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INCB018424

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Incyte Corporation|Last Updated: Mar 23, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

INCB018424 · 1 trial · 1 indication

Phase 2 1
NCT00550043A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED50 Analytics
PHASE2COMPLETED
A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement
Day 28

The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject's assessment of pain, Subject's global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), subject's self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.

Secondary Endpoints

The Percentage of Subjects Achieving ACR 50 Improvement
Day 28
The Percentage of Subjects Achieving ACR 70 Improvement
Day 28
Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score
Baseline, Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1: Treatment Group AEXPERIMENTALINCB018424 15 mg twice daily (BID) or matching placebo
Cohort 2: Treatment Group BEXPERIMENTALINCB018424 5 mg BID or matching placebo
Cohort 2: Treatment Group CEXPERIMENTALINCB018424 25 mg BID or matching placebo
Cohort 2: Treatment Group DEXPERIMENTALINCB018424 50 mg once daily (QD) or matching placebo
PlaceboPLACEBO_COMPARATORMatching placebo, oral

Interventions

NameTypeDescription
INCB018424DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Established diagnosis of rheumatoid arthritis 2. Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry. Exclusion Criteria: 1. Patients who hav...

Countries:United StatesPoland
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Frequently asked questions about INCB018424

What is INCB018424 used for in rheumatoid arthritis?

INCB018424 is an investigational small molecule being studied for the treatment of active rheumatoid arthritis. It is being developed by Incyte Corporation and is currently in Phase 2 clinical development. The drug is administered orally and has been evaluated in a placebo-controlled clinical trial.

What does INCB018424 target?

INCB018424 is a small molecule therapeutic being developed for rheumatoid arthritis. Its specific molecular target has not been disclosed in available clinical trial information. The drug is currently in Phase 2 development by Incyte Corporation for the treatment of active rheumatoid arthritis.

Who makes INCB018424?

INCB018424 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The drug is an investigational small molecule in Phase 2 clinical development for the treatment of active rheumatoid arthritis.

What phase is INCB018424 in?

INCB018424 is in Phase 2 clinical development. It is an investigational drug being studied for the treatment of active rheumatoid arthritis. The drug has completed a Phase 2 clinical trial and is not yet approved by regulatory authorities.

What clinical trials is INCB018424 in?

INCB018424 has been studied in a completed Phase 2 clinical trial identified as NCT00550043. This trial explored the safety, tolerability, and efficacy of a 4-week course of INCB018424 in 50 subjects with active rheumatoid arthritis. The study was conducted in the United States and Poland.

Is INCB018424 the same as ruxolitinib?

INCB018424 is the development code for a drug that is also known as ruxolitinib. It is a small molecule being developed by Incyte Corporation for the treatment of active rheumatoid arthritis. The drug is currently in Phase 2 clinical development.