A Randomized, Multicenter, Double-blind, Three-arm, Placebo-controlled, Parallel Design Study to Evaluate the Bioequivalence (with Clinical Endpoint) of Tapinarof Cream 1 Percent of Encube Ethicals Private Limited, India with VTAMA® (tapinarof) cream 1 Percent of Dermavant Sciences, Inc. in Participants with Plaque Psoriasis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 24
- 主要终点
- The primary efficacy endpoint is the proportion of participants with treatment success defined as a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2- grade improvement from baseline to the end of treatment (Week12).
研究概览
简要总结
· This will be a Randomized, Multicenter, Double-blind, Three-arm, Placebo-controlled, Parallel Design Study to Evaluate the Bioequivalence (with Clinical Endpoint) of Tapinarof Cream 1 percent of Encube Ethicals Private Limited, India with VTAMA (tapinarof) cream 1 percent of Dermavant Sciences, Inc. in Participants with Plaque Psoriasis
· Sample size of the study will be approximately 450 participants; male or non-pregnant, non-lactating females aged between 18 to 75 years with a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving BSA greater than or equals to 3 percent and less than or equals to 20 percent (the participants face, scalp, groin, palms and soles should be excluded from the percent of total BSA (percent BSA) calculations) to determine trial participants eligibility.
· Participants will receive either Encube Ethicals Private Limited Tapinarof Cream (n equals to 180), RLD (VTAMA cream 1 percent, n equals to 180) or Placebo (n equals to 90), once daily for 84 days (12 weeks). Participants will take the trial drug home and self-administer trial drug or have caregiver apply, if necessary, to affected areas once daily.
· At each contact with the participant, the investigator will seek information on adverse events by different safety assessments like physical examination, vital signs and clinical laboratory investigations etc.
· Telephonic follow-ups are scheduled between visits to assess AEs and concomitant medications, to review trial drug application procedure, and to confirm participant has continued participation in the trial.
End of the Study (EOS) and Follow-up safety assessment will be conducted one week after EOT Visit through telephonic or in person.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant, non-lactating female aged between 18 to 75 years with a clinical diagnosis of stable plaque psoriasis for at least 6 months prior to the study.
- •BSA involvement greater than or equals to 3 percent and less than or equals to 20 percent (the participants face, scalp, groin, palms and soles should be excluded from the percent of total BSA (percent BSA) calculations) to determine trial participants eligibility.
- •A PGA score for plaque psoriasis of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline visit.
- •Female participant with postmenopausal status (spontaneous amenorrhea for at least 12 consecutive months) OR surgically sterilized OR female of child bearing potential with a negative pregnancy test must use acceptable methods of contraception throughout the study period and until 4 weeks after the last dose of investigational product.
- •Participant must be willing to refrain from using all other topical plaque psoriasis products during the 12-week treatment period, other than the investigational product.
- •Participant willing to provide written informed consent.
- •Participant willing and able to comply with the procedures and requirements of the study.
排除标准
- •Female who is pregnant, breast-feeding, or who wish to become pregnant during the study period.
- •Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis.
- •Any sign of infection of any of the psoriatic lesions.
- •Other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
- •Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
- •History of psoriasis unresponsive to topical treatments and/or biologic treatments.
- •History of hypersensitivity to any component of the test product or reference listed drug.
- •Current immunosuppression
- •Concurrent or medical history of uncontrolled, clinically significant intercurrent medical condition(s): a.
- •Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome) or medical history of positive human immunodeficiency virus (HIV) antibody b.
- •Chronic or acute systemic infection requiring treatment with systemic antibiotics, antivirals, antiparasitic, antiprotozoals, or antifungals within 4 weeks prior to the baseline visit.
- •Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigators opinion, would make it difficult to interpret data or assessments during the study.
- •System disorder, organ disorder, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, renal disease, severe psychiatric condition, etc.
- •which in the opinion of the investigator, would interfere with optimal participation in the study or produce significant risk to the participant.
- •Use within one month or within 5 half-lives (whichever is longer) prior to baseline of: a) Systemic steroids b) Systemic antibiotics c) Systemic antipsoriatic treatment d) Vitamin D3 and analogs (greater than 5000 IU/day), retinoids (eg, acitretin, isotretinoin), or adrenocorticotropic hormone analogs e) Psoralen plus ultraviolet A (PUVA) therapy f) Ultraviolet B (UVB) therapy g) Systemic anti-inflammatory agents h) Any systemic immunosuppressive or immunomodulating agents
- •Use of any of the following therapies within two weeks prior to baseline: a) Topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene, tazarotene) b) Topical corticosteroids c) Topical immunosuppressive drugs (e.g., tacrolimus, pimecrolimus) d) Topical retinoids
- •Clinically significant abnormalities in ECG or Screening laboratory parameters.
- •Participant who has received chemotherapy or radiation therapy and/or anti-neoplastic agents within 3 months prior to screening/baseline.
- •Use of biological treatments for psoriasis within the last 6 months of the baseline evaluation.
- •Within 2 weeks of immunizations with a live viral component; drugs known to possibly worsen psoriasis, such as beta blockers (e.g. propranolol), lithium, iodides, angiotensin converting enzyme inhibitors, and indomethacin, unless on a stable dose for greater than 12 weeks.
- •Participant who consumes excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates) within one year prior to screening.
- •Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, phototherapy, tanning beds/booths, or therapeutic sunbathing) within one month prior to the baseline visit and/or plans to have such exposures during the study.
- •Employees of the Investigator or research center or their immediate family members.
- •Living in the same household of a participant who is currently participating or living in the same household of a participant who has previously participated in the study.
结局指标
主要结局
The primary efficacy endpoint is the proportion of participants with treatment success defined as a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2- grade improvement from baseline to the end of treatment (Week12).
时间窗: 12 weeks
次要结局
- 1. Body sites and size of treatment area.(2. Proportion of participants with greater than or equals to 75 percent (PASI75) improvement in Psoriasis Area and Severity Index (PASI) from baseline at Week 12)
研究者
Dr Dharmesh Domadia
Cliantha Research Limited