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Atopic DermatitisPhase 3NCT05375929

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

A Phase 3 study testing Abrocitinib 100 mg and Abrocitinib 200 mg in people with Atopic Dermatitis, run by Pfizer at 15 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Abrocitinib 100 mg and Abrocitinib 200 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
15 sitesIndia
Study dates
16 Jul 2022to 14 Mar 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 38Show fewer
  • 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;
  • The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria;
  • In the opinion of the investigator or Pfizer (or designee) exclusion is required.
  • 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:
  • Prior treatment with non B cell-specific lymphocyte depleting agents/therapies (eg, alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc.). Participants who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal cluster of differentiation (CD) 19/20+ counts by fluorescence activated cell sorting (FACS) analysis.
  • Within 12 weeks of first dose of study intervention:
  • Biologic drugs that have immunomodulatory properties or could be used to treat AD: within 12 weeks of first dose of investigational product or 5 half-lives (if known), whichever is longer.
  • Other biologics without immunomodulatory properties (eg, insulin) are permissible at the judgement of the Investigator.
  • Within 4 weeks of first dose of study intervention:
  • Use of oral immunosuppressive drugs (eg, Cyclosporine A (CsA), azathioprine, methotrexate, systemic corticosteroids, mycophenolate mofetil, Interferon gamma) within 4 weeks of first dose of study intervention or within 5 half-lives (if known), whichever is longer.
  • NOTE: Systemic corticosteroids must be discontinued before Study Day 1, but a specific timeframe for discontinuation prior to first dose of abrocitinib is not required.
  • NOTE: Corticosteroid inhalers and intranasal sprays are permissible. NOTE: Ophthalmic corticosteroids are permissible.
  • Within 1 week of first dose of study intervention:
  • Anti-platelet drugs. Note: low dose acetyl salicylic acid (<100 mg once daily [QD]) is permitted, for the purpose of cardiovascular prophylaxis, at the discretion of the investigator.
  • Require treatment with prohibited concomitant medication(s) or have received a prohibited concomitant medication.
  • Participation in other studies involving investigational drug(s) or vaccine within 8 weeks or within 5 half-lives (if known) whichever is longer, prior to study entry and/or during study participation.
  • Any of the following abnormalities in clinical laboratory tests at Screening:
  • Absolute neutrophil count of <1.0 × 109/L (<1000/mm3);
  • Platelet count of <150 × 109/L (<150,000/mm3);
  • Absolute lymphocyte count of <0.50 × 109/L (<500/mm3);
  • Estimated Creatinine Clearance <60 mL/min using the Cockcroft Gault method;
  • Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) values >2 times the Upper Limit of Normal (ULN);
  • Total Bilirubin (TBili) ≥1.5 times the ULN.
  • 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.
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

India15 sites

  • Mahatma Gandhi Mission's Medical College & Hospital

    Aurangabad, Maharashtra, 431003

  • RajaRajeswari Medical College and Hospital

    Bengaluru, Karnataka, 560074

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

    Bikaner, Rajasthan, 334001

  • Postgraduate Institute of Medical Education & Research

    Chandigarh, 160012

  • Apex Hospitals Pvt. Ltd.

    Jaipur, Rajasthan, 302017

  • Calcutta School of Tropical Medicine

    Kolkata, West Bengal, 700073

  • Father Muller Medical College Hospital

    Mangalore, Karnataka, 575002

  • Orange City Hospital and Research Institute

    Nagpur, Maharashtra, 440015

  • Assured Care Plus Hospital

    Nashik, Maharashtra, 422101

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

  • Maharaja Agrasen Hospital

    New Delhi, 110026

  • Jehangir Clinical Development Centre Pvt. Ltd.

    Pune, Maharashtra, 411001

  • Nirmal Hospital Pvt Ltd.

    Surat, Gujarat, 395002

  • Government Medical College & Shri Sayajirao General Hospital

    Vadodara, Gujarat, 390001

Other trials in India

About this study

Official title: 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

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.

Read the detailed description

Abrocitinib is an oral, once daily Janus kinase 1 (JAK1) selective inhibitor for the treatment of moderate to severe Atopic Dermatitis (AD). Selective inhibition of JAK1 with abrocitinib modulates signaling by Interleukin-4 (IL-4), Interleukin (IL-13), and other cytokines [eg, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP)] involved in the pathogenesis of Atopic Dermatitis and pruritus.

