NCT06238817已完成3 期
A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 188
- 主要终点
- VC Period: Proportion of participants who achieved Investigator's Global Assessment Treatment Success (IGA-TS)
研究概览
简要总结
This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •EASI score > 7 at screening and Day
- •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
- •DLQI score > 10 at screening and Day
- •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.
排除标准
- •Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day
- •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
- •Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before Day
- •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.
研究组 & 干预措施
VC Extension Period: Ruxolitinib 1.5% cream open-label escape arm
Experimental
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
干预措施: Ruxolitinib Cream (Drug)
VC Period: Vehicle Cream BID
Placebo Comparator
Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
干预措施: Vehicle Cream (Drug)
VC Period: Ruxolitinib 1.5% Cream BID
Experimental
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
干预措施: Ruxolitinib Cream (Drug)
VC Extension Period/Escape Arm: Vehicle Cream BID
Placebo Comparator
Participants who applied vehicle cream during the VC Period, continued applying vehicle cream as a thin film twice daily (BID) from Weeks 8 to 24 during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants will be eligible to enter the ruxolitinib 1.5% cream open-label escape arm as defined in the protocol.
干预措施: Vehicle Cream (Drug)
VC Extension Period/Escape Arm: Ruxolitinib 1.5% Cream BID
Experimental
Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 24 during the Vehicle Control Extension (VCE) Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
干预措施: Ruxolitinib Cream (Drug)
结局指标
主要结局
VC Period: Proportion of participants who achieved Investigator's Global Assessment Treatment Success (IGA-TS)
时间窗: Baseline to Week 8
Defined as Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2 grade improvement from baseline.
VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75)
时间窗: Baseline to Week 8
Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score.
次要结局
- 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.(Baseline to Day 1)
- VC Period: Time to achieve a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)(Baseline to Week 8)
- VC and VCE Periods: Change from baseline in SCORAD score(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- 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(Baseline to Week 24)
- VC Period: Proportion of participants who experience a relapse after study treatment discontinuation(Week 24 to Follow-up (30 days))
- VC Period: Proportion of participants who achieved Investigator's Global Assessment - Treatment Success (IGA-TS)(Baseline to Weeks 2 and 4)
- 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.(Baseline to Day 1)
- VC and VCE Periods: Proportion of participants achieving both EASI75 and IGA-TS(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VCE Period: Time to open-label escape arm(Baseline to Week 24)
- VC Period: Proportion of participants with a ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)(Baseline to Weeks 2 and 4)
- VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75)(Baseline to Weeks 2 and 4)
- VC Period: Time to achieve ≥ 2-point improvement from in Itch Numeric Rating Scale (NRS) score (ITCH2)(Baseline to Week 8)
- 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.(Baseline to Day 1)
- VC and VCE Periods: Change from baseline in EASI score(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VC and VCE Periods: Change from baseline in Skin Pain NRS score(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VC and VCE Periods: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VC and VCE Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VC Period: Number of Treatment Emergent Adverse Events (TEAEs)(Up to Week 24, followed by 30 days follow-up)
- VC and VCE Periods: Proportion of participants who achieved EASI90(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VC and VCE Periods: Change from Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VC and VCE Periods: Change from baseline in Itch NRS score(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- 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(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VC and VCE Periods: Proportion of participants who achieve ≥ 4-point improvement in DLQI from baseline(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VC and VCE Periods: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VC and VCE Periods: Proportion of participants who achieved EASI50(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VCE period: Time to first re-treatment(Week 8 to Week 24)
- VC and VCE Periods: Change from baseline in the HADS scores(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VCE Period: Proportion of time off study treatment due to lesion clearance(Week 8 to Week 24)
- VCE period: Proportion of time on study treatment(Week 8 to Week 24)
- VC and VCE Periods: Change From Baseline in Dermatology Life Quality Index (DLQI) Score(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VC and VCE Periods: Change from baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score(Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24)
- VC and VCE Periods: Change from baseline score in Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD)(Baseline to Week 8 and Week 24)
研究者
研究点 (188)
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