Recruiting
Phase 3

Anifrolumab

Sponsor:

AstraZeneca

Code:

NCT06455449

Conditions

Polymyositis, Dermatomyositis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Anifrolumab (blinded)

Placebo

Anifrolumab (unblinded, open label)

Study Details

Brief summary:

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.

Conditions

Polymyositis, Dermatomyositis

Study ID

NCT06455449

Start date

Jun 20, 2024

Status verified date

May, 2026

Completion date

Aug 4, 2028

Anticipated

Primary completion date

May 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Capable of giving informed consent.

Inclusion Criteria:

1. 18 - 75 years old
2. Body weight ≥40 kg
3. Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
4. Moderate or severe disease activity per core set measurements.
5. Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
6. No history of active tuberculosis or severe COVID-19.
7. Male and female participants must follow contraception guidelines.

Exclusion Criteria:

1. Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies).
2. PM and DM patients at a high risk of malignancy.
3. Participants with rapidly progressive interstitial lung disease.
4. Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion.
5. Any history of severe case of herpes zoster infection
6. History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .
7. Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
8. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
9. Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
10. Recent or concurrent enrollment in another clinical study with an investigational product.
11. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Anifrolumab (subcutaneous weekly injection)

Anifrolumab subcutaneous injection once weekly

placebo comparator: Placebo (subcutaneous weekly injection)

Matched placebo control subcutaneous injection once weekly

Interventions

Anifrolumab (blinded)

Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks

Placebo

Matched placebo delivered subcutaneously, once weekly for 52 weeks

Anifrolumab (unblinded, open label)

At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks

Primary outcome measure

  • Total Improvement Score (TIS) ≥ 40 response [ Time Frame: 52 week ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Irvine, California, United States, 92617

Research Site

Recruiting

Aurora, Colorado, United States, 80045

Research Site

Recruiting

New Haven, Connecticut, United States, 06519

Research Site

Recruiting

Boca Raton, Florida, United States, 33486

Research Site

Recruiting

Miami, Florida, United States, 33133

Research Site

Recruiting

Orlando, Florida, United States, 32819

Research Site

Recruiting

Palm Beach Gardens, Florida, United States, 33410

Research Site

Recruiting

Plant City, Florida, United States, 33563

Research Site

Recruiting

Atlanta, Georgia, United States, 30322

Research Site

Recruiting

Willowbrook, Illinois, United States, 60527

Research Site

Recruiting

Fairway, Kansas, United States, 66205

Research Site

Recruiting

Baltimore, Maryland, United States, 21224

Research Site

Recruiting

Ann Arbor, Michigan, United States, 48109

Research Site

Recruiting

Charlotte, North Carolina, United States, 28211

Research Site

Recruiting

Durham, North Carolina, United States, 27710

Research Site

Recruiting

Cleveland, Ohio, United States, 44195

Research Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Research Site

Recruiting

Charleston, South Carolina, United States, 29425

Research Site

Recruiting

Summerville, South Carolina, United States, 29486

Research Site

Recruiting

Allen, Texas, United States, 75013

Research Site

Recruiting

Austin, Texas, United States, 78759

Research Site

Recruiting

Colleyville, Texas, United States, 76034

Research Site

Recruiting

El Paso, Texas, United States, 79902

Research Site

Recruiting

Harlingen, Texas, United States, 78550

Research Site

Recruiting

North Richland Hills, Texas, United States, 76180

Research Site

Recruiting

Milwaukee, Wisconsin, United States, 53226

Research Site

Recruiting

Calgary, Alberta, Canada, T2N 4L7

Research Site

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

AstraZeneca

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • Polymyositis
  • Dermatomyositis
  • anifrolumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-05-28.