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A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504022-19-01
Acronym
D3463C00003, JASMINE
Enrollment
84
Registered
2024-08-13
Start date
2024-12-13
Completion date
Unknown
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polymyositis or dermatomyositis according to 2017 EULAR / ACR classification criteria

Brief summary

Participants who have at least moderate improvement in disease activity (TIS ≥ 40) and has not met “confirmed deterioration” criteria at 2 consecutive visits

Detailed description

MMT-8 (CSM) change from baseline at week 52, Participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at week 52 (yes/no), PM Participants who have at least moderate improvement in disease activity (TIS ≥ 40) at week 52 and has not met “confirmed deterioration” criteria at 2 consecutive visits up to and including week 52, DM Participants who have at least moderate improvement in disease activity (TIS ≥ 40) at week 52 and has not met “confirmed deterioration” criteria at 2 consecutive visits up to and including week 52, CDASI-activity change from baseline (DM participants only) at week 8, "MMT-8 (CSM) change from baseline at Week 52. Only PM participants will be included in the analysis.", "MMT-8 (CSM) change from baseline at Week 52 Only DM participants will be included in the analysis.", "Participants who achieve OCS dose ≤ 7.5 mg/day at Week 52 (yes/no). Only PM participants with baseline OCS dose > 7.5 mg/day at baseline will be included in the analysis.", "Participants who achieve OCS dose ≤ 7.5 mg/day at Week 52 (yes/no). Only DM participants with baseline OCS dose > 7.5 mg/day at baseline will be included in the analysis."

Interventions

DRUGAnifrolumab

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Participants who have at least moderate improvement in disease activity (TIS ≥ 40) and has not met “confirmed deterioration” criteria at 2 consecutive visits

Secondary

MeasureTime frame
MMT-8 (CSM) change from baseline at week 52, Participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at week 52 (yes/no), PM Participants who have at least moderate improvement in disease activity (TIS ≥ 40) at week 52 and has not met “confirmed deterioration” criteria at 2 consecutive visits up to and including week 52, DM Participants who have at least moderate improvement in disease activity (TIS ≥ 40) at week 52 and has not met “confirmed deterioration” criteria at 2 consecutive visits up to and including week 52, CDASI-activity change from baseline (DM participants only) at week 8, "MMT-8 (CSM) change from baseline at Week 52. Only PM participants will be included in the analysis.", "MMT-8 (CSM) change from baseline at Week 52 Only DM participants will be included in the analysis.", "Participants who achieve OCS dose ≤ 7.5 mg/day at Week 52 (yes/no). Only PM participants with baseline OCS dose > 7.5 mg/day at baseline will be included in the analysis.", "Participants who ac

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026