Pozelimab + Cemdisiran
DrugSubcutaneous administration as described in the protocol
NCT Number: NCT05070858
This study is researching the experimental drugs called pozelimab and cemdisiran, and cemdisiran monotherapy. The study is focused on patients with generalized Myasthenia Gravis (gMG). Myasthenia gravis is a disease that causes weakness and fatigue in muscles in the body because the nerves and muscles are not communicating properly.
The aim of the study is to see how effective pozelimab and cemdisiran are when used in combination and when pozelimab and cemdisiran are used alone for patients with gMG.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drugs * How the study drugs work inside the body * How much of the study drugs are in the blood at different times * Whether the body makes antibodies against pozelimab and cemdisiran (which could make the drugs less effective or could lead to side effects)
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Universitair Ziekenhuis Antwerpen, Edegem, Antwerp, Belgium
DBTP- Double Blind Treatment Period (24 weeks) ETP - Extension Treatment Period (28 weeks) OLTP- Open Label Treatment Period (68 weeks) FUP-Off treatment Follow Up Period (52 weeks)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
Subcutaneous administration as described in the protocol
SC administration as described in the protocol
Other names: ALN-CC5
SC administration as described in the protocol
SC administration as described in the protocol
Other names: REGN3918
Time frame: From baseline to week 24
The total MG-ADL score ranges from 0 to 24 points, with higher scores indicating greater functional impairment and disability
Time frame: Week 24
QMG total scores range from 0 to 39, with higher scores representing greater impairment
Time frame: From baseline to week 24
Time frame: From baseline to week 24
Time frame: From baseline to week 24
A participant with a ≥2-point reduction (improvement) in MG-ADL total score on 2 or more consecutive assessments spanning 4 or more weeks during the DBTP
Time frame: Week 24
Score of 0 to 1 on the MG-ADL
Time frame: Week 24
MGC score ranges from 0 to 50, with higher score indicating higher impairment
Time frame: Week 24
Total score ranges from 0 to 30 points; a higher score represents greater impairment
Time frame: From baseline to week 24
Time frame: From baseline to week 24
Time frame: Through week 24
Time frame: Through week 24
Time frame: Through week 24
Time frame: Through study duration, approximate 172 weeks
Time frame: Through study duration, approximate 172 weeks
Time frame: Through study duration, approximate 172 weeks
Time frame: Through study duration, approximately 172 weeks
Time frame: Through study duration, approximate 172 weeks
Time frame: Through study duration, approximately 172 weeks
Time frame: Through study duration, approximately 172 weeks
Regeneron Pharmaceuticals
Industry
Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Monotherapy in Patients With Symptomatic Generalized Myasthenia Gravis
Acronym: NIMBLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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