Recent Updates
Recently added Catalysts

ARQ-252

Phase 1

Chronic Hand Eczema | Small molecule | Dermatology |Arcutis Biotherapeutics, Inc.|Trials Updated: Apr 5, 2024

ARQ-252 target and mechanism

Molecular targetJAK1
Target classKinase
ModalitySmall molecule

Also known as ARQ-252 cream 0.3%, ARQ-252 0.3%, ARQ-252 cream 0.1%, ARQ-252 0.1%

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment230

FDA Designations

No designations recorded

ARQ-252 clinical trials

ARQ-252 · 1 trial · 1 indication

Phase 1 1
NCT04378569Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand EczemaChronic Hand Eczema
COMPLETED230 Analytics
PHASE1COMPLETED
Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema
Chronic Hand EczemaUnlock trial analytics

Study Endpoints

Primary Endpoints

Cohort 1: Number of Participants With ≥1 Adverse Event (AE)
Up to 3 weeks

The number of Cohort 1 participants with an AE is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research.

Cohort 1: Number of Participants With an Application Site Reaction
Up to 3 weeks

The number of Cohort 1 participants with AEs coded as application site events is reported.

Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE)
Up to 3 weeks

The number of Cohort 1 participants with an SAE is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health.

Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters
Up to 3 weeks

The number of Cohort 1 participants with a significant change in hematology is reported.

Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters
Up to 3 weeks

The number of Cohort 1 participants with a significant change in chemistry is reported.

Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12
Week 12

The IGA is 5-point scale assessing the severity of hand eczema; scores range from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' at Week 12 is presented.

Secondary Endpoints

Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline
Weeks 2, 4, 8 and 12
Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline
Weeks 2, 4, 8 and 12
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'
Weeks 2, 4, and 8
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARQ-252 cream 0.3% QD (once daily)ACTIVE_COMPARATORActive Comparator
ARQ-252 cream 0.3% BID (twice daily)ACTIVE_COMPARATORActive Comparator
ARQ-252 cream 0.1% QD (once daily)ACTIVE_COMPARATORActive Comparator
Vehicle cream BID (twice daily)PLACEBO_COMPARATORPlacebo Comparator
Vehicle cream QD (once daily)PLACEBO_COMPARATORPlacebo Comparator

Interventions

NameTypeDescription
ARQ-252 cream 0.3%DRUGARQ-252 cream 0.3%
ARQ-252 cream 0.1%DRUGARQ-252 cream 0.1%
ARQ-252 Vehicle CreamDRUGARQ-252 Vehicle Cream
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria * Participants legally competent to sign and give informed consent. * Males and females 18 years of age and older (inclusive) at the time of consent. * Clinical diagnosis of chronic hand eczema, defined as hand eczema persistent for more than 3 months, or returned twice or more w...

Countries:United StatesAustraliaCanada
Unlock Eligibility Criteria

Frequently asked questions about ARQ-252

What is ARQ-252?

ARQ-252 is an investigational topical small molecule developed by Arcutis Biotherapeutics for chronic hand eczema, a persistent inflammatory skin condition. It is formulated as a cream and has been studied in a Phase 1 clinical trial. ARQ-252 is not approved for commercial use and remains in clinical development.

What is ARQ-252 used for in chronic hand eczema?

ARQ-252 is being developed to treat chronic hand eczema, an inflammatory skin condition affecting the hands. It is a topical cream applied to the skin. The only completed clinical trial of ARQ-252 enrolled 230 adults with chronic hand eczema across the United States, Australia, and Canada.

What does ARQ-252 target?

ARQ-252 targets JAK1, a kinase enzyme involved in inflammatory signaling. By inhibiting JAK1, the topical cream is designed to reduce the inflammatory response in the skin. JAK1 inhibition is the mechanism under investigation for treating chronic hand eczema.

Who makes ARQ-252?

ARQ-252 is developed by Arcutis Biotherapeutics, Inc., a dermatology-focused biopharmaceutical company that trades under the ticker ARQT. Arcutis is responsible for the clinical development of the ARQ-252 cream formulations studied in chronic hand eczema.

What phase is ARQ-252 in?

ARQ-252 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The Phase 1 program for ARQ-252 has been completed, and the drug remains in clinical development for chronic hand eczema.

What clinical trials is ARQ-252 in?

ARQ-252 has been studied in one completed Phase 1 trial, NCT04378569, titled Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema. The randomized, double-blind, placebo-controlled trial enrolled 230 adults aged 18 and older in the United States, Australia, and Canada.

Is ARQ-252 the same as ARQ-252 cream 0.3% or ARQ-252 0.1%?

Yes. ARQ-252 cream 0.3%, ARQ-252 0.3%, ARQ-252 cream 0.1%, and ARQ-252 0.1% are alternative names for ARQ-252, referring to different cream concentrations of the same investigational topical JAK1 inhibitor being developed by Arcutis Biotherapeutics for chronic hand eczema.