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Evaluating Anifrolumab for Systemic Sclerosis

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

PHASE3 · AstraZeneca · NCT05925803

This study is testing if a new drug called anifrolumab can help adults with systemic sclerosis feel better compared to a placebo over a year.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment306 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionsmethotrexate, anifrolumab
Locations189 sites (Birmingham, Alabama and 188 other locations)
Trial IDNCT05925803 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial aims to assess the efficacy and safety of anifrolumab, administered subcutaneously, compared to a placebo in adults diagnosed with systemic sclerosis. Participants will be randomized in a 1:1 ratio to receive either the treatment or placebo for 52 weeks, with the option to continue stable background therapies. The study will include approximately 306 participants and will stratify based on factors such as the presence of interstitial lung disease and disease duration. The trial will be conducted across multiple centers in the United States.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with systemic sclerosis classified as limited or diffuse, and a disease duration of less than 6 years.

Not a fit: Patients with severe cardiopulmonary disease or those who are anticentromere antibody positive may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with systemic sclerosis.

How similar studies have performed: Other studies have shown promise with similar biologic treatments for systemic sclerosis, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Adult patients from 18 to 70 years of age inclusive
2. Systemic sclerosis according to 2013 ACR/EULAR classification criteria
3. Limited or diffuse cutaneous subsets
4. Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF
5. Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
6. mRSS \> 10 with early disease or rapid progression as defined by the protocol
7. mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol
8. Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
9. Women of childbearing potential with a negative urine pregnancy test
10. Uninvolved skin at injection sites

Key Exclusion Criteria:

1. Anticentromere antibody seropositivity on central laboratory
2. Severe cardiopulmonary disease as defined by the protocol
3. History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) \< 45 mL/min/1.73m2)
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. 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. 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. Hematopoietic stem cell transplantation or solid organ/limb transplantation
8. Any severe case of Herpes Zoster infection as defined by the protocol
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. Major surgery within 8 weeks prior to and/or during study enrollment
11. Known active current or history of recurrent infections
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

Where this trial is running

Birmingham, Alabama and 188 other locations

+139 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Systemic Sclerosis, Scleroderma, Anifrolumab, Limited, Diffuse, Cutaneous, Interstitial lung disease, Autoimmune diseases

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.