CTRI/2022/06/043406 [Registered on: 21/06/2022] Trial Registered Prospectively
Last Modified On:
20/06/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
The Study to evaluate the effectiveness of Abrocitinib Tablets in People With Atopic Dermatitis in India
Scientific Title of Study
A randomized, open-label, parallel-group study to evaluate the safety and efficacy of abrocitinib 100 mg and 200 mg tablets in participants aged 12 years and older with moderate to severe atopic dermatitis in India
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
B7451094 (Final Protocol), dated 21.12.2021
Protocol Number
NCT05375929
ClinicalTrials.gov
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
Director-Clinical Site Operations
Affiliation
Pfizer Products India Private Limited
Address
Global Site and Study Operations, Clinical Development and Operations, Global Product Development, Pfizer Products India Private Limited, The Capital, 1802/1901, Plot No. C 70, G Block, BKC, Bandra(E)
Mumbai MAHARASHTRA 400051 India
Phone
8826422322
Fax
Email
seema.pai@pfizer.com
Details of Contact Person Public Query
Name
Dr Seema Pai
Designation
Director-Clinical Site Operations
Affiliation
Pfizer Products India Private Limited
Address
Global Site and Study Operations, Clinical Development and Operations, Global Product Development, Pfizer Products India Private Limited, The Capital, 1802/1901, Plot No. C 70, G Block, BKC, Bandra(E)
Mumbai MAHARASHTRA 400051 India
Phone
8826422322
Fax
Email
seema.pai@pfizer.com
Source of Monetary or Material Support
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Primary Sponsor
Name
Pfizer Inc
Address
235 East 42nd Street, New York, NY 10017
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Pfizer Products India Private Limited
The Capital, 1802/1901, Plot No. C - 70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai 400 051
Countries of Recruitment
India
Sites of Study
No of Sites = 16
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Somesh Gupta
All India Institute of Medical Sciences
Room No. 4064, 4th Floor, Teaching Block, Department of Dermatology and Venereology, Ansari Nagar, New Delhi-110029 New Delhi DELHI
91-9868899120
someshgupta@hotmail.com
Dr Neetu Sidana
Apex Hospitals Pvt. Ltd.
OPD No - 03, Basement, Department of Dermatology, SP - 4 & 6, MIA, Malviya Nagar, Jaipur - 302017 Jaipur RAJASTHAN
91-9314661504
drneetusidana95@gmail.com
Dr Suneel Chandrakant Vartak
Assured Care Plus Hospital
Clinical Research Department, 4th & 5th Floor, Star Plus Complex, Lam Road, Near Muktidham Temple, Opp. NMC Divisional Office, Nashik Road, Nashik-422101 Nashik MAHARASHTRA
91-9373901829
suneel.vartak@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
91-9434427717
drsaswati_h@yahoo.co.in
Dr Ramesh Bhat M
Father Muller Medical College Hospital
Room No. 05, Department of Dermatology, Venereology, and Leprosy, Father Muller Road, Kankanady, Mangalore-575002, India Dakshina Kannada KARNATAKA
91-9845084224
rameshderma@gmail.com
Dr Pradyumna Vaidya
Jehangir Clinical Development Centre Pvt. Ltd.
Jehangir Clinical Development Centre Building, Jehangir Hospital Premises, 32 Sassoon Road, Pune-411001, Maharashtra Pune MAHARASHTRA
91-9822400964
drpvaidya@gmail.com
Dr Anjeeta Dhawan
Maharaja Agrasen Hospital
Room No. 07, Department of Dermatology, Ground Floor, West Punjabi Bagh, New Delhi-110026 New Delhi DELHI
91-9810631823
anjeetadr@gmail.com
Dr Vineet Relhan
Maulana Azad Medical College
Room No. 4, Department of Dermatology, Bahadur Shah Zafer Marg, New Delhi – 110002 New Delhi DELHI
91-9968604408
vineetrelhan@gmail.com
Dr Ashish Ramchandrarao Deshmukh
MGM Medical College & Hospital
602 - Pharmacology department, Clinical Trial Centre, Department of Clinical Pharmacology & Therapeutics, N6,CIDCO Aurangabad-431003, Maharashtra, India Aurangabad MAHARASHTRA
91-9422213292
ashish7557@gmail.com
Dr Dipak A Patel
Nirmal Hospital Pvt Ltd
Adult OPD, Ring Road, Surat - 395002, Gujarat, India Surat GUJARAT
Clinical Research Room, First floor, Near Male General ward, Department of Dermatology, SGRH Marg, Rajinder Nagar, New Delhi-10060, India New Delhi DELHI
91-981068687
drscbharija@gmail.com
Details of Ethics Committee
No of Ethics Committees= 16
Name of Committee
Approval Status
Clinical Research Ethics Committee (CREC-STM), Calcutta School of Tropical Medicine
Submittted/Under Review
Ethics Committee, Jehangir Clinical Development Centre Pvt. Ltd.
