Evaluation of efficacy and safety of Tofacitinib, a Janus kinase inhibitor in patient with moderate to severe Atopic dermatitis: A randomized, double-blind, placebo-controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- 1. Eczema Area and Severity Index (EASI) score ranges from 0(clear/no disease) to 72(very severe disease).
研究概览
简要总结
The present study intends to evaluate the efficacy and safety of tofacitinib in patients with moderate to severe Atopic Dermatitis. It will be done in a randomized, double-blind, placebo-controlled manner in collaboration with the Department of Dermatology and Pharmacology. The study’s primary objective is to compare the changes in the Eczema Area Severity Index score from 0 to 8 weeks. In addition, the study will also examine secondary goals. The study aims to evaluate the effectiveness of the treatment by measuring the percentage of patients who experience a 50% decrease in eczema severity within 4 weeks and a 75% decrease within 8 weeks. It also aims to determine the number of patients who achieve an Investigator Global Assessment score of 0-1 or a reduction of 2 points from the initial score at both 4 and 8 weeks. Additionally, the study will assess changes in the peak pruritus-numerical rating scale scores, looking for improvements at 4 and 8 weeks. The research will compare treatment-related side effects between two groups and explore correlations between atopic dermatitis and interleukins 4. It will also monitor changes from the baseline in complete blood count, liver and renal function tests, and serum lipid levels at 8 weeks, as well as changes in the dermatological life quality index after 4 and 8 weeks.
Tofacitinib is a Janus kinase inhibitor approved by DCGI for the treatment of Rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, and polyarticular course juvenile idiopathic arthritis. We proposed that Atopic Dermatitis is also an inflammatory condition sharing some of the cardinal features of the above conditions. Current treatment of Atopic Dermatitis is primarily on steroids, which have an extensive range of adverse effects like weight gain, immunosuppression, cataracts, increased risk of diabetes hypertension, and osteoporosis. Hence, tofacitinib may be a valuable addition to the current treatment of AD. However, the data on its efficacy and safety in Atopic Dermatitis is scanty. The safety has been well established in long-term use.
An extensive search of literature could not find any randomized controlled trial on tofacitinib in patients with AD. The present study will be the first of its kind for the above indication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Patient age ≥18 years and ≤75 years of either sex with a clinical diagnosis of chronic atopic dermatitis (according to Hanfin and Rajka criteria)
- •Patient with Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
- •Investigator Global Assessment score ≥3 (scale of 0 to 4) at the baseline visit.
- •Body surface Area ≥10% involvement in AD at baseline visit.
- •Peak pruritus-Numerical rating scale scoring of ≥4 at baseline visit.
- •History of insufficient response to topical treatments or medical contraindication to topical therapy.
排除标准
- •History of treatment with any JAK inhibitor.
- •Treatment with calcineurin inhibitor, or phosphodiesterase 4 inhibitors within 1 week of baseline visit.
- •Current treatment with topical or oral tofacitinib.
- •Treatment with systemic corticosteroid within the last 4 weeks.
- •Patient on any immunosuppressive agent such as azathioprine, cyclosporine, and Biologic DMARDs like infliximab, etanercept, adalimumab, or rituximab within one month of recruitment.
- •Phototherapy treatment within the last 4 weeks of baseline visit.
结局指标
主要结局
1. Eczema Area and Severity Index (EASI) score ranges from 0(clear/no disease) to 72(very severe disease).
时间窗: baseline, 4 weeks and 8 weeks
次要结局
- 1. Percentage of patients with Investigator Global Assessment (IGA) score of 0-1 or a 2-point reduction at weeks 4 and 8 by using a 5-point disease severity scoring system, assessed by the clinician at the time points specified in the protocol(4 and 8 weeks)
- Peak pruritus-numerical rating scale (PP-NRS). It consists of a 100 mm scale, with two endpoints representing 0 (no itch) and 100 (worst itch imaginable).(Baseline, 4 and 8 weeks)
- Dermatological life quality index (DQLI. It consists of 10 questions that assess the impact of skin conditions on different aspects of a patient’s life over the last week with a range of scores from 0 to 30.(Baseline, 4 and 8 weeks)
- Change in serum interleukin-4 levels(Baseline and 8 weeks)
- Treatment related adverse events(4 and 8 weeks)
研究者
Debasish Hota
AIIMS, BHUBANESWAR