2024-518156-24-00招募中3 期
INCB018424-316: 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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 150
- 试验地点
- 54
- 主要终点
- The binary response status of EASI75 at VC Week 8. (EASI75 response is defined as achieving ≥ 75% improvement in EASI score from baseline.)
研究概览
简要总结
To evaluate the efficacy of ruxolitinib cream in children and adolescents (6 to < 18 years old) with moderate AD who have an inadequate response to, or are intolerant to, or contraindicated to TCS and TCI.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Aged 6 to < 18 years at the VC Day 1 visit.
- •For sexually active participants, willingness to take appropriate contraceptive measures (see Appendix A of the protocol) to avoid pregnancy or fathering a child for the duration of study participation with the exception of prepubescent participants.
- •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 Section 8.1.1 and Section 8.1.2 of the protocol.
- •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.
- •Itch NRS or WI NRS score ≥ 4 at the VC Day 1 visit, 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: a. 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. b. 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. c. 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 Section 6.6.2 and Section 6.6.
- •of 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 the VC Day 1 visit.
- •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).
- •Concurrent conditions and history of other diseases as follows: a. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome). b. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the VC Day 1 visit. c. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before the VC Day 1 visit. d. 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. e. 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. f. 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. g. 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: a. Hemoglobin < 10 g/dL b. 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 is fractionated and direct bilirubin < 35%) with the exception of Gilbert disease c. Estimated glomerular filtration rate < 30 mL/min/1.73 m 2 (using the Revised [bedside] Schwartz equation) d. Positive serology test results for HIV antibody e. 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: a. 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. b. 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. c. 2 weeks or 5 half-lives, whichever is longer: strong systemic CYP3A4 inhibitors. d. 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. And etc.
- •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.
结局指标
主要结局
The binary response status of EASI75 at VC Week 8. (EASI75 response is defined as achieving ≥ 75% improvement in EASI score from baseline.)
The binary response status of EASI75 at VC Week 8. (EASI75 response is defined as achieving ≥ 75% improvement in EASI score from baseline.)
次要结局
- The binary response status of IGA-TS at VC Week 8. (IGA-TS response is defined as achieving an IGA score of 0 or 1 with ≥ 2-grade improvement from baseline.)
- The binary response status of ITCH4 at VC Week 8. (ITCH4 response is defined as achieving ≥ 4-point improvement in Itch NRS [participants aged 12 to < 18 years] or WI NRS [participants aged 6 to < 12 years] score from baseline.)
- Time to first 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.)
- The type, frequency, and severity of AEs and changes in vital signs, height, weight, and laboratory data for hematology and serum chemistry.
- The binary response status of EASI75 at each postbaseline visit except VC Week 8.
- The binary response status of IGA-TS at each postbaseline visit except VC Week 8.
- The binary response status of ITCH4 at Days 2, 3, and 7 and VC Weeks 2 and 4.
- Time to achieve ITCH4 during the VC period.
- The binary response status of both EASI75 and IGA-TS at each postbaseline visit in the VC period.
- The binary response status of DLQI-4 (or CDLQI-4) at VC Weeks 2, 4, and 8 (DLQI-4 (or CDLQI-4) is defined as achieving ≥ 4-point improvement in DLQI (or CDLQI) from baseline.)
- Change from baseline at each postbaseline visit in the VC period and DC period for the following: − DLQI (or CDLQI) score − POEM score
- Acceptability and tolerability assessment (exit interview/questionnaire)
- Number of DEs during the DC period.
- Amount of ruxolitinib cream used during the DC period.
- Plasma concentrations of ruxolitinib and PK parameters (Ctrough,ss) at VC Week 2 and VC Week 8 assessed in at least 10 evaluable ruxolitinib-treated participants in each of the 12 to < 18 year old and 6 to < 12 years old age groups.
研究者
Clinical Trial Information
Scientific
Incyte Corp.
研究点 (54)
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