Study to Determine the Efficacy and Safety of Ruxolitinib Cream in Adults with Moderate Atopic Dermatitis
Zusammenfassung der Studie
This is a randomized, 8-week, double-blind study with a placebo for comparison, followed by an additional 16-week period during which the placebo continues to be used for treatment. If patients do not respond to the treatment, they may switch to an open-label study with Ruxolitinib cream 1.5%. In this study, participants have double the chance of receiving Ruxolitinib cream 1.5% instead of the placebo. Participants are randomly selected and receive either Ruxolitinib cream 1.5% twice daily or a cream without active ingredients (placebo) twice daily during the first 8 weeks of the study. During the first 8 weeks, participants apply either Ruxolitinib cream 1.5% or the placebo cream to all areas identified by the investigator as needing treatment at baseline on day 1, even if these areas begin to heal gradually or improve. At week 8, participants whose skin continues to heal and whose symptoms improve will participate in an additional 16-week double-blind extension phase. Participants whose disease severity has not significantly improved after the first 8 weeks or who no longer respond adequately to treatment during the 16-week extension phase will have the option to receive Ruxolitinib cream 1.5% in a rescue arm. After week 24, the investigator will assess the health status of participants and the residual effect of the study cream during the follow-up period regarding safety (30 days). The aim of the study is to demonstrate the safety and efficacy of Ruxolitinib cream in patients with atopic dermatitis.
(BASEC)
Untersuchte Intervention
Men and women aged 18 years or older who have had moderate atopic dermatitis for at least 2 years and continue to exhibit symptoms of atopic dermatitis after failing treatment with topical corticosteroids (a type of medication used to treat various skin conditions such as eczema, psoriasis, atopic dermatitis, etc.) and topical calcineurin inhibitors (non-steroidal medications used to treat skin conditions such as eczema, atopic dermatitis, etc.), who have not tolerated these medications or are unable to use them, may be included in the study. Approximately 225 participants will be randomized in a 2:1 ratio to receive Ruxolitinib cream 1.5% or placebo cream, stratified by a baseline score on the Eczema Area and Severity Index (EASI) (< 16 or ≥ 16) and geographic region (rest of the world or Europe). Participants will apply Ruxolitinib cream 1.5% or the corresponding placebo cream in a thin layer twice daily for up to 24 weeks. During the first 8 weeks of treatment, participants should apply the cream to all affected areas identified at baseline (day 1) by the investigator, even if these areas begin to heal gradually or improve. During the next 16 weeks, participants should apply Ruxolitinib cream 1.5% or the corresponding placebo cream as needed only to areas with signs of active atopic dermatitis.
(BASEC)
Untersuchte Krankheit(en)
Atopic dermatitis, also known as eczema, is a skin condition that leads to dry, itchy, and inflamed skin. While the disease is not life-threatening, people with atopic dermatitis are at a higher risk of developing other conditions such as asthma and food allergies, which can be more severe.
(BASEC)
• Age ≥ 18 years at the time of signing the informed consent • Duration of atopic dermatitis of at least 2 years (BASEC)
Ausschlusskriterien
• Unstable course of atopic dermatitis (spontaneous improvement or rapid deterioration) • Uncontrolled cardiovascular disease • Cancer within the last 5 years prior to day 1 of the study • Infection with hepatitis B or C virus (BASEC)
Studienstandort
Basel, Bern, Zürich, Andere
(BASEC)
Buochs
(BASEC)
Sponsor
Incyte Corporation, US IQVIA AG, Branch Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. Claudia Lang
+41442551111
claudia.lang@clutterusz.chUniversitaetsspital Zürich, Klinik für Dermatologie
(BASEC)
Allgemeine Auskünfte
Incyte Corporation
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
20.08.2024
(BASEC)
ICTRP Studien-ID
NCT06238817 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis (BASEC)
Wissenschaftlicher Titel
A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis (ICTRP)
Öffentlicher Titel
A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis (ICTRP)
Untersuchte Krankheit(en)
Atopic Dermatitis (ICTRP)
Untersuchte Intervention
Drug: Ruxolitinib CreamDrug: Vehicle Cream (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Adults aged = 18 years at screening (Note: Legal adult age for Korea is = 19 years).
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.
- AD duration of at least 2 years.
