A 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) - JASMINE

Study identifier:D3463C00003

ClinicalTrials.gov identifier:NCT06455449

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

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)

Medical condition

Polymyositis, Dermatomyositis

Phase

Phase 3

Healthy volunteers

No

Study drug

Anifrolumab (blinded), Anifrolumab (unblinded, open label)

Sex

All

Estimated Enrollment

240

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 20 Jun 2024
Estimated Primary Completion Date: 14 May 2027
Estimated Study Completion Date: 04 Aug 2028

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria