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RI-002

Phase 3

Primary Immune Deficiency Disorder | Monoclonal antibody | Immunology |ADMA Biologics Inc|Last Updated: Oct 5, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

Clinical trial landscape

RI-002 · 1 trial · 1 indication

Phase 3 1
NCT01814800Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)Primary Immune Deficiency Disorder
COMPLETED59 Analytics
PHASE3COMPLETED
Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
Primary Immune Deficiency Disorder
NCT0181480059
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Study Endpoints

Primary Endpoints

Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008))
One year

The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency.

Secondary Endpoints

Incidence of All Infections (Serious and Non-serious)
Up to 1 Year
Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost
Up to 1 year
Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year
Up to 1 year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RI-002 TreatmentEXPERIMENTALDrug: RI-002 Dose: 300-800 mg/kg infusion Frequency: Once every 3 to 4 Weeks

Interventions

NameTypeDescription
RI-002BIOLOGICALImmune Globulin Intravenous (IGIV)
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Eligibility Criteria

Age Range2 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: To be eligible to participate in this study, the subjects must meet the following criteria: 1. Signed a written informed consent or a specific assent form for minors. 2. Have a diagnosis of primary immunodeficiency disease. 3. Be ≥ 2 years and ≤ 75 years. 4. Have body weight ≥ ...

Countries:United States
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Frequently asked questions about RI-002

What is RI-002 used for?

RI-002 is an investigational monoclonal antibody being developed for the treatment of Primary Immune Deficiency Disorder (PIDD), a condition in which the immune system is impaired. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes RI-002?

RI-002 is being developed by ADMA Biologics Inc, a biopharmaceutical company traded on the Nasdaq under the ticker symbol ADMA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for patients with Primary Immune Deficiency Disorder.

What phase is RI-002 in?

RI-002 is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 3 clinical trial has been completed to evaluate its pharmacokinetics, efficacy, and safety in subjects with Primary Immunodeficiency Diseases.

What clinical trials is RI-002 in?

RI-002 has one completed Phase 3 clinical trial registered as NCT01814800, titled 'Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)'. The trial enrolled 59 participants in the United States and included individuals aged 2 years and older.

Is RI-002 the same as IGIV?

RI-002 is an intravenous immunoglobulin (IGIV) product, as indicated by the clinical trial title. It is a monoclonal antibody therapy being studied for Primary Immune Deficiency Disorder. The trial evaluated its pharmacokinetics, efficacy, and safety in affected subjects.