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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06455449
Registration number
NCT06455449
Ethics application status
Date submitted
28/09/2023
Date registered
12/06/2024
Date last updated
12/06/2024
Titles & IDs
Public title
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)
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Scientific 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)
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Secondary ID [1]
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D3463C00003
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Universal Trial Number (UTN)
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Trial acronym
JASMINE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Polymyositis, Dermatomyositis
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Anifrolumab (blinded)
Other interventions - Placebo
Other interventions - Anifrolumab (unblinded, open label)
Experimental: Anifrolumab (subcutaneous weekly injection) - Anifrolumab subcutaneous injection once weekly
Placebo comparator: Placebo (subcutaneous weekly injection) - Matched placebo control subcutaneous injection once weekly
Other interventions: Anifrolumab (blinded)
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Other interventions: Placebo
Matched placebo delivered subcutaneously, once weekly for 52 weeks
Other interventions: 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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Total Improvement Score (TIS) = 40 response
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Assessment method [1]
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Participants who have at least moderate improvement in disease activity TIS = 40 and has not met "confirmed deterioration" criteria at 2 consecutive visits
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Timepoint [1]
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52 week
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Secondary outcome [1]
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Manual Muscle Testing 8 (MMT-8)
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Assessment method [1]
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MMT-8 change from baseline at Week 52
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Timepoint [1]
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52 week
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Secondary outcome [2]
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Oral corticosteroid dose = 7.5 mg/day
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Assessment method [2]
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Participants who achieve oral corticosteroid dose = 7.5 mg/day at Week 52
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Timepoint [2]
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52 week
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Secondary outcome [3]
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Moderate improvement in disease activity in participants with polymyositis (PM)
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Assessment method [3]
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PM participants who have at least moderate improvement in disease activity, TIS = 40, at week 52 and has not met "confirmed deterioration" criteria at 2 consecutive visits
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Timepoint [3]
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52 week
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Secondary outcome [4]
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Moderate improvement in disease activity in dermatomyositis (DM) participants.
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Assessment method [4]
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DM participants who have at least moderate improvement in disease activity, TIS = 40, and has not met "confirmed deterioration" criteria at 2 consecutive visits
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Timepoint [4]
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52 week
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Secondary outcome [5]
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Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
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Assessment method [5]
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CDASI activity change from baseline at week 8 (DM participants only)
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Timepoint [5]
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8 week
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Secondary outcome [6]
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Core Set Measures (CSMs)
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Assessment method [6]
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Change from baseline at Week 52 in CSMs:
* PGA
* PtGA
* Muscle enzymes
* MDAAT extra-muscular disease activity
* HAQ-DI
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Timepoint [6]
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52 week
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Secondary outcome [7]
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Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA)
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Assessment method [7]
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DM Participants who achieve:
* CDA-IGA score = 1 at Week 8 (yes/no)
* CDA-IGA score = 1 at Week 24 (yes/no)
* CDA-IGA score = 1 at Week 52 (yes/no)
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Timepoint [7]
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8, 24, & 52 week
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Secondary outcome [8]
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5-D itch
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Assessment method [8]
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DM participants only:
* 5-D itch change from baseline at Week 8
* 5-D itch change from baseline at Week 24
* 5-D itch change from baseline at Week 52
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Timepoint [8]
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8, 24, & 52 week
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Secondary outcome [9]
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Total Improvement Score (TIS) = 20 Response
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Assessment method [9]
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Participants who have at least minimal improvement in disease activity TIS = 20 at Week 8 and has not met "confirmed deterioration" criteria at 2 consecutive visits
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Timepoint [9]
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8 week
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Secondary outcome [10]
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Cumulative Corticosteroid Use
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Assessment method [10]
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* Cumulative corticosteroids use as determined by the normalized standardized AUC from baseline up to and including Week 24
* Cumulative corticosteroids use as determined by the normalized standardized AUC from baseline up to and including Week 52
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Timepoint [10]
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24, 52 week
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Secondary outcome [11]
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TIS = 60 Response
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Assessment method [11]
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Participants who have major improvement in disease activity TIS = 60 at week 52 and has not met "confirmed deterioration" criteria at 2 consecutive visits
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Timepoint [11]
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52 week
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Eligibility
Key inclusion criteria
Capable of giving informed consent.
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.
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Minimum age
18
Years
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
27/06/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
4/08/2028
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Actual
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Camperdown
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Recruitment hospital [2]
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Research Site - Nedlands
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Research Site - New Lambton
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Recruitment hospital [4]
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Research Site - Woodville South
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2050 - Camperdown
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment postcode(s) [3]
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2310 - New Lambton
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Recruitment postcode(s) [4]
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5011 - Woodville South
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Recruitment outside Australia
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Taiwan
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State/province [112]
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Taipei
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Country [113]
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Taiwan
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State/province [113]
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Taoyuan
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Country [114]
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United Kingdom
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State/province [114]
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Edinburgh
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Country [115]
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United Kingdom
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State/province [115]
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London
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Country [116]
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United Kingdom
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State/province [116]
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Wolverhampton
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Country [117]
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Vietnam
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State/province [117]
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Ha Noi
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Country [118]
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Vietnam
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State/province [118]
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Hanoi
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Country [119]
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Vietnam
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State/province [119]
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Ho Chi Minh city
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Country [120]
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Vietnam
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State/province [120]
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Ho Chi Minh
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Country [121]
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Vietnam
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State/province [121]
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Hochiminh city
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06455449
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Phone
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Fax
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0
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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0
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Country
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Phone
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1-877-240-9479
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Fax
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0
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Email
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0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT06455449
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