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Atopic DermatitisPhase 3TRuE-AD5NCT06832618

A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis

A Phase 3 study testing Ruxolitinib in people with Atopic Dermatitis, run by Incyte Corporation at 93 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to <18 Years Old) with moderate atopic dermatitis. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Ruxolitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
159 participants
Where
93 sitesin 10 countries
Study dates
17 Jun 2025to 6 Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Aged 6 to < 18 years at the VC Day 1 visit.
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.
  • AD duration of at least 3 months for 6 to 11 year olds and at least 2 years for 12 to < 18 year olds (participant/parent/guardian may verbally report signs and symptoms of AD).
  • EASI score > 7 at the screening and VC Day 1 visits.
  • IGA score of 3 at the screening and VC Day 1 visits.
  • Percent BSA (excluding the scalp) with AD involvement of at least 3% and up to 20% at the screening and VC Day 1 visits.
Show all 20Show fewer
  • Itch NRS or WI NRS score ≥ 4 at the screening and VC Day 1 visits, defined as the average of the 7 days directly before the VC/Day 1 visit, with Itch NRS or WI NRS values available for at least 4 of the 7 days.
  • Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs as follows:
  • Inadequate response:
  • For TCSs: Inability of a given TCS to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 [clear] or 1 [almost clear]) despite treatment for 28 days or for the maximum duration recommended by the product prescribing information (eg, 14 days for superpotent TCSs), whichever is shorter and
  • For TCIs: Inability of a given TCI to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 [clear] or 1 [almost clear]) despite treatment according to the product prescribing information.
  • Note: Documented (within 12 months before the screening visit) systemic treatment for AD (eg, oral corticosteroids, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil) or phototherapy or photo(chemo)therapy can also be considered as a surrogate for inadequate response to TCSs and TCIs.
  • Intolerance: Clinically relevant side effects, safety risks, or skin tolerability issues that outweigh the potential treatment benefits and are the reason why a topical treatment could not be restarted or continued.
  • Note: Documented history (more than 12 months prior to the screening visit) of clinically significant adverse reactions with use of TCSs and/or TCIs that in the opinion of the investigator outweigh the benefits of restarting treatment would also be considered as evidence of intolerance.
  • Contraindication: As defined in the product prescribing information.
  • Agreement by participants and guardians to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit, except as outlined in the protocol.
  • For sexually active participants, willingness to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of prepubescent participants.
  • Note: Female participants who have reached menarche must have a negative urine pregnancy test at the screening and baseline visits before the first application of study cream at baseline. They must also take appropriate precautions to avoid pregnancy from the screening visit through the safety follow-up visit.
  • Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and a verbal or written assent from the participant when possible.
  • Note: A signed written ICF must be obtained for inclusion; see protocol.

Who cannot join

  • Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to the VC Day 1 visit.
  • Concurrent conditions and history of other diseases as follows:
  • Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
  • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the VC Day 1 visit.
  • Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before the VC Day 1 visit.
  • Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome), pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
Show all 40Show fewer
  • Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds.
  • Other types of eczema within the 6 months prior to screening. Note: Seborrheic dermatitis on the scalp is allowed, as the scalp will not be treated with study cream.
  • 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 cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Any of the following clinical laboratory test results at screening:
  • Hemoglobin < 10 g/dL.
  • Liver function tests:
  • Absolute neutrophil count < 1000/μL.
  • Platelet count < 100,000/μL.
  • AST or ALT ≥ 2 × ULN.
  • Alkaline phosphatase > 1.5 × ULN.
  • Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin isfractionated and direct bilirubin < 35%) with the exception of Gilbert disease.
  • Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the Modification of Diet in Renal Disease equation).
  • Positive serology test results for HIV antibody.
  • Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.
  • Use of any of the following treatments within the indicated washout period before the VC Day 1 visit:
  • 5 half-lives or 12 weeks, whichever is longer: biologic agents. For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor.
  • 4 weeks: systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive (eg, JAK inhibitors) or immunomodulating (eg, mycophenolate or tacrolimus) agents.
  • 2 weeks or 5 half-lives, whichever is longer: strong systemic CYP3A4 inhibitors.
  • 2 weeks: immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted).
  • Note: COVID-19 vaccination is allowed.
  • 1 week: use of other topical treatments for AD, other than bland emollients (eg, Aveeno® creams, ointments, sprays, soap substitutes), such as antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap.
  • Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.
  • History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, upadacitinib) for AD or any other inflammatory condition.
  • Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study that is thought by the investigator to potentially impact the participant's AD.
  • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug Protocol.
  • Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
  • Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
  • Known allergy or reaction to any component of the study cream formulation.
  • In the opinion of the investigator, unable or unlikely to comply with the administration schedule, study evaluations, and procedures (eg, eDiary compliance).
  • Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
  • Employees of the sponsor, sponsor delegates (eg, contract research organizations), or investigators or are otherwise dependents of them.
  • The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.
  • In the EU, participants considered incapacitated (according to CTR Article 31).

Trial locations and contacts

93 sites in 10 countries.

93 sites in 10 countries

United States20 sites

  • Oakland Hills Dermatology Pc

    Auburn Hills, Michigan, 48326

  • University of Texas Physicians - Bellaire Station

    Bellaire, Texas, 77401

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Red River Research Partners

    Bolivar, Missouri, 65613

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Lane Dermatology and Dermatologic Surgery

    Columbus, Georgia, 31904

  • Cleaver Medical Group

    Cumming, Georgia, 30040

  • National Jewish Health

    Denver, Colorado, 80206

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Encore Medical Research, Llc Hollywood

    Hollywood, Florida, 33024

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Raven Clinical Research

    Marriottsville, Maryland, 21104

  • Frontier Dermatology

    Mill Creek, Washington, 98012

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Sneeze Wheeze and Itch Associates Llc

    Normal, Illinois, 61761

  • Saguaro Dermatology

    Phoenix, Arizona, 85008

  • University of Rochester Medical Center

    Rochester, New York, 14620

  • Medisearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Endeavor Health Medical Group

    Skokie, Illinois, 60077

Other trials in United States

Canada13 sites

  • Kirk Barber Research

    Calgary, Alberta, T2G 1B1

  • Dermatology Research Institute Inc.

    Calgary, Alberta, T2J 7E1

  • Laster Rejuvenation Clinics Edmonton D.T. Inc.

    Edmonton, Alberta, T5J 3S9

  • Leader Research

    Hamilton, Ontario, L8L 3C3

  • Centre de Recherche Saint-Louis

    Montreal, Quebec, H1Y3LI

  • Chu Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • Chu de Quebec Universite Laval

    Québec, Quebec, G1V 4G2

  • Skinsense Medical Research

    Saskatoon, Saskatchewan, S7K 2C1

  • Skincare Studio Dermatology Centre

    St. John's, A1E 1V4

  • Dr. Chih-Ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7

  • Facet Dermatology

    Toronto, Ontario, M4E 1R7

  • University of British Columbia (Ubc) - British Columbia Children'S Hospital (Bc Children'S Hospital)

    Vancouver, British Columbia, V6H 3V4

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Poland13 sites

  • Centrum Badan Klinicznych Pi-House Sp. Z O.O.

    Gdansk, 80-546

  • Gyncentrum Sp. Z O.O.

    Katowice, 40-600

  • Grazyna Pulka Centrum Medyczne All Med Spolka Komandytowa

    Krakow, 30-033

  • Diamond Clinic Sp. Z O.O.

    Krakow, 31-559

  • Dermoklinika

    Lodz, 90-436

  • Clinical Best Solutions Sp. Z O.O. Sp. K.

    Lublin, 20-011

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71- 500

  • Mics Centrum Medyczne Toruń

    Torun, 87-100

  • Mics Centrum Medyczne Warszawa Chlodna

    Warsaw, 00-872

  • High-Med Przychodnia Specjalistycza

    Warsaw, 01-817

  • Centrum Medyczne Evimed

    Warsaw, 02-625

  • Etg Warszawa

    Warsaw, 02-677

  • Dermmedica Sp. Z O.O.

    Wroclaw, 51-503

Other trials in Poland

Spain10 sites

  • Hospital General Unviersitario de Alicante

    Alicante, 03010

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, 08950

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario de La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Madrid, 28222

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital de Manis

    Manises, 46940

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706

Other trials in Spain

Germany9 sites

  • Fachklinik Bad Bentheim Dermatologie

    Bad Bentheim, 48455

  • Universitatsklinikum Bonn Aoer

    Bonn, 53127

  • Drk Krankenhaus Chemnitz-Rabenstein

    Chemnitz, 09117

  • Universitaetsklinikum Carl Gustav Carus Tu Dresden

    Dresden, 01307

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590

  • Universitatsmedizin Goettingen

    Göttingen, 37075

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131

  • Universitatsklinikum Munster

    Münster, 48149

Other trials in Germany

Hungary8 sites

  • Clinexpert Kft.

