A prospective, interventional, randomized, multicentric, assessor blinded, active-controlled, parallel-group, non-inferiority clinical trial to evaluate the efficacy, safety, and tolerability of Tapinarof Topical Cream compared with Tacrolimus ointment in patients with moderate to severe atopic dermatitis.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 286
- 试验地点
- 9
研究概览
简要总结
This is a multicenter, prospective, randomized, assessor-blinded, active-controlled, parallel-group, non-inferiority Phase III clinical study designed to evaluate the efficacy, safety, and tolerability of Tapinarof topical cream compared with Tacrolimus ointment in patients with moderate to severe atopic dermatitis. Potentially eligible patients including adults aged 18 years and above and pediatric patients aged 2 years to less than 18 years with a clinical diagnosis of atopic dermatitis will be screened up to 7 days prior to enrollment to confirm eligibility based on protocol defined inclusion and exclusion criteria.
Following baseline clinical and laboratory assessments, participants will be randomized in a one to one ratio at Day 0 to receive either Tapinarof topical cream 1 percent (test) applied topically once daily or Tacrolimus ointment 0.03 percent or 0.1 percent (reference) applied topically twice daily to affected areas for a treatment period of 56 days.
Participants will be evaluated at scheduled visits on Day 14, Day 28, Day 42, and Day 56 for efficacy assessments including validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), Scoring Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI), percentage of body surface area affected, Peak Pruritus Numeric Rating Scale, and Sleep Disturbance Numeric Rating Scale. Safety assessments will include monitoring of adverse events, vital signs, physical examinations, and laboratory evaluations.
Efficacy and safety data will be analyzed using descriptive and inferential statistical methods to evaluate the incidence, magnitude, and clinical relevance of treatment effects in the Tapinarof topical cream 1 percent group compared with the Tacrolimus ointment 0.03 percent or 0.1 percent reference group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female participants 2 years and above (Cohort 2: pediatric participants 2 to less than 18 years; Cohort 1: adult participants 18 years and above).
- •2.Clinical diagnosis of atopic dermatitis (atopic eczema) confirmed according to the diagnostic criteria of Hanifin and Rajka, as determined by the investigator.
- •3.Participants with body surface area involvement 5 to 35 percent, with vIGA-AD score 3 or higher and EASI score 7.1 or higher, consistent with moderate to severe atopic dermatitis at screening and baseline.
- •4.Generally good health apart from atopic dermatitis, based on medical history, physical examination, and screening laboratory tests.
- •5.Willingness and ability to apply the study medication as directed, maintain permitted skin care routines, and avoid prohibited treatments during the study.
- •6.Willingness to attend all scheduled visits, comply with follow-up schedules, and complete study diary requirements.
- •7.The participant and or their parent or legal guardian is willing and able to provide signed informed consent additional written assent for 12 to less than 18 years age group and oral assent for 7 to less than 12 years age group prior to any study related procedures to be performed.
排除标准
- •1.Participants with any clinically significant immunocompromised state, including primary immunodeficiencies, active malignancy, lymphoma, or acquired immunodeficiency syndrome AIDS, or those receiving systemic immunosuppressive therapy within 4 weeks prior to screening.
- •2.Current active infection at baseline, including clinically infected AD lesions, or a serious infection within the past 4 weeks requiring hospitalization and or intravenous anti infective therapy, or systemic anti infectives within 2 weeks prior to baseline.
- •3.Presence of dermatologic conditions other than AD for example psoriasis, rosacea, ichthyosis, erythroderma, Netherton syndrome, generalized eczema, extensive scarring, or severe sunburn that, in the opinion of the investigator, may interfere with study assessments or safety evaluation.
- •4.Lesion distribution limited to areas unsuitable for standard assessment for example only scalp, palms, or soles without other evaluable sites.
- •5.Clinically significant hepatic, renal or thyroid abnormalities at screening, including alanine aminotransferase ALT or aspartate aminotransferase AST 2 times or more the upper limit of normal ULN, total bilirubin more than 1.5 times ULN, serum creatinine more than 1.5 times ULN, TSH more than ULN.
- •6.History of malignancy within 5 years prior to screening.
- •7.Positive test for hepatitis B surface antigen HBsAg, hepatitis C virus HCV, or human immunodeficiency virus HIV infection at screening.
- •8.Use of prohibited medications or procedures prior to baseline: 8.1 Biologics for AD: 5 half lives or 12 weeks whichever is longer.
- •8.2 Systemic immunomodulators, systemic corticosteroids, phototherapy UVA, UVB, PUVA, or topical or oral Janus kinase JAK inhibitors: 4 weeks.
- •8.3 Topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 PDE 4 inhibitors, Tapinarof, or other topical prescription medications to treatment areas: 1 week.
- •8.4 Systemic antibiotics, antifungals, antivirals, or antiparasitics: 2 weeks.
- •8.5 Topical antibiotics or antifungals applied to treatment areas: 1 week.
- •9.Receipt of any live or live-attenuated vaccine within 4 weeks prior to baseline or planned during the study period.
- •10.Pregnant or lactating females, females of childbearing potential or male participants with partners of childbearing potential who are unwilling to use an acceptable method of contraception during the study.
- •11.Known hypersensitivity to Tapinarof Topical Cream 1 percent or Tacrolimus ointment 0.03 percent or 0.1 percent or to any excipients in the Tapinarof Topical Cream 1 percent or Tacrolimus ointment 0.03 percent or 0.1 percent formulation.
- •12.Participants who would not be considered suitable for topical therapy for atopic dermatitis.
- •13.Participation in another interventional clinical trial within 4 weeks or 5 half lives of the investigational product whichever is longer prior to baseline.
- •14.History of alcohol or drug abuse within 1 year prior to screening.
- •15.Any uncontrolled chronic illness or clinically significant medical, psychiatric, or laboratory abnormality that, in the investigator judgment, may pose additional risk, interfere with study participation, or confound interpretation of study results.
- •16.Any other reason that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.
研究者
Dr Jayesh Sanmukhani
Clinexcel Research