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rhuMAb IFNalpha

Phase 1

Systemic Lupus Erythematosus | Monoclonal antibody | Immunology |Roche Holding AG|Trials Updated: Sep 22, 2011

rhuMAb IFNalpha development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

rhuMAb IFNalpha clinical trials

rhuMAb IFNalpha · 1 trial · 1 indication

Phase 1 1
NCT00541749A Study of rhuMAb IFNalpha in Adults With Systemic Lupus ErythematosusSystemic Lupus Erythematosus
COMPLETED60 Analytics
PHASE1COMPLETED
A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus
Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

The incidence and nature of laboratory abnormalities
Length of study
The incidence, nature, and severity of adverse events
Length of study

Secondary Endpoints

The PK profile of rhuMAb IFNalpha
Length of study
The incidence of antibodies directed against rhuMAb IFNalpha
Length of study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
rhuMAb IFNalphaDRUGIntravenous repeating dose
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * For patients with reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) throughout their participation in the study * Diagnosis of SLE according to current...

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Frequently asked questions about rhuMAb IFNalpha

What is rhuMAb IFNalpha used for?

rhuMAb IFNalpha was studied for the treatment of systemic lupus erythematosus (SLE), an autoimmune disease. It was developed by Roche Holding AG as an investigational monoclonal antibody. The clinical program evaluated it in adults with SLE, but the drug has not been approved for any indication.

What does rhuMAb IFNalpha target?

rhuMAb IFNalpha is a monoclonal antibody designed to target interferon-alpha. By binding to interferon-alpha, it aims to neutralize this cytokine, which is thought to contribute to the inflammation and immune dysregulation seen in systemic lupus erythematosus. The target class is an antibody.

Who is developing rhuMAb IFNalpha?

rhuMAb IFNalpha is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche conducted the clinical research for this monoclonal antibody in systemic lupus erythematosus.

What phase is rhuMAb IFNalpha in?

rhuMAb IFNalpha is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA or any regulatory agency for systemic lupus erythematosus or any other condition.

What clinical trials is rhuMAb IFNalpha in?

rhuMAb IFNalpha has been evaluated in one completed Phase 1 clinical trial, NCT00541749, titled "A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus." The trial enrolled 60 adults, was randomized and double-blind, and had no active trials at the time of this report.