The Study to evaluate the effectiveness of Abrocitinib Tablets in People With Atopic Dermatitis in India

Phase 3

Not yet recruiting

• Conditions: Atopic dermatitis, unspecified,

• Registration Number: CTRI/2022/06/043406
• Lead Sponsor: Pfizer Inc

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-06-20
• Study Start: 2022-06-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• (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.

Exclusion Criteria

• (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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (16)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Apex Hospitals Pvt. Ltd.; 🇮🇳 Jaipur, RAJASTHAN, India

Assured Care Plus Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Calcutta School of Tropical Medicine; 🇮🇳 Kolkata, WEST BENGAL, India

Father Muller Medical College Hospital; 🇮🇳 Kannada, KARNATAKA, India

Jehangir Clinical Development Centre Pvt. Ltd.; 🇮🇳 Pune, MAHARASHTRA, India

Maharaja Agrasen Hospital; 🇮🇳 Delhi, DELHI, India

Maulana Azad Medical College; 🇮🇳 Delhi, DELHI, India

MGM Medical College & Hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

Nirmal Hospital Pvt Ltd; 🇮🇳 Surat, GUJARAT, India

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All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Somesh Gupta

Principal investigator

91-9868899120

someshgupta@hotmail.com