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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
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
DAISY Trial Summary
This trial will study if a drug (anifrolumab) can safely and effectively treat systemic sclerosis, a chronic autoimmune disease.
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.Check my eligibility
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.See study design
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.
DAISY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My daily activities are somewhat limited due to my health.
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I have been diagnosed with systemic sclerosis.
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My skin condition affects either small or large areas.
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My systemic sclerosis symptoms started within the last 6 years, not counting Raynaud's.
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My skin is healthy where injections are given.
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I am between 18 and 70 years old.
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My skin condition has been severe and active for at least 18 months.
DAISY Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants responding to treatment based on the Revised Composite Response Index in Systemic Sclerosis (CRISS-25)
Secondary outcome measures
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 moreDAISY 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
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,369 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My skin condition affects either small or large areas.My systemic sclerosis symptoms started within the last 6 years, not counting Raynaud's.I have no cancer history in the last 5 years, except for treated skin or cervical cancer.My skin is healthy where injections are given.I have had a stem cell or organ transplant.I have not had major surgery in the last 8 weeks.My skin condition is severe and either new or worsening quickly.I am between 18 and 70 years old.I am on stable doses of certain medications like hydroxychloroquine or methotrexate.I have a specific autoimmune condition like lupus or rheumatoid arthritis with certain antibodies.My test shows positive for anticentromere antibodies.I have had a severe kidney issue due to systemic sclerosis in the last year.I do not have any inflammatory diseases that could affect the trial's safety or results.I do not have severe liver, kidney, nerve, hormone, or digestive diseases unrelated to my current condition.I have had a severe case of shingles.I do not have severe heart or lung disease.I have a history of or currently have serious infections.My skin condition has been severe and active for at least 18 months.
Research Study Groups:
This trial has the following groups:- Group 1: Anifrolumab (subcutaneous weekly injection)
- Group 2: matched placebo control (subcutaneous weekly injection)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the eligibility criteria to partake in this research?
"In order to join this medical trial, volunteers must possess systemic sclerosis and should be in the 18-70 age range. 306 participants are being sought for recruitment."
Answered by AI
Are there a number of research centers conducting this trial in the urban area?
"Currently, this research is occurring at 111 sites situated both in and outside of Ann Arbor, Minneapolis, and Babylon. Participants should strive to pick the nearest location possible to reduce their travelling needs."
Answered by AI
Has the FDA validated Anifrolumab for weekly subcutaneous injections?
"Our team at Power assesses the safety of Anifrolumab (subcutaneous weekly injection) to be a 3, demonstrating that there is sufficient evidence for efficacy and multiple rounds proving its safety."
Answered by AI
Is the enrollment criteria of this trial inclusive of individuals over 40 years old?
"As outlined in the trial's eligibility requirements, individuals between 18 and 70 years old are able to partake."
Answered by AI
Are there any vacancies available for prospective participants of this clinical trial?
"According to the records on clinicaltrials.gov, this research endeavour is not presently enrolling participants. This medical study was made public on July 13th 2023 and its information was most recently updated June 22nd 2023. Although it isn't actively recruiting at present, 508 other trials are in search of volunteers right now."
Answered by AI
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