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efgartigimod PH20 in stage B

Phase 2

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Monoclonal antibody | Neurology |argenx SE|Last Updated: Aug 20, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment322

FDA Designations

No designations recorded

Clinical trial landscape

efgartigimod PH20 in stage B · 1 trial · 1 indication

Phase 2 1
NCT04281472A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
COMPLETED322 Analytics
PHASE2COMPLETED
A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT04281472322
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Study Endpoints

Primary Endpoints

Stage A: Percentage of Participants With Confirmed Evidence of Clinical Improvement(ECI)
Up to 12 weeks during the open-label stage A
Stage B: Time to First Adjusted INCAT Deterioration Compared to Stage B Baseline
Up to 48 weeks during the randomized placebo-controlled stage B

Secondary Endpoints

Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)
Up to 12 weeks during the open-label stage A
Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Adjusted INCAT Score
Up to 12 weeks during the open-label stage A
Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Medical Research Council (MRC) Sum Score
Up to 12 weeks during the open-label stage A
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
efgartigimod PH20 SCEXPERIMENTALpatients receiving efgartigimod PH20 SC in both stage A as stage B
PlaceboPLACEBO_COMPARATORpatients receiving efgartigimod PH20 SC during stage A and receiving placebo in stage B

Interventions

NameTypeDescription
efgartigimod PH20 SC in stage BBIOLOGICALStage A: efgartigimod PH20 SC, Stage B: efgartigimod PH20 SC
placebo in stage BOTHERStage A: N/A, stage B: placebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites216

Inclusion Criteria: 1. Ability to understand the requirements of the trial, provide written informed consent (include consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) 2....

Countries:United StatesAustriaBelgiumBulgariaChinaCzechiaDenmarkFranceGeorgiaGermanyHungaryIsraelItalyJapanLatviaNetherlandsPolandRomaniaRussiaSerbiaSpainTaiwanTurkey (Türkiye)UkraineUnited Kingdom
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Frequently asked questions about efgartigimod PH20 in stage B

What is efgartigimod PH20 used for in stage B?

Efgartigimod PH20 in stage B is an investigational monoclonal antibody being studied for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), an autoimmune disorder that affects the peripheral nerves. It is administered subcutaneously and is currently in Phase 2 clinical development.

Who makes efgartigimod PH20 in stage B?

Efgartigimod PH20 in stage B is being developed by argenx SE, a biopharmaceutical company listed on the stock exchange under the ticker symbol ARGX.

What phase is efgartigimod PH20 in stage B in?

Efgartigimod PH20 in stage B is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being evaluated for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

What clinical trials is efgartigimod PH20 in stage B in?

Efgartigimod PH20 in stage B has one completed clinical trial, identified as NCT04281472. This Phase 2 study assessed the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The trial enrolled 322 participants across multiple countries.

Is efgartigimod PH20 in stage B FDA approved?

Efgartigimod PH20 in stage B is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The completed clinical trial NCT04281472 evaluated its safety and efficacy, but regulatory approval has not been granted.

What is the mechanism of action of efgartigimod PH20 in stage B?

Efgartigimod PH20 in stage B is a monoclonal antibody that targets the neonatal Fc receptor (FcRn). By blocking FcRn, it reduces levels of pathogenic IgG antibodies, which are involved in autoimmune disorders like Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This mechanism is being studied in Phase 2 clinical trials.