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

Phase 3

• Conditions: Health Condition 1: L209- Atopic dermatitis, unspecified

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 investigatorâ??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 Ã? 109/L ( <1000/mm3);

(b) Platelet count of <150 Ã? 109/L ( <150,000/mm3);

(c) Absolute lymphocyte count of <0.50 Ã? 109/L ( <500/mm3);

(d) Estimated Creatinine Clearance ï?¼60 mL/min using the Cockcroftâ??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 ADTimepoint: 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 <br/ ><br>discontinuation.

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of abrocitinib in participants aged 12 years and older with moderate to severe AD.Timepoint: 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. <br/ ><br> <br/ ><br>Response based on achieving â?¥75% improvement from baseline in the EASI total score (EASI-75) at Week 12. <br/ ><br> <br/ ><br>Change from baseline at Week 12 in POEM and at all scheduled time points. <br/ ><br> <br/ ><br>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.Timepoint: 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.