RECRUITING

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.

Official Title

A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared With Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive With Systemic Sclerosis

Quick Facts

Study Start:2023-11-08
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05925803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult patients from 18 to 70 years of age inclusive
  2. 2. Systemic sclerosis according to 2013 ACR/EULAR classification criteria
  3. 3. Limited or diffuse cutaneous subsets
  4. 4. Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF
  5. 5. Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
  6. 6. mRSS \> 10 with early disease or rapid progression as defined by the protocol
  7. 7. mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol
  8. 8. Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
  9. 9. Women of childbearing potential with a negative urine pregnancy test
  10. 10. Uninvolved skin at injection sites
  1. 1. Anticentromere antibody seropositivity on central laboratory
  2. 2. Severe cardiopulmonary disease as defined by the protocol
  3. 3. History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) \< 45 mL/min/1.73m2)
  4. 4. Overlap syndromes, systemic lupus erythematosus with anti-double-stranded deoxyribonucleic acid antibody seropositivity or anti-citrullinated protein antibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis)
  5. 5. History of, or current, any other inflammatory diseases, eg, inflammatory bowel disease, skin disease, that, in the opinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy
  6. 6. Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease \[Child Pugh A, B, C hepatic impairment\]), or gastrointestinal disease (eg, clinical signs of malabsorption or needing parenteral nutrition) not related to SSc, as determined by the investigator
  7. 7. Hematopoietic stem cell transplantation or solid organ/limb transplantation
  8. 8. Any severe case of Herpes Zoster infection as defined by the protocol
  9. 9. Known malignancy or a history of malignancy within 5 years, with exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
  10. 10. Major surgery within 8 weeks prior to and/or during study enrollment
  11. 11. Known active current or history of recurrent infections
  12. 12. 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

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35205
United States
Research Site
Scottsdale, Arizona, 85259
United States
Research Site
Inglewood, California, 90301
United States
Research Site
Los Angeles, California, 90095
United States
Research Site
Orange, California, 92868
United States
Research Site
Orange, California, 92868
United States
Research Site
San Diego, California, 92108
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
New Haven, Connecticut, 06519
United States
Research Site
Washington, District of Columbia, 20007
United States
Research Site
Boca Raton, Florida, 33486
United States
Research Site
Fort Lauderdale, Florida, 33309
United States
Research Site
Gainesville, Florida, 32603
United States
Research Site
Jacksonville, Florida, 32216
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Miami, Florida, 33126
United States
Research Site
Tamarac, Florida, 33321
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Chicago, Illinois, 60611
United States
Research Site
Kansas City, Kansas, 66160
United States
Research Site
New Orleans, Louisiana, 70121
United States
Research Site
Shreveport, Louisiana, 71103
United States
Research Site
Baltimore, Maryland, 21224
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Minneapolis, Minnesota, 55455
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Babylon, New York, 11702
United States
Research Site
Brooklyn, New York, 11201
United States
Research Site
New York, New York, 10032
United States
Research Site
Charlotte, North Carolina, 28207
United States
Research Site
Cincinnati, Ohio, 45267
United States
Research Site
Pittsburgh, Pennsylvania, 15213
United States
Research Site
Allen, Texas, 75013
United States
Research Site
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-08
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-11-08
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Systemic Sclerosis (SSc)
  • Scleroderma
  • Anifrolumab
  • Limited
  • Diffuse
  • Cutaneous
  • Interstitial lung disease (ILD)
  • Autoimmune diseases
  • Immune system diseases
  • Immunosuppressants
  • Systemic Sclerosis interstitial lung disease (SSc- ILD)

Additional Relevant MeSH Terms

  • Systemic Sclerosis
  • Scleroderma