    Budapest, 01033

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 01036

  • Geomedical Orvosi Kft.

    Budapest, 01066

  • Semmelweis Egyetem

    Budapest, 01083

  • Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

    Debrecen, 04032

  • Bacs-Kiskun Varmegyei Oktatokorhaz

    Kecskemét, 06000

  • Pecsi Tudomanyegyetem

    Pécs, 07632

  • Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 06720

Other trials in Hungary

Belgium6 sites

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200

  • Az Sint-Lucas

    Ghent, 09000

  • Universitair Ziekenhuis Gent

    Ghent, 09000

  • Grand Hôpital de Charleroi-Les Viviers

    Gilly, 06060

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 04000

  • Dermatologie Maldegem

    Maldegem, 09990

Other trials in Belgium

United Kingdom6 sites

  • West Glasgow Ambulatory Care Hospital

    Glasgow, G3 8SJ

  • St John'S Institute of Dermatology

    London, SE1 7EH

  • The Adam Practice

    Metropolitan Borough of Wirral, CH49 5PE

  • University of Nottingham Health Service

    Nottingham, NG7 2QW

  • Sheffield Childrens Hospital

    Sheffield, S10 2TH

  • Walsall Manor Hospital

    Walsall, WS2 9PS

Other trials in United Kingdom

Italy5 sites

  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco

    Catania, 95123

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122

  • Azienda Ospedaliera Universitaria Federico Ii

    Naples, 80131

  • Azienda Ospedale Universita Di Padova

    Padova, 35128

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Rome, 00168

Other trials in Italy

France3 sites

  • Bordeaux Chu Hopital Saint - Andre

    Bordeaux, 33000

  • Polyclinique Reims-Bezannes

    Reims, 51100

  • Hopitaux Drome Nord

    Romans-sur-Isère, 26102

Other trials in France

About this study

Official title: A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to <18 Years Old) with moderate atopic dermatitis.

Being tested
Ruxolitinib, Vehicle Cream
Keywords
Atopic Dermatitis, Ruxolitinib
Medical subject headings
Dermatitis, Atopic

What participants receive

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

  • RuxolitinibDrug

    Also called Opzelura

    The study cream will be applied topically as defined in the protocol for each period.

  • Vehicle CreamDrug

    Also called Placebo

    Matching vehicle cream will be applied topically as defined in the protocol for each period.

Study groups in NCT06832618
Study groupRoleWhat they receive
Vehicle-controlled (VC) Period: Ruxolitinib (1.5% Cream)ExperimentalStudy drug will be administered twice daily.
Receives: Drug: Ruxolitinib
VC Period: Vehicle CreamPlacebo comparatorMatching vehicle cream will be administered twice daily.
Receives: Drug: Vehicle Cream
Disease Control (DC) Period: Ruxolitinib (1.5% Cream)ExperimentalStudy drug will be administered twice weekly.
Receives: Drug: Ruxolitinib
DC Period: Vehicle CreamPlacebo comparatorMatching vehicle cream will be administered twice weekly.
Receives: Drug: Vehicle Cream
DC Period: Open Label - Ruxolitinib (1.5% Cream)ExperimentalStudy drug will be administered twice daily to treat Disease Exacerbations.
Receives: Drug: Ruxolitinib
Open-label Extension (OLE) period: Ruxolitinib (1.5% Cream)ExperimentalStudy drug will be administered twice daily.
Receives: Drug: Ruxolitinib

What is being measured

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

  1. VC Period: Binary response status of Eczema Area and Severity Index 75 (EASI75)

    Defined as achieving ≥ 75% improvement in Eczema Area and Severity Index (EASI) score from baseline.

    Measured: VC Week 8

Secondary outcomes (16)

  1. VC Period: Binary response status of Investigator's Global Assessment Treatment Success (IGA-TS)

    Defined as achieving Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2-grade improvement from baseline.

    Measured: VC Week 8

  2. VC Period: Binary response status of ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

    Defined as achieving ≥ 4-point improvement in Itch NRS [participants aged 12 to < 18 years] or Worst Itch Numerical Rating Scale (WI NRS) [participants aged 6 to < 12 years] score from baseline.

    Measured: VC Week 8

  3. DC Period: Time to first disease exacerbation, defined as Investigator's Global Assessment score of ≥ 2 (DE) in the DC period

    Defined as responders [IGA score < 2] from the VC period or the OLE period rerandomized to proactive treatment, time to first DE, where DE is defined as IGA score of ≥ 2.)

