NCT06455449RecruitingPhase 3
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)
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 240
- Locations
- 237
- Primary Endpoint
- Total Improvement Score (TIS) ≥ 40 response
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding
Arms & Interventions
Anifrolumab (subcutaneous weekly injection)
Experimental
Anifrolumab subcutaneous injection once weekly
Intervention: Anifrolumab (blinded) (Combination Product)
Anifrolumab (subcutaneous weekly injection)
Experimental
Anifrolumab subcutaneous injection once weekly
Intervention: Anifrolumab (unblinded, open label) (Combination Product)
Placebo (subcutaneous weekly injection)
Placebo Comparator
Matched placebo control subcutaneous injection once weekly
Intervention: Placebo (Other)
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)
Investigators
Study Sites (237)
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