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rhuMAb IFNalpha

Phase 1

Systemic Lupus Erythematosus | Small molecule | Immunology |Roche Holding AG|Last Updated: Sep 22, 2011

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

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
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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 is an investigational drug being studied for the treatment of Systemic Lupus Erythematosus (SLE). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in adult patients with SLE.

Who makes rhuMAb IFNalpha?

rhuMAb IFNalpha is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The drug is currently in Phase 1 clinical trials for Systemic Lupus Erythematosus.

What phase is rhuMAb IFNalpha in?

rhuMAb IFNalpha is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory agencies. The drug is being studied for the treatment of Systemic Lupus Erythematosus in adult patients.

What clinical trials is rhuMAb IFNalpha in?

rhuMAb IFNalpha has one completed Phase 1 clinical trial registered under NCT00541749. This study, titled 'A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus,' enrolled 60 participants. The trial was randomized and double-blind, though it did not use a control group.

Is rhuMAb IFNalpha FDA approved?

rhuMAb IFNalpha is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Systemic Lupus Erythematosus. The drug has completed one Phase 1 trial, but it remains in the early stages of clinical testing.