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)

ClinicalTrials.gov ID: NCT06455449

Public ClinicalTrials.gov record NCT06455449. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.

Study identification

NCT ID: NCT06455449
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: AstraZeneca; Industry
Enrollment: 240 participants

Conditions and interventions

Conditions

Polymyositis, Dermatomyositis

Interventions

Anifrolumab (blinded) Combination Product
Placebo Other
Anifrolumab (unblinded, open label) Combination Product

Combination Product · Other

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 19, 2024
Primary completion: May 13, 2027
Completion: Aug 3, 2028
Last update posted: May 27, 2026

2024 – 2028

United States locations

U.S. sites: 43
U.S. states: 20
U.S. cities: 41

Facility	City	State	ZIP	Site status
Research Site	Phoenix	Arizona	85032	Not yet recruiting
Research Site	Irvine	California	92617	Recruiting
Research Site	Aurora	Colorado	80045	Recruiting
Research Site	Denver	Colorado	80230	Not yet recruiting
Research Site	New Haven	Connecticut	06519	Recruiting
Research Site	Washington D.C.	District of Columbia	20037	Withdrawn
Research Site	Boca Raton	Florida	33486	Recruiting
Research Site	Boynton Beach	Florida	33472	Withdrawn
Research Site	Gainesville	Florida	32603	Withdrawn
Research Site	Margate	Florida	33063	Suspended
Research Site	Miami	Florida	33126	Withdrawn
Research Site	Miami	Florida	33133	Recruiting
Research Site	Orlando	Florida	32819	Recruiting
Research Site	Palm Beach Gardens	Florida	33410	Recruiting
Research Site	Plant City	Florida	33563	Recruiting
Research Site	Atlanta	Georgia	30322	Recruiting
Research Site	Willowbrook	Illinois	60527	Recruiting
Research Site	Fairway	Kansas	66205	Recruiting
Research Site	Baltimore	Maryland	21224	Recruiting
Research Site	Boston	Massachusetts	02115	Not yet recruiting
Research Site	Ann Arbor	Michigan	48109	Recruiting
Research Site	Sterling Heights	Michigan	48313	Not yet recruiting
Research Site	Great Neck	New York	11021	Not yet recruiting
Research Site	Charlotte	North Carolina	28207	Withdrawn
Research Site	Charlotte	North Carolina	28211	Recruiting
Research Site	Durham	North Carolina	27710	Recruiting
Research Site	Cleveland	Ohio	44195	Recruiting
Research Site	Middleburg Heights	Ohio	44130	Withdrawn
Research Site	Philadelphia	Pennsylvania	19107	Not yet recruiting
Research Site	Pittsburgh	Pennsylvania	15213	Recruiting
Research Site	Charleston	South Carolina	29425	Recruiting
Research Site	Summerville	South Carolina	29486	Recruiting
Research Site	Allen	Texas	75013	Recruiting
Research Site	Amarillo	Texas	79124	Not yet recruiting
Research Site	Austin	Texas	78759	Recruiting
Research Site	Colleyville	Texas	76034	Recruiting
Research Site	El Paso	Texas	79902	Recruiting
Research Site	Galveston	Texas	77555	Withdrawn
Research Site	Harlingen	Texas	78550	Recruiting
Research Site	Houston	Texas	77030	Withdrawn
Research Site	North Richland Hills	Texas	76180	Recruiting
Research Site	Beckley	West Virginia	25801	Not yet recruiting
Research Site	Milwaukee	Wisconsin	53226	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 190 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06455449, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 27, 2026 · Synced Sep 2, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06455449 live on ClinicalTrials.gov.

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