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Abetimus

Phase 3

Immunologic Diseases | Small molecule | Immunology |Innoviva, Inc.|Trials Updated: Sep 25, 2006

Abetimus target and mechanism

ModalitySmall molecule

Also known as Abetimus sodium (LJP 394)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment330

FDA Designations

No designations recorded

Abetimus clinical trials

Abetimus · 1 trial · 5 indications

Phase 3 1
NCT00035308Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney DiseaseImmunologic Diseases
COMPLETED330 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
Immunologic DiseasesUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Abetimus sodium (LJP 394)DRUG -
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Eligibility Criteria

Age Range12 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites82

Inclusion Criteria * Diagnosed with SLE * Historical evidence of SLE renal disease * Elevated levels of dsDNA antibodies * Weight of 40 kg or greater Exclusion Criteria * Active SLE renal disease * Use of certain anti-inflammatory or cytotoxic therapies or therapeutic interventions during the mon...

Countries:United StatesAustriaCanadaFranceGermanyItalyMexicoSpainSwedenUnited Kingdom
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Frequently asked questions about Abetimus

What is Abetimus used for?

Abetimus was developed for immunologic diseases, specifically lupus kidney disease, including systemic lupus erythematosus, lupus nephritis, and lupus glomerulonephritis. It is a small molecule therapeutic candidate studied in a Phase 3 clinical trial. It is not approved for any indication and remains investigational.

Who is developing Abetimus?

Abetimus is being developed by Innoviva, Inc., which trades under the ticker INVA. The company holds the development program for this small molecule candidate in immunology. No other developers are associated with the asset.

What phase is Abetimus in?

Abetimus is in Phase 3 development. One Phase 3 clinical trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is Abetimus in?

Abetimus has been studied in one completed Phase 3 trial, NCT00035308, titled Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease. The trial enrolled 330 participants across the United States, Austria, Canada, France, Germany, Italy, Mexico, Spain, Sweden, and the United Kingdom.

Is Abetimus the same as Abetimus sodium?

Yes, Abetimus is also known as Abetimus sodium, and it was formerly designated LJP 394. These names refer to the same small molecule drug candidate developed by Innoviva, Inc. for immunologic diseases.

What was the design of the Abetimus Phase 3 trial?

The completed Phase 3 trial NCT00035308 was a randomized, double-blind study evaluating Abetimus sodium in lupus kidney disease. It enrolled 330 participants aged 12 years and older of all sexes. The trial was uncontrolled and did not use biomarker selection.