| CTRI Number |
CTRI/2025/11/097238 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema |
|
Scientific Title of Study
|
A 16-Week, Multicenter, Interventional, Phase 3, Randomized,
Double-Blind, Placebo-Controlled, Parallel Group Study To
Investigate Efficacy and Safety of Abrocitinib in Children 6 To
Less Than 12 Years of Age with Moderate-To-Severe Atopic
Dermatitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT06807268 |
ClinicalTrials.gov |
| Protocol B7451023 Original Protocol, 20 December 2024 |
Protocol Number |
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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 |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Pai |
| Designation |
Senior Director Clinical Site Operations – India Cluster |
| Affiliation |
Pfizer Limited |
| Address |
The Capital, 1802/1901,
Plot No. C - 70, G Block, Bandra Kurla Complex,
Bandra (East), Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
02226540274 |
| Email |
seema.pai@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
Senior Director Clinical Site Operations – India Cluster |
| Affiliation |
Pfizer Limited |
| Address |
The Capital, 1802/1901,
Plot No. C - 70, G Block, Bandra Kurla Complex,
Bandra (East), Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
02226540274 |
| Email |
seema.pai@pfizer.com |
|
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Source of Monetary or Material Support
|
| Pfizer Inc., 66 Hudson Boulevard East New York, NY 10001 |
|
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Primary Sponsor
|
| Name |
Pfizer Inc. |
| Address |
66 Hudson Boulevard East New York, NY 10001 United State |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Pfizer Limited |
The Capital, 1802/1901,
Plot No. C - 70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai 400 051.
|
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Countries of Recruitment
|
China
Germany
Hungary
India
Japan
Mexico
Poland
Spain
United States of America |
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Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neetu Bhari |
All India Institute of Medical Sciences |
Ansari Nagar, New Delhi-110029, South Delhi, Delhi, India
New Delhi
DELHI |
9650437049
drntbhari@gmail.com |
| Dr Saswati Halder |
Calcutta School of Tropical Medicine |
Department of Dermatology
108, Chittaranjan Avenue, College Square,
Kolkata-700073, West Bengal, India
Kolkata
WEST BENGAL |
7980669705
saswatihalder32@gmail.com |
| Dr Ramesha Bhat M |
Father Muller Medical College Hospital |
Father Muller Medical College, Father Muller Road, Kankanady, Mangalore-575002, Karnataka, India
Dakshina Kannada
KARNATAKA |
9845084224
rameshderma@gmail.com |
| Dr Shefali Porwal |
Medanta Hospital |
2nd Floor, OPD A-Wing, Sector-A. Pocket-1, Amar Shaheed Path, Suhshant Golf City,Lucknow-226030, Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
8052496888
shefali.porwal@medanta.org |
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Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee |
Submittted/Under Review |
| Father Muller Institutional Ethics Committee |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee Medanta Lucknow |
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 |
Abrocitinib |
Participants weighing greater than 15 kg and less than 35 kg:
50 mg once a day
Participants weighing greater than 35 kg:
100 mg once a day
Participants weighing greater than 15 kg and less than 35 kg:
100 mg once a day
Participants weighing greater than 35 kg:
200 mg once a day |
| Comparator Agent |
Placebo |
Participants weighing greater than15 kg and less than 35 kg:
50 mg once a day
Participants weighing greater than 35 kg:
100 mg once a day
Participants weighing greater than 15 kg and less than 35 kg:
100 mg once a day
Participants weighing greater than 35 kg:
200 mg once a day |
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Inclusion Criteria
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| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria Children aged 6 to less than 12 years at the time of informed consent or assent.
1. No contraception methods are required for male participants.
Disease Characteristics-
Participants who meet all of the following AD criteria-
1. A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria and
2. A diagnosis of moderate-to-severe AD at the baseline visit - must fulfill all of the following criteria- BSA greater than equal to 10 percent, vIGA greater than equal to 3, EASI greater than equal to 16, and WI-NRS greater than equal to 4 and
3. Documented history within 6 months of the screening visit of inadequate response to treatment with topical medical therapy for AD eg, TCS and TCI, for at least 4 weeks and are candidates for systemic therapy |
|
| ExclusionCriteria |
| Details |
Participants are excluded from the study if any of the following criteria apply-
Medical Conditions-
1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigators judgment, make the participant inappropriate for the study.
2. If the participant has SDQ total score greater than equal to 17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.
3. Have any of the following medical conditions-
i) Infections-
Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline) or have superficial skin infections within 1 week of Day 1.
History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.
Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
Infection with HIV, hepatitis B, and/or hepatitis C
Evidence of active TB or inadequately treated latent TB.
ii) Skin Conditions-
Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.
iii) Other Conditions-
Documented history of skeletal dysplasia.
Documented history of retinal detachment.
History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
Prior history of leukemia, lymphoma, sarcoma or any other malignancy.
Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
Any other medical conditions that in the investigators judgment make the participant inappropriate for the study.
iv) Prior or Concomitant Therapy-
Prior treatment with a systemic JAK inhibitor for AD. Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.
v) Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates is not allowed in the study.
vi) Prior or Concurrent Clinical Study Experience:
Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1. |
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Response based on achieving Validated Investigators Global Assessment score of clear or almost clear and a reduction from baseline of greater than equal to 2 points at Week 12
2. Response based on achieving greater than 75 percent improvement from baseline in the Eczema Area and Severity Index at Week 12 |
1. At Week 12
2. At week 12 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Change from Baseline in the Worst Itch Numerical Rating Scale at Week 2 |
At week 2 |
| Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12 |
At week 12 |
| Response based on achieving WI-NRS less than 2 at Week 12 |
At week 12 |
|
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Target Sample Size
|
Total Sample Size="150"
Sample Size from India="8"
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 |
|
Date of First Enrollment (India)
|
18/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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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 research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to less than 12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total. |