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NCT05219864WithdrawnPhase 3

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

TRuE-CHE1 · Run by Incyte Corporation

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Withdrawn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
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

Full criteria on ClinicalTrials.gov

Sites (49)

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

SiteCityCountrySite status
CCA Medical ResearchAjaxCanadaUnknown status
Dermatology Research Institute IncCalgaryCanadaUnknown status
Lynderm Research Inc.MarkhamCanadaUnknown status
CaRe ClinicRed DeerCanadaUnknown status
Fakultni nemocnice u sv. Anny v BrneBrnoCzechiaUnknown status
CCR Ostrava s.r.oOstravaCzechiaUnknown status
CCR Czech a.s.PardubiceCzechiaUnknown status
Clintrial S.R.O.PragueCzechiaUnknown status
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.Ústí nad LabemCzechiaUnknown status
Klinikum der Johann Wolfgang Goethe-UniversitaetFrankfurtGermanyUnknown status
Derma-Study-Center Friedrichshafen GmbHFriedrichshafenGermanyUnknown status
Dermatologikum Hamburg Gemeinschaftspraxis GbRHamburgGermanyUnknown status
Universitaetsklinikum Schleswig-HolsteinKielGermanyUnknown status
Praxis Dr. Beate SchwarzLangenauGermanyUnknown status
Beldio Research GmbhMemmingenGermanyUnknown status
KliFOs - Klinische Forschung OsnabrückOsnabrückGermanyUnknown status
Hospital General Universitario de AlicanteAlicanteSpainUnknown status
Hospital de la Santa Creu i Sant PauBarcelonaSpainUnknown status
Hospital General Universitario Gregorio MarañónMadridSpainUnknown status
Hospital de ManisesManisesSpainUnknown status
Hospital Universitario Quironsalud MadridPozuelo de AlarcónSpainUnknown status
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.ElblagPolandUnknown status
ETG WarszawaWarsawPolandUnknown status
Raoof Md EncinoEncinoUnited StatesUnknown status
First OC DermatologyFountain ValleyUnited StatesUnknown status
Grafton Dermatology and Cosmetic SurgeryHoumaUnited StatesUnknown status
Austin Institute For Clinical Research Aicr PflugervilleHoustonUnited StatesUnknown status
Marvel Clinical Research, LLCHuntington BeachUnited StatesUnknown status
Jubilee Clinical Research, Inc.Las VegasUnited StatesUnknown status
Dermatologist SpecialistLouisvilleUnited StatesUnknown status
Delricht ResearchMariettaUnited StatesUnknown status
Clinical Neuroscience Solutions Cns Healthcare Memphis Research CenterMemphisUnited StatesUnknown status
Well Pharma Medical Research CorporationMiamiUnited StatesUnknown status
International Clinical Research - Tennessee LLCMurfreesboroUnited StatesUnknown status
University of UtahMurrayUnited StatesUnknown status
Delricht ResearchNew OrleansUnited StatesUnknown status
Juva Skin and Laser CenterNew YorkUnited StatesUnknown status
Psoriasis Treatment Center of South FloridaPembroke PinesUnited StatesUnknown status
Southwest Skin Specialists Phoenix BiltmorePhoenixUnited StatesUnknown status
Oregon Medical Research CenterPortlandUnited StatesUnknown status
Oregon Health Science UniversityPortlandUnited StatesUnknown status
West End Dermatology AssociatesRichmondUnited StatesUnknown status
Arlington DermatologyRolling MeadowsUnited StatesUnknown status
Progressive Clinical ResearchSan AntonioUnited StatesUnknown status
Dermatology Specialists of SpokaneSpokaneUnited StatesUnknown status
Midwest Allergy Sinus Asthma, ScSpringfieldUnited StatesUnknown status
Washington UniversitySt LouisUnited StatesUnknown status
LENUS Research & Medical Group, LLCSweetwaterUnited StatesUnknown status
Center for Clinical Studies - WebsterWebsterUnited StatesUnknown 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.