| CTRI Number |
CTRI/2025/12/099009 [Registered on: 12/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Long-term Phase 3 Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema |
|
Scientific Title of Study
|
A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and
Efficacy of Abrocitinib, With or Without Topical Medications Administered to
Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic
Dermatitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT06807281 |
ClinicalTrials.gov |
| Protocol B7451031 - Final Protocol, 23 December 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
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),
Mumba
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),
Mumba
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
02226540274 |
| Email |
seema.pai@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Inc.,
66 Hudson Boulevard East New York, NY 10001, USA |
|
|
Primary Sponsor
|
| Name |
Pfizer Inc |
| Address |
66 Hudson Boulevard East New York, NY 10001, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
China
Germany
Hungary
India
Japan
Mexico
Poland
Spain
United States of America |
|
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 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 |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee, School of Tropical Medicine |
Submittted/Under Review |
| Father Muller Institutional Ethics Committee, Father Muller Medical College |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee Medanta Lucknow, Medanta Hospital |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abrocitinib 25mg/mL |
Abrocitinib administered as liquid oral suspension.
For participants greater than equal to 6 years of age: 100 mg or 200 mg adult equivalent dose (AED) Once daily
For participants less than 6 years of age: 100 mg adult equivalent dose (AED) (may be adjusted based on the Study B7451023 PK interim analysis) |
| Comparator Agent |
No comparator used. |
Not Applicable as no comparator is used. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria for the Extension Cohort:
1. Participants who have completed the treatment phase of the qualifying parent study - age 2 to less than 12 years old.
- No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the participant is of child-bearing potential, must use a highly effective form of contraception during the study intervention period and for at least 28 days after the last dose of study intervention.
Inclusion Criteria for the De Novo Cohort:
- Age: Children aged 6 to less than 12 years at the time of informed consent/assent.
- 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 6 months 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 10percent, 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.
- Other Inclusion Criteria:
Body weight greater than equal to 15 kg |
|
| ExclusionCriteria |
| Details |
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 investigator s judgment, make the participant inappropriate for the study.
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.
2. 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 investigator s judgment make the participant inappropriate for the study.
Prior or Concomitant Therapy:
3. Prior treatment with a systemic JAK inhibitor for AD.
4. 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.
5. Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study.
Prior or Concurrent Clinical Study Experience:
6. Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.
Diagnostic Assessments:
7. Hepatic and or renal and or hematological abnormalities defined as:
AST greater 2 x ULN
Hemoglobin less than 10 g per dL
ALT greater 2 x ULN
ANC less than 1000 per mm3
Total bilirubin greater than equal to 1.5 x ULN
ALC less than 500 per mm3
eGFR less than 60 mL per min per 1.73 m2
Platelets less than 150,000 per mm3
Other Exclusion Criteria:
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate long-term safety of abrocitinib in children less than equal to 2 years of age with moderate-to-severe disease |
0 to 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of Participants With Clinically Significant Laboratory Abnormalities |
0-24 months |
| Response based on achieving Validated Investigators Global Assessment score of clear 0 or almost clear 1 on a 5-point scale and a 2 point reduction from baseline at all scheduled time points |
Baseline, 24 months |
| Percentage of Response based on achieving a greater than equal to 4 point improvement from baseline in the Worst Itch Numerical Rating Scale at all scheduled time points in participants aged greater than equal to 2 to less than 6 years |
0-24 months |
| Percentage of Response based on achieving a greater than equal to 4 point improvement from baseline in the WSI-NRS at all scheduled time points in participants aged greater than equal to 6 to 12 years |
0-24 months |
| Percentage of Responders based on achieving Eczema Area and Severity Index EASI-50, EASI-90 and EASI-100 at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib |
0-24 months |
| Percent Change from Baseline in EASI total score at all scheduled time points. |
0-24 months |
| Percentage of Participants with Flares |
0-24 months |
| CFB in the percentage Body Surface Area affected at all scheduled time points |
0-24 months |
| CFB in Children Dermatology Life Quality Index at all scheduled time points. |
0-24 months |
| CFB in in Infants Dermatitis Quality of Life Index at all scheduled time points |
0-24 months |
| CFB in Patient-Oriented Eczema Measure at all scheduled time points |
0-24 months |
| CFB in Dermatitis Family Impact at all scheduled time points |
0-24 months |
| CFB in Patient Global Impression of Severity at all scheduled time points |
0-24 months |
| CFB in Observer Reported Global Impression of Severity at all scheduled time points |
0-24 months |
| CFB in the the EuroQol- 5 Dimension Youth |
0-24 months |
| Number of topical corticosteroid and or topical calcineurin inhibitor free days |
0-24 months |
| Percentage of Participants Achieving satisfactory response in Tdap or DTaP and or pneumococcal antibody titers as appropriate in participants who receive Tdap or DTaP and or pneumococcal vaccinations |
0-24 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="47"
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 3 |
|
Date of First Enrollment (India)
|
21/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="6"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies. |