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Hand EczemaPhase 3TRuE-CHE1NCT05219864

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

A Phase 3 study testing Ruxolitinib cream in people with Hand Eczema, run by Incyte Corporation at 49 sites in 6 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Hand Eczema
What is being tested?
Ruxolitinib cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
49 sitesin 6 countries
Study dates
31 Jan 2023to 22 Sep 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

49 sites in 6 countries.

49 sites in 6 countries

United States26 sites

  • Raoof Md Encino

    Encino, California, 91436

  • First Oc Dermatology

    Fountain Valley, California, 92708

  • Grafton Dermatology and Cosmetic Surgery

    Houma, Louisiana, 70364

  • Austin Institute For Clinical Research Aicr Pflugerville

    Houston, Texas, 77056

  • Marvel Clinical Research Llc

    Huntington Beach, California, 92647

  • Jubilee Clinical Research Inc

    Las Vegas, Nevada, 89106

  • Dermatologist Specialist

    Louisville, Kentucky, 40241

  • Delricht Research

    Marietta, Georgia, 30060

  • Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center

    Memphis, Tennessee, 38119

  • Well Pharma Medical Research Corporation

    Miami, Florida, 33173

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee, 37130

  • University of Utah

    Murray, Utah, 84107

  • Delricht Research

    New Orleans, Louisiana, 70115

  • Juva Skin and Laser Center

    New York, New York, 10022

  • Psoriasis Treatment Center of South Florida

    Pembroke Pines, Florida, 33028

  • Southwest Skin Specialists Phoenix Biltmore

    Phoenix, Arizona, 85018

  • Oregon Medical Research Center

    Portland, Oregon, 97223

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • West End Dermatology Associates

    Richmond, Virginia, 23233

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Dermatology Specialists of Spokane

    Spokane, Washington, 99202

  • Midwest Allergy Sinus Asthma, Sc

    Springfield, Illinois, 62604

  • Washington University

    St Louis, Missouri, 63110

  • Lenus Research Medical Group, Llc

    Sweetwater, Florida, 33172

  • Center For Clinical Studies Webster

    Webster, Texas, 77598

Other trials in United States

Germany7 sites

  • Klinikum Der Johann Wolfgang Goethe-Universitaet

    Frankfurt, 60590

  • Derma-Study-Center Friedrichshafen Gmbh

    Friedrichshafen, 88045

  • Dermatologikum Hamburg Gemeinschaftspraxis Gbr

    Hamburg, 20354

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105

  • Praxis Dr. Beate Schwarz

    Langenau, 89129

  • Beldio Research Gmbh

    Memmingen, 87700

  • Klifos - Klinische Forschung Osnabruck

    Osnabrück, 49074

Other trials in Germany

Czechia5 sites

  • Fakultni Nemocnice U Sv. Anny V Brne

    Brno, 656 91

  • Ccr Ostrava S.R.O.

    Ostrava, 702 00

  • Ccr Czech A.S.

    Pardubice, 53000

  • Clintrial S.R.O.

    Prague, 100 00

  • Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.

    Ústí nad Labem, 401 13

Other trials in Czechia

Spain5 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital de Manises

    Manises, 46940

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223

Other trials in Spain

Canada4 sites

  • Cca Medical Research

    Ajax, Ontario, L1S 7K8

  • Dermatology Research Institute Inc.

    Calgary, Alberta, T2J 7E1

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3

  • Care Clinic

    Red Deer, Alberta, T4P-1K4

Other trials in Canada

Poland2 sites

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.

    Elblag, 82-300

  • Etg Warszawa

    Warsaw, 02-793

Other trials in Poland

About this study

Official title: 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

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).

Conditions
Hand Eczema
Being tested
Ruxolitinib cream, Vehicle
Keywords
eczema, chronic hand eczema (CHE), dermatitis, skin disease, JAK inhibitor
Medical subject headings
Eczema, Dermatitis, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ruxolitinib creamDrug

    Also called INCB18424 cream

    Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

  • VehicleDrug

    Vehicle cream is a topical formulation applied as a thin film to affected areas.

Study groups in NCT05219864
Study groupRoleWhat they receive
RuxolitinibExperimentalRuxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.
Receives: Drug: Ruxolitinib cream
VehiclePlacebo comparatorVehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.
Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)

    The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.

    Measured: Week 16

Secondary outcomes (14)

  1. Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score

    The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis.

    Measured: Week 16

  2. Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score

    The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).

    Measured: Week 16

  3. Change from baseline in the modified Total Lesion Symptom Score (mTLSS)

    The mTLSS is a validated tool for assessing hand eczema. The scale quantifies the 7 features (erythema, scaling, hyperkeratosis/lichenification, vesiculation, oedema, fissures, and pruritus/pain) of HE (0 = none, 1 = mild, 2 = moderate, and 3 = severe).

    Measured: Up to Week 32

  4. Proportion of participants achieving an IGA-CHE-TS from baseline

    The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.

    Measured: Up to Week 32

  5. Change from baseline in CHE-related Itch Numerical Rating Scale (NRS) score (weekly average)

    The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).

    Measured: Up to Week 32

  6. Change from baseline in CHE-related Pain NRS score (weekly average)

    The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).

    Measured: Up to Week 32

  7. Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score

    The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis.

    Measured: Up to Week 32

  8. Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score.

    The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) on a daily basis.

    Measured: Up to Week 32

  9. Percentage change in Hand Eczema Severity Index (HECSI)

    The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.

    Measured: Week 16

  10. Proportion of Participants with HECSI-75

    HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.

    Measured: Weeks 2, 8, 16 and 32

  11. Proportion of participants with HECSI-90

    HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.

    Measured: Weeks 2, 8, 16, and 32

  12. Mean Patient Global Impression of Change (PGIC) score

    The Patient Global Impression of Change (PGIC)is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.

    Measured: Up to Week 32

  13. Proportion of participants with each score on the PGIC

    The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.

    Measured: Up to Week 32

  14. Proportion of Participants with a score of either 1 or 2 on the PGIC

    The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.

    Measured: Up to Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start31 Jan 2023 (estimated)
  3. Primary completion25 Apr 2024 (estimated)
  4. Study completion22 Sep 2024 (estimated)

Why it stopped: Business decision; no safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will receive ruxolitinib cream (1.5%) or vehicle cream for 16 weeks, after which they will be offered the opportunity to receive ruxilitinib cream (1.5%) in the open-label treatment extension period for another 16 weeks.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05219864
Sponsor's protocol ID
INCB 18424-313
Acronym
TRuE-CHE1
Status last verified
Nov 2022
First submitted
21 Jan 2022
Last updated
17 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ruxolitinib cream in people with Hand Eczema, run by Incyte Corporation at 49 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Germany, Czechia, Spain, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05219864.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.

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