Determine effectiveness of Anifrolumab In Systemic sclerosis

Phase 1

Recruiting

• Conditions: Cutaneous, Immune system diseases, Systemic Sclerosis (SSc), SSc-interstitial lung disease, Immunosuppressants, Interstitial lung disease (ILD), Autoimmune diseases, Scleroderma, Diffuse, Systemic Sclerosis interstitial lung disease (SSc ILD), Limited; MedDRA version: 21.0Level: LLTClassification code: 10042953Term: Systemic sclerosis Class: 10028395; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-505976-31-00
• Lead Sponsor: Astrazeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

Adult patients from 18 to 70 years of age inclusive, Uninvolved skin at injection sites, SSc according to 2013 (American College of Rheumatology/European League Against Rheumatism(ACR/EULAR) classification criteria, Limited or diffuse cutaneous subsets, SSc disease duration within 6 years from first non-Raynaud’s phenomenon manifestation, 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 early disease or rapid progression as defined by the protocol, mRSS = 15 with disease duration = 18 months and active disease as defined by the protocol, Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolic sodium, mycophenolic acid, oral glucocorticoids or tacrolimus, Women of childbearing potential with a negative urine pregnancy test

Exclusion Criteria

Anticentromere antibody seropositivity on central laboratory, Major surgery within 8 weeks prior to and/or during study enrollment, Known active current or history of recurrent infections, Severe cardiopulmonary disease, 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 12months [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 theopinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy, Evidence of moderately severe concurrent nervoussystem, renal, endocrine, hepatic (eg, underlying chronicliver disease [Child Pugh A, B, C hepatic impairment]), orgastrointestinal disease (eg, clinical signs of malabsorptionor needing parenteral nutrition) not related to SSc, as determined by the investigator., 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 5years, with exception of excised/cured local basal orsquamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified