| CTRI Number |
CTRI/2025/07/091047 [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 Other (Specify) [COMPARATIVE] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
oral Tofacitinib compared with oral Cyclosporine A for the treatment of refractory chronic spontaneous urticaria |
|
Scientific Title of Study
|
Safety and efficacy of oral tofacitinib compared with oral cyclosporin A in cases of refractory chronic spontaneous urticaria, an open label clinical 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 |
Dr Bushra Iqbal Khan |
| Designation |
Senior Resident III |
| Affiliation |
Government Medical College and Hospital Nagpur |
| Address |
SKIN OPD 41
GMC CAMPUS Rambagh Layout
Ajni Road
Nagpur
Nagpur MAHARASHTRA 440018 India |
| Phone |
8698812588 |
| Fax |
|
| Email |
dr.bushraiqbalkhan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bushra Iqbal Khan |
| Designation |
Senior Resident III |
| Affiliation |
Government Medical College and Hospital Nagpur |
| Address |
6 Central avenue
4th Floor Qazi Building
Opposite Chandralok Building
Nagpur SKIN OPD
GMC CAMPUS Rambagh Layout
Ajni Road
Nagpur Nagpur MAHARASHTRA 440018 India |
| Phone |
8698812588 |
| Fax |
|
| Email |
dr.bushraiqbalkhan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bushra Iqbal Khan |
| Designation |
Senior Resident III |
| Affiliation |
Government Medical College and Hospital Nagpur |
| Address |
SKIN OPD 41
GMC CAMPUS Rambagh Layout
Ajni Road
Nagpur
Nagpur MAHARASHTRA 440018 India |
| Phone |
8698812588 |
| Fax |
|
| Email |
dr.bushraiqbalkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Medical College Hospital |
| Address |
SKIN OPD
RAMBAGH LAYOUT
AJNI ROAD
NAGPUR |
| 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 |
skin opd 41
rambagh layout
ajni road
Nagpur 440003 Nagpur MAHARASHTRA |
8698812588
dr.bushrakhan@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE DEPARTMENT OF PHARMACOLOGY GMC NAGPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L509||Urticaria, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
oral cyclosporine A |
dose dependent oral cyclosporine A daily for a period of maximum 6 months or till the time UAS7 equals 0 |
| Intervention |
Oral tofacitinib |
5 mg oral tofacitinib twice daily daily for a period of maximum 6 months or till the time UAS7 equals 0 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in the study by giving written informed consent
Patients with age ranging between 18 to 60 years having CSU upto or more than 6 months resistant to treatment after a fourfold dosage of second-generation antihistamines for upto4 weeks
Patients with UAS7 score upto or more than 16 at baseline
|
|
| ExclusionCriteria |
| Details |
concurrent immunosuppressive use
positive autologous serum skin test
acute urticaria
specific comorbidities
or hypersensitivity to the study drugs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| UAS7 score reduction from baseline cut-off upto or more than 16 |
Month 0 1 2 3 4 5 6 9 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Urticaria control test |
month 0
month 9 |
| Dermatology Life Quality Index |
month 0
month 9 |
| Patient Global Impression of change |
month 0
month 9 |
| incidence and severity of any adverse events |
month 0 1 2 3 4 5 6 9 |
|
|
Target Sample Size
|
Total Sample Size="158" Sample Size from India="158"
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)
|
25/08/2025 |
| 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
|
This study aims to compare the efficacy and safety of oral Cyclosporin A (CsA) versus tofacitinib in managing refractory chronic spontaneous urticaria (CSU) and to evaluate patient satisfaction across treatment groups. Conducting it as a randomised, non-blind, open-label study, we will enrol male and female patients diagnosed with refractory CSU at a tertiary care centre. Patients aged 18–60 years, with persistent CSU despite fourfold second generation antihistamine therapy for up to or more than 4 weeks, will be eligible, while those with concurrent immunosuppressive use, positive autologous serum skin test, acute urticaria, specific comorbidities, or hypersensitivity to the study drugs will be excluded. Participants will be randomly assigned to receive either dose dependent CsA or 5 mg tofacitinib twice daily for up to six months or until complete symptom resolution with a post treatment monthly follow-up for 3 months. Baseline assessments will include detailed demographic and clinical history, laboratory investigations, and calculation of the urticaria activity score (UAS). Treatment response will be monitored at follow-up visits (monthly), with efficacy determined by UAS7 score reduction. Patient-reported satisfaction and any adverse events will also be recorded to assess tolerability and safety. Statistical analysis will be conducted using SPSS software to compare outcomes between the two treatment groups. The study’s structured approach will yield valuable insights into the comparative effectiveness of CsA and tofacitinib, guiding personalised treatment strategies for refractory CSU. By providing objective data on efficacy, safety, and patient-reported outcomes, this research seeks to enhance therapeutic precision with clinical management optimisation in this challenging dermatologic condition, providing insights into treatment preferences. |