NCT05233410WithdrawnPhase 3
Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2
Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2 (TRuE-CHE2): 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 10 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- Withdrawn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
- 1 Feb 2022
- Start date
- 31 Jan 2023
- Primary completion date
- 25 Apr 2024
- Lead sponsor
- Incyte Corporation
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05233410
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 (38)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Unimed Eood | Sevlievo | Bulgaria | Unknown status |
| MC Synexus Sofia EOOD | Sofia | Bulgaria | Unknown status |
| Dcc Xxviii | Sofia | Bulgaria | Unknown status |
| DCC Alexandrovska EOOD | Sofia | Bulgaria | Unknown status |
| Medical Center Hera EOOD | Sofia | Bulgaria | Unknown status |
| Simcomed Health Ltd | Barrie | Canada | Unknown status |
| Dr Chih-Ho Hong Medical Inc | Surrey | Canada | Unknown status |
| XLR8 Medical Research | Windsor | Canada | Unknown status |
| Fakultni nemocnice u sv. Anny v Brne | Brno | Czechia | Unknown status |
| Clintrial sro | Prague | Czechia | Unknown status |
| Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. | Ústí nad Labem | Czechia | Unknown status |
| Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Berlin | Germany | Unknown status |
| Universitaetsklinikum Frankfurt | Frankfurt | Germany | Unknown status |
| Derma-Study-Center Friedrichshafen GmbH | Friedrichshafen | Germany | Unknown status |
| Dermatologikum Hamburg Gemeinschaftspraxis GbR | Hamburg | Germany | Unknown status |
| Universitaetsklinikum Schleswig-Holstein - Campus Luebeck | Lübeck | Germany | Unknown status |
| Gemeinschaftspraxis | Mahlow | Germany | Unknown status |
| Beldio Research Gmbh | Memmingen | Germany | Unknown status |
| Dermatologische Klinik Der Technischen Universitat Munchen | München | Germany | Unknown status |
| KliFOs - Klinische Forschung Osnabrück | Osnabrück | Germany | Unknown status |
| Hospital General Universitario de Alicante | Alicante | Spain | Unknown status |
| Hospital Universitario Quirónsalud Madrid | Madrid | Spain | Unknown status |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Unknown status |
| Clinica Dermomedic | Madrid | Spain | Unknown status |
| Hospital de Manises | Valencia | Spain | Unknown status |
| ETG Warszawa | Warsaw | Poland | Unknown status |
| DelRicht Research | Baton Rouge | United States | Unknown status |
| University of Alabama Hospital | Birmingham | United States | Unknown status |
| Onsite Clinical Solutions, Llc Charlotte Central Office | Charlotte | United States | Unknown status |
| Marvel Clinical Research, LLC | Huntington Beach | United States | Unknown status |
| Jubilee | Las Vegas | United States | Unknown status |
| Froedtert & Medical College of Wisconsin | Milwaukee | United States | Unknown status |
| The Indiana Clinical Trials Center Ictc | Plainfield | United States | Unknown status |
| Progressive Clinical Research | San Antonio | United States | Unknown status |
| Midwest Allergy Sinus Asthma, Sc | Springfield | United States | Unknown status |
| ForCare Clinical Research | Tampa | United States | Unknown status |
| Advanced Rx Clinical Research | Westminster | United States | Unknown status |
| Advanced RX Clin Research | Westminster | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.