A Study to Learn About Abrocitinib Tablets in People With Atopic Dermatitis in India

NCT05375929 | Completed Phase 3 Results

• 1 other identifier: B7451094
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this clinical trial is to learn about the safety and how well the study medicine (called Abrocitinib) works for the potential treatment of moderate to severe Atopic Dermatitis (AD) in India. AD, also known as atopic eczema, is a chronic, relapsing skin condition characterized by dry, itchy skin lesions which can affect any part of the body. Adult peoples who participate in this study will take either 100 mg or 200 mg of abrocitinib tablets by mouth for a duration of 12 weeks and adolescents will take for duration of 52 weeks. Knee Magnetic Resonance Imagine (MRI) will be done on adolescent peoples to determine bone safety findings. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and how well they work.

Conditions

Atopic Dermatitis

Keywords

AD; Atopic Eczema

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Main Study

  An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other situations where medical or scientific judgement should be exercised by investigator. AEs included SAEs and all non-SAEs.

  From Day 1 of dosing up to 4 weeks post last dose (maximum up to Week 16)

Secondary Outcomes (6)

• Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and >= 2 Points Improvement From Baseline at Week 12: Main Study

  Baseline (prior to dosing on Day 1), Week 12

• Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >= 75% Improvement From Baseline at Week 12: Main Study

  Baseline (prior to dosing on Day 1), Week 12

• Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >= 75% Improvement From Baseline at Week 12: Main Study

  Baseline (prior to dosing on Day 1), Week 12

• Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8 and 12: Main Study

  Baseline (prior to dosing on Day 1), Weeks 2, 4, 8 and 12

• Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Score at Weeks 2, 4, 8 and 12: Main Study

  Baseline (prior to dosing on Day 1), Weeks 2, 4, 8 and 12

Study Arms (2)

Abrocitinib 100 mg

EXPERIMENTAL

Participants will receive abrocitinib 100 mg by mouth (QD).

Drug: Abrocitinib 100 mg

Abrocitinib 200 mg

EXPERIMENTAL

Participants will receive abrocitinib 200 mg QD.

Drug: Abrocitinib 200 mg

Interventions

Abrocitinib 100 mg DRUG

Orally administered, abrocitinib 100 mg tablets QD

Abrocitinib 100 mg

Abrocitinib 200 mg DRUG

Orally administered, abrocitinib 200 mg tablets QD.

Abrocitinib 200 mg

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• This study is seeking participants who:
• Must be of 12 years of age or older, at the time of informed consent.
• Meet all the following Atopic Dermatitis (AD) criteria:
• 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 AD10).
• Moderate to severe AD (affected body surface area (BSA) ≥10%, Investigator's Global Assessment (IGA) ≥3, Eczema Area and Severity Index (EASI) ≥16, and Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 at the baseline visit);
• 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.
• 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.
• Body weight ≥25 kg at Baseline
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Document (ICD) and in this protocol. Evidence of a personally signed and dated ICD indicating that the participant (or a legally acceptable representative, parent(s)/legal guardian) has been informed of all pertinent aspects of the study. For minors under the age of legal consent in India, assent of the participating child needs to be documented for the age range 12 to 18 years in addition to the parental informed consent.

You may not qualify if:

• This study does not include participants who:
• Currently have active forms of other inflammatory skin diseases or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, lupus).
• A current or past medical history of conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction or QT interval abnormalities.
• Have increased risk of developing venous thromboembolism, eg, deep vein thrombosis or pulmonary embolism:
• Have a history of any lymphoproliferative disorder such as Epstein Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
• Past history or active infection with Mycobacterium tuberculosis (TB), disseminated herpes zoster or disseminated herpes simplex, human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
• 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.
• 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. Any psychiatric condition including recent or active suicidal ideation or behavior that met any of the following criteria when screened for during the main study:
• Suicidal ideation associated with actual intent and a method or plan in the past year: "Yes" answers on items 4 or 5 of the Columbia suicide severity rating scale (C-SSRS);
• Previous history of suicidal behaviors in the past 5 years: "Yes" answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS;
• Any lifetime history of serious or recurrent suicidal behavior;
• Prior treatment with systemic janus kinase (JAK) inhibitors.
• 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.
• Have received any of the following treatment regimens specified in the timeframes outlined below:
• Within 1 year of first dose of study intervention:

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

Nirmal Hospital Pvt Ltd.

Surat, Gujarat, 395002, India

Location

Government Medical College & Shri Sayajirao General Hospital

Vadodara, Gujarat, 390001, India

Location

RajaRajeswari Medical College and Hospital

Bengaluru, Karnataka, 560074, India

Location

Father Muller Medical College Hospital

Mangalore, Karnataka, 575002, India

Location

Mahatma Gandhi Mission's Medical College & Hospital

Aurangabad, Maharashtra, 431003, India

Location

Orange City Hospital and Research Institute

Nagpur, Maharashtra, 440015, India

Location

Assured Care Plus Hospital

Nashik, Maharashtra, 422101, India

Location

Jehangir Clinical Development Centre Pvt. Ltd.

Pune, Maharashtra, 411001, India

Location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

S. P. Medical College & A. G. Hospitals

Bikaner, Rajasthan, 334001, India

Location

Apex Hospitals Pvt. Ltd.

Jaipur, Rajasthan, 302017, India

Location

Calcutta School of Tropical Medicine

Kolkata, West Bengal, 700073, India

Location

Postgraduate Institute of Medical Education & Research

Chandigarh, 160012, India

Location

Maharaja Agrasen Hospital

New Delhi, 110026, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

One participant was randomized to abrocitinib 200 mg arm but received abrocitinib 100 mg, hence for safety analysis set of main study that participant was included in 100 mg arm and for full analysis set that participant was included in 200 mg arm.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: July 16, 2022
• Primary Completion: June 9, 2023
• Study Completion: March 14, 2024
• Last Updated: October 15, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

IN (15)