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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06558279
Registration number
NCT06558279
Ethics application status
Date submitted
14/08/2024
Date registered
16/08/2024
Date last updated
15/06/2025
Titles & IDs
Public title
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis
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Scientific title
A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Ocular Myasthenia Gravis
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Secondary ID [1]
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2024-514133-38-00
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Secondary ID [2]
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ARGX-113-2315
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Universal Trial Number (UTN)
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Trial acronym
ADAPT oculus
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myasthenia Gravis, Ocular
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Efgartigimod PH20 SC
Other interventions - Placebo PH20 SC
Experimental: Efgartigimod PH20 SC in part A+B - Participants receiving efgartigimod PH20 SC during part A and part B
Experimental: Placebo PH20 SC in Part A + Efgartigimod PH20 SC in Part B - Participants receiving placebo PH20 SC in Part A and Efgartigimod PH20 SC in Part B
Other interventions: Efgartigimod PH20 SC
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Other interventions: Placebo PH20 SC
Subcutaneous placebo PH20 SC given by prefilled syringe
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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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MGII (PRO) ocular score change from baseline to day 29 in part A
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Assessment method [1]
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The MGII is a scoring tool measuring disease severity. It consists of 22 patient-reported outcomes (PRO) and 6 physical examinations (PE). The Ocular PRO score varies between 0 and 18. The higher the score, the more severe the disease.
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Timepoint [1]
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Up to 29 days
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Secondary outcome [1]
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MGII (PRO+PE) ocular score change from baseline to day 29 in part A
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Assessment method [1]
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The MGII is a scoring tool measuring disease severity. It consists of 22 patient-reported outcomes (PRO) and 6 physical examinations (PE). The Ocular PRO score varies between 0 and 18. The ocular PE score varies between 0 and 5. The higher the score, the more severe the disease.
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Timepoint [1]
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Up to 29 days
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Secondary outcome [2]
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MG-ADL ocular domain score change from baseline to day 29 in part A
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Assessment method [2]
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The MG-ADL scale assesses MG symptoms and their effects on daily activities. The ocular score varies between 0 and 16 (with 16 the most severe).
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Timepoint [2]
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Up to 29 days
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Secondary outcome [3]
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MGII total score change from baseline to day 29 in part A
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Assessment method [3]
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The MGII is a scoring tool measuring disease severity. It consists of 22 patient-reported outcomes (PRO) and 6 physical examinations (PE). The score varies between 0 and 84. The higher the score, the more severe the disease.
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Timepoint [3]
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Up to 29 days
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Secondary outcome [4]
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MGII (PE) ocular score change from baseline to day 29 in part A
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Assessment method [4]
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The MGII is a scoring tool measuring disease severity. It consists of 6 physical examinations (PE). The score varies between 0 and 5. The higher the score, the more severe the disease.
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Timepoint [4]
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Up to 29 days
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Secondary outcome [5]
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MG-ADL total score change from baseline to day 29 in part A
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Assessment method [5]
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The MG-ADL scale assesses MG symptoms and their effects on daily activities. The score varies between 0 and 24 (with 24 the most severe).
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Timepoint [5]
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Up to 29 days
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Secondary outcome [6]
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MGII ocular scores changes (PRO) from baseline in part A+B
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Assessment method [6]
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The MGII is a scoring tool measuring disease severity. It consists of 22 patient-reported outcomes (PRO) and 6 physical examinations (PE). The Ocular PRO score varies between 0 and 18. The ocular PE score varies between 0 and 5. The higher the score, the more severe the disease.
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Timepoint [6]
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Up to 111 weeks
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Secondary outcome [7]
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Incidence of (serious) adverse events
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Assessment method [7]
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Timepoint [7]
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Up to 111 weeks
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Secondary outcome [8]
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MG-QoL15r total score changes from baseline in part A+B
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Assessment method [8]
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The MG-QoL15r questionnaire is a patient-reported instrument that measures the impact of MG symptoms on Quality of Life. The score varies between 0 and 30 (with 30 the lowest quality of life).
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Timepoint [8]
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Up to 111 weeks
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Secondary outcome [9]
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NEI VFQ-25 score changes from baseline in part A+B
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Assessment method [9]
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The NEI VFQ-25 is a 25-item vision-targeted questionnaire. The score varies between 0 and 100 (with 0 being the worst score)
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Timepoint [9]
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Up to 111 weeks
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Secondary outcome [10]
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Percent change from baseline in total IgG levels over time in part A+B
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Assessment method [10]
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Timepoint [10]
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Up to 111 weeks
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Secondary outcome [11]
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Percent change from baseline in AChR-Ab levels in AChR-Ab seropositive participants over time in part A+B
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Assessment method [11]
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Timepoint [11]
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Up to 111 weeks
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Secondary outcome [12]
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Incidence of Anti-Drug Antibodies and Neutralizing Antibodies against efgartigimod in part A+B
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Assessment method [12]
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Timepoint [12]
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Up to 111 weeks
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Secondary outcome [13]
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Incidence of antibodies and Neutralizing Antibodies against rHuPH20 in part A+B
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Assessment method [13]
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Timepoint [13]
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Up to 111 weeks
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Eligibility
Key inclusion criteria
* Is at least 18 years of age and the local legal age of consent for clinical studies
* Has been diagnosed with myasthenia gravis and supported by seropositivity for AChR-Ab; or abnormal neuromuscular transmission demonstrated by abnormal neurophysiology testing and history on positive edrophonium chloride testing or demonstrated improvement on MG therapy"
* Is MGFA Class I (any ocular muscle weakness)
* Has a screening and baseline MGII (PRO) ocular score of at least 6 with at least 2 ocular items with a score of at least 2
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Minimum age
18
Years
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Maximum age
No limit
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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
* Other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia
* Known autoimmune disease or any medical condition other than indication under study that would interfere with an accurate assessment of clinical symptoms of ocular myasthenia gravis or puts the participant at undue risk
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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
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
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Actual
18/09/2024
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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
1/12/2027
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Actual
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Sample size
Target
124
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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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Box Hill Hospital - Box Hill
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Recruitment hospital [3]
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Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment outside Australia
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Ohio
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United States of America
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Texas
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Belgium
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Leuven
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Belgium
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Liège
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Canada
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Halifax
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Canada
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Ottawa
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China
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Chengdu
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China
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Chongqing
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China
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Guangzhou
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China
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Jinan
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China
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Shanghai
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Cyprus
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Egkomi
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Brno
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Czechia
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Pardubice
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Aarhus N
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Turku
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Georgia
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Tbilisi
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Italy
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Fukuoka
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Hanamaki-shi
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Hiroshima
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Kawagoe
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Kyoto-Shi
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Narita
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Shinjuku-Ku
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Daegu
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Leiden
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Bydgoszcz
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Katowice
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Lublin
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Serbia
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Serbia
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Nis
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Barcelona
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Madrid
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San Sebastián
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Spain
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Valencia
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Göteborg
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Glasgow
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
argenx
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.
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Trial website
https://clinicaltrials.gov/study/NCT06558279
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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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Address
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Phone
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Email
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Contact person for public queries
Name
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Sabine Coppieters, MD
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Address
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Phone
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857-350-4834
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
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/NCT06558279
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