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INCB009471

Phase 2

HIV Infections | Small molecule | Infectious Disease |Incyte Corporation|Last Updated: Mar 26, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

INCB009471 · 1 trial · 1 indication

Phase 2 1
NCT00393120Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected PatientsHIV Infections
COMPLETED45 Analytics
PHASE2COMPLETED
Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability will be assessed by monitoring adverse experiences.
Baseline, every 1-7 days following the initiation of treatment through Day 28 and then at Day 42 or the early study termination visit.

Secondary Endpoints

The virological response to INCB009471 as monotherapy will be assessed by measuring HIV-1 RNA levels by the Roche Amplicor HIV-1 Monitor® Test, v1.5 - Quantitative.
Baseline, Days 4, 7, 10, 14, 16, 20 and 28 or the early termination study visit.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment A - INCB009471 100mg IREXPERIMENTALINCB009471, 100 mg IR orally once daily
Treatment B - INCB009471 300mg SREXPERIMENTALINCB009471, 300 mg SR orally once daily
Treatment C - PlaceboPLACEBO_COMPARATORPlacebo matching INCB009471

Interventions

NameTypeDescription
INCB009471DRUG100mg SR (sustained release) orally once daily
Placebo comparatorDRUGOrally once daily
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: Asymptomatic HIV-1 infected individuals that are treatmen naïve (ie less than 2 weeks prior ARV exposure) or treatment experienced subjects who are not currently on HAART and have not received any ARVs for 3 months prior to Screening. * Males between 18 years and 65 years of ag...

Countries:United States
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Frequently asked questions about INCB009471

What is INCB009471 used for in HIV Infections?

INCB009471 is an investigational small molecule being studied for the treatment of HIV Infections. It is a chemokine coreceptor 5 (CCR5) antagonist, meaning it targets the CCR5 receptor to potentially block viral entry. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does INCB009471 target?

INCB009471 targets the chemokine coreceptor 5 (CCR5), a protein on the surface of certain immune cells that HIV uses to enter and infect cells. By blocking CCR5, the drug aims to prevent the virus from entering cells, which is a potential strategy for treating HIV infections.

Who makes INCB009471?

INCB009471 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting clinical research on this investigational drug for the treatment of HIV Infections.

What phase is INCB009471 in?

INCB009471 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for safety and effectiveness in patients with HIV Infections, and its clinical development is ongoing.

What clinical trials is INCB009471 in?

INCB009471 has one completed Phase 2 clinical trial, identified by the National Clinical Trial number NCT00393120. This trial, titled "Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients," enrolled 45 participants in the United States. The study was randomized, double-blind, and placebo-controlled.

Is INCB009471 the same as a CCR5 antagonist?

Yes, INCB009471 is a CCR5 antagonist. It is designed to block the chemokine coreceptor 5 (CCR5), which is a key entry point for HIV into cells. This mechanism is being investigated as a potential treatment for HIV Infections in a Phase 2 clinical trial.