| CTRI Number |
CTRI/2025/01/078988 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study will evaluate treatment response and safety of amlitelimab injection in moderate-to-severe atopic dermatitis patients aged 12 years and older. |
|
Scientific Title of Study
|
A Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel group 48-week extension study to evaluate the treatment response and safety of two amlitelimab dose regimens administered as monotherapy by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis |
| Trial Acronym |
ESTUARY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EFC17600 Version no 01, dated 01 Feb 024 |
Protocol Number |
| EU trial number: 2023-508096-36 |
Other |
| IND-153717 |
Other |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr J Dinesh Kumar |
| Designation |
Medical Advisor |
| Affiliation |
Sanofi Healthcare India Private Limited |
| Address |
Sanofi House, L&T Business Park, Saki-Vihar Road, Powai
Mumbai
MAHARASHTRA
400072
India |
| Phone |
9790753835 |
| Fax |
|
| Email |
DineshKumar.Jeyaprakash@sanofi.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Mali |
| Designation |
Clinical Project Leader |
| Affiliation |
Sanofi Healthcare India Private Limited |
| Address |
Sanofi House, L&T Business Park, Saki-Vihar Road, Powai
Mumbai
MAHARASHTRA
400072
India |
| Phone |
08422962627 |
| Fax |
|
| Email |
nitin.mali@sanofi.com |
|
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Source of Monetary or Material Support
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| Sanofi Healthcare India Pvt Limited
Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai Mumbai:400072 |
|
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Primary Sponsor
|
| Name |
Sanofi Healthcare India Pvt Limited |
| Address |
Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai Mumbai:400072 |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
|
Australia
Brazil
Canada
Chile
China
Democratic People's Republic of Korea
France
Germany
Greece
India
Israel
Poland
Taiwan
United States of America |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neena Khanna |
Amrita School of Medical Science & Research Centre |
Department of dermatology, lower ground flower, MataAmritanandamayi Marg, Sector 88,Faridabad-121002
Faridabad
HARYANA |
9312432689
neena_aiims@yahoo.co.in |
| Dr Rima Joshi |
B. J. Medical College & Civil Hospital |
D6, Research room, 2nd floor, Opposite Ashmita Bhavan & OPD Building, B.J.Medical College, Asarwa, Ahmedabad 3800
Ahmadabad
GUJARAT |
9228585960
rimajoshi99@yahoo.com |
| Dr Shiv Kumar Patil |
Bhate Hospital |
Second Floor, Clinical Research Department, Dr. B R Ambedkar Road, Opp. Civil Hospital, Belagavi - 590002
Belgaum
KARNATAKA |
9844512315
shivakumarkpatil324@gmail.com |
| Dr Saswati Halder |
Calcutta School Of Tropical Medicine |
Department of Dermatology
108, Chittaranjan Avenue,
Kolkata-700073
Kolkata
WEST BENGAL |
03322123695
Saswatihalder32@gmail.com |
| Dr Sonal Shendkar |
Lifepoint Multispecialty Hospital |
3rd Floor, Research Department, Lifepoint Multispeciality Hospital, 145 1,Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune-411057
Pune
MAHARASHTRA |
9960178611
Shendkar.sonal82@gmail.com |
| Dr Rahul Mahajan |
Postgraduate Institute of Medical education & Research |
Room 5022, 5th floor, New OPD block, Postgraduate Institute of Medical Education &Research
Sector 12, Chandigarh 160012, Punjab
Chandigarh
CHANDIGARH |
9878920348
drrahulpgi@yahoo.com |
| Dr Sudhir Mamidwar |
Shree Hospital and Critical Care center |
3rd Floor, 799, Om
Nagar Opp. Tajshree
Building Sakkardara
Square Nagpur-440009
Nagpur
MAHARASHTRA |
9881015523
drmamidwarsudhir@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee, Kolkata |
Approved |
| Institutional Ethics Committee, BIMS, Belagavi Institute of Medical Sciences, Belagavi |
Approved |
| Institutional Ethics Committee. Amrita Institute of Medical Sciences, Faridabad |
Approved |
| Lifepoint Research- ETHICS COMMITTEE |
Approved |
| Shree Hospital Ethics Committee , Nagpur |
Approved |
| The Institutional Ethics Committee, Post graduate institute of Medical Education and Research |
Approved |
| The Institutional Ethics Committee- B. J Medical College and Civil Hospital, Ahmadabad |
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 |
Amlitelimab |
For participants with body weight ≥ 40 kg
Dose formulation: 125 mg/mL amlitelimab solution in a PFS to deliver 250 mg of amlitelimab in a 2 mL injection.
Unit dose strength(s): 250 mg (125 mg/mL)
Intervention description:
250 mg Q4W or 250 mg Q12W.
Loading dose for Groups D
and E: 250 mg (1 injection of
placebo, 1 injection of
amlitelimab 250 mg) Loading dose for Group F: 500
mg (2 injections of amlitelimab
250 mg)
Route of Administration: SC to abdomen, outer thigh, or upper arm
Treatment duration:48 weeks
For participants with body weight ≥25kg and40kg
Dose formulation: 62.5 mg/mL amlitelimab solution in a PFS to deliver 125 mg of amlitelimab in a 2 mL injection.
Unit dose strength(s): 125 mg (62.5 mg/mL)
Intervention description:
125 mg Q4W or 125 mg Q12W
Loading dose for Groups D
and E: 125 mg (1 injection of
placebo, 1 injection of
amlitelimab 125 mg)
Loading dose for Group F: 250
mg (2 injections of amlitelimab
125 mg) Route of Administration: SC to abdomen, outer thigh, or upper arm
Treatment duration:48 weeks
|
| Comparator Agent |
Placebo |
Dose formulation: identical formulation to the amlitelimab formulation without amlitelimab in a PFS to deliver placebo in a 2 mL injection.
Unit dose strength(s): 0 mg/mL of amlitelimab
Intervention description: Placebo Q4W
Route of Administration: SC to abdomen, outer thigh, or upper arm Treatment duration:48 weeks
|
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Inclusion Criteria
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| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
I01. Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.
I02. Must have participated, received study treatment without permanent IMP discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD.
- Must have complied with the clinical trial protocol in EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE) to the satisfaction of the Investigator.
I03 Able and willing to comply with requested study visit and procedures.
I04 Body weight must be ≥ 25 kg
I05 All participants Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a-Male participants
Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 5 months after the last administration of study intervention-
o Refrain from donating sperm
Plus either-
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
OR
o Must agree to use contraception/barrier as detailed below:
- A male condom: the participant should also be advised of the benefit for a female partner to use a highly effective method of contraception (as will be described in Section 10.4) as a condom may break or leak when having sexual intercourse with a WOCBP who is not currently pregnant
Female Participants
A female participant is eligible to participate if she is not pregnant or breastfeeding,
and one of the following conditions applies.
- Is a woman of nonchildbearing potential (WONCBP).
OR
- Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of less than 1percent, as will be described in section 10.4, during the study intervention period (to be effective before starting the intervention) and for at least 5 months after the last administration of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test (serum as required by local regulations) within 30 days before the first administration of study intervention, as will be described in Section 8.3.5.
I 06. Capable of giving a signed informed assent and/or consent as described in Appendix 1 (Section 10.1) of the protocol which includes the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. The signed ICF must always be present at the time of inclusion. |
|
| ExclusionCriteria |
| Details |
Participants are excluded from the study if any of the following criteria apply.
E 01 Developed a medical condition that would preclude participation as described in Section 5.2 (Exclusion Criteria) or Section 7.1.1 (Permanent Discontinuation) of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols.
E02 Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE).
E03 Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an AE or a SAE deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant.
E04 Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study.
E05 Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.).
E6 In the Investigators opinion any significant abnormality on 12-lead ECG at the baseline visit that could be suggestive of an unstable or underlying cardiovascular condition that could preclude the participant’s participation in the study.
E7 Individuals accommodated in an institution because of regulatory or legal order; participants who are legally institutionalized, persons who have been placed in an institution based on an official court order.
E8 Any country-related specific regulation that would prevent the participant from entering the study.
E9 Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
E10 Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
E11 Participants dependent on the Sponsor or Investigator (in conjunction with Section 1.61 of the ICH-GCP Ordinance E6).
E12Any anticipated situation during study implementation/course that may raise ethics considerations |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate the maintenance of treatment response to amlitelimab monotherapy Q4W compared to treatment withdrawal and subsequently amlitelimab monotherapy Q12W compared to treatment withdrawal in responders with moderate-to-severe AD |
Baseline, Week 48 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To demonstrate the maintenance of treatment response to amlitelimab monotherapy compared to treatment withdrawal in responders with moderate -to-severe AD |
Baseline, Week 48 |
| To characterize the treatment response to amlitelimab monotherapy in non-responders with moderate-to-severe AD |
Baseline, Week 48 |
|
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Target Sample Size
|
Total Sample Size="961"
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" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
31/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This is a multinational, multicenter, randomized,
double-blind, placebo-controlled, parallel, Phase 3 study for treatment of
participants aged 12 years and older diagnosed with moderate-to-severe AD.
The main objective of this study is to evaluate if
those participants who received amlitelimab Q4W in the parent studies (EFC17559
[COAST-1], EFC17560 [COAST 2], EFC17561 [SHORE]) and were responders can
maintain their treatment response either remaining at Q4W frequency or
switching to a Q12W regimen of amlitelimab compared to treatment withdrawal (Group
A).
Study details include:
• The study duration will be up to 64 weeks (for
participants not entering the LTS17367 [RIVER-AD] study) including a 48-week
randomized double-blind period, and a 16-week safety follow-up.
• The study duration will be up to 48 weeks for
participants entering the LTS17367[RIVER-AD] study at the Week 48 visit of
EFC17600 (ESTUARY).
• The total treatment duration will be up to 48
weeks.
• The total number of
visits will be up to 14 visits (or 13 visits for those entering LTS17367
[RIVER-AD] study). |