Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

Withdrawn before enrolling · Phase 3

Conditions studied: Hand Eczema

In brief

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).

Key facts

Study ID

NCT05219864

Run by

Incyte Corporation

People needed

0

Starts

2023-01-31

Expected to finish

2024-09-22

Last updated by the study team

2022-11-17

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months.
• Screening and baseline IGA-CHE 3 or 4.
• Baseline CHE-related Itch NRS ≥ 4.
• Recent history (within the past 1 year of baseline) of inadequate response to treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or oral alitretinoin; or intolerance or contraindication to TCS or TCI or oral alitretinoin.
• Willingness to avoid pregnancy or fathering children based on the criteria below.

You may not qualify if…

• Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study.
• Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
• Participants with concurrent conditions and history of other diseases such as other active skin disease or infection on the hands; immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with study assessments or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids; current or history of hepatitis B or C virus infection.
• Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
• Laboratory values outside of the protocol-defined criteria.
• Use of protocol-defined treatments within the indicated washout period before baseline.
• Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline.
• Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
• Further exclusion criteria apply.

Where it is running

• Southwest Skin Specialists Phoenix Biltmore — Phoenix, Arizona, United States
• Raoof Md Encino — Encino, California, United States
• First Oc Dermatology — Fountain Valley, California, United States
• Marvel Clinical Research Llc — Huntington Beach, California, United States
• Well Pharma Medical Research Corporation — Miami, Florida, United States
• Psoriasis Treatment Center of South Florida — Pembroke Pines, Florida, United States
• Lenus Research Medical Group, Llc — Sweetwater, Florida, United States
• Delricht Research — Marietta, Georgia, United States
• Arlington Dermatology — Rolling Meadows, Illinois, United States
• Midwest Allergy Sinus Asthma, Sc — Springfield, Illinois, United States
• Dermatologist Specialist — Louisville, Kentucky, United States
• Grafton Dermatology and Cosmetic Surgery — Houma, Louisiana, United States
• Delricht Research — New Orleans, Louisiana, United States
• Washington University — St Louis, Missouri, United States
• Jubilee Clinical Research Inc — Las Vegas, Nevada, United States
• Juva Skin and Laser Center — New York, New York, United States
• Oregon Medical Research Center — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center — Memphis, Tennessee, United States
• International Clinical Research Tennessee Llc — Murfreesboro, Tennessee, United States
• Austin Institute For Clinical Research Aicr Pflugerville — Houston, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Center For Clinical Studies Webster — Webster, Texas, United States
• University of Utah — Murray, Utah, United States
• West End Dermatology Associates — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.