Table of Contents
- Clinical trials overview
- Conditions and target populations
- Trial phases and study designs
- Main endpoints and outcome measures
- Selected trial-by-trial summary
- What these trials mean for patients
Clinical trials overview
The trial data show that Anifrolumab is being studied in several autoimmune diseases, with the strongest focus on lupus-related conditions.[1] These studies are designed to test whether the treatment can improve disease signs, help specific organs such as the skin or kidneys, and remain safe in different patient groups.[1][2]
Most of the studies are interventional trials, which means participants receive a study treatment or a placebo so researchers can compare results fairly.[1] The trials include adults, and one study also includes children and adolescents with moderate to severe active systemic lupus erythematosus (SLE).[3]
Conditions and target populations
Several trials focus on cutaneous lupus erythematosus, which is lupus that mainly affects the skin.[1][10] One large Phase 3 study is in adults with chronic and/or subacute cutaneous lupus erythematosus, and another small pilot study looks at skin inflammation in cutaneous lupus erythematosus using advanced lab methods on skin and blood samples.[1][10]
Other studies include adults with systemic lupus erythematosus (SLE), active proliferative lupus nephritis, idiopathic inflammatory myopathies such as polymyositis and dermatomyositis, progressive vitiligo, primary Sjögren’s syndrome, primary antiphospholipid syndrome, and systemic sclerosis.[2][3][4][5][6][7][8][9]
The eligibility rules are different for each trial, but the source data show clear target groups such as adults only, adults with specific disease classifications, and children and adolescents aged 5 to under 18 years.[2][3] In the myositis study, participants must have polymyositis or dermatomyositis according to 2017 EULAR/ACR classification criteria, which are formal rules used to define the disease.[2]
Trial phases and study designs
The studies include Phase 2, Phase 3, and Phase 4 research.[1][3][5][6][7][8][9] Phase 3 studies are the most common in this set and usually compare Anifrolumab with placebo in larger groups to show whether it works better than placebo.[1][2][3][4][9]
Some trials add Anifrolumab to standard of care, which means the usual treatment already given for the disease.[2][4] Other studies are placebo-controlled, meaning the control group receives a look-alike treatment without active drug.[1][6][8]
The pediatric SLE study is designed to learn the right dose and also confirm safety and effect in younger participants.[3] The Phase 2 vitiligo study combines Anifrolumab with phototherapy, while the Sjögren’s syndrome study and the APS study are smaller proof-of-concept or safety-focused trials.[6][7][8]
Main endpoints and outcome measures
The main outcomes are different in each study because each disease affects the body in a different way.[1][2][3][4][5][6][7][8][9][10]
In cutaneous lupus erythematosus, the main endpoint is CLASI-70 response at Week 24, which means a meaningful skin improvement by a standard skin score.[1] In systemic lupus erythematosus, one study uses BICLA, a composite response score that combines several signs of improvement into one result.[3][5]
In lupus nephritis, the key endpoint is complete renal response at Week 52, based on urine protein and kidney function measures.[4] In the myositis study, the main outcome is moderate improvement in disease activity, measured by TIS and confirmed at two visits.[2]
Other studies measure the change in the Vitiligo Area Scoring Index (VASI), the CRESS response in Sjögren’s syndrome, adverse events in APS, and the Revised-CRISS-25 response in systemic sclerosis.[6][7][8][9] The cutaneous lupus pilot study also looks at changes in inflammatory cell composition and gene expression in skin and blood samples, which are laboratory measures that show how immune activity may change.[10]
Selected trial-by-trial summary
NCT06015737 is a Phase 3 study in 604 adults with chronic and/or subacute cutaneous lupus erythematosus, and it aims to show better skin outcomes than placebo at Week 24.[1] The study uses a subcutaneous injection and measures CLASI-70 response as the main result.[1]
2023-504022-19-01 is a Phase 3 study in 204 adults with polymyositis or dermatomyositis, added to standard care, and it looks for at least moderate improvement in disease activity at Week 52.[2]
NCT05835310 is a Phase 3 pediatric study in 100 children and adolescents aged 5 to under 18 years with moderate to severe active SLE, and it aims to define dose and confirm safety and efficacy versus placebo.[3]
NCT05138133 is a Phase 3 study in 336 adults with active proliferative lupus nephritis, and its main goal is complete renal response at Week 52.[4]
NCT04877691 is a Phase 4 study in 376 adults with moderate-to-severe SLE, and it compares subcutaneous Anifrolumab with placebo for overall disease activity.[5]
NCT05917561 is a Phase 2 study in 48 adults with progressive non-segmental vitiligo affecting more than 5% of body surface area, and it studies Anifrolumab plus phototherapy versus phototherapy alone.[6]
NCT05383677 is a completed Phase 2 proof-of-concept study in 30 people with primary Sjögren’s syndrome, and it used the CRESS response at Week 24 as the main endpoint.[7]
2025-520918-64-00 is a Phase 2 open-label pilot trial in 20 adults with primary APS, and it focuses on safety and adverse events through Week 52.[8]
NCT05925803 is a Phase 3 study in 306 people with systemic sclerosis, including limited or diffuse cutaneous subsets and interstitial lung disease, and it uses the Revised-CRISS-25 response as the main result.[9]
2025-523133-26-00 is a small open-label pilot Phase 3 study in 10 people with cutaneous lupus erythematosus, and it studies inflammatory changes in skin and blood together with clinical outcome.[10]
What these trials mean for patients
These studies show that researchers are testing Anifrolumab across several autoimmune diseases, not just one condition.[1][2][3][4][5][6][7][8][9][10]
The research is especially focused on measuring real patient benefits, such as less skin disease, better kidney function, improved disease activity, and fewer signs of inflammation in tissue samples.[1][4][5][10]
Because each trial has its own target group, phase, and outcome measures, the studies are not interchangeable and should be understood as separate research projects.[1][2][3][4][5][6][7][8][9][10]