This is a randomized, open label, parallel group study to assess the safety and efficacy of orally administered tablets of abrocitinib 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.

This study protocol also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee magnetic resonance imaging (MRI). Adolescent participants (12 to <18 years of age) will continue to receive study intervention until 1 year after randomization into the main study.

Being tested
Abrocitinib 100 mg, Abrocitinib 200 mg
Keywords
AD, Atopic Eczema
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abrocitinib 100 mgDrug

    Orally administered, abrocitinib 100 mg tablets QD

  • Abrocitinib 200 mgDrug

    Orally administered, abrocitinib 200 mg tablets QD.

Study groups in NCT05375929
Study groupRoleWhat they receive
Abrocitinib 100 mgExperimentalParticipants will receive abrocitinib 100 mg by mouth (QD).
Receives: Drug: Abrocitinib 100 mg
Abrocitinib 200 mgExperimentalParticipants will receive abrocitinib 200 mg QD.
Receives: Drug: Abrocitinib 200 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. 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

    IGA assesses severity of AD on a 5-point scale (0 to 4: higher scores = more severity). Scores: 0= clear (no AD inflammatory signs except for any residual discolouration [post-inflammatory hyperpigmentation and/or hypopigmentation]); 1= almost clear (AD not entirely cleared- light pink residual lesions [except post-inflammatory hyperpigmentation], just barely perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting); 2= mild (AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting); 3= moderate (AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting); 4= severe (AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting). >=2 points improvement from baseline: decrease of at least 2 points in IGA score from baseline at Week 12.

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

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

    EASI evaluates severity of participant's AD based on both severity of lesion clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t]-[including axillae and groin] and lower limbs [l]-[including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et + It + Ext + Lt) + 0.4*Al*(El + Il + Exl +Ll); A = EASI area score. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. >=75% improvement from baseline: decrease of 75% in EASI score from Baseline at Week 12.

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

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

    SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. Score for each body region was added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; lichenification; dryness) assessed as none =0, mild =1, moderate =2, severe =3. Severity scores were added to give B (0-18). C: pruritus and sleep, each was scored by participant/caregiver using visual analogue scale (VAS) where 0= no itch/no sleeplessness and 10= worst imaginable itch/sleeplessness. Scores for itch and sleeplessness were added to give C (0-20). Total SCORAD was calculated: A/5 + 7*B/2 + C; total SCORAD range from 0-103; higher SCORAD scores = greater severity of AD. >=75% improvement from baseline: decrease of 75% in SCORAD score from Baseline at Week 12.

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

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

    POEM is a 7-item participant reported outcome (PRO) measure to assess the impact of AD over the past week. Items were: dryness or roughness of skin in day, skin being itchy in day, skin flaking off in day, skin cracking in day, skin bleeding in day, skin weeping or oozing in day and sleep disturbed in night. Each item is scored from 0 to 4, depending on number of days/night (for sleep items) over the past week symptoms happened, where 0= no days, 1= "1-2 days", 2= "3-4 days", 3= "5-6 days" and 4= "every day". Scores from all items are added up, which results in POEM score, ranging from 0 to 28, where higher scores indicate greater severity of AD and greater symptom burden.

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

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

    ADCT score is used to measure the participants perceived AD control. It consists of 6 questions (overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions) which are evaluated over the past week on scale from 0 to 4. Scores from all 6 questions are added up to provide ADCT score, ranging from 0 to 24, where higher scores indicate lower AD control.

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

  6. Percentage of Participants With Bone Safety Findings in Knee Magnetic Resonance Imaging (MRI) at 1 Year After Randomization: Substudy

    MRI imaging session was performed when participant was in supine position in the confined space of the MRI scanner for approximately 30 mins. The assessments included evaluation of epiphyseal plate closure and mineralization of cartilage at the growth centers.

    Measured: Up to 1 year from randomization on Day 1 of main study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start16 Jul 2022
  3. Primary completion9 Jun 2023
  4. Study completion14 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05375929
Sponsor's protocol ID
B7451094
Status last verified
Sep 2024
First submitted
11 May 2022
Last updated
15 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abrocitinib 100 mg and Abrocitinib 200 mg in people with Atopic Dermatitis, run by Pfizer at 15 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Main Study (time frame: From Day 1 of dosing up to 4 weeks post last dose (maximum up to Week 16)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05375929.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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