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INCB028050

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Incyte Corporation|Last Updated: Sep 4, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment127

FDA Designations

No designations recorded

Clinical trial landscape

INCB028050 · 1 trial · 1 indication

Phase 2 1
NCT00902486INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic DrugsRheumatoid Arthritis
COMPLETED127 Analytics
PHASE2COMPLETED
INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement
Week 12

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: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.

Participants With at Least 1 Adverse Event From Baseline Through Week 12
From Baseline through week 12

Secondary Endpoints

Participants With at Least 1 Adverse Event From Week 12 to Week 24
Week 12 to Week 24
The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24
From Baseline to Week 24
The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24
Week 12 and Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INCB028050 4 mg QDEXPERIMENTALINCB028050 4mg Once daily (QD)
INCB028050 7 mg QDEXPERIMENTALINCB028050 7mg QD
INCB028050 10 mg QDEXPERIMENTALINCB028050 10mg QD
PlaceboPLACEBO_COMPARATORPlacebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules.

Interventions

NameTypeDescription
INCB028050DRUG4 mg capsules QD
PlaceboDRUGPlacebo matching INCB028050 QD
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * Must have rheumatoid arthritis which has been inadequately controlled with at least one DMARD * For subjects receiving antimalarials, they must be treated with antimalarials for at least 6 months and receiving a stable daily dose * For subjects receiving sulfasalazine, they mu...

Countries:United StatesCzechia
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Frequently asked questions about INCB028050

What is INCB028050 used for in rheumatoid arthritis?

INCB028050 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It was evaluated in a Phase 2 clinical trial in patients with active rheumatoid arthritis who had an inadequate response to disease-modifying anti-rheumatic drugs. The drug is not approved and remains in clinical development.

What does INCB028050 target?

INCB028050 is a small molecule developed by Incyte Corporation. Its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in treating rheumatoid arthritis, an autoimmune condition.

Who makes INCB028050?

INcyte Corporation (NASDAQ: INCY) is developing INCB028050. The company sponsored a Phase 2 clinical trial of the drug for rheumatoid arthritis. Incyte is a biopharmaceutical company focused on the discovery and development of novel small molecule drugs.

What phase is INCB028050 in?

INCB028050 is in Phase 2 clinical development. A Phase 2 trial for rheumatoid arthritis has been completed. The drug is investigational and has not received FDA approval. Its development status beyond Phase 2 has not been disclosed.

What clinical trials is INCB028050 in?

INCB028050 has one completed clinical trial, NCT00902486. This Phase 2 study compared the drug to background therapy in 127 patients with active rheumatoid arthritis who had an inadequate response to disease-modifying anti-rheumatic drugs. The trial was randomized, double-blind, and placebo-controlled, conducted in the United States and Czechia.