Submittted/Under Review
Ethics Committee, S.P. Medical College & A.G. Hospitals
Approved
Father Muller Institutional Ethics Committee
Submittted/Under Review
Institute Ethics Committee, All India Institute of Medical Sciences
Submittted/Under Review
Institutional Ethics Committee Post Graduate Institute of Medical Education and Research
Submittted/Under Review
Institutional Ethics Committee For Human Research (IECHR), Medical College Baroda
Participants will receive abrocitinib 200 mg QD for 12 weeks
Intervention
Experimental arm: Abrocitinib 200 mg QD
Participants will receive abrocitinib 200 mg QD for 12 weeks
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
12.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
(1) Participants must be of 12 years of age or older, at the time of informed consent.
(2) Meet all the following AD criteria:
(a) Clinical diagnosis of chronic AD (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed AD (Hanifin and Rajka criteria of AD).
(b) Moderate to severe AD (affected BSA ≥10%, IGA ≥3, EASI ≥16, and PP NRS ≥4 at the baseline visit);
(c) Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks), or who have required systemic therapies for control of their disease.
(3) Negative pregnancy test for females of childbearing potential at Screening. Female participants of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of study intervention.
(4) Body weight ≥25 kg at Baseline.
ExclusionCriteria
Details
(1)Currently have active forms of other inflammatory skin diseases or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, lupus).
(2) A current or past medical history of conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction or QT interval abnormalities.
(3) Have increased risk of developing venous thromboembolism, eg, deep vein thrombosis or pulmonary embolism.
(4) Have a history of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, history of lymphoma, leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
(5) Past history or active infection with Mycobacterium TB, disseminated herpes zoster or disseminated herpes simplex, HIV, Hepatitis B, or Hepatitis C.
(6) Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ
(7) Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgement, make the participant inappropriate for the study.
(8) Prior treatment with systemic JAK inhibitors.
(9) Participants who are vaccinated with live attenuated vaccine within the 6 weeks prior to the first dose of abrocitinib or who are expected to be vaccinated with these vaccines during treatment or during the 6 weeks following discontinuation of abrocitinib.
(10) Require treatment with prohibited concomitant medication(s) or have received a prohibited concomitant medication.
(11) Any of the following abnormalities in clinical laboratory tests at Screening:
(a) Absolute neutrophil count of <1.0 × 109/L (<1000/mm3);
(b) Platelet count of <150 × 109/L (<150,000/mm3);
(c) Absolute lymphocyte count of <0.50 × 109/L (<500/mm3);
(d) Estimated Creatinine Clearance 60 mL/min using the Cockcroft‑Gault method;
(e) AST or ALT values >2 times the ULN;
(f) TBili ≥1.5 times the ULN;
(12) Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use highly effective contraception consistently and correctly for the entire duration of the study and for at least 28 days after the last dose of study intervention.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the safety of abrocitinib in participants aged 12 years and older with moderate to severe AD
The primary estimand for safety is the incidence of AEs and SAEs in participants aged 12 years and older with moderate to severe AD, from the time of first dose to Week 16, regardless of dosing compliance or treatment
discontinuation.
Secondary Outcome
Outcome
TimePoints
To assess the efficacy of abrocitinib in participants aged 12 years and older with moderate to severe AD.
Response based on IGA score of clear (0) or almost clear (1) and greater than or equal to 2 points improvement from baseline at Week 12.
Response based on achieving ≥75% improvement from baseline in the EASI total score (EASI-75) at Week 12.
Change from baseline at Week 12 in POEM and at all scheduled time points.
Change from baseline at Week 12 in ADCT and at all scheduled time points.
To evaluate the potential effects of abrocitinib on bone development in adolescent participants 12 to 18 years of age, as assessed by knee MRI.
The proportion of abnormal bone findings in knee MRI 1 year after randomization in adolescent participants exposed to abrocitinib 100 mg and 200 mg QD.
Target Sample Size
Total Sample Size="200" Sample Size from India="200" 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)
30/06/2022
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="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Nil
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a randomized, open-label, parallel-group study to assess the safety and efficacy of orally administered tablets of abrocitinib 100 mg and 200 mg QD in participants aged 12 years and older with moderate to severe AD in India. There is a planned treatment duration of 12 weeks, with 4 weeks of off-treatment safety follow up thereafter. Study participants will be screened within 28 days prior to the first dose of study intervention to confirm that they meet the eligibility criteria for the study.
This study protocol also includes a substudy evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. Adolescent participants (12 to <18 years of age) will continue to receive study intervention until 1 year after randomization into the main study.