NCT05219864WithdrawnPhase 3
Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1
Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1 (TRuE-CHE1): A Phase 3, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema
Source: ClinicalTrials.gov · Last updated 17 Nov 2022
Reason given: Business decision; no safety concerns.
Brief summary (registry, in English)
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).
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 21 Jan 2022
- Start date
- 31 Jan 2023
- Primary completion date
- 25 Apr 2024
- Lead sponsor
- Incyte Corporation
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05219864
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
Lab values
- Laboratory values outside of the protocol-defined criteria.
Other
- Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
- Further exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (49)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CCA Medical Research | Ajax | Canada | Unknown status |
| Dermatology Research Institute Inc | Calgary | Canada | Unknown status |
| Lynderm Research Inc. | Markham | Canada | Unknown status |
| CaRe Clinic | Red Deer | Canada | Unknown status |
| Fakultni nemocnice u sv. Anny v Brne | Brno | Czechia | Unknown status |
| CCR Ostrava s.r.o | Ostrava | Czechia | Unknown status |
| CCR Czech a.s. | Pardubice | Czechia | Unknown status |
| Clintrial S.R.O. | Prague | Czechia | Unknown status |
| Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. | Ústí nad Labem | Czechia | Unknown status |
| Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt | Germany | Unknown status |
| Derma-Study-Center Friedrichshafen GmbH | Friedrichshafen | Germany | Unknown status |
| Dermatologikum Hamburg Gemeinschaftspraxis GbR | Hamburg | Germany | Unknown status |
| Universitaetsklinikum Schleswig-Holstein | Kiel | Germany | Unknown status |
| Praxis Dr. Beate Schwarz | Langenau | Germany | Unknown status |
| Beldio Research Gmbh | Memmingen | Germany | Unknown status |
| KliFOs - Klinische Forschung Osnabrück | Osnabrück | Germany | Unknown status |
| Hospital General Universitario de Alicante | Alicante | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Unknown status |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Unknown status |
| Hospital de Manises | Manises | Spain | Unknown status |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Spain | Unknown status |
| Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O. | Elblag | Poland | Unknown status |
| ETG Warszawa | Warsaw | Poland | Unknown status |
| Raoof Md Encino | Encino | United States | Unknown status |
| First OC Dermatology | Fountain Valley | United States | Unknown status |
| Grafton Dermatology and Cosmetic Surgery | Houma | United States | Unknown status |
| Austin Institute For Clinical Research Aicr Pflugerville | Houston | United States | Unknown status |
| Marvel Clinical Research, LLC | Huntington Beach | United States | Unknown status |
| Jubilee Clinical Research, Inc. | Las Vegas | United States | Unknown status |
| Dermatologist Specialist | Louisville | United States | Unknown status |
| Delricht Research | Marietta | United States | Unknown status |
| Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center | Memphis | United States | Unknown status |
| Well Pharma Medical Research Corporation | Miami | United States | Unknown status |
| International Clinical Research - Tennessee LLC | Murfreesboro | United States | Unknown status |
| University of Utah | Murray | United States | Unknown status |
| Delricht Research | New Orleans | United States | Unknown status |
| Juva Skin and Laser Center | New York | United States | Unknown status |
| Psoriasis Treatment Center of South Florida | Pembroke Pines | United States | Unknown status |
| Southwest Skin Specialists Phoenix Biltmore | Phoenix | United States | Unknown status |
| Oregon Medical Research Center | Portland | United States | Unknown status |
| Oregon Health Science University | Portland | United States | Unknown status |
| West End Dermatology Associates | Richmond | United States | Unknown status |
| Arlington Dermatology | Rolling Meadows | United States | Unknown status |
| Progressive Clinical Research | San Antonio | United States | Unknown status |
| Dermatology Specialists of Spokane | Spokane | United States | Unknown status |
| Midwest Allergy Sinus Asthma, Sc | Springfield | United States | Unknown status |
| Washington University | St Louis | United States | Unknown status |
| LENUS Research & Medical Group, LLC | Sweetwater | United States | Unknown status |
| Center for Clinical Studies - Webster | Webster | United States | Unknown status |
Are you the coordinator? Confirm the details
In 6 countries, 49 sites
United States 26, Germany 7, Czechia 5, Spain 5, Canada 4, Poland 2
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.