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RG3421

Phase 2

Psoriasis | Small molecule | Dermatology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

RG3421 · 1 trial · 1 indication

Phase 2 1
NCT00504270A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.Psoriasis
COMPLETED66 Analytics
PHASE2COMPLETED
A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events (AEs), laboratory parameters, pharmacokinetics
Throughout study

Secondary Endpoints

Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORpo daily
RG3421 120mgEXPERIMENTAL120mg po daily
RG3421 20mgEXPERIMENTAL20mg po daily

Interventions

NameTypeDescription
PlaceboDRUGpo daily
RG3421 120mgDRUG120mg po daily
RG3421 20mgDRUG20mg po daily
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * adult patients, 18-70 years of age; * medically stable, moderate to severe chronic plaque psoriasis. Exclusion Criteria: * any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions; * confounding or concomitant condition or tr...

Countries:United States
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Frequently asked questions about RG3421

What is RG3421 used for?

RG3421 is an investigational small molecule being developed for the treatment of psoriasis, specifically moderate to severe chronic plaque psoriasis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes RG3421?

RG3421 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with psoriasis.

What phase is RG3421 in?

RG3421 is in Phase 2 clinical development. A Phase 2 study has been completed, and the drug remains investigational. It has not received regulatory approval and is not yet available for commercial use.

What clinical trials is RG3421 in?

RG3421 has one completed Phase 2 clinical trial, identified as NCT00504270. This study evaluated the drug in 66 patients with moderate to severe chronic plaque psoriasis in the United States. The trial was randomized, double-blind, and placebo-controlled.

Is RG3421 FDA approved?

No, RG3421 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for psoriasis. The completed Phase 2 trial was a randomized, double-blind, placebo-controlled study, but the drug has not yet received regulatory approval.