive diseases unrelated to my current condition.

Select...

I have had a severe case of shingles.

Select...

I do not have severe heart or lung disease.

Select...

I have a history of or currently have serious infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants responding to treatment based on the Revised Composite Response Index in Systemic Sclerosis (CRISS-25)

Secondary study objectives

Anifrolumab pharmacodynamics via changes in type I IFN 21-gene signature generated from blood

Anifrolumab pharmacokinetic parameters in serum

Change from baseline in FVC

+13 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Monoclonal antibodies like anifrolumab target the type I interferon receptor, which plays a crucial role in the inflammatory and fibrotic processes of Systemic Sclerosis (SSc). By inhibiting this receptor, these treatments aim to reduce the overactive immune response and subsequent tissue fibrosis that characterize SSc. This mechanism is significant for SSc patients as it addresses the underlying pathophysiology of the disease, potentially improving symptoms and slowing disease progression.