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Ensayo clínico para evaluar la seguridad y eficacia de ALXN1720 en adultos con miastenia gravis generalizada
THE PURPOSE OF THIS TRIAL IS TO LEARN MORE ABOUT AN INVESTIGATIONAL DRUG CALLED ALXN1720 AND TO BETTER UNDERSTAND MYASTHENIA GRAVIS, THE DISEASE BEING STUDIED, AS WELL AS ASSOCIATED HEALTH PROBLEMS. MYASTHENIA GRAVIS IS A CONDITION THAT CAUSES ABNORMALITIES IN THE IMMUNE SYSTEM THAT CAN LEAD TO GENERALIZED MUSCLE WEAKNESS, INCLUDING WEAKNESS IN CARRYING OUT EYE MOVEMENTS, DECREASED ABILITY TO SPEAK OR SWALLOW, AND DIFFICULTY BREATHING. THIS DISEASE CAN ALSO CAUSE FATIGUE, WHICH CAN MAKE DAILY ACTIVITIES DIFFICULT. THE IMMUNE SYSTEM HELPS OUR BODY FIGHT DISEASE. AN IMPORTANT PART OF THE IMMUNE SYSTEM IS A GROUP OF MOLECULES CALLED COMPLEMENT PROTEINS. ABNORMAL ACTIVATION OF THESE PROTEINS CAN CAUSE RARE DISEASES SUCH AS MGG. THE ROLE OF THE DRUG USED IN THIS TRIAL IS TO BLOCK THE ACTIVATION OF ONE OF THESE COMPLEMENT PROTEINS. THIS APPROACH TO TREATING MGG HAS WORKED WELL IN OTHER TRIALS WITH SIMILAR DRUGS. TO LEARN MORE ABOUT THE TRIAL DRUG, IT WILL BE COMPARED TO A PLACEBO. ULTIMATELY, THE PURPOSE OF THIS TRIAL IS TO DETERMINE WHETHER THE TRIAL DRUG IS SAFE AND EFFECTIVE IN TREATING MGG.
Technical Summary
- PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, MULTICENTER, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ALXN1720 IN ADULTS WITH GENERALIZED MYASTHENIA GRAVIS
- Code EudraCT: 2022-00460-21
- Protocol number: ALXN1720-MG-301
- Promoter: Alexion Pharmaceuticals, Inc.
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