- IGA score of 3 at screening and Day 1.
- EASI score > 7 at screening and Day 1.
- Itch NRS score = 4 at Day 1, defined as the average of the 7 days directly before
Day 1, with Itch NRS values available for at least 4 of the 7 days.
- %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20% at
screening and Day 1.
- DLQI score > 10 at screening and Day 1.
- Documented recent history (within 12 months before the screening visit) of
inadequate response, intolerance, or contraindication to TCSs and TCIs.
- Agree to discontinue all agents used to treat AD from screening through the final
follow up visit, except as outlined in the protocol.
- Willingness to avoid pregnancy or fathering children based on the criteria as
outlined in the protocol.
Exclusion Criteria:
- Unstable course of AD (spontaneously improving or rapidly deteriorating) as
determined by the investigator in the 4 weeks prior to Day 1.
- 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 Day 1.
- Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex,
herpes zoster, chickenpox) within 1 week before Day 1.
- 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.
- 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:
- AST or ALT = 2 ULN.
- Alkaline phosphatase > 1.5 ULN.
- Bilirubin > 1.5 ULN (isolated bilirubin > 1.5 ULN is acceptable if
bilirubin is fractionated and direct bilirubin < 35%) with the exception
of Gilbert's disease.
- Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the Chronic
Kidney Disease Epidemiology Collaboration 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
Day 1:
- 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 agents (eg, mycophenolate or
tacrolimus).
- 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.
- In the opinion of the investigator, are unable or unlikely to comply with the
administration schedule, study evaluations, and procedures (eg, eDiary compliance).
Other protocol-defined Inclusion/Exclusion Criteria may apply. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75);VC Period: Proportion of participants who achieved Investigator's Global Assessment Treatment Success (IGA-TS) (ICTRP)
VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4);VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4);VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4);VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4);VC Period: Number of Treatment Emergent Adverse Events (TEAEs);VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75);VC Period: Proportion of participants who achieved Investigator's Global Assessment - Treatment Success (IGA-TS);VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4);VC Period: Time to achieve a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4);VC Period: Time to achieve = 2-point improvement from in Itch Numeric Rating Scale (NRS) score (ITCH2);VC Period: Change from baseline (pre-study cream application) in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.;VC Period: Proportion of participants achieving at least a 2-point decrease from baseline in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.;VC Period: Proportion of participants achieving at least a 4-point decrease from baseline in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.;VC and VCE Periods: Proportion of participants who achieved EASI50;VC and VCE Periods: Proportion of participants who achieved EASI90;VC and VCE Periods: Proportion of participants achieving both EASI75 and IGA-TS;VC and VCE Periods: Change from Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA);VC and VCE Periods: Change from baseline in EASI score;VC and VCE Periods: Change from baseline in SCORAD score;VC and VCE Periods: Change from baseline in Itch NRS score;VC and VCE Periods: Change from baseline in Skin Pain NRS score;VCE Period: Time to open-label escape arm;VC and VCE Periods: Proportion of participants concurrently meeting all of the following criteria: IGA score = 3, EASI score = 16, Itch NRS score = 4, BSA = 10%, and DLQI score > 10;VC and VCE Periods: Time to concurrently meeting all of the following criteria: IGA score = 3, EASI score = 16, Itch NRS score = 4, BSA = 10%, and DLQI score > 10;VC Period: Proportion of participants who experience a relapse after study treatment discontinuation;VCE period: Time to first re-treatment;VCE Period: Proportion of time off study treatment due to lesion clearance;VCE period: Proportion of time on study treatment;VC and VCE Periods: Proportion of participants who achieve = 4-point improvement in DLQI from baseline;VC and VCE Periods: Change From Baseline in Dermatology Life Quality Index (DLQI) Score;VC and VCE Periods: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score;VC and VCE Periods: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score;VC and VCE Periods: Change from baseline in the HADS scores;VC and VCE Periods: Change from baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score;VC and VCE Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score;VC and VCE Periods: Change from baseline score in Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Incyte Medical Monitor;Incyte Corporation Call Center (US), medinfo@incyte.com, 1.855.463.3463, Incyte Corporation, (ICTRP)
Sekundäre IDs
2023-505433-27-00, INCB18424-326 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06238817 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar