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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05523167




Registration number
NCT05523167
Ethics application status
Date submitted
30/08/2022
Date registered
31/08/2022

Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants with Active Idiopathic Inflammatory Myopathy.
Scientific title
A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older with Active Idiopathic Inflammatory Myopathy
Secondary ID [1] 0 0
2024-512785-33-00
Secondary ID [2] 0 0
ARGX-113-2007
Universal Trial Number (UTN)
Trial acronym
ALKIVIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Active Idiopathic Inflammatory Myopathy 0 0
Myositis 0 0
Dermatomyositis 0 0
Polymyositis 0 0
Immune-Mediated Necrotizing Myopathy 0 0
Antisynthetase Syndrome 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - EFG PH20 SC
Other interventions - PBO

Experimental: EFG PH20 SC - participants receiving efgartigimod PH20 SC on top of background treatment

Placebo comparator: PBO PH20 SC - participants receiving placebo PH20 SC on top of background treatment


Treatment: Other: EFG PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer

Other interventions: PBO
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total improvement score (TIS); measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Timepoint [1] 0 0
phase 2: 24 weeks; phase 3: 52 weeks
Secondary outcome [1] 0 0
Time to reach TIS = 20 (first "minimal clinical improvement")
Timepoint [1] 0 0
phase 2: up to 24 weeks; phase 3: up to 52 weeks
Secondary outcome [2] 0 0
Percentage of participants with TIS = 20
Timepoint [2] 0 0
phase 2: 24 weeks; phase 3: 52 weeks
Secondary outcome [3] 0 0
Time to reach TIS = 40 (first "moderate clinical improvement")
Timepoint [3] 0 0
phase 2: up to 24 weeks; phase 3: up to 52 weeks
Secondary outcome [4] 0 0
Percentage of participants with TIS = 40
Timepoint [4] 0 0
phase 2: 24 weeks; phase 3: 52 weeks
Secondary outcome [5] 0 0
Change in manual muscle testing-8 (MMT8) score
Timepoint [5] 0 0
phase 2: 24 weeks; phase 3: 52 weeks
Secondary outcome [6] 0 0
Change in Patient Global Assessment of Disease Activity (PGA)
Timepoint [6] 0 0
phase 2: 24 weeks; phase 3: 52 weeks
Secondary outcome [7] 0 0
Change in Physician Global Assessment of Disease Activity (MDGA)
Timepoint [7] 0 0
phase 2: 24 weeks; phase 3: 52 weeks
Secondary outcome [8] 0 0
Proportion of participants achieving target dose of = 5 mg (prednisone equivalent)
Timepoint [8] 0 0
Phase 3: 52 weeks

Eligibility
Key inclusion criteria
* Ability to consent in the jurisdiction in which the study is taking place and capable of giving signed informed consent.
* A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM)
* One of the following medical histories: Diagnosis of dermatomyositis (DM) or juvenile dermatomyositis (JDM), Diagnosis of polymyositis (PM) (including antisynthetase syndrome (ASyS)), Diagnosis of immune-mediated necrotizing myopathy (IMNM)
* Diagnosed with active disease as defined by the presence of at least 1 of the following criteria: Abnormal levels of at least 1 of the following enzymes: creatine kinase (CK), aldolase, lactate dehydrogenase, aspartate aminotransaminase (AST), alanine aminotransferase (ALT), based on central laboratory results; Electromyography demonstrating active disease within the past 3 months; Active dermatomyositis (DM) skin rash; Muscle biopsy indicative of active idiopathic inflammatory myopathy (IIM) in the past 3 months; Magnetic resonance imaging within the past 3 months indicative of active inflammation
* Muscle weakness
* Receiving a permitted background treatment for idiopathic inflammatory myopathy.
* Contraceptive use consistent with local regulations, where available, for individuals participating in clinical studies. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline before receiving investigational medicinal product (IMP).

The full list of inclusion criteria can be found in the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* A clinically significant active infection at screening
* A COVID-19 polymerase chain reaction (PCR)-positive test before enrollment
* Any other known autoimmune disease that, in the investigator's opinion, would interfere with an accurate assessment of clinical symptoms of idiopathic inflammatory myopathy (IIM) or put the patient at undue risk
* A history of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for = 3 years before the first administration of the investigational medicinal product (IMP). Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer ; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
* Severe muscle damage
* Glucocorticoid-induced myopathy that the investigator considers the primary cause of muscle weakness or permanent weakness linked to a non-idiopathic inflammatory myopathy (IIM) cause
* Juvenile myositis (JDM) diagnosed > 5 years from screening or juvenile myositis with extensive calcinosis or severe calcinosis.
* Uncontrolled interstitial lung disease or any other uncontrolled idiopathic inflammatory myopathy (IIM) manifestation that, in the opinion of the investigator, would be likely to require treatment with prohibited medication during the study
* Other inflammatory and noninflammatory myopathies: inclusion body myositis, overlap myositis), metabolic myopathies, muscle dystrophies or a family history of muscle dystrophy, drug-induced or endocrine induced myositis, and juvenile myositis (other than juvenile dermatomyositis (JDM))
* Clinically significant disease, recent major surgery or intends to have surgery during the study, or has any other condition in the opinion of the investigator that could confound the results of the trial or put the patient at undue risk
* Known hypersensitivity reaction to investigational medicinal product (IMP) or 1 of its excipients
* Received a live or live-attenuated vaccine less than 4 weeks before screening.
* Positive serum test at screening for active viral infection with any of the following conditions: Hepatitis B virus (HBV); Hepatitis C virus (HCV); HIV
* Participant has previously participated in an efgartigimod clinical trial and received at least 1 dose of investigational medicinal product (IMP).
* Participant is concurrently participating in any other clinical study, including a noninterventional study.
* Participant has a current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse.
* Participant is pregnant or lactating or intends to become pregnant during the study.
* Participant has severe renal impairment .
* Participant is institutionalized by a court or other governmental order or is in a dependent relationship with the sponsor or investigator.

The full list of exclusion criteria can be found in the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Wesley Medical Research - Auchenflower
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
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Ukraine
State/province [199] 0 0
Ternopil
Country [200] 0 0
Ukraine
State/province [200] 0 0
Zaporizhzhia
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Bath
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Burton-on-Trent
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Doncaster
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Leeds
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Liverpool
Country [206] 0 0
United Kingdom
State/province [206] 0 0
London
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Middlesbrough
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Newcastle
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
argenx
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sabine Coppieters, MD
Address 0 0
Country 0 0
Phone 0 0
857-350-4834
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05523167