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)

AstraZeneca243 sites in 7 countries240 target enrollmentJune 20, 2024

ConditionsPolymyositis, Dermatomyositis

InterventionsAnifrolumab (blinded)Anifrolumab (unblinded, open label)Placebo

Overview

Phase: Phase 3
Intervention: Anifrolumab (blinded)
Conditions: Polymyositis, Dermatomyositis
Sponsor: AstraZeneca
Enrollment: 240
Locations: 243
Primary Endpoint: Total Improvement Score (TIS) ≥ 40 response
Status: Recruiting
Last Updated: 11 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 20, 2024

End Date

August 4, 2028

Last Updated

11 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion 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-
•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.

Arms & Interventions

Anifrolumab (subcutaneous weekly injection)

Anifrolumab subcutaneous injection once weekly

Intervention: Anifrolumab (blinded)

Anifrolumab (subcutaneous weekly injection)

Anifrolumab subcutaneous injection once weekly

Intervention: Anifrolumab (unblinded, open label)

Placebo (subcutaneous weekly injection)

Matched placebo control subcutaneous injection once weekly

Intervention: Placebo

Outcomes

Primary Outcomes

Total Improvement Score (TIS) ≥ 40 response

Time Frame: 52 week

Participants who have at least moderate improvement in disease activity TIS ≥ 40 and has not met "confirmed deterioration" criteria at 2 consecutive visits

Secondary Outcomes

Manual Muscle Testing 8 (MMT-8) (CSM)(52 week)
Oral corticosteroid dose ≤ 7.5 mg/day(52 week)
Oral corticosteroid dose ≤ 7.5 mg/day in PM participants(52 week)
Moderate improvement in disease activity in participants with polymyositis (PM)(52 week)
Moderate improvement in disease activity in dermatomyositis (DM) participants.(52 week)
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)(8 week)
Manual Muscle Testing 8 (MMT-8) in PM participants(52 Week)
Manual Muscle Testing 8 (MMT-8) in DM participants(52 Week)
Core Set Measures (CSMs)(52 week)
Oral corticosteroid dose ≤ 7.5 mg/day in DM participants(52 week)
Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA)(8, 24, & 52 week)
5-D itch(8, 24, & 52 week)
Total Improvement Score (TIS) ≥ 20 Response(8 week)
Total Improvement Score ≥ 60 Response(52 week)
Cumulative Corticosteroid Use(24, 52 week)