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CTRI Number  CTRI/2024/08/072026 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 28/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Usefulness of tofacitinib in atopic dermatitis 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Debasish Hota 
Designation  Professor 
Affiliation  AIIMS, BHUBANESWAR 
Address  Department of Pharmacology,
All India Institute of Medical Sciences (AIIMS)
Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Rachita Meher 
Designation  Junior Resident 
Affiliation  AIIMS, BHUBANESWAR 
Address  Department of Pharmacology,
All India Institute of Medical Sciences (AIIMS)
Khordha
ORISSA
751019
India 
Phone    
Fax    
Email  meherrachita3@gmail.com  
 
Details of Contact Person
Public Query  
Name  Debasish Hota 
Designation  Professor 
Affiliation  AIIMS, BHUBANESWAR 
Address  Department of Pharmacology,
All India Institute of Medical Sciences (AIIMS)

ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
AIIMS, Bhubaneswar-751019, Odisha 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  AIIMS, Bhubaneswar-751019 (Odisha) 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rachita Meher  AIIMS Bhubaneswar  Department of Pharmacology, All India Institute of Medical Sciences
Khordha
ORISSA 		 7655904707

rachitameher3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L20||Atopic dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Matching placebo  Identical Placebo once daily orally for 8 weeks 
Intervention  Tofacitinib Tablet 11mg  Tab. Tofacitinib 11mg orally daily for 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patient age ≥18 years and ≤75 years of either sex with a clinical diagnosis of chronic atopic dermatitis (according to Hanfin and Rajka criteria)
2. Patient with Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
3. Investigator Global Assessment score ≥3 (scale of 0 to 4) at the baseline visit.
4. Body surface Area ≥10% involvement in AD at baseline visit.
5. Peak pruritus-Numerical rating scale scoring of ≥4 at baseline visit.
6. History of insufficient response to topical treatments or medical contraindication to topical therapy.
7. Patients who are willing to give informed written consent.
 
 
ExclusionCriteria 
Details  1. History of treatment with any JAK inhibitor.
2. Treatment with calcineurin inhibitor, or phosphodiesterase 4 inhibitors within 1 week of baseline visit.
3. Current treatment with topical or oral tofacitinib.
4. Treatment with systemic corticosteroid within the last 4 weeks.
5. Patient on any immunosuppressive agent such as azathioprine, cyclosporine, and Biologic DMARDs like infliximab, etanercept, adalimumab, or rituximab within one month of recruitment.
6. Phototherapy treatment within the last 4 weeks of baseline visit.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Eczema Area and Severity Index (EASI) score ranges from 0(clear/no disease) to 72(very severe disease).  baseline, 4 weeks and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/08/2024 
Date of Study Completion (India) 16/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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