RECRUITING

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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-06-20
Study Completion:2028-08-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06455449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 - 75 years old
  2. 2. Body weight 40 kg - ≤ 100 kg
  3. 3. Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
  4. 4. Moderate or severe disease activity per core set measurements.
  5. 5. Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
  6. 6. No history of active tuberculosis or severe COVID-19.
  7. 7. Male and female participants must follow contraception guidelines.
  1. 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. 2. PM and DM patients at a high risk of malignancy.
  3. 3. Participants with rapidly progressive interstitial lung disease.
  4. 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. 5. Any history of severe case of herpes zoster infection
  6. 6. History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .
  7. 7. Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
  8. 8. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
  9. 9. Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
  10. 10. Recent or concurrent enrollment in another clinical study with an investigational product.
  11. 11. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Orange, California, 92868
United States
Research Site
New Haven, Connecticut, 06519
United States
Research Site
Washington, District of Columbia, 20037
United States
Research Site
Boca Raton, Florida, 33486
United States
Research Site
Boynton Beach, Florida, 33472
United States
Research Site
Gainesville, Florida, 32608
United States
Research Site
Miami, Florida, 33126
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Fairway, Kansas, 66205
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Middleburg Heights, Ohio, 44130
United States
Research Site
Allen, Texas, 75013
United States
Research Site
North Richland Hills, Texas, 76180
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-20
Study Completion Date2028-08-04

Study Record Updates

Study Start Date2024-06-20
Study Completion Date2028-08-04

Terms related to this study

Keywords Provided by Researchers

  • Polymyositis
  • Dermatomyositis
  • anifrolumab

Additional Relevant MeSH Terms

  • Polymyositis, Dermatomyositis