Recruiting NCT06455449

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)

Phase III Interventional Polymyositis, Dermatomyositis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Anifrolumab (blinded), Placebo, Anifrolumab (unblinded, open label).
Who it may be relevant to: Registry conditions: Polymyositis, Dermatomyositis. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +24
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

Combination product Anifrolumab (blinded)
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Other Placebo
Matched placebo delivered subcutaneously, once weekly for 52 weeks
Combination product 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 measures

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

Secondary outcome measures (12)

Manual Muscle Testing 8 (MMT-8) (CSM) [Time frame: 52 week]
Oral corticosteroid dose ≤ 7.5 mg/day [Time frame: 52 week]
Moderate improvement in disease activity in participants with polymyositis (PM) [Time frame: 52 week]
Moderate improvement in disease activity in dermatomyositis (DM) participants. [Time frame: 52 week]
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) [Time frame: 8 week]
Manual Muscle Testing 8 (MMT-8) in PM participants [Time frame: 52 Week]
Manual Muscle Testing 8 (MMT-8) in DM participants [Time frame: 52 Week]
Core Set Measures (CSMs) [Time frame: 52 week]
Oral corticosteroid dose ≤ 7.5 mg/day in PM participants [Time frame: 52 week]
Oral corticosteroid dose ≤ 7.5 mg/day in DM participants [Time frame: 52 week]
Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA) [Time frame: 8, 24, & 52 week]
5-D itch [Time frame: 8, 24, & 52 week]

Eligibility criteria

Capable of giving informed consent.

Inclusion criteria

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

Exclusion criteria

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).
PM and DM patients at a high risk of malignancy.
Participants with rapidly progressive interstitial lung disease.
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.
Any history of severe case of herpes zoster infection
History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .
Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
Recent or concurrent enrollment in another clinical study with an investigational product.
Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment