| CTRI Number |
CTRI/2025/01/079089 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to investigate Dupixent (Dupilumab) in adult Indian participants with moderate-to-severe atopic dermatitis |
|
Scientific Title of Study
|
A multi-center, single-arm phase IV clinical trial to evaluate the safety of Dupilumab in adult Indian patients with moderate-to-severe atopic dermatitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LPS18048_Version 1.2 , 09- Nov-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr J Dinesh kumar |
| Designation |
Medical Advisor |
| Affiliation |
Sanofi Healthcare India Pvt. Ltd. |
| Address |
Sanofi House, CTS No.117-B,
L&T Business Park, Saki Vihar Road, Powai,Mumbai
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
9790753835 |
| Fax |
|
| Email |
DineshKumar.Jeyaprakash@sanofi.com |
|
Details of Contact Person
Public Query
|
| Name |
Laxman Deshmukh |
| Designation |
Clinical Project Leader |
| Affiliation |
Sanofi Healthcare India Pvt. Ltd |
| Address |
Sanofi House, CTS No.117-B,
L&T Business Park, Saki Vihar Road, Powai
Mumbai
Mumbai
MAHARASHTRA
400072
India |
| Phone |
9730652540 |
| Fax |
|
| Email |
laxman.deshmukh@sanofi.com |
|
|
Source of Monetary or Material Support
|
| Sanofi Healthcare India Private limited, Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki Vihar Road, Powai, Mumbai, 400 072 |
|
|
Primary Sponsor
|
| Name |
Sanofi Healthcare India Pvt. Ltd |
| Address |
Sanofi Healthcare India Pvt. Ltd, Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai Mumbai:400072 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SANOFI HEALTHCARE INDIA PRIVATE LIMITED |
2ND FLOOR, CABIN NO. 2H, SANOFI HOUSE, CTS 117 B,
SAKI VIHAR ROAD, L AND T BUSINESS PARK, POWAI,
Mumbai Suburban, Maharashtra, 400072 |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suneel Vartak |
Assured Care plus hospital, Nashik |
4TH Floor StarPlus Commercial Complex, Bytco 1, Nashik, Maharashtra-422101
Nashik
MAHARASHTRA |
9373901829
suneel.vartak@gmail.com |
| Dr Saswati Halder |
Calcutta School of tropical medicine |
108, Chittaranjan Avenue, Kolkata, West Bengal 700073
Kolkata
WEST BENGAL |
9434427717
saswatihalder32@gmail.com |
| Dr RAMESH BHAT M |
Father Muller Medical College Hospital, Mangalore |
Dept. of Dermatology, Block no. 65, OPD no- 3, Father Muller Road, Kankanady, Mangalore
Karnataka - 575002
Dakshina Kannada
KARNATAKA |
9845084224
rameshderma@fmmc.in |
| Dr G Ajay Kumar |
Govt Medical college &Hospital, Vijayanagaram |
Govt Medical college &Hospital, Vijayanagaram
Vizianagaram
ANDHRA PRADESH |
9000287288
drajaykumarresearch@gmail.com |
| Dr Sowmya C S |
KIMS Hospital Kempegowda Institute Of Medical Sciences (KIMS), Bangalore |
Banashankari 2nd Stage, Bangalore-560070
Bangalore
KARNATAKA |
9611116181
sowmya.cs17@gmail.com |
| Dr Manjunath Shenoy M |
Omega Hospital, Mangaluru |
4th Floor, Research Department, Kankanady Bypass Road, Mahaveer Circle, Kankanady, Mangaluru, Karnataka 575002
Dakshina Kannada
KARNATAKA |
91-9845009976
manjunathshenoy.dermatology@gmail.com |
| Dr Sanjeev Handa |
PGIMER Chandigarh |
Room No. 5005, Level-5, New OPD Building, Sector 12, Chandigarh-160012
Chandigarh
CHANDIGARH |
914209564
handa_sanjeev@yahoo.com |
| Dr BC Ghiya |
S.P. Medical College & A.G. of Hospitals, Bikaner |
Room No. 14, Ground Floor, Department of Skin & VD, Bikaner, Rajasthan 334001
Bikaner
RAJASTHAN |
9413389280
bcghiya@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee School of Tropical Medicine, 108, Chittaranjan Avenue,College Square, Kolkata-700073 |
Approved |
| Ethics committee S.P. Medical College, Bikaner-334003 |
Submittted/Under Review |
| Father Muller Institutional Ethics Committee Father Muller Research Centre, Father Muller Road, Kankanady, Mangalore, Karnataka-575002 |
Submittted/Under Review |
| IEC, Assured Care Plus Hospital, 4th & 5th floor, Star Plus Complex Lam Road, Near Mukhtidham Temple, Opp NMC Divisional Office, Nashik Road, Nashik, Maharashtra-422101 |
Submittted/Under Review |
| Institutional Ethics Committee, Government Medical College |
Submittted/Under Review |
| Institutional Ethics Committee, Room no 6006,6th Floor, P.N Chuttani Block, PGIMER, Sector-12, Chandigarh,UT,India-160012 |
Submittted/Under Review |
| KIMS Institutional Ethics Committee Kempegowda Institute Of Medical Sciences Attimabbe Road Banashankari 2nd Stage Bangalore Bengaluru (Bangalore) Urban Karnataka - 560070 |
Approved |
| Omega Ethical Committee Omega Hospital Mahaveer Circle, Kankanady, Mangalore – 575002 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dupilumab-Subcutaneous |
The recommended dose of Dupilumab for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W).
Duration is 16 weeks |
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant must be ≥ 18 years of age, at the time of signing the informed consent.
2. Atopic dermatitis (AD) as defined by American Academy of Dermatology Consensus Criteria, that has been present for at least ≥1 year prior to screening
3. Participants with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
4. Candidate for systemic therapy (disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable)
5. Male or Female
6. Participant with pruritus NRS ≥ 4 at baseline
7. Capable of giving signed informed consent (including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol) |
|
| ExclusionCriteria |
| Details |
1. Any contraindications according to the PI
2. Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening
3. Patients with known helminth infection (current andor past infection).
4. Current enrolment or past participation within the last 30 days before signing of informed consent in any other clinical study involving an investigational study treatment or any other type of medical research
5. Participation in a prior dupilumab clinical trial or any prior use of dupilumab
6. Immunosuppressive or immunomodulating drugs or live vaccines or phototherapy for AD within 4 weeks before baseline, or any condition that in the opinion of the investigator, is likely to require such treatments during the first 2 weeks of study treatment
7. Has a history of or ongoing drug or alcohol abuse |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To describe safety of dupilumab in Indian adult patients with moderate-to-severe Atopic Dermatitis |
16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To describe efficacy of dupilumab in Indian adult patients with moderate-to-severe Atopic Dermatitis |
Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at week 16 |
|
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Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/01/2025 |
| 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="0"
Months="7"
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 will describe safety of the study drug in adult
participants with atopic dermatitis. It will also look at the improvement of
atopic dermatitis signs and symptoms in these participants.
This is an interventional phase IV clinical study
Atopic dermatitis is a condition that causes itching,
inflammation, redness, and irritation of the skin.
Study duration: The maximum study duration would be
32 weeks which includes the below:
Up to 28 days of screening period in which the doctor will
assess if the participant can be recruited in this study
Treatment duration is 16 weeks
Follow up period: during which the participant will be
followed for 12 weeks to check for any safety events.
Visit frequency: The visit frequency will be every 4
weeks during the 16 weeks treatment duration and then 12 weeks after the last
dose of the study treatment. Total number of visits will be 7.
Number of participants:
Approximately 56 participants will be enrolled to the
investigational intervention. |