Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2

Withdrawn before enrolling · Phase 3

Conditions studied: Chronic Hand Eczema (CHE)

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

NCT05233410

Run by

Incyte Corporation

People needed

0

Starts

2023-01-31

Expected to finish

2024-09-22

Last updated by the study team

2022-11-10

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

• University of Alabama Hospital — Birmingham, Alabama, United States
• Marvel Clinical Research LLC — Huntington Beach, California, United States
• Advanced RX Clin Research — Westminster, California, United States
• Advanced Rx Clinical Research — Westminster, California, United States
• Forcare Clinical Research — Tampa, Florida, United States
• Midwest Allergy Sinus Asthma, Sc — Springfield, Illinois, United States
• The Indiana Clinical Trials Center Ictc — Plainfield, Indiana, United States
• Delricht Research — Baton Rouge, Louisiana, United States
• Jubilee — Las Vegas, Nevada, United States
• Onsite Clinical Solutions, Llc Charlotte Central Office — Charlotte, North Carolina, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Froedtert & Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Medical Center Unimed Eood — Sevlievo, Bulgaria
• Dcc 'Alexandrovska', Eood — Sofia, Bulgaria
• Medical Center Hera Eood — Sofia, Bulgaria
• Dcc Xxviii — Sofia, Bulgaria
• Mc 'Synexus - Sofia', Eood — Sofia, Bulgaria
• Dcc 'Alexandrovska', Eood — Sofia, Bulgaria
• Dr. Chih-Ho Hong Medical Inc. — Surrey, British Columbia, Canada
• Simcomed Health Ltd — Barrie, Ontario, Canada
• Xlr8 Medical Research — Windsor, Ontario, Canada
• Fakultni Nemocnice U Sv. Anny V Brne — Brno, Czechia
• Clintrial SRO — Prague, Czechia
• Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z. — Ústí nad Labem, Czechia
• Charite Universitaetsmedizin Berlin - Campus Charite Mitte — Berlin, Germany

Full record on ClinicalTrials.gov

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