Immune system diseases, Interstitial lung disease (ILD), Systemic Sclerosis (SSc) presenting with Limited or Diffuse Cutaneous Subsets, Autoimmune diseases
Conditions
Brief summary
Proportion achieving Revised Composite Response Index in Systemic Sclerosis-25 (Revised-CRISS-25) response where Revised-CRISS-25 is a composite endpoint in which a responder is defined as a participant who meets all the following criteria:, Improvement in at least 2 components [≥ 5% increase for Percent predicted forced vital capacity (ppFVC) and/or≥ 25% decrease for mRSS, HAQ-DI, PtGA, Clinician Global Assessment (CGA), Worsening in no more than one component (≥ 5% decrease for ppFVC and/or ≥ 25% increase for mRSS, HAQ-DI, PtGA, CGA), No significant SSc-related event as defined in Step 1 (Khanna et al 2021), Otherwise, a participant is a non-responder
Detailed description
Treatment related difference in mean change from baseline in pulmonary function, Treatment related difference in mean change from baseline in mRSS, Treatment related difference in proportion achieving Revised-CRISS-25 components, Treatment related difference in proportion achieving interstitial lung disease progression, Treatment related difference in patient reported outcomes based on the Scleroderma Skin patient reported outcome, Evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of subcutaneous Anifrolumab, Treatment related difference in safety and tolerability with or without standard therapy in participants with SSc, Long term treatment related difference in safety and tolerability with or without standard therapy in participants with SSc
Interventions
Sponsors
Astrazeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion achieving Revised Composite Response Index in Systemic Sclerosis-25 (Revised-CRISS-25) response where Revised-CRISS-25 is a composite endpoint in which a responder is defined as a participant who meets all the following criteria:, Improvement in at least 2 components [≥ 5% increase for Percent predicted forced vital capacity (ppFVC) and/or≥ 25% decrease for mRSS, HAQ-DI, PtGA, Clinician Global Assessment (CGA), Worsening in no more than one component (≥ 5% decrease for ppFVC and/or ≥ 25% increase for mRSS, HAQ-DI, PtGA, CGA), No significant SSc-related event as defined in Step 1 (Khanna et al 2021), Otherwise, a participant is a non-responder | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment related difference in mean change from baseline in pulmonary function, Treatment related difference in mean change from baseline in mRSS, Treatment related difference in proportion achieving Revised-CRISS-25 components, Treatment related difference in proportion achieving interstitial lung disease progression, Treatment related difference in patient reported outcomes based on the Scleroderma Skin patient reported outcome, Evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of subcutaneous Anifrolumab, Treatment related difference in safety and tolerability with or without standard therapy in participants with SSc, Long term treatment related difference in safety and tolerability with or without standard therapy in participants with SSc | — |
Countries
Austria, Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain
Outcome results
None listed