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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Withdrawn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
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

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medical Center Unimed EoodSevlievoBulgariaUnknown status
MC Synexus Sofia EOODSofiaBulgariaUnknown status
Dcc XxviiiSofiaBulgariaUnknown status
DCC Alexandrovska EOODSofiaBulgariaUnknown status
Medical Center Hera EOODSofiaBulgariaUnknown status
Simcomed Health LtdBarrieCanadaUnknown status
Dr Chih-Ho Hong Medical IncSurreyCanadaUnknown status
XLR8 Medical ResearchWindsorCanadaUnknown status
Fakultni nemocnice u sv. Anny v BrneBrnoCzechiaUnknown status
Clintrial sroPragueCzechiaUnknown status
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.Ústí nad LabemCzechiaUnknown status
Charite Universitaetsmedizin Berlin - Campus Charite MitteBerlinGermanyUnknown status
Universitaetsklinikum FrankfurtFrankfurtGermanyUnknown status
Derma-Study-Center Friedrichshafen GmbHFriedrichshafenGermanyUnknown status
Dermatologikum Hamburg Gemeinschaftspraxis GbRHamburgGermanyUnknown status
Universitaetsklinikum Schleswig-Holstein - Campus LuebeckLübeckGermanyUnknown status
GemeinschaftspraxisMahlowGermanyUnknown status
Beldio Research GmbhMemmingenGermanyUnknown status
Dermatologische Klinik Der Technischen Universitat MunchenMünchenGermanyUnknown status
KliFOs - Klinische Forschung OsnabrückOsnabrückGermanyUnknown status
Hospital General Universitario de AlicanteAlicanteSpainUnknown status
Hospital Universitario Quirónsalud MadridMadridSpainUnknown status
Hospital General Universitario Gregorio MarañónMadridSpainUnknown status
Clinica DermomedicMadridSpainUnknown status
Hospital de ManisesValenciaSpainUnknown status
ETG WarszawaWarsawPolandUnknown status
DelRicht ResearchBaton RougeUnited StatesUnknown status
University of Alabama HospitalBirminghamUnited StatesUnknown status
Onsite Clinical Solutions, Llc Charlotte Central OfficeCharlotteUnited StatesUnknown status
Marvel Clinical Research, LLCHuntington BeachUnited StatesUnknown status
JubileeLas VegasUnited StatesUnknown status
Froedtert & Medical College of WisconsinMilwaukeeUnited StatesUnknown status
The Indiana Clinical Trials Center IctcPlainfieldUnited StatesUnknown status
Progressive Clinical ResearchSan AntonioUnited StatesUnknown status
Midwest Allergy Sinus Asthma, ScSpringfieldUnited StatesUnknown status
ForCare Clinical ResearchTampaUnited StatesUnknown status
Advanced Rx Clinical ResearchWestminsterUnited StatesUnknown status
Advanced RX Clin ResearchWestminsterUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.