To hear about similar clinical trials, please enter your email below
Trial Title:
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults with Ocular Myasthenia Gravis
NCT ID:
NCT06558279
Condition:
Myasthenia Gravis, Ocular
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Conditions: Keywords:
Myasthenia Gravis
Ocular myasthenia
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Combination Product
Intervention name:
Efgartigimod PH20 SC
Description:
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Arm group label:
Efgartigimod PH20 SC in part A+B
Arm group label:
Placebo PH20 SC in Part A + Efgartigimod PH20 SC in Part B
Intervention type:
Other
Intervention name:
Placebo PH20 SC
Description:
Subcutaneous placebo PH20 SC given by prefilled syringe
Arm group label:
Placebo PH20 SC in Part A + Efgartigimod PH20 SC in Part B
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.
Criteria for eligibility:
Criteria:
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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Neurology Offices of South Florida
Address:
City:
Boca Raton
Zip:
33428-4221
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Costell, MD
Phone:
857-350-4834
Email:
clinicaltrials@argenx.com
Start date:
September 18, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
argenx
Agency class:
Industry
Source:
argenx
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06558279
