Show 17 earlier versions
2026-04-17
minor
Study Status v17
Re-verified, no change to tracked fields
2026-03-12
minor
Study Status v16
Primary completion date2026-10-09→2027-01-06
Completion date2027-12-31→2028-04-05
2026-02-02
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v15
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 306→confirmed 314
Study sites197→151
2025-11-20
minor
Study Status, Contacts/Locations v14
2025-10-21
minor
2 amendments v12-v13
2 re-verifications since 2025-09-11, no change to tracked fields
2025-08-14
minor
Study Status, Contacts/Locations v11
2025-07-14
minor
Study Status, Contacts/Locations v10
Study sitesdetails revised at 4 of 195 sites
2025-06-10
minor
Study Status, Contacts/Locations v9
2025-04-08
minor
Study Status, Contacts/Locations v8
2025-03-04
minor
Study Status, Contacts/Locations v7
2024-12-20
minor
Study Status, Contacts/Locations v6
Study sitesdetails revised at 131 of 191 sites
2024-10-21
minor
Study Status v5
Re-verified, no change to tracked fields
2024-09-19
minor
Study Status, Contacts/Locations v4
2024-08-07
minor
Study Status, Contacts/Locations v3
2024-05-24
minor
Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v2
Study sites169→184
InterventionsAnifrolumab (blinded) (Biological), Anifrolumab (unblinded, open label) (Biological), Placebo (blinded) (Drug)→Anifrolumab (blinded) (Combination Product), Anifrolumab (unblinded, open label) (Combination Product), Placebo (blinded) (Drug)
Eligibility criteria+8 characters
[...] in 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF
Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
[...] roquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolicmycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolim [...] nths (estimated glomerular filtration rate(eGFR) < 45 mL/min/1.73m2)
Overlap syndromes, systemic lupus erythematosus with anti- [...] ent
Known active current or history of recurrent infections
Severe cardiopulmonary disease
Any condition that, in the opinion of the investigator or As [...]
Study description+66 characters
[...] ofetil (MMF), mycophenolic acid or mycophenolate sodium (MPA/MPS), methotrexate, azathioprine, tacrolimus, and oral glucocorticoids.
MMF or MPA/MPS, azathioprine, and methotrexate may be used in combination [...] cipants will be randomized in a 1:1 ratio to receive either 120 mg anifrolumab (or matching placebo) given subcutaneously once [...] al lung disease (ILD) (yes, no) at Week 0 (Day1);
MMF or MPA/MPS use (yes ,no) at Week 0 (Day 1); and
Disease duration, defi [...] riod: At Week 52, all participants will be given anifrolumab 120 mg (subcutaneous) once weekly for 52 weeks (last dose at Week [...] ticipation will [...]
2024-01-08
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-12-31→2026-10-09
Start dateestimated 2023-07-13→confirmed 2023-11-08
Study sites131→169