Clinical trial 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)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Polymyositis, Dermatomyositis
Keywords: Polymyositis
Dermatomyositis
anifrolumab
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-06-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Capable of giving informed consent.

Inclusion Criteria:

1. 18 - 75 years old
2. Body weight 40 kg - ≤ 100 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 outcomes:
measure: Total Improvement Score (TIS) ≥ 40 response
timeFrame: 52 week
Secondary outcomes:
measure: Manual Muscle Testing 8 (MMT-8) (CSM)
timeFrame: 52 week
measure: Oral corticosteroid dose ≤ 7.5 mg/day
timeFrame: 52 week
measure: Moderate improvement in disease activity in participants with polymyositis (PM)
timeFrame: 52 week
measure: Moderate improvement in disease activity in dermatomyositis (DM) participants.
timeFrame: 52 week
measure: Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
timeFrame: 8 week
measure: Manual Muscle Testing 8 (MMT-8) in PM participants
timeFrame: 52 Week
measure: Manual Muscle Testing 8 (MMT-8) in DM participants
timeFrame: 52 Week
measure: Core Set Measures (CSMs)
timeFrame: 52 week
measure: Oral corticosteroid dose ≤ 7.5 mg/day in PM participants
timeFrame: 52 week
measure: Oral corticosteroid dose ≤ 7.5 mg/day in DM participants
timeFrame: 52 week
measure: Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA)
timeFrame: 8, 24, & 52 week
measure: 5-D itch
timeFrame: 8, 24, & 52 week
measure: Total Improvement Score (TIS) ≥ 20 Response
timeFrame: 8 week
measure: Total Improvement Score ≥ 60 Response
timeFrame: 52 week
measure: Cumulative Corticosteroid Use
timeFrame: 24, 52 week
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: New Haven
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facility: Research Site
state: Connecticut
city: Washington
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state: District of Columbia
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state: Florida
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state: Florida
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state: Florida
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city: Orlando
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city: Boston
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city: Ann Arbor
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state: Michigan
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state: North Carolina
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state: Wisconsin
city: Buenos Aires
country: Argentina
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city: Buenos Aires
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city: Buenos Aires
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city: Quilmes
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city: San Miguel de Tucuman
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city: Camperdown
country: Australia
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city: Nedlands
country: Australia
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city: New Lambton
country: Australia
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city: Southport
country: Australia
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city: Woodville South
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city: Graz
country: Austria
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city: Gent
country: Belgium
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city: Merksem
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city: Joinville
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city: Pelotas
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city: Porto Alegre
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city: Salvador
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city: Salvador
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city: Dongguan
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city: Guangzhou
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city: Hengyang
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city: Jining
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city: Nanjing
country: China
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city: Shanghai
country: China
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city: Shanghai
country: China
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city: Shanghai
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city: Shanghai
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city: Wenzhou
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city: Zhengzhou
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city: Praha 2
country: Czechia
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city: Aarhus N
country: Denmark
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city: Copenhagen
country: Denmark
facility: Research Site
city: Odense C
country: Denmark
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Brest Cedex 2
country: France
facility: Research Site
city: Le Mans Cedex
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Lyon
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facility: Research Site
city: Paris Cedex 13
country: France
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city: Paris
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city: Reims
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facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Strasbourg
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facility: Research Site
city: Toulouse
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facility: Research Site
city: Bad Nauheim
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
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city: Freiburg
country: Germany
facility: Research Site
city: Herne
country: Germany
facility: Research Site
city: München
country: Germany
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city: Tübingen
country: Germany
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Ahmedabad
country: India
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city: Ahmedabad
country: India
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city: Gurugram
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city: Kolkata
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city: Mumbai
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city: New Delhi
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city: Puducherry
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city: Haifa
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city: Jerusalem
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city: Ramat Gan
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city: Ancona
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city: Bari
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city: Catania
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city: Milan
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city: Padova
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city: Palermo
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city: Pavia
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city: Pisa
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city: Roma
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city: Roma
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city: Rozzano
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city: Kawasaki-shi
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country: Japan
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city: Omura-shi
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city: Sendai-shi
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country: Korea, Republic of
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country: Korea, Republic of
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city: Ciudad de Mexico
country: Mexico
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city: Culiacan
country: Mexico
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city: D.F
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
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city: Mexico
country: Mexico
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city: Mexico
country: Mexico
facility: Research Site
city: Amsterdam
country: Netherlands
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city: Białystok
country: Poland
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city: Kraków
country: Poland
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city: Kraków
country: Poland
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city: Poznań
country: Poland
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city: Poznań
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wrocław
country: Poland
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city: Łódź
country: Poland
facility: Research Site
city: Caguas
country: Puerto Rico
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city: San Juan
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city: Barcelona
country: Spain
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city: Barcelona
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city: Cordoba
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city: L'Hospitalet de Llobregat
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city: La Coruña
country: Spain
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city: Madrid
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city: Madrid
country: Spain
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city: Sabadell
country: Spain
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city: Valladolid
country: Spain
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city: Stockholm
country: Sweden
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city: Uppsala
country: Sweden
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city: Kaohsiung
country: Taiwan
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city: Kaohsiung
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city: New Taipei
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city: Taichung
country: Taiwan
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city: Taichung
country: Taiwan
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city: Taipei
country: Taiwan
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city: Taoyuan
country: Taiwan
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city: Edinburgh
country: United Kingdom
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city: London
country: United Kingdom
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city: Wolverhampton
country: United Kingdom
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country: Vietnam
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city: Ha Noi
country: Vietnam
facility: Research Site
city: Hanoi City
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh city
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Hochiminh city
country: Vietnam
facility: Research Site
city: Hue
country: Vietnam
facility: Research Site
Study officials:
References: