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Atopic DermatitisNCT06899204

Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.

An observational study of Atopic Dermatitis and Atopic Dermatitis, Unspecified, run by Pfizer at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a prospective, multi-center observational study characterizing clinical and patient reported outcomes of patients receiving abrocitinib for moderate-to-severe atopic dermatitis (M2S AD) who had inadequate response (or intolerance) to ≤2 previous biologic therapies approved for M2S AD in the United States. Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Abrocitinib
How many people
150 participants
Where
1 siteUnited States
Study dates
24 Apr 2026to 15 Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: The study population eligible for enrollment includes adult and adolescent patients aged ≥12 years diagnosed with moderate to severe AD who receive at least one dose of abrocitinib.

This NI study will enroll 150 patients from approximately 15 sites across the US. The study population eligible for enrollment includes adult and adolescent patients aged ≥12 years diagnosed with moderate to severe AD who receive at least one dose of abrocitinib and satisfy the inclusion and exclusion criteria. Patients who had inadequate response or intolerance to previous ≤2 biologic therapies will be included in this study as there is a lack of effectiveness data for abrocitinib in these patients. As this will be an observational study, there will be no sampling and all patients that meet the inclusion and exclusion criteria will be recruited consequently. The study will be open for enrollment for approximately 12 months after the first patient has been enrolled. Regarding the inclusion and exclusion criteria, in the real-world setting recruitment may be slower than expected, thus depending on the observed enrollment rate, the enrollment period and number of sites may be reassessed and revised during the study.

9.2.1. Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Participants who have chronic AD that has been present for ≥1 year before screening.
  2. Male and female patients aged >12 years at baseline.
  3. Patients with diagnosis of moderate-to-severe atopic dermatitis confirmed by a certified dermatologist, who are prescribed abrocitinib for use in accordance with the product label (USPI) and independently of the decision to enroll the patient in this study
  4. Patients who have inadequate responses or are intolerant to ≤2 previous biologic therapy approved for M2S AD. (Patients shall have had an inadequate response and/or intolerance to at least one, but no more than 2 biologic therapies approved for moderate-to-severe AD)
  5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the study, the adolescent (depending on local institutional review board/independent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.
  6. Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.

9.2.2. Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study:

  1. Patients, that currently have active forms of other inflammatory skin diseases, other than AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day 1 that would interfere with evaluation of atopic dermatitis or response to treatment.
  2. Patients previously treated with abrocitinib or other oral/systemic JAK inhibitors
  3. 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.
  4. Patient eligibility should be reviewed, documented, and confirmed by an appropriately qualified member of the investigator's study team before patients are enrolled in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

United States1 site, 1 recruiting

  • Allergy and Asthma Medical Group and Research Center

    San Diego, California, 92123

    Recruiting

Other trials in United States

About this study

Official title: A Prospective, Multi-center Observational Study Characterizing Clinical Outcomes of Patients Receiving Abrocitinib for Moderate-to-severe Atopic Dermatitis Who Had an Inadequate Response (or Intolerance) to ≤2 Previous Biologic Therapies Approved for Moderate-to-severe Atopic Dermatitis

This is a prospective, multi-center observational study characterizing clinical and patient reported outcomes of patients receiving abrocitinib for moderate-to-severe atopic dermatitis (M2S AD) who had inadequate response (or intolerance) to ≤2 previous biologic therapies approved for M2S AD in the United States.

The aim of this study is to measure the effectiveness of abrocitinib in a real-world setting in patients with moderate-to-severe atopic dermatitis, with inadequate response or intolerance to ≤2 biologic therapies.

Being tested
Abrocitinib
Keywords
Real world efficacy
Medical subject headings
Dermatitis, Atopic

What participants receive

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

  • AbrocitinibDrug

    Also called Cibinqo

    Study Drug for Observational Data Collection.

Study groups in NCT06899204
Study groupRoleWhat they receive
TreatmentPatients that are taking treatment with abrocitinib for moderate to severe atopic dermatitis.
Receives: Drug: Abrocitinib

What is being measured

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

  1. Percentage of patients achieving EASI-75 improvement from baseline at Week 16 after index date

    EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 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; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD

    Measured: Baseline, week 16

  2. Percentage of patients achieving ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) collected daily all through the study from baseline at Week 2 by e-diary assessment

    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

    Measured: Baseline, week 2

Secondary outcomes (20)

  1. Percentage of patients achieving EASI-75, 90 and 100 from baseline at Week 4 and 16 after index date

    EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 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; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD

    Measured: Baseline, week 4, week 16

  2. Percentage of patients achieving v-IGA response of Clear (0) or Almost Clear (1) and ≥ 2 points improvement from baseline at Week 4 and 16 after index date

    Validated IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just 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 and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.

    Measured: Baseline, week 4, week 16

  3. Change from baseline in total percentage of BSA at week 4 and 16

    4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD

    Measured: Baseline, week 4, week 16

  4. Percentage of patients achieving Peak Pruritus Numerical Rating Scale (PP-NRS) of 0 or 1 collected daily all through the study at Wk 4, 12 and 16

    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

    Measured: Baseline, week 4, 12 and 16

  5. Percentage of patients achieving PP-NRS-4 at week 2, 4, 12 and 16 from baseline.

    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch

    Measured: Baseline, week 2, 4, 12 and 16

  6. Absolute change from baseline in PP-NRS score at week 2

    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch

    Measured: Baseline, week2

  7. Proportion of patients overall "Very Satisfied" and "Satisfied" with abrocitinib at Wk 4, 12 and 16 with TSQM-9

    TSQM-9 is a generic satisfaction assessment instrument to measure patient satisfaction with the medication taken.

    Measured: Baseline, week 4, 12 and 16

  8. Percentage of patients that report symptoms to be "minimal" or "absent" on the patient global impression of severity at week 4, 12 and 16

    PGI-S: A single-item PRO questionnaire assessing overall current disease severity on a 7-point verbal response scale

    Measured: Baseline week 4, 12 and 16

  9. Change from baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Wk 4, 12 and 16

    The MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II). An additional single item assessed quantity of sleep. Each of the sleep domains were scored on a range of 0 to 100, and higher scores indicated worse outcomes. The quantity of sleep scores ranged from 0 to 24 (number of hours slept). Change from baseline scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.

    Measured: Baseline, week 4, 12 and 16

  10. Percentage of Participants with an ADCT Total Score Reduction ≥ 5 from baseline at week 4, 12 and 16

    The ADCT is a validated, brief and easily scored tool for use in clinical practice and clinical research to evaluate 6 symptoms and effects associated with AD over the past week.

    Measured: Baseline, week 4, 12 and 16

  11. Percentage of Participants Achieving Improvement (reduction) in DLQI/CDLQI of ≥ 4 points vs baseline at week 4, 12 and 16

    CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. DLQI is the adult version of the same index.

    Measured: Baseline week 4, 12 and 16

  12. Observational change in pigment alteration from baseline at week 4 and 16 by visual assessment of available photography

    Physician visual evaluation of the pigmentation changes of the AD lesions.

    Measured: Baseline, week 4, and 16

  13. Cilinical Characteristics: Type of prior AD treatment at specific medication level and Route of Administration

    Measured: Baseline

  14. Demographic charasteristics: Number/percentage of patients by age, sex, race, ethnicity, socioeconomic status, state of residence

    Measured: Baseline

  15. Clinical Characteristics: Number/percentage of patients by smoking status, medical history

    Measured: Baseline

  16. Clinical Characteristics: Duration of prior therapy/frequency

    Measured: Baseline

  17. Clinical Characteristics: Total number of AD treatments used prior to abrocitinib initiation

    Measured: Baseline

  18. Clinical characteristics : Reason for switching to abrocitinib from previous biologic

    Measured: Baseline

  19. Outcome: Assessment of efficacy in patients who received a dose change after baseline visit (dose increase or decrease)

    Measured: Week 4, week 16

  20. Assess early improvement in itch (within min/hrs) after first dose

    Patients will be asked when they realized improvement in their itch within the first day of abrocitinib treatment

    Measured: Baseline, day 1 after index date

Timeline

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

  1. First posted27 Mar 2025
  2. Study start24 Apr 2026
  3. Primary completion15 Feb 2027 (estimated)
  4. Study completion15 Feb 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06899204
Sponsor's protocol ID
B7451125
Other IDs
JADE-ADVANCED
Status last verified
Aug 2026
First submitted
21 Mar 2025
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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?

An observational study of Atopic Dermatitis and Atopic Dermatitis, Unspecified, run by Pfizer at 1 site in United States.

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

Who may be eligible to take part?

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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients achieving EASI-75 improvement from baseline at Week 16 after index date (time frame: Baseline, week 16). The study lists 2 primary outcomes in all. 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 NCT06899204.

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 17 Aug 2026.

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