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Rontalizumab

Phase 2

Systemic Lupus Erythematosus | Small molecule | Immunology |Roche Holding AG|Last Updated: Aug 12, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment238

FDA Designations

No designations recorded

Clinical trial landscape

Rontalizumab · 1 trial · 1 indication

Phase 2 1
NCT00962832A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus Erythematosus
COMPLETED238 Analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of responders at Week 24
Until study discontinuation or up to 24 weeks

Secondary Endpoints

Time-adjusted area under the curve (AUC) of the BILAG index global score
Until study discontinuation or up to 24 weeks
Treatment failure status
Until study discontinuation or up to 24 weeks
Time to treatment failure
Until study discontinuation or up to 24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1 - Placebo intravenouslyPLACEBO_COMPARATORParticipants received placebo intravenously every 4 weeks for 24 weeks.
Part 1 - Rontalizumab 750 mg intravenouslyEXPERIMENTALParticipants received rontalizumab 750 mg intravenously every 4 weeks for 24 weeks.
Part 2 - Placebo subcutaneouslyPLACEBO_COMPARATORParticipants received placebo subcutaneously every 2 weeks for 24 weeks.
Part 2 - Rontalizumab 300 mg subcutaneouslyEXPERIMENTALParticipants received rontalizumab 300 mg subcutaneously every 2 weeks for 24 weeks.
Part 3 - Rontalizumab 750 mg intravenouslyEXPERIMENTALParticipants received rontalizumab 750 mg intravenously every 4 weeks for 120 weeks.

Interventions

NameTypeDescription
PlaceboDRUGPlacebo was supplied as a sterile liquid solution.
RontalizumabDRUGRontalizumab was supplied as a sterile liquid solution.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites79

Inclusion Criteria: * Diagnosis of SLE. * Active disease at the time of screening. * Agreement to use an effective form of contraception for the duration of the study. Exclusion Criteria: * Acutely life- or organ-threatening manifestations of systemic lupus erythematosus (SLE) (eg, proliferative ...

Countries:United StatesArgentinaColombiaMexicoPolandRussia
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Frequently asked questions about Rontalizumab

What is Rontalizumab used for?

Rontalizumab is an investigational small molecule being developed for the treatment of systemic lupus erythematosus (SLE). It is intended for patients with moderately to severely active disease. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes Rontalizumab?

Rontalizumab is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with systemic lupus erythematosus.

What phase is Rontalizumab in?

Rontalizumab is in Phase 2 clinical development. A Phase 2 trial has been completed, which evaluated the drug in patients with moderately to severely active systemic lupus erythematosus. The drug remains investigational and has not received FDA approval.

What clinical trials is Rontalizumab in?

Rontalizumab has one completed clinical trial, registered as NCT00962832. This Phase 2 study evaluated the efficacy and safety of the drug in 238 patients with moderately to severely active systemic lupus erythematosus. The trial was randomized, double-blind, and placebo-controlled, and was conducted in the United States, Argentina, Colombia, Mexico, Poland, and Russia.

Is Rontalizumab the same as any other drug?

Rontalizumab is a distinct investigational drug with no alternative names listed. It is a small molecule being developed for systemic lupus erythematosus, and it is not known to be identical to any other approved or investigational medication.