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Clinical Trials in India / NCT06455449
Recruiting Phase 3

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)

NCT06455449 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-06-20
Last updated
2026-05-28

Condition(s) studied

Polymyositis, Dermatomyositis

Investigational drug(s) / intervention(s)

Anifrolumab (blinded)PlaceboAnifrolumab (unblinded, open label)

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (236)

FacilityCityRegionStatus
Research Site Phoenix Arizona Not Yet Recruiting
Research Site Irvine California Recruiting
Research Site Aurora Colorado Recruiting
Research Site Denver Colorado Not Yet Recruiting
Research Site New Haven Connecticut Recruiting
Research Site Washington D.C. District of Columbia Withdrawn
Research Site Boca Raton Florida Recruiting
Research Site Boynton Beach Florida Withdrawn
Research Site Gainesville Florida Withdrawn
Research Site Margate Florida Suspended
Research Site Miami Florida Withdrawn
Research Site Miami Florida Recruiting
Research Site Orlando Florida Recruiting
Research Site Palm Beach Gardens Florida Recruiting
Research Site Plant City Florida Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Willowbrook Illinois Recruiting
Research Site Fairway Kansas Recruiting
Research Site Baltimore Maryland Recruiting
Research Site Boston Massachusetts Not Yet Recruiting
Research Site Ann Arbor Michigan Recruiting
Research Site Sterling Heights Michigan Not Yet Recruiting
Research Site Great Neck New York Not Yet Recruiting
Research Site Charlotte North Carolina Withdrawn
Research Site Charlotte North Carolina Recruiting
Research Site Durham North Carolina Recruiting
Research Site Cleveland Ohio Recruiting
Research Site Middleburg Heights Ohio Withdrawn
Research Site Philadelphia Pennsylvania Not Yet Recruiting
Research Site Pittsburgh Pennsylvania Recruiting
Research Site Charleston South Carolina Recruiting
Research Site Summerville South Carolina Recruiting
Research Site Allen Texas Recruiting
Research Site Amarillo Texas Not Yet Recruiting
Research Site Austin Texas Recruiting
Research Site Colleyville Texas Recruiting
Research Site El Paso Texas Recruiting
Research Site Galveston Texas Withdrawn
Research Site Harlingen Texas Recruiting
Research Site Houston Texas Withdrawn

+ 196 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06455449 on ClinicalTrials.gov ↗ ← All trials in India