    Measured: Up to 44 Weeks

  4. Number of Treatment Emergent Adverse Events (TEAEs)

    Defined as any AE reported for the first time or worsening of a pre-existing event after the first application of study cream.

    Measured: From Baseline up to 70 weeks

  5. Binary response status of Eczema Area and Severity Index 75 (EASI75) at each postbaseline visit except Week 8

    Defined as achieving ≥ 75% improvement in Eczema Area and Severity Index (EASI) score from baseline.

    Measured: Up to 44 weeks

  6. Binary response status of Investigator's Global Assessment Treatment Success (IGA-TS) at each postbaeline visit except Week 8

    Defined as achieving Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2-grade improvement from baseline.

    Measured: Up to 44 weeks

  7. Binary response status of ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)

    Defined as achieving ≥ 4-point improvement in Itch NRS [participants aged 12 to < 18 years] or Worst Itch Numerical Rating Scale (WI NRS) [participants aged 6 to < 12 years] score from baseline.

    Measured: Days 2, 3, and 7 and VC Weeks 2 and 4

  8. VC Period: Time to achieve ITCH4

    Defined as time to achieve ≥ 4-point improvement in Itch NRS [participants aged 12 to < 18 years] or Worst Itch Numerical Rating Scale (WI NRS) [participants aged 6 to < 12 years] score from baseline.

    Measured: Up to 8 weeks

  9. VC Period: Binary response status of both EASI75 and IGA-TS at each postbaseline visit in the VC period

    Measured: Up to 44 weeks

  10. VC Period: The binary response status of DLQI-4/CDLQI-4 at VC Weeks 2, 4, and 8

    Dermatology Life Quality Index (DLQI)-4/ Children's Dermatology Life Quality Index (CDLQI)-4 is defined as achieving ≥ 4-point improvement in DLQI/CDLQI from baseline.

    Measured: Weeks 2, 4 and 8

  11. VC Period and DC Period: Change from baseline in the CDLQI (or DLQI) score at each postbaseline visit

    The DLQI will be administered to participants aged 16 and 17 years. The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. The CDLQI will be administered to participants aged 6 to 15 years. The CDLQI is a simple validated questionnaire to measure how much the skin problem has affected the participant over the past week (7-day recall). The higher the score, the more quality of life is impaired.

    Measured: Up to 52 weeks

  12. VC Period and DC Period: Change from baseline in the Patient-Oriented Eczema Measure (POEM) score at each postbaseline visit

    The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. A negative change from Baseline indicates improvement.

    Measured: Up to 52 weeks

  13. VC Period and DC Period: Acceptability and tolerability assessment (exit interview/questionnaire)

    The overall impression of the acceptability and tolerability of study cream will be assessed quantitatively using the Pediatric Impression of Cream Acceptability and Tolerability questionnaire. This is a structured questionnaire with 2 questions: one for assessing overall impression of acceptability and one for assessing tolerability. Each question has 4 possible response options, with a corresponding score from 1 to 4. The total score will range from 2 (most acceptable and tolerable) to 8 (least acceptable and tolerable).

    Measured: VC Period Week 8 and DC Period Week 44

  14. DC Period: Number of disease exacerbations (DEs)

    Defined as Investigator's Global Assessment score of ≥ 2.

    Measured: Up to 44 weeks

  15. DC Period: Amount of ruxolitinib cream used

    Measured: Up to 44 weeks

  16. VC Period: Plasma concentrations of ruxolitinib and PK parameters (Ctrough,ss)

    Trough and steady-state concentrations for ruxolitinib in plasma will be determined.

    Measured: VC Week 2 and VC Week 8

Timeline

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

  1. First posted18 Feb 2025
  2. Study start17 Jun 2025
  3. Primary completion7 Aug 2026
  4. Study completion6 Sep 2027 (estimated)

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06832618
Sponsor's protocol ID
INCB018424-316
Other IDs
2024-518156-24-00
Acronym
TRuE-AD5
Status last verified
Aug 2026
First submitted
4 Feb 2025
Last updated
19 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ruxolitinib in people with Atopic Dermatitis, run by Incyte Corporation at 93 sites in 10 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 20 inclusion and 40 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Canada, Poland, Spain, Germany and 5 more countries. 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?

This study is still under way. Results are not available in the source record yet.

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?

VC Period: Binary response status of Eczema Area and Severity Index 75 (EASI75) (time frame: VC Week 8). 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 NCT06832618.

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 19 Aug 2026.

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