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Determine effectiveness of Anifrolumab In Systemic sclerosis
EU CTIS ID: 2023-505976-31-00
What this study is testing
To demonstrate the superiority of anifrolumab to placebo with or without standard therapy on measures of signs, symptoms, and impacts associated with SSc.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients from 18 to 70 years of age inclusive
- Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolatemofetil, mycophenolic sodium, mycophenolic acid, oralglucocorticoids or tacrolimus
- Uninvolved skin at injection sites
- Women of childbearing potential with a negative urine pregnancy test
- Body weight ≤ 145.0 kg (≤ 319.7 lb)
- Confirmed classification of SSc according to 2013 (American College of Rheumatology/European League Against Rheumatism(ACR/EULAR)) classification criteria
You likely can't join if
- Anticentromere antibody seropositivity on central laboratory
- Hematopoietic stem cell transplantation or solid organ/limb transplantation
- Any severe case of Herpes Zoster (HZ) infection as defined by the protocol
- 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
- Major surgery within 8 weeks prior to and/or during study enrollment
- Known active current or history of recurrent infections
See the full eligibility criteria
- Adult patients from 18 to 70 years of age inclusive
- Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolatemofetil, mycophenolic sodium, mycophenolic acid, oralglucocorticoids or tacrolimus
- Uninvolved skin at injection sites
- Women of childbearing potential with a negative urine pregnancy test
- Body weight ≤ 145.0 kg (≤ 319.7 lb)
- Confirmed classification of SSc according to 2013 (American College of Rheumatology/European League Against Rheumatism(ACR/EULAR)) classification criteria
- Limited or diffuse cutaneous subsets
- SSc disease duration ≤ 6 years from first non-Raynaud’s phenomenon manifestation at the time of signing the ICF
- Either Health Assessment Questionnaire Disability Index (HAQ-DI) score ≥ 0.25 points or Patient Global Assessment (PtGA) score≥ 3 points
- Modified Rodnan Skin Score (mRSS) > 10 with DiseaseDuration <18 months and/or Diagnosis of ILD by Chest CT
- If a participant does not meet Inclusion Criterion #7, mRSS ≥15 with disease duration ≥ 18 months and active disease at screening with at least one of the following: -Elevated CRP unrelated to other conditions or ESR -New skin involvement/progression by mRSS score change -presence of at least one tendon friction rub within 3 months of screening
- Anticentromere antibody seropositivity on central laboratory
- Hematopoietic stem cell transplantation or solid organ/limb transplantation
- Any severe case of Herpes Zoster (HZ) infection as defined by the protocol
- 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
- Major surgery within 8 weeks prior to and/or during study enrollment
- Known active current or history of recurrent infections
- Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with efficacy or safety evaluation of the study intervention or put participant at safety risk
- Severe cardiopulmonary disease as defined by the protocol
- History of systemic sclerosis renal crisis within past 12 months [Estimated glomerular filtration rate (eGFR) < 45mL/min.]
- Overlap syndromes, Systemic lupus erythematosus(SLE) with anti-dsDNA antibody seropositivity or Anti-citrullinated protein antibodies-positive (ACPA-positive) rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis)
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Turkey
- United Kingdom
- United States
- China
- Japan
- India
- Korea, Republic of
- Israel
- South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Turkey; United Kingdom; United States; China; Japan and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.