| CTRI Number |
CTRI/2025/08/093223 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of two drugs ,secukinumab and adalimumab in the treatment of hidradenitis suppurativa |
|
Scientific Title of Study
|
Efficacy Of Secukinumab Vs Adalimumab in the treatment Of Hidradenitis Suppurativa: A Randomized 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 |
Debatraya Paul |
| Designation |
Assistant Professor dermatology |
| Affiliation |
Military Hospital Jaipur |
| Address |
Military Hospital Jaipur
Jaipur
RAJASTHAN
302006
India |
| Phone |
9432879780 |
| Fax |
|
| Email |
drdebatrayapaul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debatraya Paul |
| Designation |
Asst Prof dermatology |
| Affiliation |
Military Hospital Jaipur |
| Address |
dept of dermatology
Military hospital bareilly
Jaipur
RAJASTHAN
302006
India |
| Phone |
9432879780 |
| Fax |
|
| Email |
drdebatrayapaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debatraya paul |
| Designation |
graded specialist dermatology |
| Affiliation |
Military Hospital jaipur |
| Address |
Military Hospital jaipur
Jaipur
RAJASTHAN
302006
India |
| Phone |
9432879780 |
| Fax |
|
| Email |
drdebatrayapaul@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
military hospital jaipur |
| Address |
D-112 Ram mandir road
sen colony
bani park
jaipur |
| Type of Sponsor |
Other [military hospital ] |
|
|
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 |
| DEBATRAYA PAUL |
MILITARY HOSPITAL JAIPUR |
D112 ram mandir road
sen colony
bani park jaipur
Jaipur
RAJASTHAN |
9432879780
drdebatraya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,MH JAIPUR |
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 |
Adalimumab |
Injection Adalimumab 120 mg sc every 4 weekly |
| Intervention |
Secukinumab |
Injection Secukinumab 300 mg sc onve every 4 weekly |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases Of Hidradenitis Suppurativa with poor response to conventional therapy for more than 12 months |
|
| ExclusionCriteria |
| Details |
Pregnant ladies, autoimmune disorders, immunocompromised patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical response to treatment by assessing modified sartorius score |
4 weekly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical response to treatment by assessing hurley staging & patient satisfaction level |
4 weekly |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 is a randomized open labelled parallel group single
centre trial to compare the safety and efficacy of secukinumab 300 mg and
adalimumab 120 mg every 4 weekly for 6 months in 40 patients of
hidradenitis suppurativa not responding to conventional therapies for more than
12 months.The study will be conducted in a tertiary care military hospital .Our primary
objective is to compare the efficacy of secukinumab and adalimumab by assessing
the clinical response in the form of modified sartorius score at 4 weekly
intervals. The secondary objective is to assess the clinical response via
patient satisfaction level and hurley staging. All the enrolled patients will
be assessed at baseline followed by 4,8,12,16,20 and 24 weeks. Data will be
assessed using appropriate statistical test for each of the variables.
|