| CTRI Number |
CTRI/2025/07/091046 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Hidradeinitis suppurativa treated with twice daily dose of oral tofacitinib |
|
Scientific Title of Study
|
The efficacy and safety of tofacitinib for the treatment of hidradeinitis suppurativa |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bushra Iqbal Khan |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College and Hospital Nagpur |
| Address |
OPD 41 Skin OPD
Rambagh Layout
GMC Nagpur
Ajni Road
nil
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8698812588 |
| Fax |
|
| Email |
dr.bushraiqbalkhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bushra Iqbal Khan |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College and Hospital Nagpur |
| Address |
OPD 41 Skin OPD
Rambagh Layout
GMC Nagpur
Ajni Road
nil
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8698812588 |
| Fax |
|
| Email |
dr.bushraiqbalkhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bushra Iqbal Khan |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College and Hospital Nagpur |
| Address |
OPD 41 Skin OPD
Rambagh Layout
GMC Nagpur
Ajni Road
nil
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8698812588 |
| Fax |
|
| Email |
dr.bushraiqbalkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| No monetary or material support from any sponsor |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
nil |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bushra Iqbal Khan |
GMC Nagpur |
OPD 41 Skin OPD
Rambagh Layout
Ajni Road
Ajni Road
Nagpur
MAHARASHTRA |
8698812588
dr.bushraiqbalkhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GMC NAGPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L732||Hidradenitis suppurativa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable as single arm study |
Not applicable as single arm study |
| Intervention |
Oral tofacitinib |
Oral tofacitinib 5 mg twice daily
Duration: 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 diagnosis confirmed by European S1 guideline criteria presence of characteristic lesions in typical anatomical distributions with chronic or recurrent progression
2 refractory disease documented inadequate response or intolerance to upto or more than 2 prior systemic therapies including antibiotics, biologics, or immunosuppressants
3 availability of complete baseline data with a minimum 12week follow-up |
|
| ExclusionCriteria |
| Details |
concurrent use of other HS targeted systemic therapies or pregnancy or lactation status |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome Hidradenitis Suppurativa Clinical Response |
Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes included absolute changes in Sartorius score
Pain Numerical Rating Scale scores
Dermatology Life Quality Index scores
from baseline through 36 weeks along with timeto first flare following treatment discontinuation |
week 36 |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Hidradenitis suppurativa (HS) is a chronic, inflammatory follicular disorder causing substantial morbidity in postpubertal individuals. This study assesses the safety and efficacy of oral tofacitinib in treating moderate to severe HS.A prospective clinical study will be conducted to enrol patients with Hurley stages II & III. Based on the history, clinical examination, and clinical pictures, the Sartorius score before and after the treatment will be obtained. The patients will be started on tofacitinib tablets at a dose of 5 mg twice a day for at least 6 months and followed up monthly for 6 more months. The institutional ethics committee approved the study protocol. Participants will be required to meet three inclusion criteria 1 diagnosis confirmed by European S1 guideline criteria presence of characteristic lesions in typical anatomical distributions with chronic or recurrent progression 2 refractory disease that has documented inadequate response or intolerance to upto or more than two prior systemic therapies including antibiotics, biologics, or immunosuppressants 3 availability of complete baseline data with a minimum 12 week follow up. Key exclusion criteria comprise concurrent use of other HS targeted systemic therapies or current pregnancy or lactation status.
All participants will received oral tofacitinib 5 mg twice daily with dose adjustments permitted based on clinical response. The primary efficacy endpoint is achievement of Hidradenitis Suppurativa Clinical Response at week 12. Secondary outcomes includes absolute changes in Sartorius score, Pain Numerical Rating Scale scores, Dermatology Life Quality Index scores from baseline through 36 weeks along with time to first flare following treatment discontinuation. Standardised clinical evaluations will be conducted at baseline and every four weeks thereafter supported by serial photographic documentation. Statistical Analyses shall utilise paired t-tests or Wilcoxon signed-rank tests for continuous variables reported as mean plus minus standard deviation or median interquartile range, Kaplan Meier methodology for time to event analyses and logistic regression to identify predictors of treatment response SPSS version 27.0. |